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