Press Releases
OncoNano Medicine To Present a Trials in Progress Poster for ON-5001 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
- Ongoing Phase 1/1b Clinical Trial Evaluating ONM-501, a Dual-activating STING Agonist, Alone and In Combination with Cemiplimab in Solid Tumors
SOUTHLAKE, Texas – May 30, 2024 – OncoNano Medicine, Inc. (“OncoNano”), a clinical-stage biotechnology company pioneering the development of polymeric micelles encapsulating anti-cancer payloads, today announced that it will present a Trials in Progress poster at the upcoming 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois, May 31st–June 4th, 2024.
The poster will highlight the study objectives and design of the ongoing ON-5001 study, a phase 1/1b, multicenter, open label, non-randomized dose escalation and dose expansion to examine the safety, tolerability and optimal dosing of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist, as a monotherapy and in combination with cemiplimab (Libtayo®) in patients with advanced solid tumors and lymphomas (NCT06022029).
Details for the ASCO Annual Meeting Trials in Progress poster presentation are as follows:
TITLE: A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas.
PRESENTER: Julia Foldi, M.D., Ph.D., Assistant Professor of Medicine, Oncology, University of Pittsburgh Medical Center
SESSION: Developmental Therapeutics—Immunotherapy
POSTER: Poster Board #160a; Abstract TPS2693
DATE/TIME: June 1, 2024; 9:00 AM-12:00 PM CDT
Once presented the poster will be made available on the OncoNano website at Publications — OncoNano (www.onconano.com/publication).
About ONM-501
ONM-501 is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 development for the treatment of solid tumors. STING activation mediates a multifaceted type-1 interferon response that is critical in the activation of innate and adaptive immunity against infection and, potentially, cancer. ONM-501 is a pH-sensitive polymer, PC7A, carrying a cyclic guanosine monophosphate–adenosine monophosphate (cGAMP) payload, that together induce prolonged STING activation. In preclinical models, when delivered to the tumor microenvironment, ONM-501 produces dendritic cell maturation and cytotoxic T cells priming, while demonstrating antitumor efficacy. ONM-501 is currently being evaluated in a phase 1, multicenter, open label, non-randomized dose escalation and dose expansion trial to examine the safety, pharmacokinetics, pharmacodynamics, and early activity of ONM-501 as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor, cemiplimab, in patients with advanced solid tumors and lymphomas. The trial is open in the United States and planned to open in Australia in 2H2024; visit clinicaltrials.gov (NCT06022029) for more details. ONM-501 development has been supported in part by a grant from the Cancer Prevention and Research Institute of Texas.
About OncoNano Medicine
OncoNano Medicine, Inc. is a clinical-stage biotechnology company working to transform cancer therapeutics with its proprietary nanotechnology platform. OncoNano's ON-BOARD™ polymeric micelle platform is designed to leverage a universal tumor target, namely pH, to precisely deliver anti-cancer payloads to the tumor microenvironment. Our product candidates are designed to improve the pharmacokinetic and pharmacodynamic properties of various payloads from small molecules to large biologics through encapsulation and localized tumor targeting. OncoNano is utilizing ON-BOARD™ to generate a robust oncology pipeline to support novel therapeutic development for patients with high unmet medical needs. Learn more about our platform and pipeline at www.OncoNano.com.
Contacts
LA Communications
Lauren Arnold
781-235-3060
Lauren@LACommunications.net
OncoNano Medicine Presents Preclinical Data for ON-BOARD™ IL-12 Program at AACR Annual Meeting 2024
OncoNano Medicine Presents Preclinical Data for ON-BOARD™ IL-12 Program at AACR Annual Meeting 2024
muONM-412 significantly improved tolerability over unencapsulated IL-12Fc and showed potent anti-tumor efficacy in mice
ONM-412 demonstrates the potential for clinical translation of the ON-BOARD™ platform
SOUTHLAKE, Texas – April 10, 2024 – OncoNano Medicine, Inc. presented a late-breaking poster detailing the preclinical efficacy and safety of muONM-412, an ON-BOARD™ nanoparticle-encapsulated murine interleukin-12 fusion protein (IL-12Fc), and in vitro characterization of ONM-412, encapsulating human IL-12Fc, at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California.
Despite its potent pleiotropic and well-established anti-cancer effects, the clinical application of IL-12 has been hindered by significant adverse toxicities. OncoNano developed ON-BOARD™, an ultra-pH sensitive nanoparticle platform, to shield payloads from systemic exposure and target solid tumors by responding to the highly acidic tumor microenvironment. Encapsulation of payloads like IL-12 by ON-BOARD™ may provide the opportunity to improve the therapeutic index of a variety of anti-cancer therapies.“
As part of the study presented at AACR, the preclinical safety and activity of muONM-412 were evaluated with the data demonstrating it significantly improved tolerability over unencapsulated IL-12Fc while showing potent antitumor efficacy in mice. Findings also reveal that ONM-412 illustrates favorable stability and pH-responsive IL-12 bioactivity in vitro,” said Tian Zhao, Ph.D., Vice President of Research and Development for OncoNano Medicine. “We believe our ON-BOARD™ ultra-pH sensitive micelle technology can transform the targeted delivery of oncology therapeutics and look forward to continuing the development of new treatments for patients with cancer.”
muONM-412 key findings:
Exhibited improved tolerability in vivo compared to unencapsulated IL-12Fc through the observation of reduced body weight loss, absence of liver toxicity and lower plasma IFNy levels.
