• This is the second asset Menarini Group has inlicensed from Insilico Medicine which was discovered through their generative AI platform, similar to the preclinical stage KAT6 inhibitor (MEN2312) licensed a year ago and which advanced rapidly into the clinical phase.

• Under the agreement, Menarini Group will be granted global rights to develop and commercialize the asset. The deal includes a $20m upfront payment, and the combined value, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties.

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, today announced 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.

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.

About The Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com.

About Stemline Therapeutics Inc.

Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU? (elacestrant) in the U.S. and in the E.U., an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS? (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes NEXPOVIO? (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com