Insilico Medicine and TaiGen sign exclusive licensing deal for AI-designed PHD inhibitor ISM4808 to treat anemia in chronic kidney disease

Insilico Medicine and TaiGen Biotechnology (including its Beijing subsidiary) announced an exclusive pipeline out‑licensing collaboration for ISM4808, an AI‑designed oral prolyl hydroxylase domain (PHD) inhibitor for anemia associated with chronic kidney disease (CKD).12

Under the deal, TaiGen receives exclusive rights in Greater China (Mainland China, Hong Kong, Macau, Taiwan) to further develop, commercialize, and sub‑license ISM4808 and its related forms and structures.1

Insilico is eligible for a one‑time upfront payment, development and sales‑based milestone payments, and tiered royalties on net sales, with the total deal value described as in the double‑digit million dollars range.1

ISM4808 is a potential best‑in‑class oral PHD inhibitor discovered and optimized using Insilico’s generative AI drug discovery platform; the discovery and development journey of the ISM4808 series was published in the Journal of Medicinal Chemistry in January 2024.1

The ISM4808 program received IND clearance from China’s Center for Drug Evaluation (CDE) in 2023, enabling clinical development in China.1

Preclinical data showed ISM4808 has strong potency in vitro and in vivo, lower effective doses in CKD rat models, favorable oral drug‑like and PK properties, and a broad safety margin with higher maximum tolerated doses.1

Insilico highlights ISM4808 as one of two AI‑designed PHD‑targeting programs; the other, ISM5411 (a gut‑restricted PHD inhibitor for inflammatory bowel disease), has completed two Phase I trials with a favorable safety profile, supporting confidence in the PHD inhibitor class.1

TaiGen plans to leverage its regional clinical development and commercialization capabilities to accelerate ISM4808 development and address the growing CKD‑anemia market in Mainland China, where there are over one million dialysis patients and a rapidly expanding oral PHD inhibitor market.1

TaiGen’s chairman notes that the China PHD inhibitor market has grown from roughly 50 million RMB to 2.45 billion RMB in about five years, driven by oral drugs replacing injectable therapies for anemia in CKD.1

The partnership combines Insilico’s Pharma.AI generative platform and automated R&D workflow with TaiGen’s experience in multi‑country clinical trials and regional market access to bring an AI‑driven CKD‑anemia therapy to patients in Greater China.16

Sources:

1. https://www.prnewswire.com/news-releases/insilico-medicine-and-taigen-achieves-license-agreement-to-develop-and-commercialize-ai-driven-phd-inhibitor-for-anemia-of-chronic-kidney-disease-ckd-302640098.html

2. https://firstwordhealthtech.com/river/tag/fw_company/TaiGen

6. https://insilico.com