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

Rhea-AI Summary

Kite, a Gilead Company (Nasdaq: GILD), has signed a worldwide license agreement with Refuge Biotechnologies for exclusive rights to its gene expression platform aimed at developing treatments for blood cancers. This partnership seeks to enhance CAR T-cell therapies' efficacy and safety through innovative gene regulation. Kite will assume all costs related to research and commercialization and will make an upfront payment to Refuge, which may also receive milestone payments based on performance. Kite aims to broaden patient access to CAR T therapies with this collaboration.

Positive

• Kite secures exclusive rights to Refuge's proprietary gene expression platform for blood cancer treatments, enhancing its CAR T-cell therapy portfolio.
• The collaboration aims to improve efficacy and safety of existing CAR T-cell therapies, potentially leading to better patient outcomes.
• Kite's commitment to covering all costs for research, development, and commercialization indicates strong investment in advancing cancer therapies.

Negative

• Kite bears all financial responsibilities for the agreement, which may impact its short-term financials.
• The forward-looking statements indicate uncertainties regarding the potential success of the collaboration and the risks associated with clinical trials.

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

SANTA MONICA, Calif. & MENLO PARK, Calif.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221020005633/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Tracy Rossin, Media

trossin@kitepharma.com

Source: Gilead Sciences, Inc.

FAQ

What is the significance of Kite's licensing agreement with Refuge Biotechnologies?

The agreement allows Kite to use Refuge's gene expression platform to enhance its CAR T-cell therapies for blood cancers.

What are the financial implications of the agreement for Gilead (GILD)?

Kite will cover all costs related to research and development, which could affect its financials, and it will provide an upfront payment to Refuge.

How does this agreement impact CAR T-cell therapy development?

The partnership aims to improve the safety and effectiveness of CAR T-cell therapies, potentially benefiting more patients.

What are the risks mentioned in the press release regarding the agreement?

Risks include the possibility of not realizing anticipated benefits, unanticipated expenses, and unfavorable clinical trial results.