Nurix Therapeutics Reports New Clinical Data from First-in-Class Oral CBL-B Inhibitor, NX-1607, Demonstrating Single-Agent Activity Across Multiple Tumor Types at the European Society for Medical Oncology (ESMO) Congress
Nurix Therapeutics (NASDAQ: NRIX) reported Phase 1a data for NX-1607, a first-in-class oral CBL-B inhibitor, presented at ESMO 2025.
In 82 treated patients (71 evaluable as of July 26, 2025) across 5–80 mg total daily doses, NX-1607 showed dose-dependent exposure, peripheral immune activation, reductions in tumor biomarkers (PSA, CEA), tumor shrinkage, long-term stable disease, and a confirmed partial response in a patient with MSS colorectal cancer. The disease control rate was 49.3%. Six patients had immune-related adverse events; most treatment-emergent adverse events were Grade ≤2. Data support initiating expansion cohorts at the two highest doses as monotherapy or in combination for advanced solid tumors.
Nurix Therapeutics (NASDAQ: NRIX) ha riferito dati di fase 1a per NX-1607, un inibitore orale CBL-B di prima classe, presentati all'ESMO 2025.
In 82 pazienti trattati (71 valutabili al 26 luglio 2025) con dosi totali giornaliere da 5 a 80 mg, NX-1607 ha mostrato esposizione dose-dipendente, attivazione immunitaria periferica, riduzioni nei biomarcatori tumorali (PSA, CEA), restringimento del tumore, malattia stabile a lungo termine e una risposta parziale confermata in un paziente con cancro colorettale MSS. Il tasso di controllo della malattia è stato del 49,3%. Sei pazienti hanno avuto eventi avversi di natura immune; la maggior parte degli eventi avversi correlati al trattamento sono stati di grado ≤2. I dati supportano l'avvio di coorti di espansione alle due dosi più alte come monoterapia o in combinazione per tumori solidi avanzati.
Nurix Therapeutics (NASDAQ: NRIX) informó datos de Fase 1a para NX-1607, un inhibidor oral de CBL-B de primera clase, presentado en ESMO 2025.
En 82 pacientes tratados (71 evaluables a 26 de julio de 2025) con dosis totales diarias de 5 a 80 mg, NX-1607 mostró exposición dosis-dependiente, activación inmunitaria periférica, reducciones en biomarcadores tumorales (PSA, CEA), disminución del tumor, enfermedad estable a largo plazo y una respuesta parcial confirmada en un paciente con cáncer colorrectal MSS. La tasa de control de la enfermedad fue del 49,3%. Seis pacientes experimentaron eventos adversos relacionados con el sistema inmune; la mayoría de los eventos adversos inducidos por el tratamiento fueron de Grado ≤2. Los datos respaldan iniciar cohortes de expansión en las dos dosis más altas como monoterapia o en combinación para tumores sólidos avanzados.
Nurix Therapeutics (NASDAQ: NRIX)는 NX-1607의 제1상 1a 데이터를 발표했습니다. 경구 CBL-B 억제제의 첫-in-class로, ESMO 2025에서 발표되었습니다.
2025년 7월 26일 기준으로 82명의 치료를 받은 환자(그 중 71명은 평가 가능)에서 총 5~80 mg의 1일 용량으로 NX-1607은 용량 의존적 노출, 말초 면역 활성화, 종양 바이오마커(PSA, CEA) 감소, 종양 축소, 장기간의 질환 안정성, MSS 대장암 환자에서 확인된 부분 반응을 보였습니다. 질병 조절률은 49.3%였습니다. 여섯 명의 환자에서 면역 관련 이상반응이 있었고, 대부분의 치료 관련 이상반응은 등급이 2 이하였습니다. 이 데이터는 고용량 두 가지 용량에서 단독 요법 혹은 고형 종양에 대한 조합 요법으로 확장 코호트를 시작하는 것을 뒷받침합니다.
Nurix Therapeutics (NASDAQ: NRIX) a rapporté des données de la phase 1a pour NX-1607, un inhibiteur oral de CBL-B de première classe, présentées lors d'ESMO 2025.
Chez 82 patients traités (71 évaluables au 26 juillet 2025) couvrant des doses journalières totales de 5 à 80 mg, NX-1607 a montré une exposition dose-dépendante, une activation immunitaire périphérique, des réductions des biomarqueurs tumoraux (PSA, CEA), une réduction de la tumeur, une maladie stable à long terme et une réponse partielle confirmée chez un patient atteint d'un cancer colorectal MSS. Le taux de contrôle de la maladie était de 49,3%. Six patients ont présenté des événements indésirables liés à l'immunité; la plupart des événements indésirables associées au traitement étaient de grade ≤2. Les données soutiennent l'initiation de cohortes d'expansion aux deux doses les plus élevées en monothérapie ou en association pour les tumeurs solides avancées.
