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Menarini Group and Insilico Medicine Sign Exclusive Global License Agreement for Novel KAT6 Inhibitor for Potential Treatment of Breast Cancer and Other Oncology Indications

FLORENCE, Italy and NEW YORK, Jan. 5, 2024 /PRNewswire/ — The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a Menarini Group’s wholly-owned subsidiary focused on bringing transformational oncology treatments to cancer patients, along with clinical-stage generative artificial intelligence (AI)-powered biotechnology company Insilico Medicine (“Insilico”), today announced that it has signed a exclusive licensing agreement granting Stemline global rights to develop and commercialize a novel small molecule KAT6A inhibitor designed using the AI ​​platform, as a potential treatment for hormone-sensitive cancers and other oncology indications.

Breast cancer is the most frequently diagnosed type of tumor and the leading cause of cancer death among women worldwide.[1] Approximately 70% of breast cancers are estrogen receptor (ER) positive, and endocrine therapy remains the backbone of treatment for patients with ER breast cancer. However, tumors can develop resistance to endocrine therapy, which in turn can lead to disease progression. This is a major clinical challenge and highlights the urgent need for new therapies to help overcome treatment resistance.

KAT6A is known to play an important role in several cancers. KAT6A overexpression correlates with poor clinical outcomes in patients with ER/HER2- breast cancer, the most common subtype of breast cancer. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6A in multiple CDX and PDX models with good efficacy and safety. Insilico presented data on the molecule at the San Antonio Breast Cancer Symposium in early December.

“We are delighted to enter into a collaboration with Insilico that harnesses the power of generative AI as a leader in the field, to explore a promising new treatment approach and potentially unlock transformative new cancer therapies,” said Elcin Barker Ergun, CEO of Menarini Group. “Having brought the first innovation in endocrine therapy after almost 20 years to the United States and Europe with elacestrant for patients with ER, HER2- breast cancer, we aim to further increase patient outcomes, and target KAT6A can potentially serve that purpose in breast cancer and beyond.”

The new molecule was designed by Insilico’s R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6A and block the endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance. to endocrine therapies due to mutation or constitutive activation of the ligand-independent ER. Currently, endocrine therapy in combination with CDK4/6 inhibitors is the standard treatment for ER/HER2- breast cancer patients with advanced or metastatic disease. New combinations with CDK4/6 inhibitors and/or new oral SERDs are needed to further extend the results.

“We are excited about the promise of our latest AI-designed generative therapy to provide a potential new treatment option for patients with breast cancer,” said Alex Zhavoronkov, PhD, founder and co-CEO of Insilico Medicine. “With its innovative vision and deep focus on delivering transformative therapies in oncology, Stemline is the ideal partner to lead this molecule into development and clinical trials.”

Under the terms of the agreement, Stemline will provide an upfront payment of $12 million to Insilico. The combined value of the deal, including all commercial, regulatory and development milestones, exceeds $500 million, followed by up to double-digit royalties.

About Menarini Group

Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of more than $4.4 billion and more than 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information, 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 therapies. Stemline markets ORSERDU® (elacestrant) in the United States and the EU, an oral endocrine therapy indicated for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative postmenopausal women or adult men. , advanced or metastatic breast cancer with ESR1 mutation with disease progression after at least one line of endocrine therapy. Stemline also markets ELZONRIS® (tagraxofusp-erzs), a novel CD123-targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasia (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in US and EU to date. Stemline also markets NEXPOVIO® (selinexor), an XPO1 inhibitor for multiple myeloma, in Europe. Stemline also has an extensive clinical portfolio of small molecules and biologics in various stages of development for a variety 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 artificial intelligence platforms that use deep generative models, reinforcement learning, transformers and other modern machine learning techniques for the discovery of novel targets and the generation of novel molecular structures with desired properties. Insilico Medicine is developing innovative solutions to discover and develop innovative medicines for cancer, fibrosis, immunity, diseases of the central nervous system, infectious diseases, autoimmune diseases and diseases related to aging. www.Insilico.com

[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4. doi: 10.3322/caac.21660. Epub ahead of print. PMID: 33538338.

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