Press Releases
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