Nurix Therapeutics, a clinical-stage company known for developing drugs that adjust protein levels to target cancer and inflammatory diseases, has announced a significant milestone. The European Medicines Agency (EMA) has designated its drug, NX-5948, for PRIME (PRIority MEdicines) status. This innovative drug, which selectively degrades Bruton’s tyrosine kinase (BTK), is aimed at treating adults suffering from advanced chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) that show resistance despite previous treatments with BTK and BCL-2 inhibitors. To qualify for PRIME, a medicinal product must address unmet medical requirements and exhibit potential advantages for patients based on initial clinical research.
This recognition is crucial given the growing patient population whose conditions worsen even after undergoing treatment with both BTK and BCL-2 inhibitors, expressed Arthur T. Sands, the current CEO and president of Nurix. “The designation reflects positive results we’ve gathered so far in terms of safety and effectiveness from our ongoing Phase 1 trial,” he explained, further emphasizing the significant potential NX-5948 shows independent of typical resistance-causing mutations.
Since 2016, the PRIME framework by the EMA has aimed to promote and expedite the development of promising drugs, ensuring they reach those in need at a quicker pace by offering immediate and comprehensive support during the development phases.
NX-5948, an experimental drug, is a small molecule capable of penetrating brain barriers and is orally administered. It works by targeting BTK—a pivotal protein that propels B cell growth—by utilizing the ubiquitin proteasome system for degradation. Current evaluations for NX-5948 are taking place in a Phase 1 trial involving patients confronting recurring or treatment-resistant B cell cancers. Nurix has previously revealed that NX-5948 is effective against various cancer cell lines, even those resistant to existing BTK inhibitor treatments, particularly relevant for patients with advanced CLL/SLL. Information on this ongoing clinical trial is available on clinicaltrials.gov (NCT05131022).
Nurix Therapeutics specializes in the innovation, development, and subsequent commercialization of novel small molecules and antibody treatments that modulate enzyme activity in cells, providing new avenues for managing conditions such as cancer and inflammatory diseases.