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Gilead and Xilio Enter Exclusive License Agreement for Tumor-Activated IL-12 Program

Saturday, March 30, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) have recently announced an exclusive agreement to collaborate on the development and commercialization of Xilio's Phase 1 tumor-activated IL-12 program, known as XTX301.

Xilio Therapeutics is a biotechnology company in the clinical stage that specializes in discovering and developing tumor-activated immuno-oncology therapies. The company employs a proprietary tumor-activation platform to create a range of innovative molecules aimed at optimizing therapeutic effects within the tumor microenvironment while minimizing adverse effects. XTX301, currently undergoing Phase 1 evaluation in patients with advanced solid tumors, is a significant focus of their efforts.

Dr. Bill Grossman, Senior Vice President of Oncology Clinical Development at Gilead Sciences, expressed enthusiasm about the partnership, stating that Xilio's tumor-activation platform aligns well with Gilead's focus on challenging cancers. He emphasized the potential of IL-12 to treat various tumor types and the excitement surrounding advancing XTX301 both as a standalone therapy and in combination treatments.

René Russo, Pharm.D., President and CEO of Xilio, also emphasized the importance of Gilead's confidence in their technology and expertise in immuno-oncology. She highlighted the potential of XTX301 to benefit patients with a range of tumor types, including those traditionally less responsive to immunotherapy, while minimizing the severe side effects typically associated with IL-12.

Key terms of the agreement include Gilead obtaining an exclusive global license for XTX301, with upfront payments totaling $43.5 million, comprising a cash payment of $30.0 million and an initial equity investment of $13.5 million in Xilio common stock. Xilio stands to receive up to $604.0 million in additional contingent payments, along with tiered royalties on global net product sales.

Xilio will continue to oversee the clinical development of XTX301 through the ongoing Phase 1 trial. Upon completion of specified clinical milestones, Gilead has the option to assume responsibility for further development and commercialization, subject to terms outlined in the agreement and payment of a transition fee.

The transaction is expected to impact Gilead's 2024 earnings per share by approximately $0.03 to $0.04, with no exclusion of acquired IPR&D expenses from its non-GAAP financial measures.

XTX301, an investigational tumor-activated IL-12, aims to stimulate anti-tumor immunity and alter the tumor microenvironment. Xilio is currently assessing its safety and tolerability in a Phase 1 clinical trial involving patients with advanced solid tumors.



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