FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will invest $300 million to acquire a 49.9 percent equity interest in Tizona Therapeutics, Inc., a privately held company developing first-in-class cancer immunotherapies. Gilead will also receive an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion, including an option exercise fee and potential future milestone payments.
Gilead can exercise its option to acquire the remainder of Tizona following the readout of a Phase 1b study of Tizona’s investigational antibody, TTX-080, or earlier if Gilead decides to do so. TTX-080, discovered by Tizona, is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types. The expression pattern of HLA-G often appears distinct from that of PD-(L)1, suggesting potential utility to address tumors that do not respond to current anti-PD-(L)1 treatments and to deepen responses in tumors that are sensitive to anti-PD-(L)1 therapies.
The U.S. Food and Drug Administration has cleared Tizona’s Investigational New Drug (IND) application for TTX-080, and in the third quarter of this year, Tizona plans to initiate a Phase 1 clinical trial evaluating TTX-080 both as a monotherapy and in combination with other agents in patients with advanced cancers.
“Tizona is pursuing first-in-class cancer immunotherapies that could make an important difference in oncology by helping patients who don’t respond to current checkpoint inhibitors,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “This agreement with Tizona adds to the significant progress we’ve made in the first half of this year in building out a strong and diverse immuno-oncology pipeline. We now have multiple opportunities to develop novel therapies that will improve the treatment of cancer.”
“Gilead’s support will enable Tizona to accelerate and broaden our TTX-080 clinical program while also enabling us to rapidly advance our rich, first-in-class preclinical portfolio and target validation efforts,” said Scott Clarke, Chief Executive Officer, Tizona. “Our mission is dedicated to translating novel scientific insights into first-in-class immunotherapies and Gilead is a partner that shares our passion for science and delivering breakthrough innovation to people with cancer.”
Terms of the Agreement
Under the terms of the agreement, Tizona equity holders will receive $300 million upon closing. Gilead will obtain a 49.9 percent equity stake and an exclusive option to purchase the remaining equity exercisable following the completion of Phase 1b studies for TTX-080, or earlier if Gilead chooses. Tizona equity holders will be eligible to receive up to $1.25 billion in an option exercise fee and potential future milestone payments. Gilead will also provide funding to support Tizona’s ongoing research and development to advance its novel pipeline.
The transaction is expected to close in the third quarter of this year and is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Gilead will have the right to appoint two individuals to Tizona’s Board of Directors upon closing of the transaction.
Tizona will spin off TTX-030, the company’s investigational, first-in-class anti-CD39 antibody partnered with AbbVie, into a separate entity prior to closing of this transaction. TTX-030 is not subject to this agreement.
TTX-080 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.
Cowen is acting as financial advisor and Ropes & Gray is acting as legal counsel to Gilead. Latham & Watkins is acting as legal counsel and Squire Patton Boggs is acting as IP counsel to Tizona.
About Tizona Therapeutics
Tizona is a privately held, clinical-stage immunotherapy company that develops first-in-class medicines to deliver transformational benefits for people with cancer. Tizona translates scientific breakthroughs into therapeutics that stimulate the immune system and counter immune suppression. Its novel pipeline includes the clinical-stage TTX-080, an anti-HLA-G antibody, and rich preclinical portfolio. Tizona investors include MPM, Canaan, Abingworth, Interwest Partners, Lightstone Ventures, Amgen Ventures, Astellas Venture Management, and AbbVie Ventures.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of the parties to close this transaction in a timely manner or at all, the ability of the parties to initiate and complete clinical trials involving TTX-080 in the currently anticipated timelines or at all, the possibility of unfavorable results from one or more of such trials involving TTX-080, the ability of the parties to meet potential milestones in the estimated timelines or at all and the risk that the parties may not realize the expected benefits of this collaboration. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.