Induced tumor immune remodeling, with increased infiltration by IFNγ+ and GzmB+ CD8 T and NK cells.
Strong dose-responsive anti-tumor efficacy shown in MC38 tumor-bearing animals.
ONM-412 key findings:
Demonstrated high encapsulation efficiency (>85%) in uniformly distributed particles (Dh<50nm) with 12-month on-going shelf-life stability.
Rapid and complete recovery of IL-12 bioactivity shown <10 minutes after acid-activation.
Confirmed pH-specific release in vitro with a >100-fold activation window between the acid-activated and intact formulations by a HEK reporter assay and an IFNγ induction assay.
Presentation Overview:
TITLE: Preclinical characterization of ONM-412, an ultra-pH sensitive nanoparticle encapsulated IL-12 fusion protein
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano MedicineLink to the poster may be found on the OncoNano Medicine website at: News - OncoNano Medicine.
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer therapeutics that exploit pH to diagnose and treat solid tumors with high specificity. OncoNano’s ON-BOARD™ platform is generating a robust oncology pipeline to support novel therapeutic development for patients with high unmet medical needs. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care including a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer and agents for real-time image guided surgery.
ONM-501, OncoNano’s first therapeutic program is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 studies. ONM-412, the highly potent pro-inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ ultra-pH sensitive micelle system is currently in preclinical development along with other novel targets. Additionally, the ON -BOARD™ platform has been used for pegsitacianine, a fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. The work of OncoNano is supported through grants from the Cancer Prevention & Research Institute of Texas. Learn more about OncoNano’s platform and pipeline at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine to Present Late-Breaking Poster at the American Association for Cancer Research (AACR) Annual Meeting 2024
OncoNano Medicine to Present Late-Breaking Poster at the American Association for Cancer Research (AACR) Annual Meeting 2024
SOUTHLAKE, Texas – March 6, 2024 – OncoNano Medicine, Inc. today announced a late-breaking research poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10, 2024 in San Diego, California.
Presentation Overview
TITLE: Preclinical characterization of ONM-412, an ultra-pH sensitive nanoparticle encapsulated IL-12 fusion protein
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
DATE: April 10, 2024
TIME: 9:00 – 12:30 PM PT
SECTION AND PRESENTATION NUMBER: Poster Section 54, No. LB438
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer therapeutics that utilize principles of molecular cooperativity in their design to exploit pH to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno- oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.
OncoNano’s ON-BOARD™ platform is generating a robust oncology pipeline to support novel therapeutic development for patients with high unmet medical need. ONM-501, OncoNano’s first therapeutic program is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 studies. ONM-412, the highly potent pro-inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system is currently advancing in preclinical development. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. OncoNano is the top recipient of grants from CPRIT, which has supported the pegsitacianine and ONM-501 programs. Learn more about OncoNano’s platform and pipeline at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Appoints Kartik Krishnan as Chief Executive Officer and Promotes Melissa Paoloni to Chief Operating Officer
OncoNano Medicine Appoints Kartik Krishnan as Chief Executive Officer and Promotes Melissa Paoloni to Chief Operating Officer
SOUTHLAKE, Texas – March 1, 2024 – OncoNano Medicine, Inc. today announced the appointment of Dr.Kartik Krishnan, MD, PhD to Chief Executive Officer (CEO) and member of the Board of Directors. Dr. Krishnan joined OncoNano as Chief Medical Officer in 2022 and ascended to the role of President and Head of Research and Development last year. He succeeds Martin Driscoll, who served as CEO since January 2021, and helped advance the company’s therapeutic pipeline into the clinic.
“Kartik is a highly experienced executive and passionate physician-scientist who has been an essential force for OncoNano’s success in the last two years,“ said Dr. Brett Giroir, Chairman of the Board of Directors of OncoNano. “We are confident as CEO he will champion not only the science, but OncoNano’s continued growth and development as a pioneer in innovative cancer therapies.”
Dr. Krishnan has over two decades of experience dedicated to people suffering from cancer. Prior to joining OncoNano, he served as Chief Medical Officer of Arcus Biosciences, a publicly traded immunooncology company, for which he led a portfolio of biologics and small molecules in multiple phases of development. Dr. Krishnan has excelled in both R&D and pharmacovigilance at multiple biotechnology and large pharmaceutical companies in roles of increasing responsibility. During his tenure at OncoNano, he has spearheaded the progression of ONM-501, a dual-activating STING agonist, into first in human studies and prioritized the next set of novel pipeline medicines.
“I joined OncoNano almost two years ago on the promise of a technology that could change how cancer is treated and today am even more enthusiastic about its prospects”, said Dr. Krishnan. “Our goal is to accelerate development of OncoNano’s core technology platform and bring transformative medicines to patients. Thanks to Marty’s leadership we have a team focused on executing this mission, and I look forward to charting our progress.”
With Dr. Krishnan’s appointment comes the promotion of Dr. Melissa Paoloni to Executive Vice President and Chief Operating Officer. Dr. Paoloni joined OncoNano in December of 2023 to lead both corporate and strategic development and will work alongside Dr. Krishnan to oversee the management team. Melissa brings long standing expertise in business development, alliance management and portfolio strategy across several organizations, most recently as Vice President of Corporate Development and External Alliances at Arcus Biosciences. Her elevation will support OncoNano’s corporate planning, communications, partnering and stakeholder engagement.
