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Biotechnology News Magazine

Caris Life Sciences and HotSpot Therapeutics Announce Collaboration to Advance Precision Medicine Development for Difficult-to-Drug Therapeutic Targets

Preferred Portfolio Partnership with Caris Will Streamline Development of HotSpot's Portfolio by Integrating Broad Tissue and Liquid Molecular Profiling, Artificial Intelligence Driven Mining of Large Datasets, and Clinical-Translational Innovations to Deliver Novel Allosteric Medicines to Patients

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Caris Life Sciences ®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first- and best-in-class allosteric therapies targeting regulatory sites on proteins referred to as “natural hotspots,” today announced a strategic partnership to advance precision medicine approaches for HotSpot’s emerging product portfolio.

The partnership will focus initially on two therapeutic programs, the first of which is HotSpot’s novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy, spanning from pre-First in Human (FIH) trials through potential Companion Diagnostics (CDx) and launch.

“HotSpot’s Smart Allostery™ drug discovery platform is built on AI-enabled technologies unlocking a cutting-edge pipeline of small molecules designed against difficult-to-drug or yet to be drugged targets in cancer and autoimmune disease,” said Jonathan Montagu, Co-Founder and Chief Executive Officer of HotSpot Therapeutics. “Access to Caris’ comprehensive suite of tissue and liquid profiling, real-world data, and broader capabilities will enable robust interrogation of large datasets to accelerate our drug development efforts. This collaboration will yield data-informed insights to inform and speed clinical development and rapidly deliver new treatment options to patients.”

Since the launch of its molecular profiling service in 2009, Caris has amassed molecular data on more than 356,000 patients and clinical outcomes on more than 275,000 patients. Insights gained from Caris’ best-in-class real-world clinico-molecular matched database will be leveraged to optimize HotSpot’s development programs, including cohort design, biomarker strategy, and future CDx needs and strategies. Under the terms of the agreement, patients enrolled in HotSpot’s Phase 1 through Phase 3 trials will undergo longitudinal testing with Caris’ comprehensive tissue and liquid molecular profiling analysis. Through their combined expertise and innovative technology platforms, Caris and HotSpot will work together to bring forward novel treatment options that maximize benefits to patients.

“Our partnership with HotSpot Therapeutics aligns with our organizations’ shared passion to bring comprehensive data to bear for patients and amplify our impact on precision medicine,” said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. “Our breadth and depth of whole exome and whole transcriptome sequencing will provide important information at the individual patient level both in tissue and in blood, and the amount of actionable data generated per patient from HotSpot’s studies will be unprecedented, potentially translating into smarter trials and an acceleration of benefit to patients.”

In addition to the commitment to profiling and real-world data insights, Caris is granted negotiation rights for CDx programs of partnership therapeutic programs. While detailed partnership financial terms have not been disclosed, the financial commitment is based on program specifics and has the potential to exceed $40 million if programs progress through regulatory approval and additional milestones are met.

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