On December 30th, 2022 AskGene Pharma Inc. reported that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of ASKG915, a novel and proprietary anti-PD-1-IL-15 prodrug fusion molecule for the treatment of cancer (Press release, AskGene Pharmaceuticals, DEC 30, 2022, View Source [SID1234625681]). Under this IND, AskGene will soon initiate a phase 1 study in the United States to investigate the safety, tolerability, pharmacokinetics, and efficacy of ASKG915 in patients with advanced solid tumors. ASKG915 will be the first anti-PD-1-IL-15 prodrug fusion molecule moving into clinical development in the world.
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Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: "We are pleased that we received IND clearance for ASKG915, which is our third cytokine prodrug program entering clinical development. This important milestone brings us closer to delivering a truly bifunctional molecule with synergistic effect of an IL-15 agonist and PD-1 blockage to treat oncology patients. ASKG915 is expected to benefit patients who do not respond to current immunotherapies."
About ASKG915
ASKG915 is the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development. The molecule can achieve tumor targeting through the anti-PD-1 antibody and be locally activated at the tumor site. It is also designed to allow high enough of a dosage so that the anti-PD-1 antibody has full PD-1 blockage functionality. Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than an anti-PD-1 antibody monotherapy, and an expanded therapeutic window. ASKG915 is expected to benefit patients who are not responding to existing anti-PD-1 antibody therapies. A Phase I clinical trial is expected to start in the first half of 2023.