Kite and Refuge Biotechnologies Announce Exclusive License Agreement for Investigational Gene Expression Platform for Blood Cancers

By: Gilead Sciences, Inc. via Business Wire

October 20, 2022 at 09:00 AM EDT

-- Agreement Provides Kite with Additional Expertise in Synthetic Biology Space for Oncology --

Kite, a Gilead Company (Nasdaq: GILD) and Refuge Biotechnologies, Inc. (“Refuge”), today announced that Kite has entered into an exclusive, worldwide license agreement with Refuge, a synthetic biology company for cancer immunotherapy, for exclusive rights to utilize Refuge’s proprietary gene expression platform to develop potential treatments for blood cancers.

Refuge’s proprietary platform is a synthetic biology system that utilizes an expression modulation strategy to repress or activate transcription of target genes. Early pre-clinical data suggest a potential for this highly modular platform to regulate target antigen-dependent gene expression as a means to improve upon both the efficacy and safety of first-generation CAR T-cell therapies. Kite will have an exclusive license to Refuge’s intellectual property portfolio for use in blood cancers, as well as a library of synthetic gene expression programs for these indications. Refuge will retain all rights and programs related to solid tumor indications.

“First-generation autologous CAR T-cell therapies have dramatically changed outcomes for people with certain blood cancers yet more work needs to be done to reach additional patients. As the global CAR T-cell therapy leader, Kite is working on the next generation of cell therapies with the goal to improve upon the great results we have today so more patients can benefit,” said Francesco Marincola, MD, Global Head of Cell Therapy Research, Kite. “Through this exclusive license agreement with Refuge’s platform, coupled with our unique in-house research capabilities, we aim to create a new generation of CAR T-cell products to induce long-term remissions for more patients.”

“As a leader in the advancement of cell therapy from research to life-changing therapeutics, Kite is an ideal partner for Refuge as we seek to further evaluate the promise of Refuge’s proprietary platform,” said Jing Zhao, Chief Business Officer, Refuge. “We look forward to collaborating closely with Kite in this area, while continuing to advance our internal therapeutic research and programs focused on solid tumors.”

Under the terms of the agreement, Kite will be responsible for all costs and activities related to research, development, manufacturing and commercialization. Kite will also make an upfront payment to Refuge and Refuge will be eligible to receive potential performance-based regulatory milestone payments.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

About Refuge Biotechnologies

Refuge Biotechnologies is a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy. By connecting ligand specific receptors to dCas, Refuge enables cells to sense its surroundings and conditionally activate or repress multiple genes when they encounter specific external antigens. In particular, with receptor-dCas, immune cells can now be engineered to conditionally turn off or on certain immune-inhibitory or immune-stimulatory genes on-demand, to generate more potent CAR-T immune cells when it senses the presence of a tumor cell. For further information, please visit www.refugebiotech.com.

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 risk that Kite may not realize the anticipated benefits of this licensing agreement with Refuge Biotechnologies; difficulties or unanticipated expenses in connection with the licensing agreement and the potential effect on Kite's earnings; the possibility that the parties may make a strategic decision to terminate this agreement at any time; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving potential treatments for blood cancers developed utilizing Refuge’s proprietary gene expression platform; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

Kite, the Kite logo, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.