Press Releases
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
OncoNano Medicine Appoints Brett Giroir, M.D., to Board of Directors
- Former Assistant Secretary of Health and Admiral in the U.S. Public Health Service to help advance company's mission to advance the identification and treatment of cancer
SOUTHLAKE, Texas – December 17, 2021 – OncoNano Medicine, Inc. today announced the appointment of Brett Giroir, M.D., to the company’s Board of Directors. “It is my pleasure to welcome Dr. Giroir to our Board and work with him as we advance our differentiated technology platform for the development of novel interventions and treatments for cancer patients,” said Martin Driscoll, CEO of OncoNano Medicine, Inc. “Brett’s wealth of experience and expertise in clinical practice, public health and entrepreneurial enterprises will be instrumental as we enter a pivotal stage for the growth of our company.”
Dr. Giroir is a physician-scientist and innovator, whose career has been dedicated to improving public health and medicine. Formerly, he served as the 16th Assistant Secretary for Health in the U.S. Department of Health and Human Services, Acting FDA Commissioner and Admiral in the U.S. Public Health Service Commissioned Corps. Dr. Giroir also served as the U.S. Representative to the Executive Board of the World Health Organization within the Department of State, and was on the front lines of the COVID-19 response as a member of the White House Task Force and the national lead for testing and diagnostics. Dr. Giroir is a graduate of Harvard University and the University of Texas Health Science Center, where he served on the faculty for ten years. “I am excited to assist in the development and commercialization of OncoNano’s novel platform technology, which has the realistic potential to revolutionize targeting of tumors with anti-cancer therapies and cancerimaging agents,” said Dr. Giroir. “I look forward to working with OncoNano’s outstanding team and world-renowned scientific founders to advance this broadly applicable anti-cancer technology for the benefit of patients with unmet medical needs.”
About pegsitacianine
Pegsitacianine utilizes OncoNano’s proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of solid tumors – the relatively acidic pH of the tumor microenvironment – to provide real-time surgical imaging for cancer surgeons. Pegsitacianine is currently in Phase 2 trials involving patients with peritoneal metastases and lung tumors.
About ONM-501
ONM-501 is a novel immune-therapeutic that activates the STimulator of INterferon Genes (STING) target and has demonstrated efficacy and good tolerability in multiple preclinical oncology models. ONM-501 utilizes PC7A, a novel synthetic polymer from the proprietary OncoNano library that binds STING through a non-canonical biomolecular condensation. The combination of a payload consisting of a synthetic version of the endogenous ligand, cGAMP, with PC7A yields a polyvalent or dual-activation of the STING target. ONM-501 has been demonstrated to stimulate a robust adaptive immune response in the tumor microenvironment in preclinical studies. OncoNano is currently conducting IND-enabling activities for ONM-501 and anticipates submitting an IND for a Phase 1a/1b trial in the second half of 2022.
Pegsitacianine and ONM-501 have been partially funded by the Cancer Prevention and ResearchInstitute of Texas.
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
Lauren Arnold
781-235-3060
larnold@macbiocom.com
$18.4 Million Equity Investment by the Cancer Prevention and Research Institute of Texas
-Will convert previous grant awards to an equity investment in OncoNano’s Series B-Additional capital infusion will close OncoNano’s Series B at $68.4 million and continue to support the clinical program for pegsitacianine and IND-enabling activities for ONM 501
SOUTHLAKE, Texas – October 25, 2021 – OncoNano Medicine, Inc. today announced that the Cancer Prevention and Research Institute of Texas (CPRIT) will convert $18.4 million in grant award funding into an equity investment in OncoNano. Proceeds of the financing will be used to support the clinical development of pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first internal therapeutic development program, ONM-501, a novel immune therapeutic formulated with the company’s core delivery technology. This conversion will close OncoNano’s Series B financing round with $68.4 million in total committed capital.
CPRIT awarded OncoNano with a grant totaling $15.4 million in 2019 to advance the company’s differentiated STING (STimulator of INterferon Genes) agonist development candidate, ONM 501, and provided a $9.97 million grant in 2020 to advance pegsitacianine, the company’s IV fluorescent nanoprobe for use in image-guided cancer surgeries. After this investment, OncoNano will still have $6.97 million of the 2020 grant available to advance the use of pegsitacianine in the visualization and resection of metastatic disease.
