AskGene Announces Clearance of IND Application by US FDA for ASKG915, A First-in-Class Anti-PD-1-IL-15 Prodrug Fusion Molecule for the Treatment of Patients with Solid Tumors
Camarillo, California, December 30th, 2022 – AskGene Pharma Inc. is pleased to announce 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. 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.
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.”
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.
About AskGene Pharma
AskGene, founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics. It has established the proprietary SmartKine® cytokine platform, which significantly improves the developability of cytokines for oncology and inflammation indications. AskGene has multiple programs in clinical and preclinical developments. In addition to the cytokine programs, AskGene is also developing ASKB589, an anti-CLDN18.2 antibody currently in phase 2 development for gastric cancer; and ASKG712, a bifunctional molecule targeting both VGEF and ANG-2 pathways currently in phase 1 development for ophthalmology indications.