KITE ANNOUNCES U.S. FDA CLEARANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR KITE-363, A DUAL-TARGETING CAR T-CELL THERAPY CANDIDATE FOR LARGE B-CELL LYMPHOMA
— KITE-363 is Company’s First Dual-Targeting CAR T-Cell Therapy to Proceed to Phase 1 Study —
— Multi-Center Clinical Trial in Large B-Cell Lymphoma to Launch by End of 2021 —
Santa Monica, Calif., – August 19, 2021 – Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KITE-363, the company’s first chimeric antigen receptor (CAR) T-cell therapy targeted against two antigens, CD19 and CD20. With this clearance, Kite plans to initiate a multi-center Phase 1 clinical trial evaluating KITE-363 in large B-cell lymphoma (LBCL) by the end of this year.
“CD19-directed CAR T-cell therapies have transformed outcomes for patients with relapsed or refractory large B-cell lymphomas, and we are excited to continue our research on the next generation of potential cell therapy advances for patients,” said Francesco Marincola, MD, Kite’s Senior Vice President and Global Head of Cell Therapy Research. “KITE-363 which targets two antigens highly expressed in large B-cell lymphomas – CD19 and CD20 – is the next step forward in our research that may improve current treatments to help more patients.”
KITE-363 is an autologous T cell therapy engineered to specifically target both CD19 and CD20. In pre-clinical studies, KITE-363 has demonstrated robust antigen-specific CAR T cell function against either target. KITE-363 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.
About Large B-Cell Lymphoma (LBCL)
LBCL is an aggressive subtype of B-cell non-Hodgkin lymphoma (NHL) accounting for 30% to 40% of NHL cases with approximately 22,000 new diagnoses in the U.S. each year. About 40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to treatment. Among patients with relapsed or refractory disease, there remains an unmet need for novel therapies to further increase the durability of response.
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial 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.
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.
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 Kite’s ability to initiate and complete clinical trials in the anticipated timelines or at all, including the Phase 1 clinical trial evaluating KITE-363 in LBCL. There is also the possibility of unfavorable results clinical trials involving KITE-363. 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, 2021, 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. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are 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 or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.