AskGene Announces Submission of IND to FDA for ASKG915

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Camarillo, California, November 21st, 2022 – AskGene Pharma Inc. is pleased to announce the submission of an Investigational New Drug (IND) application for ASKG915 to the United States Food and Drug Administration (FDA).  ASKG915 is a recombinant human anti-PD-1 monoclonal antibody and IL-15 prodrug fusion protein for oncology indications.

Jian-Feng (Jeff) Lu, Ph.D., CEO of AskGene commented: “ASKG915 is our third cytokine prodrug entering clinical development, which was discovered and developed using our propriety SmartKine® cytokine platform technology.  Based on the projected dose, it will have full bifunction activities encompassing the combined therapeutic potencies of IL-15 super-agonist and Anti-PD1.  ASKG915 is the first anti-PD-1-IL-15 prodrug fusion molecule moving into clinical development.  It represents the next generation of immunotherapy and is expected to achieve better safety, efficacy, and overall benefit for patients, especially those who may not respond to current immunotherapies.”

About AskGene Pharma

AskGene (California, USA), founded in 2012 in Los Angeles, California, is dedicated to the discovery and development of novel antibody and fusion protein therapeutics.  AskGene is a pioneer in the discovery and development of next generation cytokine therapeutics.  It has established the cutting edge SmartKine® cytokine platform.  The SmartKine® platform significantly improves the developability of cytokines for oncology and inflammation indications.  AskGene is actively moving multiple projects into clinical and preclinical developments.

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 moiety and be locally activated at the tumor site.  It is also designed to allow high enough doses for the anti-PD-1 moiety to have full receptor blocking 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 therefore expected to offer greater benefit to patients than existing anti-PD-1 antibody monotherapies.  The IND application for ASKG915 to the US FDA will be followed by an application to the Chinese authorities in the fourth quarter of 2022.  A Phase I clinical trial is expected to start in 2023.

AskGene Presents Latest Results on ASKG315 and ASKG915 at SITC 2022

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Camarillo, California, November 15th, 2022 – AskGene presented the pre-clinical results of ASKG315 (IL-15 prodrug) and ASKG915 (PD-1/IL-15 prodrug) at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting in Boston on November 8 – 12, 2022.  For ASKG315 phase I clinical study design was also presented.  The two posters were:

  • #1101, Chunxiao Yu et al., ASKG315 – An IL-15 Prodrug with Antibody-like PK, Enhanced Safety and Expanded Therapeutic Window
  • #1183, Kurt Shanebeck et al., ASKG915 – An Anti-PD-1 Antibody-IL-15 Prodrug Fusion Molecule with Enhanced Therapeutic Potential

About ASKG315

ASKG315 is the first prodrug molecule derived from the SmartKine® platform, which is AskGene’s proprietary cytokine prodrug technology platform. It is projected to be the world’s first IL-15 prodrug to enter clinical development.  Preclinical data of ASKG315 showed that this molecule can selectively activate NK cells and CD8+ cells.  Compared to previous generations of cytokine drugs, the prodrug design effectively improved the safety window, significantly extended the half-life, and reduced toxicity.  ASKG315 has been approved for clinical trials in Australia and China, and phase I trials will be initiated in both countries in the near future.

About ASKG915

ASKG915 is projected to be the world’s first PD-1 antibody-IL-15 prodrug fusion molecule to enter clinical development.  The molecule can achieve tumor targeting through PD-1 and be locally activated at the tumor site.  At the same time, the molecule can achieve high dosage, so the PD-1 antibody has full PD-1 blockage functionality.  Preclinical data showed that ASKG915 has extended PK, significantly better efficacy than PD-1 antibody monotherapy, and expanded therapeutic window.  ASKG915 is expected to benefit more patients than existing PD-1 antibody monotherapies.  IND applications for ASKG915 will be submitted in US and China in the fourth quarter of 2022.  Phase I clinical trials are expected in 2023.