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

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

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