Florence, Italy and New York (ots/PRNewswire) – Menarini Group (“Menarini”) is a leading international manufacturer of pharmaceuticals and diagnostic products, Stemline Therapeutics, Inc. (“Stemline”) a wholly owned subsidiary of Menarini Group, dedicated to helping cancer patients with transformative oncology therapies. Together with Insilico Medicine (“Insilico”), a generative artificial intelligence (AI)-powered clinical-stage drug discovery biotechnology company, the companies today announced that Stemline has received an exclusive license agreement for worldwide rights Using Insico’s AI platform to develop and commercialize a new, small molecule KAT6A inhibitor that could be a treatment option for hormone-sensitive cancers and other oncological indicators.
- KAT6 is a novel target in hormone-sensitive breast cancer tumors and other cancers. Overexpression of KAT6A/B is associated with poor clinical outcomes in patients with ER+/HER2- breast cancer, one of the most common subtypes.
- The molecule showed high preclinical activity. Insilico presented data on this new molecule at the San Antonio Breast Cancer Symposium in early December.
- The agreement includes upfront and milestone payments with a total potential of over $500 million, as well as royalties.
Breast cancer is one of the most frequently diagnosed tumor types and is one of the leading causes of cancer-related deaths in women worldwide.[1] Approximately 70% of breast cancer tumors are estrogen receptor positive (ER+). Endocrine therapy is and remains the treatment of choice for ER+ breast cancer. However, tumors can develop resistance to endocrine therapy, which can lead to worsening of the disease. This is a major clinical challenge and shows how important it is to develop new forms of therapy that can overcome treatment resistance.
KAT6A plays an important role in many types of cancer. Overexpression of KAT6A is associated with poor clinical outcomes in patients with ER+/HER2- breast cancer, one of the most common subtypes. In preclinical studies, the molecule demonstrated potent inhibition of KAT6A in multiple CDX and PDX models with good efficacy and safety. Insilico presented data on this molecule at the San Antonio Breast Cancer Symposium in early December.
“We look forward to working with Insilico. “It gives us as a leading company the opportunity to use generative AI to explore a promising new treatment approach and develop potentially transformative new cancer therapies,” said Elcin Barker Ergun, CEO of Menarini Group. “With Elacestrant, we have in the US and Europe After almost 20 years, the first innovation in endocrine therapy for ER+ and HER2- breast cancer patients has been brought onto the market. Our goal is to further improve the treatment results of patients. KAT6A as a target can prove to be extremely effective not only in breast cancer. “
The new molecule was developed by the R&D team at Insilico using a pharmaceutical-specific generative AI platform to inhibit KAT6A and block the endocrine receptor (ER) at the transcription level. This opens up the opportunity to overcome resistance to endocrine therapies that can develop due to mutations or ligand-independent constitutive activation of ER. Currently, endocrine therapy in combination with CDK4/6 inhibitors is considered the standard treatment for ER+/HER2- breast cancer patients with advanced metastases. New combinations with CDK4/6 inhibitors and/or new orally administered SERDs are required to further expand on the results.
“Our latest therapy developed using generative AI is very promising. It could represent a new treatment option for breast cancer patients,” explains Dr. Alex Zhavoronkov, founder and co-CEO at Insilico Medicine. “With its innovative vision and focus on transformative oncology therapies, Stemline is the ideal partner to further develop this molecule and through the clinical trials.”
As part of the agreement, Stemline will pay Insilico $12 million up front. The total value of the agreement, including all development, regulatory and commercial milestones, is over $500 million, followed by double-digit royalties.
Information about the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company with revenues of over $4.4 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, see 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) in the United States and the EU, an oral endocrine therapy 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 after at least one endocrine therapy. Stemline also markets ELZONRIS® (Tagraxofusp-erzs), a novel CD123-targeted treatment for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer in the United States and Europe is currently the only approved treatment for BPDCN in the US and 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.
Information about Insilico Medicine Insilico Medicine, a generative artificial intelligence (AI)-powered international clinical-stage drug discovery biotechnology company, combines biology, chemistry and clinical trial analysis using state-of-the-art 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 for the discovery and development of innovative medicines for the treatment of cancer, fibrosis, immunity, central nervous system diseases, infectious diseases and age-related diseases. 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. (International Cancer Statistics 2020: GLOBOCAN estimates of global incidence and mortality for 36 types of cancer in 185 countries). CA Cancer J Clin. February 4, 2021 doi: 10.3322/caac.21660. Epub before print version. PMID: 33538338.
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