Nurix Therapeutics (NASDAQ: NRIX) berichtete Daten der Phase-1a für NX-1607, einen first-in-class oralen CBL-B-Inhibitor, vorgestellt auf der ESMO 2025.
Bei 82 behandelten Patienten (71 bis zum 26. Juli 2025 evaluierbar) mit insgesamt 5–80 mg täglichen Dosen zeigte NX-1607 eine dosisabhängige Exposition, periphere Immunaktivierung, Reduktionen von Tumormarkern (PSA, CEA), Tumorschrumpfung, langfristig stabiler Erkrankung und eine bestätigte partielle Remission bei einem Patienten mit MSS-Darmkrebs. Die Erkrankungslenkung (DCR) betrug 49,3%. Sechs Patienten erhielten immunbedingte unerwünschte Ereignisse; die meisten behandlungsbedingten unerwünschten Ereignisse waren Grad ≤2. Die Daten unterstützen das Initiieren von Expansionskohorten bei den beiden höchsten Dosierungen als Monotherapie oder in Kombination für fortgeschrittene solide Tumoren.
Nurix Therapeutics (NASDAQ: NRIX) أبلغت عن بيانات المرحلة 1a لـ NX-1607، مثبط فموي لـ CBL-B من فئة أولى، وقد عُرِضت في ESMO 2025.
عند 82 مريضاً تمت معالجتهم (71 قابلة للتقييم حتى 26 يوليو 2025) عبر جرعات يومية إجمالية من 5 إلى 80 ملغ، أظهر NX-1607 تعرضاً يعتمد على الجرعة، وتفعيلاً مناعياً طرفياً، وانخفاضاً في العلامات البيولوجية الورمية (PSA، CEA)، وانكماش الورم، ومرضاً مستقراً على المدى الطويل، واستجابة جزئية مؤكدة لدى مريض مصاب بسرطان القولون والمستقيم MSS. معدل السيطرة على المرض كان 49.3%. شهد ستة مرضى أحداثاً سلبية متعلقة بالمناعة؛ وكانت معظم الأحداث السلبية المرتبطة بالعلاج من الدرجة ≤2. تدعم البيانات بدء توسيع Cohorts عند أعلى جرعتين كعلاج أحادي أو بالاشتراك لأورام صلبة متقدمة.
Nurix Therapeutics (NASDAQ: NRIX) 报告了 NX-1607 的 Phase 1a 数据，一种首创口服 CBL-B 抑制剂，在 ESMO 2025 年会上公布。
在 82 名受试者中（截至 2025 年 7 月 26 日可评估的为 71 名），剂量总日剂量范围为 5–80 mg，NX-1607 显示出剂量依赖性暴露、外周免疫激活、肿瘤生物标志物（PSA、CEA）下降、肿瘤缩小、长期病情稳定，以及在 MSS 结直肠癌患者中的一个确认部分缓解。疾病控制率为 49.3%。六名患者出现免疫相关不良事件；大多数与治疗相关的不良事件为 I 级或 II 级。数据支持在两种最高剂量下以单药或联合用药启动扩展队列，用于晚期实体瘤的治疗。
- Disease control rate of 49.3% (71 patients evaluable)
- Confirmed partial response in a patient with MSS colorectal cancer treated 27 months
- 6 of 13 prostate patients in BID groups had PSA reductions ≥50%
- Dose-dependent biomarker increases and peripheral immune activation observed
- Only one confirmed PR reported among 71 evaluable patients
- Immune-related adverse events observed in 6 patients
- Nausea and vomiting were common TEAEs, requiring BID dosing or a step-up regimen
Insights
Early human data show on‑target immune activation and single‑agent anti‑tumor signals, supporting dose expansion.
**NX-1607** produced dose‑dependent pharmacology and peripheral immune activation consistent with its mechanism as a CBL‑B inhibitor, and showed single‑agent clinical activity across multiple tumor types including a confirmed partial response in microsatellite‑stable colorectal cancer and reductions in tumor biomarkers. The study enrolled 82 patients across dosing regimens and, at the
The program’s value hinges on reproducibility and durability across expansion cohorts and on safety at active doses; immune‑related adverse events occurred in six patients and most events were Grade 2 or lower, with mitigations such as BID dosing and step‑up titration noted. Watch for outcomes from the planned expansion cohorts at the two highest doses, additional confirmatory response rates by tumor type, and detailed safety breakdowns over the next 6–18 months to gauge clinical meaningfulness and feasibility of combination regimens.
