AskGene Achieves “First in Human” Milestone for ASKG915, A First-in-Class Anti-PD-1/IL-15 Prodrug for the Treatment of Solid Tumors

Camarillo, California, August 21, 2023 – AskGene Pharma Inc. is pleased to announce that the first patient has been dosed at Columbia University Irving Medical Center in New York City in the phase I clinical trial of ASKG915. The study is an open label, multi-regional phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors. ASKG915 is the first anti-PD-1/IL-15 prodrug in clinical development in the world.

Barbara Hickingbottom, J.D., M.D., Chief Medical Officer of AskGene commented: “Cytokines are natural immune stimulants, which cannot be used widely due to their short half-lives and narrow therapeutic windows. AskGene uses its proprietary technology of SmartKine® to overcome these challenges. We already have on-going clinical studies of ASKG315 (an IL-15 prodrug) and an IL-2 prodrug through a partnership. With ASKG915, we expand our platform to include a molecule that should produce both full anti-PD-1 and IL-15 effects. Such molecules may be able to treat both patients who have failed anti-PD-1 treatment, as well as those who need the extra boost of IL-15 to achieve a response to checkpoint inhibitor therapy. FIH dosing of ASKG915 is an important milestone towards making this next-generation immunotherapy available to patients in need. We are very excited about the progress made so far and look forward to the upcoming POC data from our clinical studies in the future.”

About ASKG915

ASKG915 is the world’s first anti-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 a high enough dose 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 anti-PD-1 antibody monotherapy, and an expanded therapeutic window. ASKG915 is expected to benefit patients who are not responding to current anti-PD-1 antibody therapies. A multi-regional phase I clinical trial in the US and China was started in Aug 2023.

About AskGene Pharma

AskGene Pharma, 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 prodrug 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 first-in-class cytokine prodrug programs in clinical state, AskGene is actively advancing several programs with the potential of being best-in-class or first-in-class into late-stage or mid-stage clinical development.

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