Processa Pharmaceuticals Announces Formation of Oncology Advisory Board with Renowned Key Opinion Leaders

Company To Leverage World-Class Oncology Advisory Board in the Design of Oncology Trial Protocols, Including the Anticipated Phase 2 Trial for NGC-Cap

HANOVER, MD, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces the formation of its Oncology Advisory Board featuring key opinion leaders from multiple nationally-recognized institutions.

Processa’s Chief Development and Regulatory Officer and Processa founder, Sian Bigora, Pharm.D., commented, “As we continue development of our Next Generation Chemotherapy (NGC) products, it is important that we rely on the guidance of the most respected advisors in the field. We are excited about the formation of our advisory board and grateful to its respected members for their dedication toward optimizing patient care with new drugs that are distributed preferentially to cancer cells and metabolized more efficiently to molecules that have been proven to kill cancer. We expect that these NGC drugs will improve the treatment of cancer by improving not only the safety and efficacy in cancer patients, but they will also allow for more cancer patients to be treated given the improved safety-efficacy profile.”

Advisory Board members include:

• Philip A. Philip, M.D., Ph.D., Henry Ford Cancer Institute
• Mitesh Borad, M.D., Mayo Clinic
• Patrick Boland, M.D., Rutgers Cancer Institute
• Howard Hochster, M.D., F.A.C.P., Rutgers Cancer Institute
• Sunil Sharma, M.D., F.A.C.P., Translational Genomics (TGen) Research Institute
  

Philip A. Philip, M.D., Ph.D., F.R.C.P., is Director, Gastrointestinal Oncology, Co-Director, Pancreatic Cancer Center, Medical Director, Research and Clinical Care Integration, Henry Ford Cancer Institute, and Professor of Oncology and Pharmacology, Wayne State University School of Medicine, Detroit. Dr. Philip is an internationally renowned medical oncologist specializing in gastrointestinal cancers. He focuses on new drug development and translational research in GI and neuroendocrine malignancies with a particular focus in pancreatic cancer.

His extensive influence in various national and international arenas includes chairing the GI committee for SWOG (the NCI-sponsored clinical trials collaborative), serving on the NCI's Cancer Therapy Evaluation Program committee, authoring more than 250 publications, co-editing a book on pancreatic cancer, and serving as an international/national lecturer with more than 400 presentations.

Mitesh Borad, M.D., is Professor of Medicine, Program Leader for the Gene and Virus Therapy Program, and Director of the Precision Cancer Therapeutics Program at Mayo Clinic. He received his M.D. from Rutgers New Jersey Medical School, completed internal medicine training at Cedars-Sinai and medical oncology training at Tulane University and was a Genomics Medicine and Drug Development Scholar at TGen under the tutelage of Dr. Daniel Von Hoff.

Dr. Borad’s team was the first to demonstrate anti-tumor activity in FGFR2-fusion cholangiocarcinoma using small molecule FGFR2 inhibitors and to introduce an oncolytic Rhabdovirus into human clinical studies.

Patrick M. Boland, M.D., is Associate Professor of Medical Oncology and Associate Program Director of GI Medical Oncology within the Department of Medicine at Rutgers Cancer Institute in New Jersey. Dr. Boland graduated from Jefferson Medical College (now Sidney Kimmel Medical College) in 2006. Following completion of his residency at Boston University Medical Center, he went on to an oncology fellowship at Fox Chase Cancer Center.

Dr. Boland spent the first several years of his career at Roswell Park Cancer Institute as a GI oncologist. His clinical and translational research spans colorectal, anal, gastroesophageal, and pancreatic cancer, gastrointestinal malignancies, and neuroendocrine tumors. Dr. Boland has both developed and conducted multiple clinical trials and is an active member in the NCI National Clinical Trial Network system, in addition to multiple other active research consortia.

Howard Hochster, M.D. is the Associate Cancer Center Director for Clinical Research and Director, Gastrointestinal (GI) Oncology, at the Rutgers Cancer Institute and Director of Oncology Research for Robert Wood Johnson (RWJ) Barnabas, where he directs clinical research. Dr. Hochster graduated from the Yale School of Medicine. He then worked at NYU Medical School and Bellevue Hospital where he completed an internship, residency, and fellowship in Hematology-Oncology. He is certified in Internal Medicine by the American Board of Internal Medicine and by the Hematology and Oncology Boards. He then joined the NYU faculty in medical oncology, rising to full professor before moving to the Yale Cancer Center where he served as Associate Director for Clinical Research and head of GI Oncology until joining Rutgers Cancer Institute.

Dr. Hochster has led numerous clinical trials, particularly in GI Oncology, and was instrumental in the approval of eight new drugs for the treatment of colon cancer. He has authored more than 150 peer-reviewed articles on cancer therapy, new drug development, and clinical trials. He has been very involved with the NCI National Clinical Trials Network (NCTN) and chaired ten Phase 2 and Phase 3 studies in the NCI cooperative groups. He serves as Deputy Editor for the Journal of the National Cancer Institute and regularly reviews manuscripts for Journal of Clinical Oncology, Cancer, British Medical Journal, and Lancet.

Sunil Sharma, M.D. is the Physician-In-Chief at TGen Research Institute in addition to Deputy Director of Clinical Sciences and Professor and Division Director of Applied Cancer Research and Drug Discovery and Professor of Medicine at City of Hope. He earned his medical degree at the University of Delhi in New Delhi, India and his Medical Oncology fellowship at the University of Texas Health Science Center, San Antonio, TX.

He has extensive experience in drug development, including over 200 clinical trials, and has primary interest in conducting drug discovery and translational research on novel therapies for cancer. His clinical interests are focused on the treatment of patients across the gastrointestinal cancer spectrum (colon, pancreatic, esophageal, gallbladder, liver, stomach, small intestine, bowel, rectum, and anus).

About Processa Pharmaceuticals, Inc.

Processa is a clinical stage pharmaceutical company focused on developing the Next Generation Chemotherapy drugs to improve the safety and efficacy of cancer treatment. By combining Processa’s novel oncology pipeline with proven cancer-killing active molecules and the Processa Regulatory Science Approach as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will be providing better therapy options to cancer patients but also increase the probability of FDA approval for its Next Generation Chemotherapy drugs. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of drugs while maintaining the existing mechanisms of killing the cancer cells. Our approach to drug development is based on more than 30 years of drug development expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship. Using its proven Regulatory Science Approach, we have experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s Next Generation Chemotherapy drugs are expected to include fewer patients experiencing side effects that lead to dose discontinuation; more significant cancer response; and a greater number of patients who will benefit from each Next Generation Chemotherapy drug. Currently in our pipeline are three Next Generation Chemotherapy drugs: Next Generation Capecitabine (PCS6422 and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers).

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

For More Information:
Investors:
Bret Shapiro
CORE IR
ir@processapharma.com

Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com

Released November 1, 2023