“CPRIT has played a crucial role in the establishment and advancement of the expanding life sciences research community in Texas. We are thrilled to continue our close partnership with CPRIT and welcome them as shareholders in OncoNano through this conversion of earlier grant awards to an equity investment in our over-subscribed Series B financing,” said Martin Driscoll, CEO at OncoNano Medicine, Inc. “With the continued support of our investors, including this infusion of new capital from CPRIT, we can accelerate the development of our novel programs and expand our operations in North Texas. Our successful Series B financing will be instrumental in advancing pegsitacianine into a pivotal trial program in the U.S. and Europe and advance ONM 501 to a first in human trial in early 2023. We look forward to working together with CPRIT and our partners to bring important new interventions and treatments to cancer patients in need.”
“CPRIT supported the initial research in Dr. Gao’s laboratory at The University of Texas Southwestern Medical Center that led to the therapies OncoNano Medicine is commercially developing today,” said Wayne Roberts, CEO, CPRIT. “We’re thrilled to see the company translating that groundbreaking research into products to improve cancer patient care. With the additional equity investment in OncoNano Medicine, CPRIT helps secure Texas’ investment in, and ability to benefit from, this technology and the potential therapies it could produce.”
About the Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention.
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 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 product candidates 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 second half of 2022. Learn more at www.OncoNano.com.
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com
Pegsitacianine Demonstrates Tumor-Agnostic Real-Time Surgical Imaging in Phase 2 Study
Update on pH-sensitive fluorescent nanoprobe from late-breaking oral presentation at The World Molecular Imaging Congress
Pegsitacianine has successfully detected disease in six different tumor types with four different FDA-approved imaging devices
SOUTHLAKE, Texas – October 14, 2021 – OncoNano Medicine, Inc. announced results from a Phase 2 study of its lead clinical development candidate, pegsitacianine, presented as a late- breaking oral presentation at the 2021 World Molecular Imaging Congress (WMIC). This late- breaking oral presentation by Dr. Jason Newman of the University of Pennsylvania Health System revealed the fluorescent nanoprobe, pegsitacianine, provided real-time surgical imaging in a tumor-agnostic manner for the accurate identification of malignant tissue in the operating room.
Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine 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. Pegsitacianine has previously been studied in a Phase 1 clinical trial where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.
“The Phase 2 study results for pegsitacianine presented at the recent World Molecular Imaging Congress indicate this fluorescent nanoprobe has the potential to change the current surgical paradigm,” said Dr. Newman. “With the real-time feedback that pegsitacianine provides, we could now have a tool that offers real-time surgical imaging on margin status and provides a greater degree of confidence in achieving complete tumor resection. Given the unique activation mechanism of targeting a universally dysregulated tumor metabolic signature, pegsitacianine could be beneficial in aiding surgical oncologists across multiple tumor disciplines.”
The recently completed Phase 2 study (NCT03735680) was a non-randomized, open-label, multi-center study being conducted at three U.S. sites. This exploratory study further confirmed the selected dose-schedule, expanded upon the drug’s safety profile and increased the number of tumor types in which pegsitacianine imaging was shown to be feasible. Together, the results demonstrated that pegsitacianine is well-tolerated in patients and provides the surgeon with accurate, real-time feedback in the operating room. Intraoperative imaging observations demonstrated a high correlation with the pathological assessments of collected tissues, and imaging can be reliably performed using multiple FDA-cleared NIR imaging devices. Results from evaluable patients demonstrated favorable sensitivity (100%) and specificity (92%) values, as well as a strong negative predictive value (100%) for detecting histologically normal tissue that was collected as part of standard of care surgery.
“The high sensitivity and specificity valuesfrom the Phase 2 trial not only corroborated our Phase 1 observations to further support the use of OncoNano’s ON-BOARDTM platform in surgical imaging, but also highlight the potential benefit of this pH-activatable platform for tumor-targeted delivery of therapeutic payloads with an increased therapeutic window,” commented Jinming Gao, PhD, OncoNano’s Chief Scientific Officer.More information on the Phase 2 trial can be found at ClinicalTrials.Gov
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 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 product candidates 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 second half of 2022. Learn more at www.OncoNano.com.
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com
Positive Preclinical Data for ONM-501 at AACR Virtual Conference
OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR Virtual Conference on Tumor Immunology and Immunotherapy
SOUTHLAKE, Texas – October 8, 2021 – OncoNano Medicine, Inc. announced positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications. The data, presented at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models.
