ATX-101 pharmaceutical product development

Offentlig prosjektsammendrag

APIM Therapeutics is currently developing ATX-101, an investigational anti-cancer agent based on a novel mechanism of action highly relevant for cancer escape and resistance. ATX-101 has recently been tested in a first-in-human phase 1 clinical study in advanced cancer patients and will soon enter subsequent clinical testing in ovarian cancer and sarcoma. Preparing for expanded clinical development activities that increase the needs for drug supplies and cost-effective patient dosing, the aim of the current project is to further optimize current drug manufacturing processes to deliver drug amounts in the kg scale. Furthermore, it focuses on developing new drug product strengths that reduce waste and translate in significant cost-of good reductions. Finally, new drug analysis methods required for subsequent clinical development activities as per regulatory standards will also be validated. Collectively, this work will expand the proprietary knowledge and know-how of the company and will contribute to further product de-risking and company value creation.