Intellia Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug Application for NTLA-5001, its CRISPR/Cas9-Engineered TCR-T Cell Candidate for Acute Myeloid Leukemia

Excerpt from the Press Release:

• NTLA-5001 is Intellia’s first ex vivo candidate using its proprietary cell engineering process for the treatment of cancer to enter clinical study
• NTLA-5001 targets Wilms’ Tumor 1 (WT1), an overexpressed intracellular antigen on many hematologic malignancies and solid tumors
• Initiation of patient screening in Phase 1/2a study of NTLA-5001 expected by year-end

CAMBRIDGE, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, today announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for NTLA-5001, the company’s first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. NTLA-5001 is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor (WT1) antigen for the treatment of all genetic subtypes of acute myeloid leukemia (AML). Intellia intends to initiate patient screening by year-end in a Phase 1/2a study evaluating NTLA-5001 in adults with persistent or recurrent AML who have previously received first-line therapy.

“The FDA’s acceptance of our IND for NTLA-5001 is an important milestone in our pursuit of developing advanced cell therapies utilizing Intellia’s proprietary engineering platform to treat patients with cancer. NTLA-5001 is our first wholly-owned ex vivo candidate to enter the clinic, and we expect to initiate this first-in-human study in adults with AML by year-end. Our treatment strategy is to leverage CRISPR/Cas9 genome editing technology to create next-generation engineered immune cells with the potential to attack cancer cells more effectively and safely than previously developed cell therapies,” said Intellia President and Chief Executive Officer John Leonard, M.D. “Our study is an important first step toward improving treatment for people living with this aggressive form of cancer. AML is the most common type of acute leukemia in adults, that, despite currently available treatments, has a five-year survival rate of less than 30 percent.”

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