Nurix Therapeutics Receives PRIME Designation from the European Medicines Agency for NX-5948 for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia
Nurix Therapeutics (NRIX) has received PRIME designation from the European Medicines Agency for NX-5948, its selective BTK degrader, for treating relapsed or refractory chronic lymphocytic leukemia patients who have previously received BTK and BCL-2 inhibitor therapy. The PRIME designation, which provides enhanced support for promising medicines addressing unmet medical needs, was granted based on encouraging safety and efficacy data from ongoing Phase 1 trials. NX-5948 has shown potential activity against mutations resistant to current BTK inhibitors, with pivotal trials planned for 2025.
Nurix Therapeutics (NRIX) ha ricevuto la designazione PRIME dall'Agenzia Europea dei Medicinali per NX-5948, il suo degradatore selettivo di BTK, per il trattamento di pazienti con leucemia linfocitica cronica in recidiva o refrattaria che hanno già ricevuto terapie con inibitori di BTK e BCL-2. La designazione PRIME, che fornisce un supporto potenziato per medicinali promettenti che soddisfano esigenze mediche non ancora soddisfatte, è stata concessa sulla base di dati di sicurezza ed efficacia incoraggianti provenienti da trial di Fase 1 in corso. NX-5948 ha mostrato un'attività potenziale contro mutazioni resistenti agli attuali inibitori di BTK, con trial fondamentali pianificati per il 2025.
Nurix Therapeutics (NRIX) ha recibido la designación PRIME de la Agencia Europea de Medicamentos para NX-5948, su degradador selectivo de BTK, para el tratamiento de pacientes con leucemia linfocítica crónica en recaída o refractaria que han sido tratados previamente con terapias de inhibidores de BTK y BCL-2. La designación PRIME, que proporciona un apoyo mejorado para medicamentos prometedores que abordan necesidades médicas no satisfechas, fue otorgada en base a datos alentadores de seguridad y eficacia de ensayos de Fase 1 en curso. NX-5948 ha demostrado actividad potencial contra mutaciones resistentes a los actuales inhibidores de BTK, con ensayos clave planificados para 2025.
Nurix Therapeutics (NRIX)는 유럽 의약품청으로부터 NX-5948의 PRIME 지정을 받았습니다. 이는 재발성 또는 불응성 만성 림프구 백혈병 환자를 치료하기 위한 BTK 선택적 분해제로, 이전에 BTK 및 BCL-2 억제제 치료를 받은 적이 있는 환자에게 사용됩니다. PRIME 지정은 충족되지 않은 의료 요구에 대한 유망한 약물에 대한 향상된 지원을 제공하며, 진행 중인 1상 임상 시험에서의 안전성과 유효성 데이터가 고무적이라는 근거로 부여되었습니다. NX-5948는 현재 BTK 억제제에 내성이 있는 변이에 대해 잠재적인 활성을 보여주었으며, 2025년에 중요한 임상 시험이 계획되어 있습니다.
Nurix Therapeutics (NRIX) a reçu la désignation PRIME de l'Agence européenne des médicaments pour NX-5948, son dégradateur sélectif de BTK, pour traiter les patients atteints de leucémie lymphoïde chronique en rechute ou réfractaire ayant déjà reçu des thérapies avec des inhibiteurs de BTK et de BCL-2. La désignation PRIME, qui offre un soutien renforcé pour des médicaments prometteurs répondant à des besoins médicaux non satisfaits, a été accordée sur la base de données de sécurité et d'efficacité encourageantes provenant d'essais de phase 1 en cours. NX-5948 a montré une activité potentielle contre des mutations résistantes aux inhibiteurs de BTK actuels, avec des essais décisifs prévus pour 2025.
Nurix Therapeutics (NRIX) hat von der Europäischen Arzneimittel-Agentur die PRIME-Auszeichnung für NX-5948, seinen selektiven BTK-Degrader, erhalten, um Patienten mit rezidivierender oder refraktärer chronischer lymphatischer Leukämie zu behandeln, die zuvor mit BTK- und BCL-2-Hemmertherapien behandelt wurden. Die PRIME-Auszeichnung, die eine verbesserte Unterstützung für vielversprechende Arzneimittel bietet, die unerfüllte medizinische Bedürfnisse ansprechen, wurde auf der Grundlage ermutigender Sicherheits- und Wirksamkeitsdaten aus laufenden Phase-1-Studien vergeben. NX-5948 hat ein potenzielles Aktivitätsprofil gegen Mutationen gezeigt, die resistent gegen derzeitige BTK-Hemmer sind, wobei entscheidende Studien für 2025 geplant sind.
- Received EMA PRIME designation for NX-5948, potentially accelerating drug development and approval process
- Demonstrated promising safety and efficacy data in Phase 1 trials
- Shows activity against mutations resistant to existing BTK inhibitors
- Pivotal trials not starting until 2025, indicating lengthy timeline to potential commercialization
Insights
The EMA's PRIME designation for NX-5948 represents a significant regulatory milestone for Nurix's BTK degrader program in CLL/SLL treatment. The designation validates the drug's potential in addressing a critical unmet need for patients who have failed both BTK and BCL-2 inhibitor therapies. Two key aspects make this particularly noteworthy: First, the drug's demonstrated ability to work independently of BTK inhibitor resistance mutations and second, the accelerated regulatory pathway that could expedite market access in Europe.
The Phase 1 data suggesting efficacy against resistant mutations could position NX-5948 as a valuable treatment option in an increasingly crowded BTK inhibitor market. However, with pivotal trials planned for 2025, market impact remains a medium-term prospect. The PRIME designation significantly de-risks the regulatory pathway in Europe and could accelerate development timelines, though concrete commercialization is still years away.
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-5948
NX-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 pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).
About Nurix
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.
Forward-Looking Statements
This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding the potential advantages and therapeutic benefits of NX-5948, including its potential role in the treatment of patients whose cancer has progressed following BTK inhibitor and BCL2 inhibitor therapy or its role in addressing mutations that confer resistance to covalent and non-covalent BTK inhibitors; and the potential benefits of PRIME designation. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) the risks inherent in the drug development process, including the unexpected emergence of adverse events or other undesirable side effects during clinical development; (ii) uncertainties related to the timing and results of clinical trials; (iii) the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; (iv) whether Nurix will be able to successfully complete clinical development for, obtain regulatory approval of and ultimately commercialize NX-5948; (v) whether Nurix will be able to fund its research and development activities and achieve its research and development goals; (vi) the impact of economic and market conditions and global and regional events on Nurix’s business and clinical trials; (vii) whether Nurix will be able to protect intellectual property and (viii) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal period ended August 31, 2024, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.
Contacts:
Investors
Jason Kantor, Ph.D.
Nurix Therapeutics
ir@nurixtx.com
Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
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Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
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FAQ
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