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer therapeutics that utilize principles of molecular cooperativity in their design to exploit pH to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.
OncoNano’s ON-BOARD™ platform is generating a robust oncology pipeline to support novel therapeutic development for patients with high unmet medical need. ONM-501, OncoNano’s first therapeutic program is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 studies. ONM-412, the highly potent pro-inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system is currently advancing in preclinical development. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. OncoNano is the top recipient of grants from CPRIT, which has supported the pegsitacianine and ONM-501 programs. Learn more about OncoNano’s platform and pipeline at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces First Patient Dosed in Phase 1 Study Evaluating ONM-501 in Patients with Advanced Solid Tumors and Lymphomas
OncoNano Medicine Announces First Patient Dosed in Phase 1 Study Evaluating ONM-501 in Patients with Advanced Solid Tumors and Lymphomas
Dual-activating STING agonist formulated with OMNI™, the company’s core immune activating polymer technology.
SOUTHLAKE, Texas – November 27, 2023 – OncoNano Medicine, Inc. today announced that the first patient has been dosed at University of Pittsburgh Medical Center (UPMC) in its Phase 1 clinical trial evaluating ONM-501, a dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications formulated with OMNI™, the company’s core immune activating polymer technology.
The ONM-501 trial (NCT06022029) is a multicenter Phase 1, dose escalation and dose expansion study in patients with advanced solid tumors and lymphomas. ONM-501 features dual STING activation, with the polymers used to construct the micelles binding to and activating STING alongside the payload critical to activation. This is the synthetic version of the endogenous ligand cGAMP. During the combinatorial dose escalation and expansion cohort segments of the trial, ONM-501 will be dosed in combination with Regeneron’s Libtayo® (cemiplimab-rwlc), an anti-PD-1 monoclonal antibody. OncoNano and Regeneron have entered into a clinical trial supply agreement for this ONM-501 study.
“This marks an exciting milestone in the development of ONM-501 as preclinical data support an enduring activation of STING with the potential for an improved clinical profile compared to earlier experimental cyclic dinucleotide STING agonists,” said Kartik Krishnan, M.D., Ph.D., President & Head of R&D for OncoNano Medicine. “The initiation of our first human trial for ONM-501 brings us one step closer to providing cancer patients with our differentiated approach to targeted therapeutics.”
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.
ONM-501, OncoNano’s first therapeutic program, is a next generation dual-activating STING (STimulator of INterferon Genes) agonist. OncoNano’s second therapeutic development program is ONM-412, the highly potent pro-inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas (CPRIT). Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces Promotion of Kartik Krishnan, MD, PhD, to President and Head of Research & Development
OncoNano Medicine Announces Promotion of Kartik Krishnan, MD, PhD, to President and Head of Research & Development
Accomplished oncology research scientist and drug developer, Dr. Krishnan will oversee all research and development activities at OncoNano
SOUTHLAKE, Texas – November 6, 2023 – OncoNano Medicine, Inc. today announced that Kartik Krishnan, M.D., Ph.D., has been promoted to the new role of President and Head of Research and Development. He has served as Chief Medical Officer since 2022. Dr. Krishnan will continue to report to Chief Executive Officer Martin Driscoll and will lead all the research and development activities at the company, including basic discovery science, translational medicine and clinical development efforts.“
Kartik has made significant contributions since joining OncoNano. His deep knowledge of oncology drug research and his many years of immuno-oncology clinical development experience has allowed us to accelerate our lead oncology therapeutic into our first human trial,” said Martin Driscoll, Chief Executive Officer of OncoNano. “A strong and collaborative leader, Kartik possesses an exceptional grasp of the dynamic oncology research field which will allow us to attract top talent to our research team and leverage our core platform technology to advance novel treatments that benefit cancer patients.”
Dr. Krishnan has more than 20 years of experience with experimental therapeutics in cancer as both an investigator and sponsor. Prior to joining OncoNano, he served as Chief Medical Officer of Arcus Biosciences where he oversaw a portfolio of agents including both biologics and small molecules at multiple phases of development. Dr. Krishnan has spent time in clinical development and pharmacovigilance at multiple biotechnology companies. Before joining the biotechnology industry, Dr. Krishnan held a faculty position in the Department of Pediatrics at the University of Arizona, with both clinical and primary research responsibilities. Dr. Krishnan received his B.A. in History (with Distinction) from the University of Virginia. He completed his M.D. and Ph.D. in Cellular, Molecular and Biophysical Studies at Columbia University’s College of Physicians and Surgeons.“
I joined OncoNano because I felt its pH-sensitive polymeric micelle technology has the potential to disrupt cancer treatment paradigms and provide meaningful benefit to patients,” said Dr. Krishan. “I am honored to transition to this expanded position and look forward to working with this exceptional team and lead the company in this next stage of growth.”
