Evopoint Biosciences AU Pty Ltd

SUZHOU, China--(BUSINESS WIRE)-- Evopoint Biosciences Co., Ltd.(“Evopoint”), a biopharmaceutical company focused on discovering and developing innovative and transformative medicines, announced today a collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate Evopoint’s XNW5004, a selective EZH2 inhibitor, in combination with KEYTRUDA®(pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase Ib/II study in Chinese patients with advanced solid tumors. XNW5004 is a rationally designed, highly selective and potent EZH2 inhibitor with potentially best-in-class efficacy and safety pro in a Phase I trial in patients with lymphoma. The combination trial is an open label, single-arm Phase Ib/II study designed to establish the RP2D dose of XNW5004 in combination with KEYTRUDA® and to evaluate the safety and efficacy of XNW5004 in combination with KEYTRUDA® for patients with advanced solid tumors. “We are extremely pleased to collaborate with MSD, a well-established world leader and pioneer in the field of cancer immunology,” said Jing Qiang, Chairmen of Evopoint. “Our promising drug candidate, XNW5004, has demonstrated a potential additive benefit when given in combination with anti-PD-1 therapy in animal models. Based on the mechanism of action of EZH2 in tumor cells and tumor microenvironment, the observations in our preclinical studies, and the excellent efficacy and safety pro XNW5004 exhibited in the Phase I study, we are very optimistic that XNW5004 in combination with KEYTRUDA® may significantly improve the clinical outcome in patients with advanced solid tumors, potentially providing meaningful clinical benefits to those patients for improving their lives.” Under the terms of the agreement, Evopoint will sponsor the Phase Ib/II trial and MSD will supply KEYTRUDA®. Evopoint maintains the global rights to XNW5004. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About XNW5004 XNW5004 is a rationally designed, highly selective and potent small molecule inhibitor of EZH2 with the potential of being the best-in-class EZH2 inhibitor. Studies have revealed that EZH2 play important roles in the pathological processes including tumorigenesis, tumor progression and tumor immunogenicity. Targeting EZH2 has been proven a relatively effective treatment strategy in liquid tumors. In preclinical studies, XNW5004 has demonstrated excellent anti-tumor activity and safety in various liquid tumor and solid tumor models, either as single agent or in combination with other therapies including immune checkpoint inhibitors. In a recently completed Phase I trial, XNW5004 exhibited excellent single-agent efficacy and safety in lymphoma, and the potential to be best-in-class selective EZH2 inhibitor. Interim results of the Phase 1 study were presented at the ASH meeting in December, 2022. About Evopoint Evopoint Biosciences was founded by highly accomplished leaders in fields of R & D, business, and investment. Our mission is to discover and develop transformative medicines to address significant unmet needs globally. Leveraging our world - class scientific platforms for target therapy, PROTAC and antibiotics, Evopoint Bio has built a broad and innovative pipeline of 7 clinical and 14 pre-clinical candidates in oncology, anti - infectives, and metabolic diseases. Aiming to rapidly evolve into a leading global biopharma, Evopoint Bio has established a highly efficient global R & D organization with presence in China, Australia, and United States.

This novel ADC is expected to have a wider therapeutic index and superior clinical profile across a broad range of solid tumors IND submission is planned for mid-2023 REDWOOD CITY, Calif. and SUZHOU, China, Jan. 09, 2023 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, and Evopoint Biosciences Co., Ltd (“Evopoint”), a leading biopharmaceutical company applying its cutting-edge platform technologies to discover and develop innovative medicines, today announced that AmMax has entered into an exclusive option with Evopoint for a worldwide license, excluding Greater China, for the development and commercialization of a novel ADC for treating solid tumors. With its proprietary linker-payload system and monoclonal antibody, this technology has demonstrated robust antitumor activity in multiple preclinical models which presents significant opportunities to treat many different types of cancer. The animal efficacy and toxicity studies also support a significantly widened therapeutic index (TI) that is expected to provide a much-improved efficacy and safety profile. “AmMax’s mission is to develop and commercialize oncology therapeutics that have the potential to become the new standard of care,” said Larry Hsu, Ph.D., Chairman & Chief Executive Officer of AmMax, “Today’s agreement with Evopoint underscores this commitment by adding a potentially best-in-class ADC program to our portfolio. We are excited to partner with Evopoint and, upon exercising the option, to move this highly differentiated drug candidate into patient studies in the second half of 2023.” “We are very pleased to enter into this agreement with AmMax,” said Jason Meijie Le, Chief Executive Officer of Evopoint Biosciences. “Evopoint is dedicated to develop and deliver innovative medicines to physicians and patients. We are very impressed with AmMax’s therapeutic area expertise and proven track record in drug development and commercialization. We look forward to partnering with AmMax to advance this transformative product worldwide. This collaboration evidences the superiority of our product pipeline.” Under the exclusive option agreement, the parties have pre-negotiated licensing terms and will work together to complete the upcoming IND filing and design subsequent dose-escalating clinical studies. About AmMax Bio Inc.AmMax is a private biotechnology company focused on the clinical development of innovative oncology products. AmMax is currently leveraging positive clinical data and an improved safety profile to advance AMB-05X for tenosynovial giant cell tumor (TGCT). AmMax is building on its core expertise to expand a clinical portfolio through in-licensing first-in-class and/or best-in-class oncology products in areas of significant unmet medical need. For more information, please visit the company’s website at www.AmMaxBio.com. About Evopoint Evopoint Biosciences was founded by highly accomplished leaders in research and development, business and investment. The Company’s mission is to discover and develop transformative medicines to address significant unmet needs globally. Leveraging its world-class scientific platforms for targeted therapy, PROTAC and antibiotics, Evopoint has built a broad and innovative pipeline of 6 clinical and 15 pre-clinical candidates in oncology, anti-infectives, and metabolic diseases. Aiming to rapidly evolve into a leading global biopharma, Evopoint has established a highly efficient global research and development organization with presence in China, Australia, and the United States. To learn more, please visit www.evopointbio.com. Contact AmMax Bio, Inc.Andrew Sauter, CFOEmail: andrewsauter@ammaxbio.comTel: 650-787-3777 Evopoint Biosciences Co., LtdXiaojun (Jun) LiuEmail: Xiaojun.liu@evopointbio.com