Nurix gets BTK degrader back on track after FDA lifts partial hold

Preview

来源: FierceBiotech

Nurix now plans to restart enrollment, prioritizing patients with aggressive forms of non-Hodgkin lymphoma.

Nurix is hoping to continue to surf the wave of interest in its BTK degraders now that the FDA has lifted a partial hold on a phase 1 trial of a B-cell malignancy drug.

The agency placed the hold in November 2023 after Nurix alerted the FDA it was planning to improve the manufacturing process for NX-2127, a small molecule that drives targeted BTK and IKZF3 degradation. The change meant that screening and enrollment of new patients for the phase 1 study in relapsed or refractory B-cell malignancies was paused.

“We are pleased with the timely resolution of the partial clinical hold, which allows us to reinitiate enrollment in the NX-2127 phase 1 study utilizing drug product from our new manufacturing process,” Nurix’s Head of Clinical Development Paula O’Connor, M.D., said in a statement this morning. “Following our clinical data disclosures at the American Society of Hematology Annual Meeting last year and the recent scientific publication in the journal Science, we are seeing an acceleration of interest in our BTK degrader programs.”

Nurix now plans to restart enrollment, prioritizing patients with aggressive forms of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma where durable complete responses have 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,” the biotech explained.

Nurix has already seen some interest from Big Pharma. Gilead Sciences bought into the first licensing option stemming from a 2019 collaboration last year, snagging exclusive rights to Nurix’s IRAK4 degrader NX-0479 in exchange for $20 million in upfront cash and $425 million in biobucks. And in September 2023, Seagen paid $60 million to Nurix to collaborate on degrader-antibody conjugates—a new class of antibody therapies that are also being pursued by the likes of Merck & Co.

Nurix’s shareholders seemed relatively unfazed by the FDA’s hold in the fall and responded to today’s news with an equally negligible 1% bump in the company’s share price to $15.01 in pre-market trading Monday.

Since the hold was implemented, Nurix has read out phase 1a dose escalation and phase 1b dose expansion data for NX-2127 in chronic lymphocytic leukemia, mantle cell lymphoma and diffuse large B-cell lymphoma. The drug induced “robust and sustained degradation of BTK and biologically relevant degradation of IKZF1,” according to Nurix.

The biotech’s other clinical-stage BTK degrader, called NX-5948, is being studied in a phase 1 trial of adults with relapsed or refractory B-cell malignancies. Nurix expects to expand the study into patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma this year.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。