OncoNano Announces Presentations at the 2019 SITC Annual Meeting

Two abstracts and posters highlight the diverse applications of OncoNano’s ultra pH-sensitive micelle technology

SOUTHLAKE, TX. – November 5, 2019 – OncoNano Medicine, Inc., a biotechnology company developing ultra pH-sensitive micelles for the detection, staging and treatment of cancer, today announced two poster presentations – including a late-breaking abstract – for the Society for the Immunotherapy of Cancer (SITC) Annual Meeting to be held in National Harbor, Maryland, November 6-10. OncoNano’s core technology is a library of tunable, ultra pH-sensitive micelles that exist intact under baseline physiological pH conditions but dissociate to release their payload under different, predesignated pH levels.

“We are very pleased to share data for two of our lead products at the SITC Annual Meeting this year,” commented Ravi Srinivasan, CEO of OncoNano Medicine. “Our proprietary micelle technology is designed to enable us to deliver high-value and challenging payloads to target tissues with high specificity in ways that have not been possible before.”

The first poster, which is a late-breaking abstract, will feature ONM-500 [Mi-VaxTM] – an injectable micelle composed of STING (Stimulator of Interferon Genes)-activating polymers and packaged with a human papilloma virus tumor specific antigen. These micelles are subcutaneously injected where they accumulate in the lymph nodes and are endocytosed by dendritic cells. The lower pH of intracellular endosomes causes micelle dissociation, releasing both the antigen and STING-activating polymer to coordinate a targeted attack on cancer cells. OncoNano was awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to continue the advancement of ONM-500 through pre-clinical and clinical development.

The second poster features ONM-400 [ON-BOARDTM], OncoNano’s injectable pH-sensitive therapeutic delivery platform that exploits a universal feature of cancer, the relatively acidic tumor microenvironment. ONM-400 can be loaded or conjugated with a variety of cancer therapeutics including cytokines, small molecules and engineered antibody fragments to focus therapeutic delivery specifically at the site of the tumor, minimizing off-target delivery to potentially improve the efficacy and safety profile. OncoNano plans to continue advancing the ONM-400 program through preclinical development and toward the clinical stage where there is substantial unmet need for more effective strategies to target cancer.

Late-breaking Poster Presentation

Abstract title: ONM-500 - A Novel STING-Activating Therapeutic Nanovaccine Platform for Cancer Immunotherapy

Presenting Author: Jason B. Miller, Ph.D., OncoNano Medicine, Inc.

Poster Number: P857

Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

Poster Presentation

Abstract title: Delivery of Interleukin-2 to the Acidic Tumor Microenvironment by Ultra-pH Sensitive Nanoparticles for Immunotherapy

Presenting Author: Xinliang Ding, Ph.D., OncoNano Medicine, Inc.

Poster Number: P617

Date: November 8, 2019, 12:30-2:00 PM and 6:30-8:00 PM

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.

Contacts

Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060

ONM-100 to be Featured in Presentation at World Molecular Imaging Congress 2019

- Presentation will highlight the technology of pH-sensitive micelles for tumor-agnostic intraoperative detection of residual tumor-positive margins

- Data from Phase 1 clinical trial for ONM-100 will be shared

SOUTHLAKE, TX—September 5, 2019 – OncoNano Medicine, Inc. announced today that ONM-100 will be featured at the World Molecular Imaging Congress (WMIC), which is being held September 4-7, 2019 in Montreal. The presentation will include results from a Phase 1 clinical trial of ONM-100 as an intraoperative tumor imaging agent as well as information about OncoNano’s pH-sensitive micelle technology platform.

“We are excited to share these promising clinical trial results for ONM-100 at WMIC this year, as many of the world’s foremost experts in molecular imaging will be in attendance,” commented Ravi Srinivasan, Ph.D., CEO of OncoNano. “ONM-100 is designed to take advantage of one of cancer’s simplest biomarkers – acidic pH – to image tumor resection borders regardless of tissue origin and meaningfully improve the accuracy of tumor detection.”

