Brings extensive experience in all phases of oncology drug development
HANOVER, Md., April 30, 2024 (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 with improved efficacy and safety, today announced that it has named Steven Cha, M.D. as Senior Vice President of Clinical Research. In this newly created position, Dr. Cha’s experience as an oncologist as well as in oncology drug development will be important additions to Processa.
“We are delighted to have Dr. Cha join our team to lead the clinical development of our three oncology programs. Steven has successfully guided multiple oncology therapies from early discovery through late-stage clinical development, regulatory approval and post-marketing commitments,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “His extensive relevant experience and outstanding leadership abilities will be valuable as we advance our programs in the clinic, with plans to initiate our NGC-Cap Phase 2 trial in breast cancer later this year.”
Dr. Cha has nearly two decades of drug development experience through global approval and commercialization of drugs in hematological and solid tumor indications including romiplostim (first-in-class thrombopoietin), blinatumomab (first-in-class bispecific T-Cell engager) and neratinib (HER2+ breast cancer). Specifically, Dr. Cha has extensive experience in breast cancer drug development, ranging from early to late phase clinical trials.
While at Puma Biotechnology, Dr. Cha was responsible for the global Phase 3 study in HER2+ breast cancer for the combination of neratinib and capecitabine (the NALA Study), which led to regulatory approval and commercialization of the drug. In addition, he has worked at various biotech and pharmaceutical companies, including Pfizer, on a wide spectrum of modalities and platforms in breast cancer research including NG-HER2 antibody-drug conjugates (ADC), gedatolisib, CDK 2/4/6 inhibitors, pan-CLK inhibitors and hematopoietic progenitor kinase 1 (HPK1) inhibitors. Further, his academic research at Stanford University School of Medicine included autologous blood and marrow transplantation in breast cancer patients.
Dr. Cha has also worked on other solid tumor indications including pancreatic ductal adenocarcinoma, prostate cancer, head and neck squamous cell carcinoma, lung cancer and melanoma utilizing cell therapy (CAR-T, NK cell), immuno-oncology, ADC and a vaccine approach.
Dr. Cha received his Bachelor of Science in Biochemistry and Cell Biology from the University of California, San Diego and his Medical Degree from Tufts University School of Medicine. He subsequently completed his postgraduate and fellowship training in hematology, as well as blood and marrow transplant at the Stanford University School of Medicine.
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs to improve the safety and efficacy of cancer treatment. By combining its 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 provide better therapy options to cancer patients, but will also increase the probability of FDA approval for its NGC drugs following an efficient path to approval. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. The Company’s approach to drug development is based on more than 30 years of expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship. The Processa team has a track record of obtaining over 30 approvals for indications across almost every division of the FDA. Using its proven Regulatory Science Approach, the Processa Team has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s NGCs are expected to include fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response and a greater number of patients – in excess of 200,000 for each NGC drug – who will benefit from each NGC drug. Currently under development are three NGC treatments: Next Generation Capecitabine (PCS6422 and capecitabine to treat breast, metastatic colorectal, gastrointestinal, pancreatic and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, biliary, lung, ovarian, breast and other cancers) and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic and other cancers).
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.