“We are excited by the positive preclinical results for ONM-501 recently presented at AACR. STING plays a crucial role in mediating our innate immune systems but has consistently been a challenging pathway to target,” said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. “We are encouraged by the constellation of preclinical data that demonstrates ONM-501 could have a clinical profile differentiated from earlier generation cyclic dinucleotide STING agonist compounds. The novel ONM-501 formulation consisting of our STING activating pH-sensitive micelle loaded with an endogenous agonist has demonstrated a capability to produce a dual and prolonged activation of STING while recruiting a robust adaptive immune response to the tumor microenvironment. We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials.”
Presentation Overview
TITLE: ONM-501 ― A synthetic polyvalent STING agonist for cancer immunotherapy
PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine, Inc.
ONM-501 demonstrated antitumor efficacy in six different syngeneic mouse models from different tissues of origin (MC38, 4T1, TC-1, B16-F10, CT26 and A20). The animals were treated intratumorally with ONM-501 as a monotherapy or in combination with PD-1 blockade. The findings indicate that ONM-501 demonstrated:
Strong antitumor efficacy across all tumor models tested as a mono or combo therapy
Significantly improved efficacy with increased complete response in several modelswhen combined with PD-1 blockade
Successful combination of a novel, proprietary STING activating micelle with theendogenous cGAMP potentially offers a synergistic immunotherapy strategy against cancer
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
Present at The American Association for Cancer Research Virtual Conference
OncoNano Medicine to Present at The American Association for Cancer Research Virtual Conference on Tumor Immunology and Immunotherapy
SOUTHLAKE, Texas – September 30, 2021 – OncoNano Medicine, Inc. today announced a poster presentation at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy to be held on October 5-6, 2021.
Full details of the presentation are listed below:
TITLE: ONM-501 ― A Synthetic Polyvalent STING Agonist for Cancer Immunotherapy
PRESENTER: Qintai Su, Ph.D.
DATE: October 5-6, 2021
LOCATION: Virtual
The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonists. ONM-501 encapsulates the endogenous STING agonist cGAMP with a proprietary micelle that induces polyvalent STING condensation and prolongs innate immune activation to offer dual ‘burst’ and ‘sustained’ STING activation for a potential highly effective immunotherapy against cancer.
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
Expanded Research Collaboration with UT Southwestern Medical Center
OncoNano Medicine Announces Expanded Research Collaboration with UT Southwestern Medical Center to Advance Development of New Cancer Therapies
- Expanded collaboration for multi-year translational research of novel cancer treatments- OncoNano has an exclusive option to license new technologies from the collaboration
SOUTHLAKE, Texas – September 22, 2021 – OncoNano Medicine, Inc., a clinical-stage company utilizing the principles of molecular cooperativity in drug design to exploit universal tumor and immune targets to diagnose and treat cancer, today announced a multi-year collaboration with The University of Texas Southwestern Medical Center (UTSW) to discover and conduct translational research of novel cancer therapeutics that leverage OncoNano’s core nanotechnology platform. OncoNano will sponsor research efforts in the laboratory of Professor Jinming Gao of UTSW with the objective of uncovering new cancer therapies that can benefit from OncoNano’s ultra pH-sensitive polymeric micelles. OncoNano will have an exclusive option to license new technology arising from the research conducted under this agreement.
“We are excited to expand our research collaboration with the UT Southwestern Medical Center and the prominent UTSW laboratory led by Dr. Jinming Gao,” said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. “UTSW’s rich scientific discovery environment combined with world-class translational research capabilities presents a wonderful opportunity for our scientists to engage in a multi-year cooperative research effort to leverage our core technology platform and advance more novel cancer therapeutics into clinical development.”
Dr. Gao and his team at UTSW invented the ultra pH-sensitive nanoparticle technology that represents the core of OncoNano’s differentiated oncology research platform. OncoNano iscurrently advancing two development programs that utilize the ultra pH-sensitive nanoparticle technology. Pegsitacianine, a fluorescent nanoprobe for real-time surgical imaging, is currentlyin Phase 2 clinical trials for multiple tumor types, and ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications, is advancing toward a first in human study planned for early 2023.
“OncoNano’s multi-year support for basic research will broaden our capability to harness molecular cooperativity design that incorporates pathophysiological responses into the development of tumor-activatable compounds with increased therapeutic windows,” said Jinming Gao, Professor of Oncology, Pharmacology and Cell Biology in the Harold C. Simmons Comprehensive Cancer Center at UTSW and Chief Scientific Officer of OncoNano. “We are working to expand the micelle technology platform developed at UTSW so it can be used to deliver additional payloads, including protein therapeutics such as cytokines, checkpoint inhibitors and bispecific antibodies. We look forward to this research collaboration with OncoNano Medicine to continuously translate lab discoveries into potentially important clinical applications.”
