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

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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.

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

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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.”

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.

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.