OncoNano’s proprietary pH-sensitive micelles exploit a unique feature of cancer cell metabolism – excess acid. This metabolic defect creates a tumor microenvironment that is acidic relative to normal tissue and enables pH to be used as a stable biomarker of the diseased tissue. OncoNano is developing multiple product candidates using their pH-sensitive micelle platform, which are ultra-sensitive to subtle changes in pH that trigger dissociation when exposed to acidic environments. Thus, the micelle is activated preferentially in the tumor microenvironment to initiate tagging of the tumor but remains intact when exposed to normal physiological pH levels.

Full details of the presentation are listed below:

TITLE: Metabolic Acidosis in Cancer: A New Strategy Using a pH Transistor Nanoprobe for Fluorescence-Guided Surgery in Humans

PRESENTER:  Pieter J. Steinkamp, M.D., University Medical Center Groningen, the Netherlands

DATE: September 7, 2019

TIME: 2:30 PM EDT

LOCATION: Palais des congrès de Montréal, Room 519a

About ONM-100

Surgical tumor resection remains a critical tool of oncology medicine, but detection of tumor borders and residual tumors is notoriously difficult. ONM-100, which utilizes OncoNano’s ultra pH-sensitive micelle platform, is a tumor-agnostic intraoperative tumor imaging agent currently in Phase 2 clinical trials. ONM-100 is designed to be injected intravenously prior to surgery and tags diseased cancerous tissue to provide real-time detection of tumor borders and residual tumors with commercially available imaging equipment. 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 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.

Contacts

Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060

OncoNano Awarded $15.4 Million Grant from Cancer Prevention and Research Institute of Texas

• Funding will support pre-clinical and clinical development through Phase 1 trial of ONM500, an immunoadjuvant complex utilizing pH-sensitive micelles

• ONM-500 is currently being developed for treating cancers caused by the human papilloma virus, including cervical and head/neck cancers

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 and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 181 distinguished researchers; supported the establishment, expansion, or relocation of 37 companies to Texas, and generated $3 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 5.7 million life-saving cancer prevention and early detection services reaching Texans from 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.

Contacts

Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060

OncoNano Closes Additional $23.7 Million in Second Tranche of Series A Financing, Bringing Total Series A Raise to $35.4 Million

Proceeds will be used to support new and ongoing cancer imaging clinical trials and to advance development of its pH-activated compound platform for cancer therapeutics and vaccines

SOUTHLAKE, TX. – July 9, 2019 – OncoNano Medicine, Inc. today announced the completion of $23.7 million in a second tranche of Series A financing, bringing the total Series A round to $35.4 million. The round was arranged by Salem Partners, who also participated as a principal investor. Proceeds of the financing will fuel OncoNano’s cancer imaging clinical trials and support the expansion of its technology into candidates for therapeutic applications.

“Over the last year, OncoNano has made significant strides in the completion of a Phase 1 trial for our intraoperative cancer imaging agent, ONM-100, which saw a 100 percent imaging response in patients, as well as the expansion of the use of our pH sensitive micelle platform into exciting new areas such as therapeutics and cancer vaccines,” said Ravi Srinivasan, CEO of OncoNano Medicine. “The continued support of our distinguished investors and the addition of new investors into the OncoNano family will enable us to further our mission to change how cancer is detected and treated.”

ONM-100 is the first product in a platform based upon the company’s library of unique micelles that are ultra-sensitive to changes in pH. The intravenously administered imaging agent, which detects tumors and metastatic lymph nodes, is entering a Phase 2 clinical trial. The company announced earlier this year that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for ONM-100 and granted a Fast Track designation in response to a separate application. OncoNano’s micelle platform is also being used to develop therapeutics, including a T-cell activator that targets lymph nodes and dendritic cells to treat cancers.

