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Nurix Therapeutics Receives PRIME Designation from the European Medicines Agency for NX-5948 for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia
The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation Pivotal trials of
About this update from Nurix Therapeutics, Inc.
[{"type":"text","content":"The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation Pivotal trials of NX-5948 are planned to initiate in 2025 SAN FRANCISCO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the European Medicines Agency (EMA) has granted PRIME designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least a BTK inhibitor and a BCL-2 inhibitor. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data. “PRIME designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed following BTK inhibitor and BCL2 inhibitor therapy,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit as well as mechanistic data supporting the activity of NX-5948 independent of mutations that confer resistance to covalent and non-covalent BTK inhibitors.” The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation so these medicines can reach patients faster. About NX-5948NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is designed to specifically eliminate BTK, a key growth signaling protein in B cells, through degradation by the ubiquitin proteasome system of the cell. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily...