-- Kite is currently enrolling patients in an ongoing Phase 1 trial of KITE-222, the company’s first CAR T-cell therapy candidate in AML --
-- AML causes the largest number of annual leukemia deaths in the U.S. and five-year overall survival in adults is only 27% --
Santa Monica, CA. – September 30, 2022 – Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for KITE-222, the company’s first chimeric antigen receptor (CAR) T-cell therapy targeted at C-type lectin-like molecule-1 (CLL-1), for the treatment of acute myeloid leukemia (AML). Research has shown that CLL-1 is expressed on malignant cells in up to 90% of patients with AML. Kite is currently enrolling patients in a multi-center Phase 1 clinical trial evaluating KITE-222 in participants with relapsed/refractory AML.
The FDA provides ODD to investigational therapies that are intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people in the United States. Approximately 20,000 people in the U.S. are diagnosed with AML each year.
“The FDA’s decision to grant this designation to KITE-222 reflects the urgent need to develop novel therapeutics for people living with AML – a devastating disease with poor prognosis,” said Frank Neumann, MD, PhD, SVP, Kite’s Global Head of Clinical Development. “We look forward to its continued investigation and sharing results with the scientific community.”
More information about Kite’s Phase 1 trial of KITE-222 in participants with relapsed or refractory AML may be found at www.clinicaltrials.gov (NCT04789408).
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%.
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.
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 the possibility that Kite may be unable to progress or complete 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; uncertainties relating to regulatory applications for KITE-222 and related filing and approval timelines; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of KITE-222 and as a result, KITE-222 may never be commercialized; and any assumptions underlying any of the foregoing. These and other risks 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 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.