Insilico Medicine gets first clinical milestone payment of $10 million for XL309

Insilico Medicine (‘Insilico’), a clinical-stage generative artificial intelligence (AI)-driven drug discovery and development company, today announced that it has received the first clinical milestone payment of $10 million for XL309 (previously known as ISM3091) from Exelixis. 

Exelixis is one of the best oncology discovery and development organizations globally, and they continue to deliver on their data-driven patient-centric strategy. We are very happy to be part of this strategy as our goal is to see AI transform patient lives for the better faster. This advancement underscores our mutual commitment to the existing partnership and enables us to concentrate on AI-driven early-stage drug discovery and development, while leaving the clinical and commercialization efforts to our trusted partners.”

Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine

XL309 is a selective, orally bioavailable small molecule USP1 inhibitor, discovered by Insilico with the support of its proprietary AI platform and out-licensed to Exelixis in 2023. In the preclinical studies, XL309 demonstrated efficacy across multiple tumor cell lines and in vivo models with BRCAm, as well as in HRR-proficient models. The Phase 1 clinical trial currently being conducted by Exelixis in the U.S. is a multicenter, open-label trial evaluating XL309 as a single-agent and combination therapy in patients with select advanced solid tumors. Additional information about the XL309 Phase 1 trial can be found at ClinicalTrials.gov (Identifier NCT05932862).

In September 2023, Insilico entered into an exclusive global license agreement with Exelixis. Under the terms of the agreement, Insilico granted Exelixis global rights to develop and commercialize XL309 in exchange for an upfront payment of $80 million. Insilico is also eligible to receive future development, commercial, and sales-based milestone payments, as well as tiered royalties on net sales.

“We are excited that our partner Exelixis is rapidly advancing the clinical development of XL309,” said Michelle Chen, Ph.D., Chief Business Officer of Insilico Medicine. “This type of partnership is critical to Insilico Medicine’s business model, where we can leverage our strength in AI-powered drug discovery and our partner’s strength in clinical development and commercialization. We look forward to continuing to work with Exelixis to develop XL309 for the potential to treat cancer patients globally.”