AskGene Announces Completion of First Human Dosing of ASKG315, The First IL-15 Prodrug in Clinical Development

Camarillo, California, December 30th, 2022 – AskGene Pharma Inc. is pleased to announce that the first patient completed their first dose (Cycle 1, Day 1) in the phase I clinical trial of ASKG315 in Shanghai, China.  The study is an open label, multicenter phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of ASKG315 for injection in patients with locally advanced or metastatic solid tumors.  ASKG315 is the first IL-15 prodrug in clinical development in the world.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “ASKG315 is the second cytokine prodrug incubated from our propriety SmartKine® cytokine prodrug platform technology.  Preclinical data showed that ASKG315 selectively stimulated NK cells and CD8+ T cells.  We are looking forward to achieving initial clinical proof of concept of the molecule as well as the platform.  With multiple clinical programs, AskGene is establishing its global leading position in the field of cytokine prodrug.”

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 expects to use its proprietary technology to overcome these challenges.  With the recent clearance of the ASKG915 IND by FDA, and an IL-2 prodrug in clinical development through a partnership, AskGene now has three cytokine prodrug programs in clinical development.  We are very excited about the progress made in 2022 and look forward to the upcoming POC data from our clinical studies in 2023”.

About ASKG315

ASKG315 is a novel and proprietary IL-15 prodrug discovered and developed by AskGene.  It is the world’s first IL-15 prodrug moved into clinical development.  Preclinical data of ASKG315 showed that this molecule selectively stimulated NK cells and CD8+ T cells in cynomolgus monkeys. Compared to previous generations of cytokine drugs, the prodrug design significantly extended the half-life, effectively improved the safety window, and reduced toxicity.  ASKG315 has the longest half-life in cynomolgus monkeys among similar cytokine drugs in development.

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.