“The combination of OncoNano’s experienced executive and scientific team coupled with the progress the company is making in expanding the platform across multiple imaging and therapeutic applications underscores the tremendous interest in the company from both existing and new investors,” said John Dyett, Co-Founder and Managing Director at Salem Partners, who also serves on OncoNano’s Board of Directors. “We have full confidence in the company’s potential to make a significant impact in the future of cancer care.” 207077734 v1

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.

Contacts

Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060

OncoNano to Present Poster on First-in-Human Study of pH-Activated Platform for Detection of Solid Tumors During Surgery at 2019 ASCO Annual Meeting

ONM-100 was able to detect occult disease which was otherwise missed by standard surgery and pathology

No ONM-100 related serious adverse events observed for all 30 patients enrolled in trial

SOUTHLAKE, TX. – May 23, 2019 – OncoNano Medicine, Inc. announced today that data from its first-in-human study of ONM-100, an intravenously administered imaging agent, was well tolerated and enables fluorescent visualization of tumor positive margins and occult disease in solid tumors during surgery. The full results will be presented in a poster at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019.

Low pH is a well-known indicator of diseased tissue and ONM-100 has the potential to act as a broadly indicated tumor agnostic imaging agent. ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which enables surgeons to visualize the tumor during surgery using existing near infrared surgical cameras. OncoNano recently concluded a Phase 1 clinical trial for ONM-100 at the University Medical Center Groningen (UMCG) in The Netherlands with principal investigator Professor Go van Dam. The OncoNano micelle platform is also being used to develop therapeutics, including T-cell activating agents that target lymph nodes and dendritic cells, as well as immunomodulation of the tumor micro-environment.

“pH is a simple and robust biomarker to distinguish cancer cells from healthy ones, but until now, there has not been a way to accurately visualize tumors broadly using tumor acidity in real-time during surgery and incomplete tumor resection can result in cancer recurrence and metastasis. We are thrilled with the results of our Phase 1 study which clearly demonstrated that surgeons were able to detect tumor margins and occult disease which was otherwise missed by standard of care surgery and pathology, and we look forward to expanding our trial later this year,” said Ravi Srinivasan, Ph.D, founder, President and Chief Executive Officer of OncoNano.

Poster Presentation Details and Study Results:

TITLE: Image-guided surgery for tumor agnostic detection of solid tumors using the pH-activated micellar imaging agent ONM-100

POSTER: Poster Board: #60; Abstract 3068

DATE /TIME: Saturday, June 1, 2019; 8:00 am – 11:00 am CT

The trial found that no ONM-100 related serious adverse events were observed and the agent was well tolerated in all 30 patients with histopathologically confirmed breast cancer, head and neck squamous cell carcinoma, colorectal cancer and esophageal cancer who were enrolled in the study. This first-in-human data demonstrate the feasibility for potential use of ONM-100 for image guided surgery, margin assessment and detection of occult disease. Tumors in four patients with breast cancer or head and neck squamous cell carcinoma that went unnoticed during surgery were detected on the margin or wound bed using ONM-100 fluorescence imaging. Additionally, two breast tumor lesions that were missed by conventional pre-operative imaging and pathological assessment were detected with ONM-100.

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.

Contacts

Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060

OncoNano Receives Authorization to Proceed from FDA for IND Application and Fast Track Designation for ONM-100, Intraoperative Imaging Agent to Detect Tumors and Metastatic Lymph Nodes

FDA says proposed Phase 2 clinical trial may proceed

SOUTHLAKE, TX. – January 4, 2019 – OncoNano Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ONM-100, an intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery. In addition, OncoNano received Fast Track designation from the FDA for ONM-100.

ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which will allow surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.

“These two positive responses from the FDA reflect the progress that we have made on ONM100,” said Kathy Rath, Vice President, Regulatory Affairs at OncoNano Medicine. “The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time.”

“We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day,” said Yalia Jayalakshmi, Vice President, Clinical Development at OncoNano Medicine. “With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019.”

More information on the FDA’s Fast Track designation can be found here.

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.

Contacts

Lauren Arnold
MacDougall Biomedical Communications
larnold@macbiocom.com
781-235-3060