Press Releases

MacDougall Creative 8/10/20 MacDougall Creative 8/10/20

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

MacDougall Creative 6/26/20 MacDougall Creative 6/26/20

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

Contact

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

MacDougall Creative 11/4/19 MacDougall Creative 11/4/19

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

MacDougall Creative 9/10/19 MacDougall Creative 9/10/19

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

MacDougall Creative 8/27/19 MacDougall Creative 8/27/19

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

Contacts

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

MacDougall Creative 7/9/19 MacDougall Creative 7/9/19

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

Contacts

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

MacDougall Creative 5/23/19 MacDougall Creative 5/23/19

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

Contacts

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

MacDougall Creative 1/3/19 MacDougall Creative 1/3/19

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

Contacts

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

MacDougall Creative 12/4/18 MacDougall Creative 12/4/18

OncoNano Announces Completion of Phase 1a Study and Expands into Phase 1b for Intraoperative Imaging Agent to Detect Tumors and Metastatic Lymph Nodes That Often Go Undetected During Surgery

Results Selected for Poster presentation at San Antonio Breast Cancer Symposium

SOUTHLAKE, TX. –December 5, 2018 – OncoNano Medicine, Inc. today announced the completion of its Phase 1a clinical trial and expansion into Phase 1b to evaluate ONM-100, the intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery. The results of Phase 1a will be included in a poster presentation at the San Antonio Breast Cancer Symposium being held on December 4-8, 2018.

The trial is being conducted at Tracer Center of Expertise, University Medical Center Groningen (UMCG) in Groningen, The Netherlands with Professor Go van Dam as the Principal Investigator. The Phase 1b portion of the study is currently enrolling patients and is an expansion phase at the highest dose tested in Phase 1a. In addition to testing for breast cancer and head and neck squamous cell carcinoma (HNSCC) which were studied in Phase 1a, Phase 1b includes patients with colorectal and esophageal cancers.

Surgery remains the standard treatment for most solid tumors today, with postoperative margin status and tumors left behind being the leading prognostic factor to predict tumor metastasis and potential recurrence. Despite tremendous advances in imaging modalities, current techniques do not provide real-time feedback and surgeons must rely upon preoperative imaging data with visual information during surgery. ONM-100 targets the acidic pH environment within tumors, potentially providing surgeons with a method to assess lymph nodes and tumor margins in real-time. ONM-100 features a digital on-off response to pH changes – switching on in the tumor’s acidic environment and remaining off in blood circulation and normal cells.

“OncoNano’s intraoperative imaging agent appears to provide surgeons with the ability to see tumors that might have otherwise been missed, potentially resulting in more targeted treatment plans and enhanced patient management,” said Ravi Srinivasan, Ph.D, founder, President and Chief Executive Officer of OncoNano. “We are buoyed by the results of Phase 1a where tumors were detected that had previously been undetected by standard of care preoperative methods and by the surgeon or the pathologist, and we look forward to continuing this important trial.”

The poster (Program Number: P2-14-29), “Image guided surgery for tumor detection in breast cancer using the PH activated micellar imaging agent ONM-100: The SHINE study” will be presented on Thursday 12/6/2018, Session: Treatment – Surgery; Session time: 7:30 am – 9:00 am.

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 and provides 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

MacDougall Creative 7/10/18 MacDougall Creative 7/10/18

OncoNanoAnnounces Dosing of Patientsin Phase 1 Clinical Trial with ONM-100, an Intraoperative Imaging Agent that Targets Tumor Acidosisforthe Detection of Solid Tumors

The study, being conducted at TRACER Center of Expertise, University Medical Center in Groningen, The Netherlands, is evaluating safety, pharmacokinetics and feasibility to detect residual tumors and lymph nodes often missed by surgeons

SOUTHLAKE, TX. – July 11, 2018 – OncoNano Medicine, Inc. today announced the initiation of its Phase 1 clinical trial evaluating ONM-100 as an injectable imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery. The Phase 1 trial is being conducted at Tracer Center of Expertise, University Medical Center Groningen (UMCG) in Groningen, The Netherlands.

Surgery remains a main pillar for the treatment of most solid tumors today, including breast cancer, head and neck squamous cell carcinoma (HNSCC), esophageal cancer and colorectal cancer, with postoperative margin status being one of the most important prognostic factors to determine the chance for recurrent disease or tumor metastasis. Despite the growing options in imaging modalities, techniques such as CT, MRI or ultrasound used for intra-operative navigation do not provide feedback in real-time during surgery and surgeons must rely upon pre-operative imaging data with tactile and visual information during surgery.

Since cancers are known to be more acidic than healthy tissue, OncoNano’s SHINe study is evaluating ONM-100, which targets the acidic pH environment within tumors to provide surgeons with a method to assess lymph nodes and tumor margins in real-time during surgery. ONM-100 features a digital on-off response to pH changes – switching on in the tumor’s acidic environment and remaining off in blood circulation and normal cells. By accurately distinguishing cancer cells from healthy tissues during surgery, ONM-100 has the potential to eliminate the “guesswork” often associated with the removal of tumors.

