RTTNews | Sep 16, 2021 08:40AM EDT

08:39 Thursday, September 16, 2021 (RTTNews.com) - Intellia Therapeutics, Inc. (NTLA) announced Thursday 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 Phase 1/2a study will evaluate the safety, tolerability, cell kinetics and anti-tumor activity of a single dose of NTLA-5001 in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants.

In addition to the U.S., Intellia has also submitted a regulatory application to the U.K. for NTLA-5001.

AML is a cancer of the blood and bone marrow that is rapidly fatal without immediate treatment. It is the most common type of acute leukemia in adults, with more than 20,000 estimated new cases in 2020.

Read the original article on RTTNews ( https://www.rttnews.com/3226274/intellia-says-fda-accepts-ind-for-ntla-5001-to-treat-acute-myeloid-leukemia-quick-facts.aspx)

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