About The University of Texas Southwestern Medical Center
UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 23 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,500 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.
About OncoNano Medicine, Inc.
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit universal and immune targets for cancer diagnosis and therapy. 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 fight 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 to Present at The World Molecular Imaging Congress
SOUTHLAKE, Texas – September 20, 2021 – OncoNano Medicine, Inc. today announced an oral presentation at The World Molecular Imaging Congress 2021 (WMIC) to be held virtually on October 6-9, 2021.
Full details of the presentation are listed below:
TITLE: Fluorescence Image-Guided Surgical Resection of Solid Tumors Using the pH-Responsive Micellar Imaging Agent Pegsitacianine: A Summary of an Ongoing Phase 2 Study
PRESENTER: Dr. Jason Newman
DATE: October 8th, 2021
TIME: 10:00 – 11:30 AM
LOCATION: Virtual
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 Raises ~$50 Million in Series B Financing
Financing round led by Advantech healthcare investment team
Funds will support Phase 3 program for pegsitacianine and IND-enabling activities for ONM-501
June 17, 2021
SOUTHLAKE, Texas - (BUSINESS WIRE) - OncoNano Medicine, Inc. today announced the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund. Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.
“We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform,” said Martin Driscoll, CEO at OncoNano Medicine, Inc. “We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients.”
“We are impressed with the potential for OncoNano’s innovative core technology,” said Benjamin Qiu, partner at Advantech Capital. “We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment.”
About Advantech Capital
Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.
About Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.
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 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 product candidates 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 second half of 2022. Learn more at www.OncoNano.com.
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com
OncoNano Medicine to Present at the 2nd Annual LifeSci Partners Private Company Summer Symposium
July 19, 2021
SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced a presentation at the 2nd Annual LifeSci Partners Private Company Summer Symposium, to be held virtually July 21-23, 2021. Martin Driscoll, CEO of OncoNano, will present on Thursday, July 22nd at 1:30 p.m. ET.
To register for the event, please click here.
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 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 product candidates 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 second half of 2022. Learn more at www.OncoNano.com.
OncoNano Medicine Raises ~$50 Million in Series B Financing
Financing round led by Advantech healthcare investment team
Funds will support Phase 3 program for pegsitacianine and IND-enabling activities for ONM-501
June 17, 2021
SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund. Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.
“We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform,” said Martin Driscoll, CEO at OncoNano Medicine, Inc. “We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients.”
“We are impressed with the potential for OncoNano’s innovative core technology,” said Benjamin Qiu, partner at Advantech Capital. “We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment.”
About Advantech Capital
Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.
About Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.
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 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 product candidates 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 second half of 2022. Learn more at www.OncoNano.com.
OncoNano Awarded $15.4 Million Grant
SOUTHLAKE, Texas – August 27, 2019 – OncoNano Medicine, Inc. today announced that it has been awarded $15.4 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance ONM-500, one of OncoNano’s innovative oncology product candidates. In ONM500, OncoNano leverages its proprietary pH-sensitive micelle technology to deliver antigens while activating innate immunity for the treatment of cancers caused by the human papilloma virus (HPV). This grant award adds to an initial $6 million grant that the company received from CPRIT in 2014 for advancement of the company’s ONM-100, where OncoNano’s micelle technology is being used to intraoperatively image tumors during surgical resection, currently in Phase 2 clinical trials.
“We are excited to be awarded this impactful grant and are extremely grateful to CPRIT for their continued recognition and support of the development of OncoNano’s technology platform for identifying and treating cancer in its various forms,” says Ravi Srinivasan, Ph.D., CEO of OncoNano Medicine. “Our pH-sensitive micelle approach to cancer therapy with ONM500 and our other product candidates have the potential to meaningfully advance cancerspecific targeting and administration.” In part utilizing CPRIT-funded technology first invented at UT Southwestern Medical Center, ONM-500 combines contemporary advances in immunoadjuvant therapy with OncoNano’s proprietary pH-sensitive micelle delivery technology to recruit the body’s own immune system to attack cancer cells. An HPV tumor-specific antigen is packaged into immune-activating micelles that, when intradermally injected, accumulate in the lymph nodes and are endocytosed by dendritic cells. The relatively lower pH of intracellular endosomes causes the micelles to dissociate, resulting in the intracellular release of the antigen, activation of STING (STimulator of INterferon Genes) and subsequent activation of the body’s own T-cells directed at the tumor. Through the delivery of an antigen by the STING-activating micelle, the ONM-500 immunoadjuvant complex enables a targeted and orchestrated attack on cancer cells. With this grant, OncoNano will continue advancing ONM-500 through pre-clinical development towards the clinical stage where there is a substantial unmet patient need for therapies to treat cancers caused by HPV.