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery. ONM-501, OncoNano’s first therapeutic program, is a next generation dual-activating STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the fourth quarter of 2023. OncoNano’s second therapeutic development program is ONM-412, the highly potent proinflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas (CPRIT). Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces Positive Preclinical Data for ON-BOARD™ IL-12 Program at SITC 2023 Annual Meeting
OncoNano Medicine Announces Positive Preclinical Data for ON-BOARD™ IL-12 Program at SITC 2023 Annual Meeting
SOUTHLAKE, Texas – November 3, 2023 – OncoNano Medicine, Inc. today presented positive preclinical data describing the effective delivery of interleukin-12 (IL-12) with the ON-BOARD™ platform technology at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
The study findings show that encapsulation of a therapeutic IL-12 fusion protein (IL-12Fc) for tumor specific delivery and pH-dependent activation was achieved using the ON-BOARD™ polymeric micelle technology. The study also found that ON-BOARD™ significantly improved the tolerability of IL-12Fc, as compared to unencapsulated IL-12. The encapsulated IL-12Fc demonstrated potent anti-tumor efficacy and durable anti-tumor memory in the MC38 colorectal cancer model. ONM-412, the development product candidate with the IL-12 encapsulated in the ON-BOARD™ polymeric micelle system, is advancing through IND-enabling activities.“
These findings underscore the potential application of the ON-BOARD™ polymeric micelle system for the delivery of IL-12 as an anti-tumor agent,” said Tian Zhao, PhD, Vice President of Research and Development at OncoNano. “We look forward to the continued development of ONM-412 and the ONBOARD™ platform as a potential technology for the targeted delivery of therapeutics to benefit cancer patients.”
The data presented demonstrated that:
ON-BOARD™ enables murine and human IL-12Fc encapsulation with favorable stability and pH-responsive IL-12 bioactivity in vitro in a HEK reporter assay and in primary cell IFNγ induction. Compared to a protease cleavable masked IL-12, the ON-BOARD™ formulation shows rapid and complete activation over a short period of time.
ON-BOARD™ encapsulated IL-12Fc exhibited potent anti-tumor efficacy and prolonged survival in MC38 tumor-bearing animals with long-term memory effect.
ON-BOARD™ formulation demonstrated effective IL-12 signaling in the tumor as evidenced by activation of CD8 T cells and NK cells; increased levels of IFNγ were seen in the tumor but not systemic circulation.
Reduced systemic exposure was observed with ON-BOARD™ encapsulated IL-12Fc with a significant improvement in the tolerability as evidenced by reduced body weight loss, normal plasma transaminase levels for liver function, reduced splenomegaly, and reduced systemic free IL-12 levels and IL-12 related cytokines when compared to unencapsulated IL-12Fc.
Presentation Details
TITLE: Encapsulation of IL-12 with an ultra pH-sensitive tumor delivery platform improves tolerability and promotes antitumor response in a preclinical model
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
POSTER NUMBER: 1147-B
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.
ONM-501, OncoNano’s first therapeutic program, is a next generation dual-activating STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the fourth quarter of 2023. OncoNano’s second therapeutic development program is ONM-412, the highly potent proinflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas (CPRIT). Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine to Present Preclinical Data for ON-BOARD™ Platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting
OncoNano Medicine to Present Preclinical Data for ON-BOARD™ Platform at the Society for Immunotherapy of Cancer (SITC) Annual Meeting
SOUTHLAKE, Texas – October 18, 2023 – OncoNano Medicine, Inc. today announced it will be presenting positive preclinical data detailing delivery of interleukin-12 (IL-12) with the ON-BOARD™ platform at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 1-5, 2023 in San Diego, California.
ON-BOARD™ is an ultra pH-sensitive tumor delivery platform designed to minimize systemic exposure and toxicity by protecting oncology intervention payloads and releasing them specifically in the acidic tumor microenvironment. The poster presentation will detail encapsulation and delivery of IL-12, a potent pleiotropic cytokine, using ON-BOARD™ in immunocompetent mice.
Presentation Overview
TITLE: Encapsulation of IL-12 with an ultra pH-sensitive tumor delivery platform improves tolerability and promotes antitumor response in a preclinical model
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
DATE: Friday, November 3, 2023
TIME: 9:00 a.m. – 7:00 p.m. PT
LOCATION: Exhibit Hall B – San Diego Convention Center
POSTER NUMBER: 1147-B
About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.
ONM-501, OncoNano’s first therapeutic program, is a next generation dual-activating STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the fourth quarter of 2023. OncoNano’s second therapeutic development program is ONM-412, the highly potent pro- inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas (CPRIT). Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo® (cemiplimab) in ONM-501 Study
OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo® (cemiplimab) in ONM-501 Study
Libtayo to be used in the Phase 1b segment of the ONM-501 trial
SOUTHLAKE, Texas – September 6, 2023 – OncoNano Medicine, Inc. today announced a clinical trial supply agreement with Regeneron for the use of Libtayo® (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate.
The ONM-501 first-in-human trial (NCT06022029) is a multicenter Phase 1a/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab.
“We believe that our ONM-501 program, which leverages cyclic dinucleotide activation and polyvalent binding to STING to generate both a burst and a sustained immune response, has the potential to show an improved clinical profile as compared to earlier experimental STING agonists,” said Kartik Krishnan, M.D., Ph.D., Chief Medical Officer of OncoNano Medicine. “We are thrilled to collaborate with a leading company such as Regeneron as we continue working toward our mission of delivering targeted therapeutics to cancer patients.”
