Nurix Therapeutics has temporarily halted a phase 1 trial for its B-cell malignancy drug, NX-2127, as it undertakes a manufacturing process upgrade. The FDA imposed this partial hold after Nurix informed them of their intention to enhance the manufacturing process for NX-2127, a small molecule designed to target BTK and IKZF3 degradation. Consequently, patient screening and enrollment for the phase 1 study, focusing on 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. 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.”
– Nurix CEO Arthur Sands, M.D., Ph.D
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It’s worth highlighting that Nurix’s other drug programs remain unaffected by the FDA’s decision. The biotech earned recognition for its portfolio earlier this year when Gilead Sciences invested in the first licensing option arising from their 2019 partnership, granting Gilead exclusive rights to Nurix’s IRAK4 degrader, NX-0479, in exchange for an upfront payment of $20 million and potential milestone payments of $425 million.
In September, Nurix further strengthened its position through a $60 million collaboration with Seagen to develop a novel class of antibody drugs known as degrader-antibody conjugates.
Despite the FDA’s partial hold, investors have shown confidence in Nurix, with the company’s stock experiencing only a slight decline to $5.50 per share during premarket trading, marking a 3% drop from the wednesday closing price of $5.66.
