The Menarini Group, an international pharmaceutical and diagnostics company, Stemline Therapeutics Inc., a wholly-owned subsidiary of the Menarini Group, and Insilico Medicine, a clinical stage generative artificial intelligence (AI)-driven biotechnology company, have entered into an exclusive licensing agreement granting Stemline the global rights to develop and commercialize a preclinical small molecule targeting high unmet needs in oncology.

The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, developed with the help of Chemistry42, Insilico’s generative chemistry engine, and Insilico’s drug discovery team. The asset has successfully completed preclinical development and has demonstrated broad anti-tumor activity in selected cancers.

Prior to this collaboration, the Menarini Group and Insilico entered an exclusive licensing agreement in January 2024 for MEN2312, an innovative small molecule for breast cancer treatment and other oncology indications.

“We are thrilled to enter our second collaboration with Insilico Medicine, a leader in the field of generative AI, for a highly selective and potentially best-in-class small molecule targeting a broad range of cancers,” said Elcin Barker Ergun, CEO of the Menarini Group. “This asset will help us enter into new areas of high unmet need, expanding the tumor areas where we can help cancer patients with ground-breaking therapies.”

“Our previous experience with Menarini Stemline proved that the company is efficient, agile, strategic, and committed to rapidly delivering the best novel therapeutic solutions to patients with cancer, maximizing the probability of success of the program,” said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. “Menarini Stemline’s strategic visionary management is rapidly re-shaping the field of oncology, and we are very happy to take part in their quest to extend patients’ lives around the world.”

Under the terms of the agreement, Stemline will provide a $20 million upfront payment to Insilico. The combined value of the deal, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties.