Gilead & Xilio Ink Exclusive License Agreement to Develop XTX301

Gilead & Xilio Ink Exclusive License Agreement to Develop XTX301

By, Admin 1 April 2024

Gilead, Xilio ink exclusive license agreement to develop and commercialize tumour-activated IL-12 programme, XTX301

Overview

Gilead Sciences, Inc. and Xilio Therapeutics, Inc. announced an exclusive license agreement to develop and commercialize Xilio’s phase 1 tumour-activated IL-12 programme, XTX301.

Xilio Therapeutics

  • Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumour-activated immuno-oncology therapies. 
  • The company is using its proprietary tumor-activation platform to build a pipeline of novel, tumour-activated molecules, including antibodies, cytokines, bispecifics, and cell engagers, which are designed to optimize the therapeutic index and localize anti-tumour activity within the tumour microenvironment. 
  • XTX301 is currently being evaluated in a phase 1 dose escalation trial in patients with advanced solid tumours.

Words from Gilead Sciences

“Xilio’s novel tumour-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, senior vice president, oncology clinical development, Gilead Sciences. “We believe IL-12 has the potential to treat a broad range of tumour types and are excited to partner with Xilio to advance XTX301, a tumour-activated IL-12, as a monotherapy and a combination therapy across a variety of solid tumours.”

Words from CEO: Xilio

“Gilead’s confidence in our tumour-activated technology, combined with their deep expertise in developing and commercializing novel immuno-oncology products, will enable us to accelerate and expand the development of XTX301, our tumour-activated IL-12,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “We look forward to collaborating with Gilead as we seek to deliver on the potential for XTX301 to provide a meaningful benefit for a range of tumour types, including immunologically cold tumours, while overcoming the severe toxicities historically associated with IL-12.”

Terms of the Agreement

  • Under the terms of the agreement, Xilio granted Gilead an exclusive global license to develop and commercialize XTX301, Xilio’s tumour-activated IL-12. 
  • Xilio will receive $43.5 million in upfront payments, including a cash payment of $30 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a premium. 
  • Xilio will be eligible to receive up to $604 million in additional contingent payments, including additional equity investments by Gilead, a transition fee and specified development, regulatory and sales-based milestones. 
  • Xilio will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.

Responsibilities Post- Agreement

  • Xilio will be responsible for conducting clinical development of XTX301 in the ongoing phase 1 clinical trial through dose expansion. 
  • Following the delivery by Xilio of a specified clinical data package for XTX301, Gilead can elect to transition responsibilities for the development and commercialization of XTX301 to Gilead, subject to the terms of the agreement and payment by Gilead of a $75 million transition fee. 
  • Prior to the potential transition fee, Xilio is eligible to receive up to a total of $29 million in additional equity investments and a development milestone payment.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.03 – $0.04.

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