NX-1607 demonstrated on-target peripheral immune activation characteristic of an active immune-oncology agent with a novel immune checkpoint mechanism distinct from PD-1/PD-L1 therapies
NX-1607 demonstrated evidence of monotherapy anti-tumor activity with reductions in tumor biomarkers, tumor shrinkage, long-term stable disease, and a confirmed partial response in heavily pretreated patients
Data support initiation of expansion cohorts at the two highest doses tested as monotherapy or combination for the treatment of advanced solid tumors
SAN FRANCISCO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced the presentation of new clinical data from its first-in-human Phase 1a study of NX-1607, a first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) in patients with relapsed/refractory solid tumors. The data are being presented at the European Society for Medical Oncology Congress (ESMO 2025), taking place October 17–21, 2025, in Berlin, Germany.
“As a first-in-class oral inhibitor of CBL-B, NX-1607 may offer a novel therapeutic approach to treat solid tumors by targeting a previously unaddressed pathway in immune regulation affecting not only T cells, but also multiple immune cell types, including dendritic cells and natural killer cells, which all play critical roles in the tumor microenvironment,” said Paula O’Connor, M.D., chief medical officer of Nurix. “These data highlight NX-1607’s activity as an immuno-oncology agent, showing promising signs of biologic activity and clinical benefit, and supporting its continued development as an innovative next generation checkpoint inhibitor therapy designed to improve outcomes for cancer patients.”
In a poster titled: First-in-Class CBL-B Inhibitor NX-1607: Phase 1a Data in Patients with Advanced Solid Tumors, data were presented from a total of 82 patients with eleven different tumor types treated across six once-daily (QD) and five twice-daily (BID) dosing regimens ranging from 5 mg to 80 mg total daily dose. Patients were heavily pre-treated with a median of 3 prior regimens including a median of 1 prior chemo/immunotherapy regimen. NX-1607 demonstrated dose-dependent exposure, increases in proximal and distal biomarkers, evidence of peripheral immune activation, and reductions in tumor volume and cancer biomarkers. Despite the advanced stages of disease and the broad range of tumor types included in the trial, NX-1607 demonstrated evidence of clinical activity including reductions in tumor-specific biomarkers (prostate-specific antigen (PSA) in prostate cancer and carcinoembryonic antigen (CEA) in colorectal cancer), long-term stable disease, and a confirmed partial response in a patient with micro-satellite stable colorectal cancer (MSS CRC), a tumor type typically unresponsive to immune checkpoint therapy. As of the 26 July 2025 data cut, 71 patients were evaluable for response, with a disease control rate (DCR) of
NX-1607 was shown to be tolerable at pharmacologically active doses and has a safety profile comparable to approved immuno-oncology agents, with most adverse events Grade 2 or less in severity. Immune-related adverse events were observed in 6 patients, indicating on-target immune activation, similar to what is observed with PD-1/PD-L1 therapies. The most common treatment emergent adverse events included nausea and vomiting, which were mitigated by both BID dosing and the introduction of a step-up dosing regimen where patients were initially treated at lower doses and increased to the target dose during the first cycle of treatment.
“NX-1607 has demonstrated potent single agent activity preclinically and now most importantly, we see clear signals of anti-tumor activity in patients with advanced disease. The results are particularly intriguing in MSS colorectal cancer and metastatic prostate cancer, two important indications where current immunotherapies have failed to demonstrate efficacy,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “We look forward to further exploring the broad therapeutic potential of NX-1607 while we advance our lead asset bexobrutideg, an oral BTK degrader, into pivotal trials in patients with relapsed or refractory chronic lymphocytic leukemia.”
About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor-induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Nurix’s wholly owned, clinical stage pipeline includes degraders of Bruton’s tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix’s partnered drug discovery pipeline consists of a preclinical stage degrader of STAT6, a clinical stage degrader of IRAK4, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease. 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. All statements that reflect Nurix’s expectations, assumptions or projections about the future are forward-looking statements, including, without limitation, statements regarding the therapeutic potential of NX-1607, Nurix’s plans for the clinical development of NX-1607, Nurix’s plans for its other clinical assets, including bexobrutideg, and the planned timing for the provision of updates and findings from Nurix’s clinical trials. 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) whether Nurix will be able to advance, obtain regulatory approval of and ultimately commercialize NX-1607; (ii) whether Nurix will be able to fund development activities and achieve development goals; (iii) whether Nurix will be able to protect intellectual property and (iv) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended August 31, 2025, 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
Kris Fortner
Nurix Therapeutics, Inc.
mailto:kfortner@nurixtx.com
Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
lwolffe@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
FAQ
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