Insilico Medicine Secures Over $550 Million AI-Driven Oncology Deal with Menarini Group for Second Preclinical Candidate

Menarini Group (“Menarini”), an internationally leading pharmaceutical and diagnostics company, together with its wholly owned subsidiary Stemline Therapeutics (“Stemline”), has entered into a licensing agreement with InSilico Medicine, an AI-driven clinical-stage biotechnology company. Under the agreement, Stemline will obtain exclusive global rights to develop and commercialize MEN2312, a preclinical candidate drug from InSilico Medicine that holds promise for addressing significant unmet clinical needs in oncology.

MEN2312, a highly selective, potential best-in-class small-molecule inhibitor developed by InSilico Medicine’s premier drug discovery team with the assistance of its proprietary generative chemistry engine, Chemistry42, inhibits KAT6A and blocks ERα expression at the transcriptional level. This mechanism holds the potential to overcome endocrine therapy resistance caused by ESR1 mutations, positioning MEN2312 as a promising therapeutic candidate for various solid tumors.

In preclinical studies, this molecule has demonstrated potent inhibition of KAT6A in multiple cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models, exhibiting superior efficacy and a favorable safety profile. It has been nominated as the preclinical candidate for the project and is currently in the IND-enabling development stage.

Under the agreement, the total value of this collaboration exceeds $550 million. Stemline Therapeutics will pay InSilico Medicine a $20 million upfront payment, as well as subsequent development, regulatory, and commercial milestone payments. Additionally, InSilico Medicine will be eligible for tiered royalties on net sales. Previously, in January 2024, Menarini entered into an exclusive license agreement with InSilico Medicine for MEN2312, an innovative small-molecule drug for the treatment of breast cancer and other oncology indications.

Elcin Barker Ergun, CEO of Menarini Group, stated: “We are delighted to embark on a second collaboration with InSilico Medicine, a leader in the field of generative AI, to develop a highly selective, potential best-in-class small-molecule inhibitor with promise for treating multiple types of cancer. This asset will enable us to enter the oncology space, where there is a significant unmet need, and expand our capacity to help cancer patients with breakthrough therapies.”

Dr. Alex Zhavoronkov, Founder and CEO of InSilico Medicine, stated: “Our previous collaboration with Menarini has demonstrated that our partner is efficient, agile, and strategically visionary, committed to rapidly delivering optimal innovative treatment solutions to cancer patients while maximizing project success rates. The forward-thinking leadership of the Menarini Group is rapidly reshaping the landscape of oncology therapy, and we are delighted to participate in their endeavor to extend the lives of patients worldwide.”

InSilico Medicine is a generative artificial intelligence (AI)-driven, clinical-stage drug discovery company. By integrating biology, chemistry, and clinical trial analytics through its next-generation AI system, and leveraging modern machine learning techniques such as deep generative models, reinforcement learning, and transformer models, the company has built a powerful and efficient AI-driven drug discovery platform. This platform enables the identification of novel targets and the generation of candidate drugs with specific molecular properties. InSilico Medicine focuses on addressing unmet medical needs in areas including cancer, fibrosis, immunology, central nervous system disorders, and age-related diseases, thereby advancing and accelerating the development of innovative therapeutics.

For more information, please visit www.insilico.com

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Menarini Group is a leading international pharmaceutical and diagnostics company with annual revenues exceeding $4.4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with significant unmet needs, offering products in cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 manufacturing sites and 9 research and development centers, Menarini’s products are marketed in 140 countries and regions worldwide. For more information, please visit www.menarini.com.

Stemline Therapeutics, Inc. (hereinafter referred to as “Stemline”), a wholly owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative oncology therapies. In the United States and the European Union, Stemline has commercialized ORSERDU® (elacestrant), an oral endocrine therapy approved for the treatment of postmenopausal women or adult men with locally advanced or metastatic breast cancer that is ER+/HER2- and harbors ESR1 mutations, and whose disease has progressed following at least one prior line of endocrine therapy.

Stemline is also advancing the commercialization of ELZONRIS® (tagraxofusp-erzs), a novel CD123-targeted therapeutic agent approved for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive cancer. It remains the only therapy approved for BPDCN in both the United States and the European Union to date. In Europe, Stemline has also commercialized NEXPOVIO®, an XPO1 inhibitor for the treatment of multiple myeloma. Furthermore, Stemline maintains a broad pipeline of small molecules and biologics at various clinical stages, aimed at treating a range of solid tumors and hematologic malignancies.