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Elpiscience Announces CDE IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors


SHANGHAI & SUZHOU, China & GERMANTOWN, Md.–(BUSINESS WIRE)–Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, today announced that the Center of Drug Evaluation (CDE) has cleared Elpiscience’s Investigational New Drug Application (IND) for ES014 to initiate a Phase 1 clinical study for patients with advanced solid tumors. ES014 is a first-in-class anti-CD39xTGF-β bispecific antibody (bsAb) that simultaneously targets the CD39-adenosine and TGF-β pathways to synergistically activates T cells for ICB-resistant cancer immunotherapy.

“We are delighted that our IND for ES014 was cleared by CDE. Solid tumors frequently express TGF-β, which suppresses T cell activation and induces CD39 expression, the rate-limiting enzyme in the ATP-adenosine pathway. The anti-CD39 target is designed to selectively direct ES014 to the TME where CD39 expression level is high and the anti-TGF-β activity promotes effector T cell entry into TME, resulting in immune activation and eventually tumor killing, while avoiding or minimizing systemic immunotoxicity,” said Dr. Hongtao Lu, Co-Founder and Chief Scientific Officer of Elpiscience.

ES014’s anti-CD39 activity aims to reverse TME immunosuppression by reducing suppressive adenosine, while maintaining high levels of immune-stimulatory extracellular ATP. The combined removal of immune suppression and immune stimulating effects of ES014 were recently demonstrated in a PD-1 antibody non-responsive in vivo animal model where tumor growth was significantly inhibited after treatment.

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“ES014 is an innovative product targeting suppressive tumor microenvironment, aiming to convert ‘cold’ tumor into ‘hot’ tumor by simultaneously blocking ATP-adenosine and TGF-beta pathways, the two most important suppressive pathways within TME. In ex vivo human cancer 3D studies, ES014 has demonstrated excellent ability in promoting CD8 T cell survival and T cell cytotoxicity towards cancer. We look forward to seeing cancer patients deriving benefit in our Phase 1 study,” said Dr. Steve Chin, Chief Medical Officer of Elpiscience.

About Elpiscience:

Elpiscience is a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapy to benefit cancer patients worldwide. The Company has a robust pipeline of globally innovative cancer immunotherapies covering wide range of oncology targets and multiple proprietary technologies to enable discovery including its Bispecific Macrophage Engager (BiME®) antibody platform for solid tumors, human antibody Fab library ElpiSource™ and H-L interchain disulfide bond engineering BsAb platform Acebody™.

Founded and managed by a team of biotechnology industry leaders and scientists, Elpiscience is supported by a world-class Scientific Advisory Board and high-quality investors including, Lilly Asia Ventures, GL Ventures, Hyfinity Investments, Greater Bay Area Homeland Development Fund, CDH, DYEE Capital and Cormorant Asset Management.

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