Hengenix Biotech, Inc.

[03-October-2023] Proteomic Pattern Recognition Technology to Help Identify and Characterize Potential Resistance Patterns in Recruited Patients, Provide Correlative Biomarkers to Guide Outcomes BINYAMINA, Israel , Oct. 3, 2023 /PRNewswire/ -- OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, today announced a collaboration with Hengenix Biotech, Inc. (Henlius USA), affiliated with Shanghai Henlius Biotech, Inc., a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Henlius USA will utilize OncoHost's PROphet® platform to identify exploratory, correlative biomarkers for patients recruited in its comprehensive Phase III clinical trial (NCT05468489). The trial is evaluating the efficacy and safety of Serplulimab plus chemotherapy (carboplatin - etoposide) in previously untreated US-based patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC). OncoHost's PROphet® platform combines bioinformatics, system biology, proteomic pattern recognition and machine learning to predict clinical benefit probability (defined as prolonged progression-free survival) in response to immunotherapy. PROphet® analyzes 7,000 proteins in patient blood samples using aptamer-based assays (SomaScan® by Somalogic (NASDAQ: SLGC)) and combines data collection with machine learning models for patient selection, OS (overall survival)/PFS (progression-free survival) prediction, MoA (Mechanisms of Action) discovery, AE (adverse events) prediction, and response prediction. The platform is applicable in oncology, autoimmune diseases, inflammation, and inflammatory bowel disease. PROphet® has been added to the comprehensive Phase III clinical trial to evaluate the efficacy of Serplulimab combined with chemotherapy in comparison to the standard-of-care atezolizumab combined with chemotherapy, identifying potential proteomics-based biomarkers to better characterize possible resistance patterns in recruited patients. The goal of this collaboration is to add another layer of information to the study by offering insight into who will benefit from the targeted combination therapy. "We stand at the height of a transformative era in cancer therapeutics, and we are honored to support Henlius USA in better understanding resistance mechanisms to truly personalize care," said Ofer Sharon, MD, CEO of OncoHost. "Our shared goal is to improve cancer patients' outcomes by developing robust, scientifically sound technologies to support them and their caregivers. We believe that such collaborations hold the potential to bring new hope to those affected by this challenging disease." About Henlius USA Hengenix Biotech, Inc. (Henlius USA), located in Milpitas, CA, is the U.S. specialty division of Henlius (2696.HK), a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing, and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous Non-Small Cell Lung Cancer (sqNSCLC), Extensive-Stage Small Cell Lung Cancer (ES-SCLC), and Esophageal Squamous Cell Carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. For more information, visit , or follow Henlius on LinkedIn. About OncoHost OncoHost is a technology company headquartered in Binyamina, Israel, and Cary, North Carolina, transforming the approach to precision medicine for improved patient outcomes. OncoHost's proprietary platform, PROphet®, is a plasma-based, proteomic pattern analysis tool whose initial offering in non-small cell lung cancer (NSCLC) uses a single blood sample to guide first-line immunotherapy decision-making. The PROphet® NSCLC test provides clear clinical utility by offering physicians crucial guidance on the optimal first-line immunotherapy treatment plan for each individual patient, with a significant effect on overall survival. Led by an experienced team of entrepreneurs and industry experts and supported by a large-scale prospective clinical trial with over 40 sites and 1,700 patients recruited worldwide, OncoHost is well positioned to lead precision diagnostics and biomarker development to the next stage. For more information, visit  , or follow OncoHost on LinkedIn, Twitter, Facebook and YouTube.

SHANGHAI, Sept. 30, 2021 /PRNewswire/ -- IMPACT Therapeutics announced that Dr. Chun-Pyn Shen was appointed as Head of Regulatory Affairs (Vice President). Reporting to CEO directly, Dr Shen will lead the Department of Regulatory Affairs which is responsible for the formulation and execution of global regulatory strategy for all IMPACT pipeline products. Dr Shen has nearly 30 years of experience in bio-pharmaceutical industry and academic research. Before joining IMPACT Therapeutics, he served as Vice President, Global Project Head in DymaniCure Biotechnology. He has a broad experience in regulatory affairs and pharmaceutical R&D, started his industry career from Merck & Co. where he spent 11 years. After a brief stint in a regulatory consulting firm, he joined Adaptimmune as Director, clinical research and development, and subsequently Questcor/Mallinckrodt as Director, R&D. He then spent 4 years in Merck KGaA. In his capacity as Director, Global Regulatory and Scientific Policy (US and China), Dr Shen made significant contribution to the approval of BAVENCIO® (avelumab) for multiple oncology indications in US. Then he served as the RA Head and strategy consultant to CEO at Hengenix Biotech (an affiliate of Shanghai Henlius Biotech). Dr Shen completed his post-doc fellowship at University of California San Francisco with the specialty in genetics and neuroscience. He received his PhD in molecular biology and genetics from School of Medicine, University of Pennsylvania. Dr Shen graduated with a DDS in Dentistry from School of Dentistry, College of Medicine, National Taiwan University. He also completed two years of hospital dentistry resident training, specialized in oral and maxillofacial surgery at National Taiwan University Hospital. Dr Shen also hold one US patent and authored 33 peer-reviewed scientific publications. Dr. Jun Bao, President and CEO, stated: "We are very pleased to welcome Dr. Shen on board. IMPACT Therapeutics has always maintained global development strategy for our pipeline. As more of our products enter the clinical stage, it becomes critical to have a global regulatory affairs strategy and a strong leader to execute the strategy. We believe that Dr. Shen's is such a leader with his extensive experiences in the industry. We look forward to his leadership to take IMPACT product development to a new level." Dr. Chun-Pyn Shen will split his time between the US and Shanghai offices. "I am thrilled to join IMPACT Therapeutics as Head of Regulatory Affairs. I look forward to working with my colleagues to strengthen the company's regulatory affairs capability." said Dr. Shen. About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (senaparib/ IMP4297), Wee1 inhibitor (IMP7068), and other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (senaparib/ IMP4297), is in Phase II/III studies for ovarian cancer, prostate cancer, small cell lung cancer and other indications worldwide, including China. Senaparib's preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared with other PARPi. Phase I study of Wee1 inhibitor (IMP7068) is conducted globally. Hedgehog pathway inhibitor (IMP5471) has received IND approval from NMPA to initiate clinical studies in China.