Benzinga | Nov 12, 2021 07:15AM EST

Nurix Therapeutics Reports Clearance Of Investigational New Drug Application For DeTIL-0255 For Variety Of Solid Tumors

Food and Drug Administration clears DeTIL-0255 to initiate Phase 1 clinical trial

Phase 1 clinical trial initiation anticipated by year-end 2021

SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Food and Drug Administration (FDA) has cleared Nurix's Investigational New Drug Application (IND) for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte (TIL) therapy. DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patient's tumor expanded ex vivo with NX-0255, a small molecule Casitas B lineage lymphoma-b (CBL-B) inhibitor developed by Nurix. DeTIL-0255 is a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Based on extensive preclinical characterization, Nurix believes DeTIL-0255 could allow a broader application of TIL therapy in a range of solid tumors. DeTIL-0255 will be the subject of a poster presentation by Nurix at the Society for Immunotherapy of Cancer (SITC) conference held at the Washington Convention Center on Saturday, November 13. DeTIL-0255 complements Nurix's oral CBL-B inhibitor drug candidate, NX-1607, which is currently in a Phase 1a clinical trial.

"Given the favorable phenotypic characteristics of TIL developed in our CBL-B inhibitor program, we believe DeTIL-0255 has the potential to be an effective cell therapy for a wide variety of advanced malignancies," said Dr. Robert Brown, Nurix's senior vice president of clinical development. "Our initial clinical focus for DeTIL-0255 will be for patients with gynecological cancers where the unmet medical need is high and where we believe our drug-enhanced TIL approach may help patients."

The Phase 1 trial of DeTIL-0255 is an open-label, non-randomized clinical trial anticipated to enroll up to 50 patients with gynecological malignancies following a safety run-in. The three expansion cohorts will enroll either patients with recurrent or persistent platinum-resistant epithelial ovarian cancer, patients with recurrent, metastatic, or persistent cervical cancer, or patients with advanced or recurrent endometrial cancer. Nurix is currently working to initiate this trial at multiple sites in the United States that have experience in conducting TIL and other adoptive cell therapy (ACT) trials. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT05107739).