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

May 9, 2022 |

2 min read

Elpiscience Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared Elpiscience’s ES014 Investigational New Drug (IND) Application to initiate a Phase 1 clinical study.

May 9, 2022 12:30 UTC

SHANGHAI & SUZHOU, China & GERMANTOWN, Md.--(BUSINESS WIRE)-- Elpiscience Biopharma, Inc. (“Elpiscience”), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has cleared Elpiscience’s ES014 Investigational New Drug (IND) Application 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, two major immunosuppressive mechanisms in the tumor microenvironment (TME).

“We are delighted that our IND for ES014 was cleared by FDA,” said Steve Chin, Chief Medical Officer of Elpiscience. “ES014 is a first-in-class anti-CD39xTGF-β bispecific antibody. In preclinical studies, ES014 demonstrated significant anti-tumor activity in a PD-1 resistant in vivo efficacy model. We look forward to starting the Phase 1 study soon.”

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 the anti-TGF-β activity promotes effector T cell function and immune activation, while avoiding or minimizing systemic immunotoxicity. ES014’s anti-CD39 activity further 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.

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. 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. Elpiscience endeavors to advance at least one innovative program into the clinic each year.

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