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARD platform, that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
larnold@macdougall.bio
OncoNano Medicine Presents Positive Final Results from Phase 2 Trial of Pegsitacianine in Podium Presentation at 2023 ASCO Annual Meeting
OncoNano Medicine Presents Positive Final Results from Phase 2 Trial of Pegsitacianine in Podium Presentation at 2023 ASCO Annual Meeting
Study met primary endpoint of detection of residual disease following completion of standard of care surgery
Residual cancer was identified by pegsitacianine-directed fluorescence in 50% of evaluable patients
Results demonstrated acidic pH is a viable marker for use in targeted delivery
SOUTHLAKE, Texas - May 31, 2023 - OncoNano Medicine, Inc. will present positive final results from its Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for enhanced intra-operative visualization of cancer, in a podium presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023. Results of the study show that acidic pH is a viable marker and can be used for tumor targeting by the company’s ON-BOARD™ micelle platform.
Pegsitacianine has been studied in more than 135 patients across multiple tumor types, including peritoneal metastatic, breast, head and neck, colorectal, esophageal, ovarian and prostate cancers. Results show that pegsitacianine is able to localize different tumor types regardless of their histology or anatomic location. The ON-BOARD platform, therefore, is able to target solid tumors, deploying its payload specifically within the acidic tumor microenvironment (TME).
“We are encouraged by this data as it demonstrates the potential of pegsitacianine to augment the visualization of cancer during an operation, which has the potential to be a significant advance in real-time surgical imaging,” said Kartik Krishnan, M.D., Ph.D., Chief Medical Officer of OncoNano Medicine. “We look forward to taking pegsitacianine to the next levels of development and continue our mission to diagnose and treat cancer with high specificity.”
The results of this Phase 2 study reveal that pegsitacianine was well tolerated and that 20 of 40 evaluable patients (50%) had pathology-confirmed disease resected, that was not resected in the planned standard of care surgery, under pegsitacianine guidance. Approximately 25% of patients experienced a pegsitacianine-related adverse event, which was a transient, selfresolving, non-anaphylactic infusion-related reaction.
“We were highly encouraged with the results observed in this Phase 2 trial and look forward to validating these findings in the upcoming Phase 3 trial,” said Patrick Wagner, M.D., lead author and Director of Complex General Surgical Oncology, Allegheny Health Network Cancer Institute. “The results demonstrate that acidic pH is a viable tumor agnostic marker and highlight pegsitacianine’s ability to target different tumor types regardless of their genotype or anatomic location.”
“This Phase 2 data brings new hope to both clinicians and patients,” said Charles M. Balch, M.D., former EVP and Chief Executive Officer of ASCO and present Chair of the Scientific Advisory Board at OncoNano Medicine. “Having demonstrated the capacity to identify tumors that were previously not clinically visible to surgeons, pegsitacianine has the potential to improve the accuracy of staging and surgical outcomes, while reducing operating time for several types of abdominal cancers. Newer versions in the pipeline have great potential to expand therapeutic targets and enable new combinations of drugs previously hindered by toxicity.”
Presentation Overview:
TITLE: Detection of peritoneal metastases during cytoreductive surgery using pegsitacianine, a pH sensitive imaging agent: Final results from a phase 2 study
PRESENTER: Patrick Wagner, MD, Director of Complex General Surgical Oncology, Allegheny Health Network Cancer Institute
DATE: June 5, 2023
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARD platform, that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces Oral Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023
OncoNano Medicine Announces Oral Presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023
Final results from Phase 2 study of pegsitacianine for image-guided cancer surgery featured in oral presentation
SOUTHLAKE, Texas – April 27, 2023 – OncoNano Medicine, Inc. today announced an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023, taking place June 2-6, 2023 at McCormick Place, Chicago, Illinois.
Presentation Overview:
TITLE: Detection of peritoneal metastases during cytoreductive surgery using pegsitacianine, a pH sensitive imaging agent: Final results from a phase 2 study
PRESENTER: Patrick Wagner, MD, Director of Complex General Surgical Oncology, Allegheny Health Network Cancer Institute
DATE: June 5, 2023
SESSION TIME: 8:00 - 11:00 am CT
SESSION: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
ABSTRACT: 3003
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON- BOARD platform, that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Presents Compelling Data for ONM-501 and a Novel Tumor Specific Delivery Technology at AACR Annual Meeting 2023
OncoNano Presents Compelling Data for ONM-501 and a Novel Tumor Specific Delivery Technology at AACR Annual Meeting 2023
- ONM-501 demonstrates enhanced tumor retention with a favorable nonclinical safety profile
- The ON-BOARD™ platform demonstrates enhanced therapeutic indices with tumor specific delivery of a bispecific antibody and a cytokine
SOUTHLAKE, Texas – April 18, 2023 – OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023. The posters detail positive nonclinical data for ONM-501, the Company’s dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate, formulated with the company’s OMNI™ polymer technology as well as positive data for encapsulated bispecific antibody and cytokine using ON-BOARD™ tumor specific delivery technology.
“STING plays a critical role in innate immune response against infection and cancer, and we continue to be pleased with the data which support further advancement of the ONM-501 program,” said Ruolan Han, Ph.D., Vice President of Nonclinical & Translational Medicine for OncoNano Medicine. “We look forward to bringing ONM-501 to the clinic this year and furthering the development of OMNI™ as we work toward our goal of delivering critical treatments to patients in need. Previous preclinical studies have shown that ONM-501 works by stabilizing the STING protein and delivering cGAMP intracellularly, where it is shielded from degradation by ectonucleotide pyrophosphatase/phosphodiesterase 1(ENPP1). Combining these observations and the immune stimulation with limited systemic toxicity observed in the nonclinical species, we believe that ONM-501 has the potential to show an improved clinical profile as compared to earlier experimental STING agonists.”
