FDA places Nurix's cancer drug on partial hold while manufacturing process upgraded

Nurix Therapeutics has had a phase 1 trial of its B-cell malignancy drug put on partial hold by the FDA while the biotech revamps its manufacturing process.

The hold follows the company alerting the FDA that it was planning to improve the manufacturing process for NX-2127, a small molecule that drives targeted BTK and IKZF3 degradation. It means screening and enrollment of new patients for the phase 1 study in relapsed or refractory B-cell malignancies has been paused.

“The initial NX-2127 manufacturing process produced a phase 1 drug product that has yielded important proof-of-concept results with meaningful clinical responses in patients with advanced B-cell malignancies,” Nurix CEO Arthur Sands, M.D., Ph.D., said in the postmarket release Nov. 1.

"While the partial hold is in effect, we will supply the current drug product for patients who continue on therapy in the phase 1 study and will work expeditiously with FDA to introduce the improved NX-2127 manufacturing process and drug product into our clinical development plan,” Sands explained.

Nurix’s other drug programs are not affected by the FDA’s decision, the biotech stressed. The company received a welcome show of faith in its portfolio back in March when Gilead Sciences bought into the first licensing option stemming from a 2019 collaboration, giving the Big Pharma exclusive rights to Nurix’s IRAK4 degrader NX-0479 in exchange for $20 million in upfront cash and $425 million in biobucks.

This was followed up in September when Seagen paid $60 million to Nurix to collaborate on an intriguing new class of antibody drugs called degrader-antibody conjugates.

Investors appeared unfazed by the FDA’s move, with Nurix’s stock down very slightly at $5.50 per share in premarket trading Thursday, a 3% drop on its Wednesday closing price of $5.66.