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Company Statements

KITE ANNOUNCES U.S. FDA CLEARANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR KITE-222, AN ANTI-CLL-1 CAR T-CELL THERAPY CANDIDATE FOR ACUTE MYELOID LEUKEMIA

-- Kite to Initiate Multi-Center Clinical Study for a CAR T-Cell Therapy in Acute Myeloid Leukemia --

Santa Monica, Calif. – February 9, 2021 – Kite, a Gilead Company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KITE-222, the company’s first chimeric antigen receptor (CAR) T-cell therapy targeted at C-type lectin-like molecule-1 (CLL-1). Kite plans to initiate a multi-center Phase 1 clinical trial evaluating KITE-222 in relapsed/refractory acute myeloid leukemia (AML) later this year.

“The clearance of our IND application for KITE-222 is an important milestone against the ambitious and innovative aims of our CAR T development program,” said Francesco Marincola, MD, Kite’s Senior Vice President and Global Head of Cell Therapy Research. “As the leader in cell therapy, Kite has established the industry’s first-ever CAR T franchise of CD19-targeted therapies and we are broadening our research approach with CLL-1 in AML, where CAR T development has historically been limited due to the lack of a specific target. We look forward to initiating our multicenter CAR T study for patients with AML who are greatly in need of novel treatment approaches.” 

About KITE-222

KITE-222 is an autologous T cell therapy engineered with a CAR that specifically targets CLL-1. CLL-1 expression is restricted to lineage-committed myeloid cells and does not appear on healthy hematopoietic stem cells. In pre-clinical studies, KITE-222 has demonstrated robust antigen-specific function of CAR T cells and the ability to clear AML cells in aggressive tumor models.

KITE-222 is investigational and not approved anywhere globally. Its efficacy and safety have not been established.

About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML starts in the bone marrow and can quickly move to the blood and other parts of the body, including the lymph nodes, spleen and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults is only 24 percent. Among patients with relapsed/refractory disease, the need is greatest, where there is currently no standard of care, and overall survival is approximately 3 to 9 months.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

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.

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 possibility that Kite may be unable to initiate the Phase 1 clinical study evaluating KITE-222 in relapsed/refractory AML in the currently anticipated timelines or at all and the possibility of unfavorable results from clinical studies involving KITE-222. 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 September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation 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.