Previously, ONM-501, a dual-activating STING agonist, has demonstrated the ability to produce a burst and sustained activation of STING signaling that leads to a robust adaptive immune response through a unique polymer-STING binding mechanism which differs from earlier cyclic di-nucleotide (CDN) STING agonist programs. This novel mechanism provides potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both “hot” and “cold” tumor microenvironments. In vivo pharmacodynamic (PD) analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501 and demonstrated the target-engagement activity of ONM-501 in multiple species. New pharmacokinetics/biodistribution data presented at the conference in tumor-bearing mice revealed that intratumorally injected ONM-501 showed high tumor retention and very low systemic exposure due to the polymeric micelle formulation, maximizing antitumor efficacy while minimizing systemic toxicity. This new data further differentiates ONM- 501 from other small molecule STING agonist programs. Safety studies in multiple species established a wide therapeutic window for ONM-501 making it a promising candidate for clinical evaluation.
Two additional posters were presented earlier in the conference, reporting encapsulation and masked delivery of Interleukin-12 (IL-12) and T cell engager bispecific antibodies using ON- BOARD™. The results demonstrate significantly improved tolerability, anti-tumor efficacy in mice and potential for clinical translation.
“Our ON-BOARD™ pH-sensitive micelle delivery platform continues to demonstrate improvement of therapeutic indices with a variety of therapeutic protein payloads including the highly potent interleukin-12 and T-cell engagers,” said Tian Zhao, Ph.D., Vice President of Research and Development for OncoNano Medicine. “We have seen challenges with other IL-12 and T-cell engager programs related to suboptimal therapeutic index, associated with toxicities related to systemic exposure. In contrast, the tumor-specific delivery of ON-BOARD™ encapsulated molecules demonstrates a much broader therapeutic window. The promising data that we presented at AACR 2023 suggest our technology may provide a solution to overcome the clinical application limitations of these highly potent protein therapeutics.”
Presentation Overview:
TITLE: Improved tolerability and tumor specific delivery of a therapeutic bispecific T cell engager using a pH-sensitive nanoparticle platform
PRESENTER: Qingtai Su, Ph.D.
TITLE: Encapsulation of IL-12 with an ultra pH-sensitive nanoparticle platform improves tolerability and promotes antitumor response in mice
PRESENTER: Tian Zhao, Ph.D.
TITLE: ONM-501, a dual-activating polyvalent STING agonist, enhances tumor retention and demonstrates favorable preclinical safety profile
PRESENTER: Zirong Chen, Ph.D.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Presents Data from Phase 2 Pegsitacianine Study at Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care
OncoNano Medicine Presents Data from Phase 2 Pegsitacianine Study at Society of SurgicalOncology (SSO) 2023 International Congress on Surgical Cancer Care
- Pathology-confirmed residual disease was detected in 50% of patients following the completion of intended surgery under pegsitacianine-guidance
SOUTHLAKE, Texas – March 27, 2023 – OncoNano Medicine, Inc. presented data from a Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, at the Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care, occurring March 22-25 in Boston, MA. Data from the study revealed that the primary endpoint was achieved in 50% of the evaluable patients undergoing peritoneal carcinomatosis surgery.
The primary objective of this Phase 2 study was to determine if the administration of pegsitacianine (1 mg/kg) prior to surgery results in the detection of additional disease following standard of care surgical resection of peritoneal metastases. The results reveal that, under pegsitacianine guidance, 20 of 40 evaluable patients (50%) had pathology-confirmed disease resected after fluorescent visualization that was not resected in the planned standard of care surgery. In this trial, pegsitacianine was well tolerated; the only notable pegsitacianine related adverse event was a transient, self-resolving, non-anaphylactic infusion-related reaction experienced by approximately 25% of patients.
“These results show that pegsitacianine can safely be administered up to three days in advance of surgery, without any impact on the planned surgical approach. Importantly, the results of this Phase 2 trial demonstrate pegsitacianine’s potential as a new advance for real-time surgical imaging for peritoneal metastasis surgery,” said Kartik Krishnan MD, PhD, Chief Medical Officer of OncoNano Medicine. “I look forward to working alongside the U.S. Food and Drug Administration (FDA) to plan for further development and explore the most efficient opportunities to bring pegsitacianine to patients.”
The results come at the heels of the Company’s January 2023 announcement that pegsitacianine received Breakthrough Therapy Designation by the U.S. FDA as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARDTM platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas.
Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine to Present at the American Association for Cancer Research (AACR) Annual Meeting 2023
Southlake, TX – January 4, 2023 – OncoNano Medicine, Inc. today announced three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023 at the Orange County Convention Center, Orlando, Florida.
Presentation Overview:
TITLE: Improved tolerability and tumor specific delivery of a therapeutic bispecific T cell engager using a pH-sensitive nanoparticle platform.
PRESENTER: Qingtai Su, Ph.D.
DATE: April 16
TIME: 2023 1:30 – 5:00 PM ET
SECTION and PRESENTATION NUMBER: Poster Section 30, No. 815
TITLE: Encapsulation of IL-12 with an ultra pH-sensitive nanoparticle platform improves tolerability and promotes antitumor response in mice
PRESENTER: Tian Zhao, Ph.D.
DATE: April 16, 2023
TIME: 1:30 – 5:00 PM ET
SECTION and PRESENTATION NUMBER: Poster Section 34, No. LB001
TITLE: ONM-501, a dual-activating polyvalent STING agonist, enhances tumor retention and demonstrates favorable preclinical safety profile.
