Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly owned subsidiary of Menarini Group focused on providing transformative oncology treatments to cancer patients, and Insilico Medicine (“Insilico”), a clinical-stage generative artificial intelligence (AI)-based biotechnology company, today announced that the companies have entered into an exclusive licensing agreement Stemline granted global rights to develop and commercialize a preclinical small molecule that targets a high unmet need in oncology.
- This is the second compound that the Menarini Group has licensed from Insilico Medicine and developed through their generative AI platform, similar to the KAT6 inhibitor (MEN2312), which was licensed for the preclinical phase a year ago and is rapidly in use the clinical phase passed.
- As part of the agreement, Menarini Group receives worldwide rights to develop and commercialize the active ingredient. The agreement includes an upfront payment of $20 million and the total value, including all development, regulatory and commercial milestones, is over $550 million, followed by tiered royalties.
The compound is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad spectrum of solid tumor diseases, developed with the help of Chemistry42, Insilico’s generative chemical AI engine, and Insilico’s drug discovery team. The active ingredient has successfully completed preclinical development and demonstrated broad anti-tumor activity in selected cancer types.
“We are excited about our second collaboration with Insilico Medicine, a leader in generative AI, on a highly selective and potentially best-in-class small molecule targeting a broad spectrum of cancers,” said Elcin Barker Ergun, CEO of Menarini Group. “This compound will help us move into new areas of high unmet need and expand the tumor areas where we can help cancer patients with breakthrough therapies.”
“Our experience to date with Menarini Stemline has demonstrated that the company is efficient, agile and strategic, committed to rapidly delivering the best novel therapeutic solutions to cancer patients, thereby maximizing the program’s likelihood of success,” said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. “Menarini Stemline’s strategically visionary management is rapidly transforming the field of oncology and we are excited about the company’s commitment to improving patient lives around the world to extend and participate.”
As part of the agreement, Stemline will make an upfront payment of $20 million to Insilico. The total value of the agreement, including all development, regulatory and commercial milestones, is over $550 million, followed by tiered royalties.
Prior to this collaboration, in January 2024, Menarini Group and Insilico entered into an exclusive licensing agreement for MEN2312, an innovative small molecule for the treatment of breast cancer and other oncology indications.
About MEN2312
MEN2312 was developed by Insilico’s R&D team using its end-to-end Pharma Generative AI platform to inhibit KAT6 and block the endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies that due to mutation or ligand-independent constitutive estrogen receptor (ER) activation. In preclinical studies, the molecule has demonstrated potent inhibition of KAT6 in multiple CDX and PDX models with good efficacy and safety.
Information about Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company with revenues of over $4.7 billion and over 17,000 employees. Menarini focuses on therapeutic areas with high unmet need for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia products. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information please visit menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”), a wholly owned subsidiary of Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline markets ORSERDU® ( Elacestrant), an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive human epidermal disease Stemline also markets ELZONRIS® (Tagraxofusp-erzs), a novel CD123-targeted treatment for patients with growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression after at least one endocrine therapy blastic plasmacytoid dendritic cell neoplasms (Blastic Plasmacytoid Dendritic Cell Neoplasm, BPDCN), an aggressive one hematologic cancer in the United States and Europe, which is currently the only approved treatment for BPDCN in the United States and the EU. Stemline also markets NEXPOVIO® (selinexor), an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development across a range of solid and hematologic cancers.
About Insilico Medicine
Insilico Medicine, a global clinical-stage biotechnology company powered by generative AI, combines biology, chemistry and clinical trial analysis with next-generation AI systems. The company has created AI platforms that use deep generative models, reinforcement learning, transformers and other advanced machine learning techniques to discover new targets and engineer molecular structures with desired properties. Insilico Medicine develops breakthrough solutions to discover and develop innovative medicines for cancer, fibrosis, central nervous system diseases, infectious diseases, autoimmune diseases and age-related diseases. www.insilico.com
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