Menarini Group and Insilico Medicine Enter a Second Exclusive Global License Agreement for an AI Discovered Preclinical Asset Targeting High Unmet Needs in Oncology

On January 10, 2025 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported that the companies 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 (Press release, Menarini, JAN 10, 2025, View Source [SID1234649607]).

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The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, devel oped 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.

"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.

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.

About MEN2312

MEN2312 was designed by Insilico’s R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6 and block endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies due to mutation or ligand-independent constitutive activation of ER. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6 in multiple CDX and PDX models with good efficacy and safety.