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Press Releases
OncoNano Announces Positive Preclinical Data for ONM-400 Tumor Specific IL-2 Delivery at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Findings indicate proof of mechanism and strong antitumor efficacy in preclinical models
SOUTHLAKE, Texas – November 9, 2020 – OncoNano Medicine, Inc. today announced positive results from its preclinical study of ONM-400, a novel interleukin-2 (IL-2) encapsulating pHactivated nanoparticle that targets metabolic acidosis of cancer. ONM-400 employs OncoNano’s ON-BOARDTM platform designed to provide tumor specific delivery of a variety of cancer therapeutics. The data, presented today at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, demonstrate successful tumor acidosis-driven accumulation that provides a high local concentration of IL-2 within tumors potentially resulting in an improved therapeutic index for this cancer therapeutic.
“While IL-2 is established as a highly effective solid tumor therapy for treatment of metastatic melanoma and renal cell cancers, the clinical application is greatly hindered by healthy tissue toxicity,” said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. “Exploiting low pH relative to normal tissues as a common trait of all solid tumors, ONM-400 has the potential to deliver IL-2 directly to the tumor microenvironment. We are highly encouraged by these findings and look forward to evaluating ONM-400 in patients.”
Presentation Overview
TITLE: ONM-400, a Novel Approach for Interleukin-2 Therapy Using a pH-Activated Nanoparticle Targeting Metabolic Acidosis in Solid Cancers
ABSTRACT ID: 385
LOCATION AND TIME: Virtual Poster Hall, 11/11/2020 - 11/14/2020, 9:00 am - 5:00 pm
PRESENTER: Qingtai Su, Ph.D.The results announced today are based on in vitro characterization and in vivo demonstration in multiple mice models. Tumor accumulation and biodistribution following intravenous injection (I.V.) of ONM-400 were evaluated in mice bearing head and neck tumors and antitumor efficacy of ONM-400 after I.V. injection was studied in MC38 colon cancer-bearing mice and compared with unencapsulated IL-2 at the same dose. The findings indicate that ONM-400:
Showed high encapsulation efficiency and drug loading density of IL-2
Enabled pH-dependent IL-2 release and bioactivity
Demonstrated successful tumor acidosis-driven release and minimum normal tissue exposure
Allowed for a significantly higher tumor accumulation and lower renal elimination of IL-2 when compared to free IL-2 control
Induced strong antitumor efficacy with complete tumor regression as a monotherapy and a durable antitumor memory effect
About ONM-400
ONM-400 is a next-generation interleukin-2 (IL-2) program that has demonstrated a highly differentiated mechanism of action in preclinical studies. ONM-400 utilizes a proprietary pHsensitive micelle platform to encapsulate IL-2 and exploit a universal biomarker of all solid cancers – the low pH tumor microenvironment that is acidic relative to normal tissues – to deliver IL-2 directly to the tumor. ONM-400 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and IL-2 release. This has the potential to increase IL-2 accumulation within the tumor while avoiding healthy tissue toxicity, a common challenge of IL-2 therapy.
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
OncoNano Announces Positive Clinical Data for Cancer Imaging Agent ONM-100 at The World Molecular Imaging Congress
Findings indicate favorable tolerability and proof of mechanism in various solid tumors
SOUTHLAKE, Texas – October 7, 2020 – OncoNano Medicine, Inc. today announced positive results from its ongoing Phase 2a study of ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors. The data, presented today at the World Molecular Imaging Congress (WMIC) Virtual 2020, demonstrate successful imaging of various solid tumors.
“As low pH is a hallmark of all solid tumors, our novel imaging agent ONM-100 has the potential to become a useful tool for successful tumor resection surgeries,” said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. “These data indicate that ONM-100 was well-tolerated and was able to visualize various solid tumor types. We are encouraged by these findings and are excited to continue developing ONM-100 to address this persistent and challenging unmet need in detection of cancer.”
OncoNano is currently enrolling patients in the Phase 2a trial to further evaluate the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of ONM-100. More information can be found at ClinicalTrials.gov
Presentation Overview
TITLE: Image Guided Robotic Prostatectomy Using the pH-Activated Micellar Imaging Agent ONM-100 – A Phase 2 Study of Tumor and Camera Agnostic Detection of Solid Cancers
PRESENTER: Aditya Bagrodia, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center
Results announced today are based on 16 patients with various cancers (4 breast, 5 head and neck, 6 prostate and 1 ovarian), all of whom received a single intravenous dose of ONM-100 the same day as, or previous to the day of surgery. The findings indicate that ONM-100:
Is well tolerated at doses 3X higher than doses administered in Phase 1
Detects pathologically confirmed tumor regions through the prostatic capsule, indicating imaging feasibility during robotic prostatectomy
Demonstrates ability to provide fluorescence signals even within a few hours after dosing, which combined with a half-life > 55 hours enables a wide imaging window
Can feasibly image breast, head and neck, prostate, and ovarian cancers.
