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

On May 9, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported 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 (Press release, Elpiscience, MAY 9, 2022, View Source [SID1234613964]). 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).

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"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.