“This award emphasizes CPRIT’s priority of investing in early translational research into cancer detection, prevention, and treatment. OncoNano’s technologies have significant potential for breakthroughs in cancer detection and treatment,” said Wayne Roberts, CEO of CPRIT. “Nurturing projects like OncoNano’s will continue to make Texas a hub for scientific advancement and innovation. I look forward to OncoNano’s progress as they take their technologies through development.”
About the Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.4 billion in grants to Texas research institutions andorganizations through its academic research, prevention, and product development researchprograms. CPRIT has recruited 181 distinguished researchers; supported the establishment,expansion, or relocation of 37 companies to Texas, and generated $3 billion in additional publicand private investment. CPRIT funding has advanced scientific and clinical knowledge andprovided 5.7 million life-saving cancer prevention and early detection services reaching Texansfrom all 254 counties. www.cprit.state.tx.us
About OncoNano Medicine
OncoNano Medicine is developing a new class of pH-activated compounds that digitalize and exploit the variability of pH in disease. pH variability is a proven, simple, and effective identifier of diseased tissue providing a foundation for the development of a broad range of highly targeted therapeutics and imaging agents. OncoNano is the first company to advance product candidates using pH as a biomarker for cancer immunotherapy, therapeutic use and intraoperative imaging based on its pH-sensitive micelle technology. www.OncoNanoMed.com
Contacts
MacDougall
Lauren Arnold
781-235-3060
larnold@macbiocom.com
Publication of ONM-100 Phase 1
Southlake, TX. – June 26, 2020 – OncoNano Medicine, Inc. announced today the publication of Phase 1clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging productcandidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 inimage-guided surgery, occult tumor detection and visualization of tumor margins in four differentcancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9patients in whom histology confirmed tumor positive margins, and also detected occult lesions in anadditional 5 patients whose tumors were undetected by standard of care. The research paper, Exploitingmetabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescenceguided surgery, will appear in the June 26 issue of Nature Communications.
Surgical resection remains a cornerstone treatment strategy for solid tumors today and incompletetumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, thereare no approved imaging options to provide real-time feedback to surgeons that specifically targettumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to afluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarkerof solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior tosurgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploitingthis universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancertypes, irrespective of tissue of origin.
“We are extremely pleased to have this critical work published in Nature Communications,” commentedGooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Centerof Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript hestates, “ONM-100 was able to detect tumor positive resection margins and several cancerous lesionsthat standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeingONM-100’s potential further explored in Phase 2 clinical trials.”
“We are delighted to see the scientific community’s validation of ONM-100 that is demonstrated by thisacceptance in Nature Communications,” commented Ravi Srinivasan, PhD, Cofounder and CEO ofOncoNano. “ONM-100 has the potential to substantially simplify and enhance the effectiveness oftumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broadpatient populations in the future. We look forward to this same pH-sensitive micelle technology beingutilized for other oncology applications, such as tumor-specific therapeutic delivery.”ONM-100 is currently being evaluated in Phase 2 clinical trials in the United States in several uniquecancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trialat www.clinicaltrials.gov.
About ONM-100
ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform toencapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidicpH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remaininactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelledissociation and fluorescent tag expression, making tumors visible during surgery with standard surgicalimaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded forclinical research by the Cancer Prevention and Research Institute of Texas.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnoseand treat cancer with high specificity. Our product candidates are designed to help patients across thecontinuum of cancer care and include solid tumor therapeutics, agents for real-time image-guidedsurgery and a platform of product candidates that activate and guide the body’s immune system totarget cancer. Learn more at OncoNano.com.
Contact
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060
Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer
- UTSW scientists demonstrate that a novel pH-sensitive polymer prolongs STING-mediated activation of innate immunity against solid cancers
- OncoNano Medicine’s ONM-501, containing the polymer and an endogenous STING ligand, could overcome the clinical challenges observed with related immuno-oncology compounds
February 10, 2021
SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced that a research paper titled “Prolonged activation of innate immune pathways by a polyvalent STING agonist” published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticle-based drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW) could boost the body’s innate immune pathways in the treatment of multiple cancers with a unique mechanism of activating the STimulator of INterferon Genes (STING). OncoNano licensed this technology from UTSW for further development as part of the company’s proprietary pH-activated micelle platform, and Dr. Gao, a co-founder of OncoNano, currently also serves as a consultant for the company.
