Press Releases
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 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
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
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 Announces Martin Driscoll as CEO
Mr. Driscoll’s deep experience in the biopharmaceutical industry particularly the immuneoncology field makes him ideally suited to assume the leadership of OncoNano Medicine
SOUTHLAKE, TX – February 1, 2021 – OncoNano Medicine, Inc. today announced the appointment of Martin Driscoll as Chief Executive Officer and a member of the company’s Board of Directors. An accomplished industry veteran with multiple decades of biopharmaceutical development and commercialization experience, Mr. Driscoll most recently served as President and Chief Executive Officer of Spring Bank Pharmaceuticals. Mr. Driscoll succeeds co-founder and CEO Ravi Srinivasan, Ph.D., who has stepped down in a planned transition to pursue other interests.
“We are thrilled to welcome Marty to our team. Marty’s extensive experience and proven track record at the helm of several successful biopharmaceutical development companies will undoubtedly provide OncoNano with the leadership to advance our business and translate our novel discoveries into important new interventions and treatments for cancer patients,” said Al Guillem, Ph.D., Chairman of OncoNano. “Marty joins OncoNano at an important time as we progress our lead program into the pivotal trial stage and advance our first oncology therapeutic, ONM-501, towards the first human studies for this novel immuno-modulator.” Dr. Guillem continued, “On behalf of the OncoNano board of directors, I want to thank Ravi for his many contributions to the growth of our company and wish him great success in his future endeavors.”
“I’m joining OncoNano at an exciting point in the evolution of the company and I look forward to building on the strong foundation established by Ravi and the OncoNano team as we advance the clinical development of our impressive portfolio of differentiated programs,” said Mr.Driscoll. “I was attracted to this opportunity to lead OncoNano by the exciting potential for the company’s innovative core technology that exploits the universal pH biomarker of solid tumors to enhance real-time surgical imaging and enable more efficient and effective delivery of cancer treatments.”
Mr. Driscoll brings a proven record in leading privately-held and publicly-traded biopharmaceutical development and commercial-stage companies. He has been involved with or led the commercialization of several important therapies, the direct negotiation of numerous licensing and M&A transactions, multiple private and public capital fundraising efforts and the successful submission of major global product regulatory filings. Mr. Driscoll has also served as a director on the boards of eight biopharmaceutical and diagnostic companies during his career.
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 www.OncoNano.com.
Contacts
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060