About ONM-100
ONM-100 is OncoNano’s lead product candidate under development. ONM-100 utilizes a proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag activation. This has the potential to make tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas (CPRIT).
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.
Contact
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060
OncoNano Awarded $9.97 Million Grant from Cancer Prevention and Research Institute of Texas
Grant to support expanded application of lead product, ONM-100, for imaging metastatic disease that may have gone undetected
SOUTHLAKE, Texas – August 20, 2020 – OncoNano Medicine, Inc. today announced that it has been awarded $9.97 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to expand the application of its lead product, ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors, for imaging metastatic disease.
This grant adds to the initial $6 million that the company received from CPRIT in 2014 for the advancement of ONM-100 to intraoperatively image tumors during surgical resection. ONM-100 was granted a Fast Track designation from the Food and Drug Administration (FDA) and is currently in Phase 2 clinical trials.
During these trials, researchers discovered that ONM-100 can also be used to image and stage metastatic disease, which represents 45-50% of all cancer diagnoses and is responsible for 90% of patient deaths. Improvement in visualization of metastatic disease, both preoperatively and during surgery, is critical for initial diagnosis, accurate staging, therapeutic choice and efficacy, and is closely tied to patient survival. The grant from CPRIT will enable the company to expand the application of ONM-100 to the identification of metastatic disease in the peritoneum, lymph nodes and pleural surfaces – areas that comprise 40% of metastatic disease and result from primary tumors originating from numerous cancer types.
“With limited tools available today that allow doctors to visualize tumors that have metastasized, especially small and disperse ones often characteristic of metastatic disease, the funding we received from CPRIT for our pH-sensitive micelle approach for imaging metastatic disease has the potential to solve a tremendous unmet need,” said Ravi Srinivasan, Ph.D., CEO of OncoNano Medicine. “CPRIT has been our partner since our founding and we greatly appreciate their ongoing support as we bring our technologies through development to benefit patients.”
In addition to the grants received for ONM-100, OncoNano was awarded $15.4 million from CPRIT in August 2019 to advance ONM-500, which leverages its proprietary pHsensitive micelle technology to deliver antigens while activating innate immunity for the treatment of cancers caused by the human papilloma virus (HPV).
“CPRIT continues to be impressed with OncoNano Medicine’s outcomes using their unique micelle technology to detect metastatic cancer,” said Cindy WalkerPeach, PhD, Chief Product Development Officer at CPRIT. “We’re looking forward to successful clinical trials that clearly demonstrate favorable impact to cancer patient care.”
About the Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.6 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 213 distinguished researchers, supported the establishment, expansion or relocation of 42 companies to Texas, and generated over $5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 6.6 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 ONM-100
ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag expression, making tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical 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 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
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060
OncoNano Announces Publication of ONM-100 Phase 1 Data in Nature Communications
Publication data suggests ONM-100 was safe and provides preliminary feasibility data for use in resection surgery in 4 diverse tumor types
SOUTHLAKE, TX. – June 26, 2020 – OncoNano Medicine, Inc. announced today the publication of Phase 1 clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging product candidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 in image-guided surgery, occult tumor detection and visualization of tumor margins in four different cancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9 patients in whom histology confirmed tumor positive margins, and also detected occult lesions in an additional 5 patients whose tumors were undetected by standard of care. The research paper, Exploiting metabolic 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 incomplete tumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, there are no approved imaging options to provide real-time feedback to surgeons that specifically target tumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to a fluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarker of solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior to surgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploiting this universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancer types, irrespective of tissue of origin.
“We are extremely pleased to have this critical work published in Nature Communications,” commented Gooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Center of Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript he states, “ONM-100 was able to detect tumor positive resection margins and several cancerous lesions that standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeing ONM-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 this acceptance in Nature Communications,” commented Ravi Srinivasan, PhD, Cofounder and CEO of OncoNano. “ONM-100 has the potential to substantially simplify and enhance the effectiveness of tumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broad patient populations in the future. We look forward to this same pH-sensitive micelle technology being utilized 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 unique cancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trial at www.clinicaltrials.gov.
About ONM-100
ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag expression, making tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical 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 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.
Contact
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060