Press Releases
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 to Present Data on Novel Development Candidates at the Society for Immunology of Cancer (SITC) Annual Meeting
SOUTHLAKE, Texas – October 5, 2022 – OncoNano Medicine, Inc. today announced it will be presenting data on two development candidates, as well as its ON-BOARD™ delivery platform, at the 37th Annual Meeting of the Society for Immunology of Cancer (SITC), taking place November 8-12, 2022 in Boston, Massachusetts.
An oral and poster presentation by Dr. Qiang Feng detail new pre-clinical data for ONM-405, an IL-2-Fc construct formulated with OncoNano’s proprietary ON-BOARD™ polymeric-micelle delivery system. OncoNano’s lead clinical candidate, pegsitacianine, currently in Phase 2 clinical trials, is formulated with ON-BOARD™. The ON-BOARD™ platform is designed to carry oncology intervention payloads systemically to the tumor microenvironment, minimizing systemic exposure and toxicity.
OncoNano will also present a poster detailing data from studies involving the use of the ON-BOARD™ platform for encapsulation and delivery of bispecific T cell engagers. In addition, a poster will feature new preclinical data of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications.
Presentations Overview
Title: Ultra-pH Sensitive Nanoparticles Increase Therapeutic Index of IL-2-Fc
Presenter: Dr. Qiang Feng, Postdoctoral Fellow, Jinming Gao Lab, UT Southwestern Medical CenterDate: 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
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
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
About OncoNano MedicineOncoNano 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 immuneoncology 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
(617) 694-5387
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
OncoNano Medicine Appoints Kartik Krishnan, M.D., Ph.D., as Chief Medical Officer
- Oncology Development Veteran to Lead the Advancement of OncoNano’s Portfolio
SOUTHLAKE, Texas – June 1, 2022 – OncoNano Medicine, Inc. today announced the appointment of Kartik Krishnan, M.D., Ph.D., as Chief Medical Officer. Dr. Krishnan will be responsible for formulating and leading all clinical development efforts and operations at OncoNano. Additionally, Dr. Krishnan will develop and implement the strategic clinical plans for OncoNano, including the creation of a medical affairs team, as the company further advances its clinical oncology development programs.
“We are thrilled that OncoNano has been successful in attracting such a noted and impressive scientist as Dr. Krishnan. Kartik is a proven and respected oncology drug developer, with extensive experience in leading the development of novel oncology therapeutic programs,” said Martin Driscoll, CEO of OncoNano. “His breadth of experience and history of drug development success will be instrumental to our company as we progress our differentiated portfolio of oncology development candidates into multiple clinical trials.”
Dr. Krishnan previously served as Chief Medical Officer at Arcus Biosciences, where he led the expansion of the company’s portfolio into novel indications and combinations, as well as the initiation of a number of pivotal Phase 3 trials. Prior to joining Arcus, he served as Executive Medical Director at Astex Pharmaceuticals, providing strategic direction and tactical support across multiple programs in all phases of development. Dr. Krishnan has also held positions in clinical drug development at Genentech, FivePrime Therapeutics, BioMarin and Amgen. Dr. Krishnan earned both his M.D. and Ph.D. in Cellular, Molecular, and Biophysical Studies from Columbia University.
“My passion is working with novel technologies that have the potential to benefit the treatment of patients with cancer. I am excited about the potential for the core platform technology at OncoNano that can deliver oncology payloads in a targeted and efficient manner to the tumor microenvironment,” said Dr. Krishnan. "I believe I am joining OncoNano at an ideal time because I can immediately impact the strategic development plans for the OncoNano therapeutics programs and lead the execution of the clinical programs at the company. I am impressed with the OncoNano organization and look forward to working with Marty and the OncoNano team to successfully advance our pipeline and achieve the company’s mission to benefit 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 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 and Research Institute of Texas. Learn more at www.OncoNano.com.
Contacts
Media:
MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio
Investor Relations:
LifeSci Advisors
Ashley R. Robinson
617-430-7577
arr@lifesciadvisors.com
OncoNano Medicine Announces the Appointment of Elina Lavit as Vice President, Business Development
SOUTHLAKE, Texas – May 10, 2022 – OncoNano Medicine, Inc. today announced the appointment of Elina Lavit as Vice President, Business Development. Mrs. Lavit brings over 18 years of experience in leadership roles in organizations ranging from start-ups to Fortune 100 corporations in various therapeutic areas, including oncology and surgery. At OncoNano, Mrs. Lavit will be responsible for driving strategic partnerships and business development activities to support the company’s continued growth.
“OncoNano continues to build momentum as we are entering a rapid phase of growth with pegsitacianine poised to enter Phase 3 clinical trials and our first therapeutic candidate, ONM 501, currently in IND-enabling studies,” said Martin Driscoll, CEO of OncoNano Medicine, Inc. “Elina’s background and her track record of success in leading business development efforts for pharmaceutical companies will be instrumental in helping us execute upon our goals.”
Mrs. Lavit previously served as Executive Director, Program Management at Taysha Gene Therapies, where she led alliance, strategy, and execution for one of the company’s leading assets. Prior, she served as Director of Program Management at Myokardia (acquired by BMS) providing strategic program management support for first in class drug candidate. Mrs. Lavit gained significant strategic collaboration experience while working at Pharmacyclics, Abbvie, and Ethicon (a subsidiary of Johnson & Johnson). Mrs. Lavit earned her Bachelor of Science in Economics and Biology and Master of Science in Medical Science from Tel Aviv University.
