ASKG915 for Injection, a subsidiary of AskG915, was approved in the US

AskGene, a subsidiary of AskGene, has received a "clinical trial Approval letter" from the US Food and Drug Administration (FDA), marking the entry of the world's first PD-1/ cytokine prodrug fusion molecule into the clinical stage.

01
Basic information of drugs

Drug name: ASKG915 for injection
Registration Classification: Biological products for therapeutic use 1 class
Application stage: clinical
Applicant: AskGene Pharma, Inc.
Acceptance number: IND164135

02
Drug related information

ASKG915 for injection is a PD-1 antibody /IL-15 prodrug bi-functional fusion molecule with independent intellectual property rights. It is a biological innovative drug independently developed by the company and has international independent intellectual property rights. It is the first antipd-cytokine fusion protein incubated by the company's prodrug technology platform SmartKine®.

ASKG915 is available as a complete prodrug in normal systemic circulation. It is targeted to tumors by PD-1 antibodies and locally activated at the tumor site through the company's proprietary technology, which stimulates the expansion and activation of immune cells and significantly reduces systemic toxicity while improving drug efficacy. Preclinical data show that ASKG915 has good antitumor activity when activated in the tumor microenvironment, the efficacy is significantly better than PD-1 antibody monotherapy, and the safety is good, the therapeutic window is significantly better than traditional cytogenic drugs, and can achieve a higher safe dose, so that PD-1 antibody can not only achieve the tumor targeting effect, It also has complete PD-1 blocking function.

03
The impact on the company

Currently, no PD-1/ cytokine prodrug fusion molecule has entered the clinical stage in the world. ASKG915 is proposed to be used for the treatment of advanced solid tumors, which is expected to cover many cancer types with poor efficacy of the existing PD-1 monotherapy, and further fill the gap in the anti-tumor immunotherapy market.

According to the requirements of laws and regulations related to registration in the United States, the drug has been reviewed and approved by the United States Drug Administration (FDA), and clinical trials can be carried out in the United States. Positive clinical results will further enrich the company's biological innovation drug pipeline and enhance the company's market competitiveness.