PRESENTER: Zirong Chen, Ph.D.
DATE: April 18, 2023
TIME: 1:30 – 5:00 PM ET
SECTION and PRESENTATION NUMBER: Poster Section 34, No. LB245
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine’s Pegsitacianine Granted Breakthrough Therapy Designation for Real-Time Surgical Imaging by the Food and Drug Administration
Southlake, TX – January 4, 2023 – OncoNano Medicine, Inc. today announced that its lead clinical development candidate, pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, has received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
“We are thrilled to receive breakthrough therapy designation, which underscores the potential of pegsitacianine to alter the paradigm of surgical imaging in oncology,” said Kartik Krishnan, Chief Medical Officer of OncoNano. “Providing real-time feedback, pegsitacianine demonstrates the capacity to identify tumors that may otherwise go undetected.”
The FDA's Breakthrough Therapy Designation is designed to expedite development and regulatory review of medicines that aim to address a serious or life-threatening condition with showing preliminary clinical evidence demonstrating substantial improvement over existing treatments on one or more clinically significant endpoints. A Breakthrough Therapy Designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.
Based on the results of an ongoing Phase 2 clinical trial evaluating the safety and efficacy of pegsitacianine following standard of care cytoreductive surgery, pegsitacianine enabled surgeons to detect additional cancerous tissue at a clinically significant rate of >50%. It is estimated that each year in the United States more than 17,000 patients undergo cytoreductive surgery due to metastasis from many different tumor types, including appendiceal, colorectal or ovarian cancer.
About Pegsitacianine
Pegsitacianine is an intraoperative fluorescence imaging agent for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark (“Off”) state at physiological pH but transitions rapidly to a fluorescently “On” state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor-agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces New Preclinical Data for ON-BOARD™ Platform for Delivery of Bispecific T Cell Engagers and a Therapeutic Cytokine at SITC Annual Meeting
Clinically validated pH-sensitive nanomedicine platform allows for tumor specific delivery of protein therapeutics and increased tolerabilitySOUTHLAKE, Texas – November 14, 2022 – OncoNano Medicine, Inc. today announced the presentations of positive preclinical data on the company’s ON-BOARD™ pH-activatable delivery platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts.
The data presented at SITC 2022 demonstrated the capability of the ON-BOARD™ platform for effective encapsulation and improvement of the therapeutic index of a variety of therapeutic payloads, including bispecific T cell engagers (TCE) and a therapeutic cytokine – IL-2-Fc, using relevant animal models.
The ON-BOARD™ platform is designed to protect oncology intervention payloads systemically and release them in the acidic tumor microenvironment, minimizing systemic exposure and toxicity. OncoNano’s lead clinical candidate, pegsitacianine, currently in Phase 2 clinical trials, is formulated with ON-BOARD™, and the clinical data has validated its pH-activated tumor specificity.
In the two separate presentations, a variety of TCEs including solitomab, runimotamab and several TCEs with undisclosed targets as well as a human IL-2 fused with IgG Fc were encapsulated using the ON- BOARD™ platform. The data demonstrated that:
ON-BOARD™ successfully encapsulated TCEs across a range of different targets and structural configurations without any protein engineering involved
ON-BOARD™-encapsulated TCEs demonstrated rapid release and high pH specificity as well as pH- activated cytotoxicity against various cancer cell lines in vitro
ON-BOARD™ encapsulation of an undisclosed TCE significantly improved its tolerability in vivo compared to the unencapsulated molecule and inhibited the growth of a poorly immunogenic “cold” tumor model with in-tumor payload activation confirmed by PD markers
ON-BOARD™-encapsulated IL-2-Fc showed robust anti-tumor efficacy in both the "hot" MC38 and the "cold" B16F10 tumors and greatly suppressed systemic toxicity compared to unencapsulated IL-2-Fc
“We were excited to share the positive data on the encapsulation of a variety of bispecific T cell engagers and a therapeutic cytokine and the significant improvement of therapeutic index without complicated protein engineering,” said Tian Zhao, PhD, Vice President of Research and Development at OncoNano. “We look forward to developing this technology for clinical translation with these types of payload molecules in the near future.”
Presentation Overview
Title: A Clinically Validated pH-Sensitive Nanomedicine Platform for Encapsulating Therapeutic Bispecific T Cell Engagers for Tumor Specific Delivery and Activation
Date: November 10 - 11, 2022
Time: 9:00 am – 9:00 pm EST
Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA
Title: Ultra-pH Sensitive Nanoparticles Increase Therapeutic Index of IL-2-Fc
Date: November 12, 2022
Time: 10:40 am – 10:50 am EST
Location: Session 302: Thomas Waldmann Memorial Plenary Session: New Immunotherapies, Boston Convention and Exhibition Center, Boston, MA
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno- oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON- BOARD™ platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces Pre-Clinical Data for Dual-Activating STING agonist at the Society for Immunotherapy of Cancer (SITC) Annual Meeting
ONM-501 shown to be promising immuno-therapeutic candidate for clinical evaluation in solid tumorsSOUTHLAKE, Texas – November 10, 2022 – OncoNano Medicine, Inc. today announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts. ONM-501, OncoNano’s lead therapeutic program in development, is a dual-activating STING (Stimulator of Interferon Genes) agonist advancing towards a first in human trial planned to be initiated in the first half of 2023.
