Evopoint Announces Clinical Trial Collaboration Agreement with MSD for the Study of XNW5004 in Combination with KEYTRUDA® (pembrolizumab) in Advanced Solid Tumors

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 profile demonstrated 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 profile of 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.

Contacts

Evopoint Biosciences Co., Ltd

Xiaojun (Jun) Liu, CBO

Email: xiaojun.liu@evopointbio.com