“While it is established that pH is a strong biomarker that can be used to distinguish cancer cells from healthy tissue, it has not been fully explored until now as a way to image, diagnose or treat tumors with therapeutic agents,” said Ravi Srinivasan, Ph.D., founder, President and Chief Executive Officer of OncoNano Medicine. “The initiation of our Phase 1 trial for tumor and lymph node detection is a tremendous milestone toward addressing the unmet need of enhanced visualization of tumors during surgery and sets the stage for us to reach our ultimate goal of improving patients’ lives.”

The SHINe study is an open-label, single center clinical trial to evaluate the safety, pharmacokinetics(PK) and imaging feasibility of ONM-100 in patients with solid cancers that require surgical excision. The study contains two parts – dose escalation and dose expansion. Phase 1a will be performed in a dose-escalating design to determine the range of optimal doses of ONM-100 that are safe and provide adequate contrast to noise ratio in detecting tumors in cancer patients undergoing surgery with breast cancer and HNSCC. The dose expansion will occur in Phase 1b to further characterize safety, PK and imaging at the dose selected from phase 1a.

“We are extremely pleased to be part of this clinical study that has the future potential to bring about important changes in optical imaging of cancer,” said Dr. G.M. Van Dam, professor of surgery and principal investigator at UMCG and CEO of TRACER EUROPE BV. “Being able to accurately visualize and differentiate healthy tissue from cancer cells during surgery is critical and despite tremendous advances in cancer diagnostics and treatment, there is still an unmet need in getting real-time information during surgery on whether you were able to remove all the diseased tissue.”

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. Our lead program, ONM-100,targets tumor acidosis to accurately differentiate cancer from healthy tissue for use in surgery.

Contacts

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

MacDougall Creative 5/17/18 MacDougall Creative 5/17/18

OncoNano Announces $11.7 Million Series A Financing to Support Development of pH-activated Compound Platform for Disease Detection and Treatment

SOUTHLAKE, TX. – May 17, 2018 – OncoNano Medicine, Inc. today announced the closing of a $11.7 million Series A financing. The transaction was arranged by Salem Partners, who also participated as a principal investor. The Series A funding supplements a $6 million grant previously received from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will be used to support the company’s continued clinical development of a new class of pH-activated compounds that digitalize and exploit the variability of pH in disease indications such as cancer. The company is also pleased to announce the appointment of five established industry leaders to its Board of Directors.

“The raise of our Series A and the expansion of our Board of Directors underscores our tremendous clinical momentum and the excitement surrounding our approach to targeting disease,” said Ravi Srinivasan, Ph.D., founder, President and Chief Executive Officer of OncoNano Medicine. “The team is highly motivated to advance our unique pH-activated compound platform for the development of a broad range of highly targeted therapeutics and imaging agents with the objective of contributing to the improvement of patients’ lives.”

OncoNano is using pH variability, a simple and robust biomarker, to detect and treat diseased tissue. By targeting pH, a clear delineation between diseased and healthy tissue can be digitalized to develop a broad range of targeted applications. The technology and compounds were invented at the University of Texas Southwestern Medical Center by Dr. Jinming Gao, Professor of Pharmacology and Otolaryngology, and Dr. Baran D. Sumer, Associate Professor of Otolaryngology with the Harold C. Simmons Comprehensive Cancer Center, and are featured in numerous publications, including Nature Materials, Nature Biomedical Engineering, Nature Communications and Advanced Materials.

After co-founding OncoNano, Drs. Gao and Sumer remain on the Scientific Advisory Board while continuing to conduct research in related areas.

The company’s first program with its pH-activated compound platform is ONM100, an injectable imaging agent that targets the acidic pH within tumors to accurately distinguish cancer cells from healthy tissue during surgery. ONM-100 aims to eliminate the “guesswork” often associated with the removal of tumors by providing surgeons with an easier and more effective method to assess lymph nodes and tumor margins in real-time during surgery. The delivery of ONM-100 is designed to fit seamlessly with current surgical practices and can be employed during all steps of cancer surgery including intraoperative, cancer staging and post-surgery evaluation.

“The breadth and depth of medical applications for OncoNano’s pH-activated compounds are tremendous. With these new funds, we will aim to prove the clinical utility of ONM-100 in cancer surgeries and expanding the platform across multiple therapeutic applications,” said Al Guillem, Ph.D, Chairman of the Board. “I am excited to join the company’s Board as Chairman and look forward to working with OncoNano to deliver a new class of products that can help patients combat disease.”

OncoNano’s new Board of Directors are:

Al Guillem, Ph.D., Chairman of the Board, Former President of ZS Pharma, Inc.
Ravi Srinivasan, Ph.D., Founder and CEO of OncoNano Medicine
John Dyett, Founder and Managing Director of Salem Partners, LLC
Paritosh Dhawale, Ph.D., General Manager of Contrast Media at GE Healthcare
Joydeep Goswami, Ph.D., President, Clinical NGS and Oncology at Thermo Fisher Scientific

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. Our lead program, ONM-100, targets tumor acidosis to accurately differentiate cancer from healthy tissue for use in surgery.

Contacts

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