Previously published data has demonstrated the differentiated mechanism of ONM-501 with dual “burst” and “sustained” STING activation, enhanced cytosolic delivery and tumor retention through encapsulation of an endogenous STING agonist - cGAMP with OnocoNano’s proprietary STING-activating OMNI™ polymeric micelles. These two mechanisms operate in concert to activate STING and potentiate this activation, providing potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both “hot” and “cold” tumor microenvironments. In vivo PD analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501, and demonstrated the target-engagement activity of ONM-501 in multiple species, and high tolerability in rodents and non-human primates, making it a promising therapeutic candidate for clinical evaluation.
“The results presented here confirm many of our hypotheses regarding the potential of ONM-501 to provide a robust therapeutic index of immune activating STING activity that may be differentiated from other STING agonists. This is why we are so buoyed by the continued positive preclinical results for ONM-501, underscoring its potential as a monotherapy and in combination with anti-PD1 in multiple‘hot’ and ‘cold’ murine syngeneic tumor models,” said Kartik Krishnan, MD, PhD, Chief Medical Officer at OncoNano. “We look forward to bringing ONM-501 to the clinic in 2023 as we continue on our mission to deliver critical new treatments to patients in need.”
Presentation Overview
Title: ONM-501, a Polyvalent STING Agonist, Exhibits Anti-Tumor Efficacy with Increased Tumor T-Cell Infiltration in Mice and is Well Tolerated in Rats and Non-Human Primates
Date: November 10 - 11, 2022
Time: 9:00 am – 9:00 pm EST
Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune- oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
(781) 235-3060
larnold@macdougall.bio
OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis
- Interim Phase 2 results presented at World Molecular Imaging Conference 2022 -
- Pegsitacianine demonstrated a >50% clinical event rate allowing the surgeons in the trial to detect residual disease following cytoreductive surgery -
SOUTHLAKE, Texas, September 29, 2022 – OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS). Study results were presented by Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, during an oral presentation at the World Molecular Imaging Congress (WMIC) in Miami, FL on September 29th. The interim results from this trial provide evidence that pegsitacianine could offer surgeons a real-time optical imaging capability that enhances their ability to detect residual cancerous tissue that would otherwise be left behind from their standard of care process for cytoreductive surgery of peritoneal metastases.
“We are encouraged by the Phase 2 study results for pegsitacianine in the detection of residual disease for both mucinous and non-mucinous metastatic nodules across multiple cancer types and look forward to further exploring the clinical utility of this novel molecular imaging agent in cancer surgery,” said Patrick Wagner, MD, one of the lead investigators on the trial.
The Phase 2 study (NCT04950166) remains open to enrollment and is designed to evaluate the ability of pegsitacianine, a micellar fluorescence agent, to detect residual malignancies following CRS, an operation to completely resect peritoneal metastases. As an adjunct to tactile and visual cues for detecting residual disease, pegsitacianine may allow surgeons a more accurate evaluation of the completeness of surgery, or potentially to augment the results by removing additional lesions. A total of 27 patients were administered pegsitacianine at a dose of 1 mg/kg, proceeded to surgery with intra- operative imaging occurring between 24- and 72-hours post-dose, and completed pathology examination of resected specimens. The data presented revealed that 15 patients (55%) have demonstrated a clinically significant detection of pathology-confirmed residual disease following the completion of intended surgery. In this ongoing study, pegsitacianine continues to be well-tolerated with no observed drug-related serious adverse events. The most common adverse event observed with the use of pegsitacianine has been infusion-related reactions that have been mild to moderate and self-resolving.
About Pegsitacianine
Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing surgical resection. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARD™ platform, pegsitacianine exists in a fluorescently dark “Off” state at physiological pH but transitions rapidly to a fluorescently “On” state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential for intraoperative near infrared imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in Phase 1 and 2 clinical trials where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD™ platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agon ist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM -501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
larnold@macdougall.bio
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OncoNano Medicine to Present at Cantor Fitzgerald Oncology & HemOnc Conference
SOUTHLAKE, Texas – September 19, 2022 – OncoNano Medicine, Inc., a clinical-stage biotechnology company focused on the development of novel cancer interventions, today announced that Chief Medical Officer Kartik Krishnan, MD, PhD, will present at the Cantor Fitzgerald Oncology, Hematology & HemeOnc Conference at the Lotte New York Palace in New York City on Wednesday, September 28, 2022.
Dr. Krishnan will be participating in the panel discussion, “Predictive Biomarkers, Sequencing and Diagnostics, Oh My!” at 9:50 am ET.
For more information or to schedule a one-on-one meeting with Dr. Krishnan, CEO Martin Driscoll and CFO Matthew Head at the meeting, please contact your Cantor representative directly or contact OncoNano at https://onconano.com/#contact.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com
OncoNano Medicine Announces Oral Presentation of Phase 2 Study Data at the World Molecular Imaging Congress 2022
SOUTHLAKE, Texas – September 14, 2022 – OncoNano Medicine, Inc. today announced a presentation of data from its ongoing Phase 2 study of pegsitacianine at the World Molecular Imaging Congress (WMIC), occurring September 27 – October 1, 2022. The presentation will be given during the Cancer: Innovations in Molecular Imaging session.
Details of the oral presentation are as follows:
Presenter: Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania
Date/Time: Thursday, September 29, 3:12 - 3:22 PM EST
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com