“OncoNano’s highly innovative platforms have produced promising and differentiated therapeutic candidates,” said Mrs. Lavit. “I look forward to working with the OncoNano team on advancing these platforms and candidates that exploit the universal pH biomarker of solid tumors to enhance real-time surgical imaging and precisely deliver potent anti-tumor therapeutics.”
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
Media:
MacDougall Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio
Investor Relations:
LifeSci Advisors
Ashley R. Robinson
617-430-7577
arr@lifesciadvisors.com
OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR 2022 Annual Meeting
- ONM-501 is a dual-activating polyvalent STING agonist for immuno-oncology applications formulated with OMNI™, the company’s core immune activating polymer technology -
SOUTHLAKE, Texas – April 13, 2022 – OncoNano Medicine, Inc. today announced positive results from a preclinical study of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications. The data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrate the efficacy and tolerability of ONM-501 in animal models for multiple tumor types. ONM-501 is formulated with the core OncoNano OMNITM polymer technology consisting of STING-activating pH-sensitive micelles loaded with an endogenous agonist.
“We are thrilled by the continued positive preclinical results for ONM-501. STING has consistently been a challenging pathway to target, so we are encouraged by the constellation of our impressive preclinical data showing anti-tumor efficacy and an adaptive response differentiated from cyclic dinucleotide (CDN) STING agonists,” said Ruolan Han, Ph.D., Vice President of Nonclinical & Translational Medicine for OncoNano Medicine. “In preclinical studies to date, ONM-501 has demonstrated the ability to produce a burst and sustained activation of the STING signaling pathway that leads to a robust adaptive immune response with low systemic drug exposure and toxicity. We look forward to continuing our IND-enabling activities as we advance ONM-501 toward our first in human trial in early 2023.”
ONM-501 was evaluated for anti-tumor efficacy and tolerability in multiple animal oncology models. The findings from multiple preclinical studies evidence the following about ONM-501:
STING activation was observed by measuring IFNB1 and CXCL10 mRNA in PBMCs from different species
Anti-tumor efficacy both as a monotherapy and in combination with anti-PD1 in both immune “hot” and “cold” tumor models
Anti-tumor effect mediated by host STING and dependent on CD8+ T cells
Ability to induce an abscopal effect - tumor inhibition was observed in both primary and distal tumors in the same animal
Ability to induce adaptive immune memory
Ability to inhibit lung metastasis in an immune “cold” triple negative orthotopic breast cancer 4T1 model
Unique nanoparticle formulation delivered intratumorally achieves high local drug retention, low systemic exposure and a potential for a reduced risk of toxicity
Presentation Overview
TITLE: ONM-501: A polyvalent STING agonist for oncology immunotherapy
PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine
About OncoNano MedicineOncoNano 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 imageguided 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 Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio
OncoNano Medicine Announces Positive Preclinical Data for Tumor Specific Delivery with the ON-BOARD Platform at AACR 2022 Annual Meeting
SOUTHLAKE, Texas – April 12, 2022 – OncoNano Medicine, Inc. today announced positive results from the company’s ON-BOARD™ pH-sensitive nanoparticle platform. The data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrate that the clinically validated ON-BOARD™ platform has the potential to be a universal tool for tumor specific activation and the efficient delivery of proteins for an improved therapeutic index.
“Our ON-BOARD micelle platform is designed to efficiently carry a broad range of payloads to the tumor microenvironment. Capable of being tuned to deliver either small molecules or biologics, the ON-BOARD platform has the potential to be a universal tool for targeted delivery of therapeutics to a range of cancers,” said Tian Zhao, Ph.D., Vice President of Research & Development for OncoNano Medicine, Inc. “We are pleased with the positive data from our research efforts to encapsulate therapeutic antibodies with our ON-BOARD delivery technology and look forward to the further development of protein payloads with an improved therapeutic index.”
A variety of biosimilar monoclonal antibodies including those of atezolizumab, cetuximab, pembrolizumab, trastuzumab and ipilimumab were encapsulated by the ON-BOARD™ platform.
The findings indicate that ON-BOARD™ demonstrated:
Encapsulation of antibodies without additional modification of the original antibody
Encapsulation efficiency ranging from 50-100%
Formulations characterized as uniformly distributed particles < 100nm in size with good stability
Over a 100-fold activation window between the acid-activated and intact formulations based on in vitro assessment by cell-based reporter assays
pH-dependent activation that was further confirmed by affinity and binding assay
Tumor specific accumulation that was demonstrated by a biodistribution study
Presentation Overview
TITLE: Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
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 imageguided 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 Advisors
Nick Chang
781-235-3060
NChang@macdougall.bio
OncoNano Medicine to Present at the American Association for Cancer Research (AACR) Annual Meeting 2022
March 10, 2022
SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022 in New Orleans, Louisiana.
Full details of the presentations are listed below:
TITLE: Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform
PRESENTER: Jason Miller, Ph.D.
DATE: April 11, 2022
TIME: 1:30 – 5:00 PM CT
LOCATION: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 20
TITLE: ONM-501: A polyvalent STING agonist for oncology immunotherapy
PRESENTER: Qingtai Su, Ph.D.
DATE: April 13, 2022
TIME: 9:00 AM – 12:30 PM CT
LOCATION: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates 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 product candidates that activate and guide the body’s immune system to target cancer. Learn more at OncoNano.com.
Contacts
MacDougall Advisors
Lauren Arnold
781-235-3060
larnold@macdougall.bio