FDA Lifts Partial Clinical Hold on Nurix Therapeutics Study

By Tamara Parker • Monday, March 11 15:27 • Permanent Link

Nurix Therapeutics, Inc. (NASDAQ: NRIX) has recently announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S. phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies. This comes after the company communicated its intention to transition to an improved manufacturing process. Following this announcement, the company's Executive Vice President and Head of Clinical Development, Paula G. O'Connor, M.D., expressed pleasure with the timely resolution and the ability to reinitiate enrollment in the NX-2127 phase 1 study using the new drug product.

Nurix plans to reinitiate enrollment with the new chirally controlled drug substance in a standard dose escalation study within the current phase 1a/1b trial. The company is prioritizing the enrollment of patients with aggressive forms of non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) where durable complete responses have previously been observed. Patients currently enrolled in the clinical study who are deriving clinical benefit from NX-2127 manufactured with the prior process may continue to receive that treatment in accordance with the study protocol.

NX-2127 is a novel bifunctional, orally bioavailable, investigational new drug that degrades Bruton’s tyrosine kinase (BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). It is currently being evaluated in a phase 1 clinical trial in patients with relapsed or refractory B-cell malignancies. This development represents a significant step forward for Nurix Therapeutics, a clinical-stage biopharmaceutical company focusing on the discovery, development, and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels for the treatment of cancer, inflammatory conditions, and other challenging diseases.

The company's clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates the activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California.

Following these announcements, the company's shares moved -4.6%, and are now trading at a price of $14.17. For more information, read the company's full 8-K submission here.

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