“We are excited about the study published by our colleagues at UTSW demonstrating that the STING activating polymeric micelle can be selectively triggered in the endosomes and enter the cytoplasm of phagocytic cells to achieve robust antitumor immunity,” said Marty Driscoll, CEO at OncoNano Medicine, Inc. “The novel polymer component can bind uniquely to the STING target and produce longer activation of this critical innate immune pathway. Our development candidate, ONM-501, utilizes the STING activating pH-sensitive micelle technology encapsulated with an endogenous high affinity ligand to produce a dual and prolonged activation of STING.”
The STING pathway plays a crucial role in mediating the body’s innate immune system. The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonist compounds. ONM-501 micelles enable targeted and efficient delivery of the endogenous ligand and the STING activating polymer to the phagocytic cells in tumors where they are released by low pH-induced micelle dissociation. Preclinical studies have shown that both the polymer and the endogenous ligand payload of ONM-501 bind to and activate the STING protein in the cell in a synergistic manner, enabling activation for up to 48 hours. The polymers bind to a non-competitive STING surface site distinct from the conventional cyclic dinucleotide-binding pocket, and also induce condensation of STING proteins via polyvalent interactions. Preclinical studies showed that ONM‑501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types.
OncoNano Medicine, Inc. is developing ONM-501 as a potential immuno-therapeutic treatment for multiple cancers. Development of the core technology of ONM-501, the STING activating polymer, has been partially funded by a grant from the Cancer Prevention and Research Institute of Texas.
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 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 product candidates that activate and guide the body’s immune system to target cancer. Learn more at www.OncoNano.com.
Contact
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060
Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer
- UTSW scientists demonstrate that a novel pH-sensitive polymer prolongs STINGmediated activation of innate immunity against solid cancers
- OncoNano Medicine’s ONM-501, containing the polymer and an endogenous STING ligand, could overcome the clinical challenges observed with related immuno-oncology compounds
SOUTHLAKE, Texas – February 10, 2021 – OncoNano Medicine, Inc. today announced that a research paper titled “Prolonged activation of innate immune pathways by a polyvalent STING agonist” published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticlebased drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW) could boost the body’s innate immune pathways in the treatment of multiple cancers with a unique mechanism of activating the STimulator of INterferon Genes (STING). OncoNano licensed this technology from UTSW for further development as part of the company’s proprietary pH-activated micelle platform, and Dr. Gao, a co-founder of OncoNano, currently also serves as a consultant for the company.
“We are excited about the study published by our colleagues at UTSW demonstrating that the STING activating polymeric micelle can be selectively triggered in the endosomes and enter the cytoplasm of phagocytic cells to achieve robust antitumor immunity,” said Marty Driscoll, CEO at OncoNano Medicine, Inc. “The novel polymer component can bind uniquely to the STING target and produce longer activation of this critical innate immune pathway. Our development candidate, ONM-501, utilizes the STING activating pH-sensitive micelle technology encapsulated with an endogenous high affinity ligand to produce a dual and prolonged activation of STING.”
The STING pathway plays a crucial role in mediating the body’s innate immune system. The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonist compounds. ONM-501 micelles enable targeted and efficient delivery of the endogenous ligand and the STING activating polymer to the phagocytic cells in tumors where they are released by low pH-induced micelle dissociation. Preclinical studies have shown that both the polymer and the endogenous ligand payload of ONM-501 bind to and activate the STING protein in the cell in a synergistic manner, enabling activation for up to 48 hours. The polymers bind to a non-competitive STING surface site distinct from the conventional cyclic dinucleotide-binding pocket, and also induce condensation of STING proteins via polyvalent interactions. Preclinical studies showed that ONM-501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types.
OncoNano Medicine, Inc. is developing ONM-501 as a potential immuno-therapeutic treatment for multiple cancers. Development of the core technology of ONM-501, the STING activating polymer, has been partially funded by a grant from the Cancer Prevention and Research Institute of Texas.
About OncoNano MedicineOncoNano 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 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 product candidates that activate and guide the body’s immune system to target cancer. Learn more at www.OncoNano.com.
Contacts
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060