Pirtobrutinib

Objective response rate of 69.2% observed in heavily pretreated patient population including patients with BTK inhibitor resistance mutations Clinical responses in CLL patients were rapid and deepening with longer time on treatment Nurix intends to advance NX-5948 into pivotal trial(s) in 2025 Company will host a webcast conference today, June 16, 2024, at 9:00 a.m. ET (3:00 p.m. CEST) June 16, 2024 -- 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 the presentation of updated clinical data for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK), being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including CLL and non-Hodgkin lymphoma (NHL). Dr. Kim Linton, M.B.Ch.B, MRCP, Ph.D., FRCP, senior lecturer at the University of Manchester, a consultant at The Christie NHS Foundation Trust and an investigator on the clinical trial, presented the data in an oral session at the European Hematology Association Congress, which is being held from June 13–16, 2024, in Madrid, Spain. “The current results from this study of advanced patients are very impressive for this early stage of development and we are optimistic that NX-5948 has the potential to be an exciting breakthrough for patients with relapsed CLL, particularly in light of the emerging patterns of resistance to the currently available targeted therapies,” said Dr. Linton. “As a clinical investigator, it is highly gratifying to be able to offer patients who are refractory to other therapies a once daily, oral drug that can address a range of CLL disease states.” The data presented at EHA include safety findings for all patients in the Phase 1a dose escalation study regardless of diagnosis (n=79) and include efficacy findings for those patients with relapsed or refractory CLL (n=31). Patients were treated with NX-5948 at doses ranging from 50 mg to 600 mg once daily by oral administration. NX-5948 was well tolerated across all doses evaluated with most common treatment emergent adverse events of purpura/contusion, thrombocytopenia and neutropenia. Among the efficacy evaluable patients with CLL (n=26), NX-5948 treatment resulted in a robust objective response rate (ORR) of 69.2% across all doses tested with responses observed as early as the first scan (8 weeks) and with many patients experiencing deepening of their response with longer time on treatment. All responses remained ongoing as of the April 17 data cutoff. This cohort of CLL patients was a heavily pretreated population that had received a median of four prior lines of therapy (range = 2–14) including prior covalent BTK inhibitors (96.8%), prior BCL2 inhibitors (90.3%), and prior non-covalent BTK inhibitors (25.8%). At baseline, a large number of patients had mutations associated with BTK inhibitor resistance including mutations in BTK (43.3%) and PLC2G (20.0%). Poor prognostic features were common including TP53 mutations (46.7%), and two patients (6.5%) had central nervous system (CNS) involvement. Responses were observed across all populations regardless of prior treatment, baseline mutations, or CNS involvement. Dr. Linton also presented an updated case report that detailed the response of one patient who entered the study with CLL with CNS involvement after having undergone three prior therapies, including treatment with a BTK inhibitor. After daily treatment with 100 mg, and later 300 mg, of NX-5948, the patient exhibited a deepening response approaching complete response criteria by 36 weeks, with elimination of malignant cells in the cerebrospinal fluid (CSF) by 24 weeks. Another case report presented by the company involved a patient who had received eleven prior lines of therapy, including all available BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib). After daily treatment with 200 mg of NX-5948, the patient achieved a response by week 8 which deepened over time and was ongoing with over 6 months of follow up. “The responses we are observing across the entire CLL cohort at all dose levels are extremely encouraging. As a next step, we will expand the Phase 1b portion of the trial across a range of CLL subpopulations to prepare for initiation of pivotal, registration-directed clinical evaluation in 2025,” said Paula G. O’Connor, M.D., chief medical officer of Nurix. “While we did not cover the clinical activity data from the NX-5948 study in the various subtypes of NHL in this presentation, we have observed responses across subtypes including complete responses in patients with advanced DLBCL, MCL, MZL, and PCNSL, as well as consistent responses in advanced WM. We look forward to presenting additional data from the study for both CLL and NHL as it matures and to providing further details around our plans for the next stage of development of NX-5948.” “With a growing body of positive clinical data, demonstrated activity in the CNS and a favorable safety profile, NX-5948 is emerging as a best-in-class medicine that has the potential to provide an important treatment option for patients with CLL and NHL,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix “We intend to move rapidly forward with the goal of initiating pivotal trial(s) with NX-5948 in 2025.” On June 16, 2024, at 9:00 a.m., ET (3:00 p.m., CEST), Nurix will host a conference call and webcast to discuss data from the NX-5948 clinical trial and plans for the program. The live webcast, with an accompanying presentation, will be accessible under the Events and Presentations page in the Investors section of the company’s website here. To participate in the live conference call please pre-register online here. A replay of the webcast and call will be archived on the Nurix website for approximately 30 days after the event. NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies including chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL), diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary central nervous system lymphoma (PCNSL) and Waldenström's macroglobulinemia (WM). Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022). 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 cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com. The content above comes from the network. if any infringement, please contact us to modify.

More than 20 abstracts will be presented from clinical trials and real-world evidence using clonoSEQ for MRD assessment across multiple types of blood cancersSEATTLE, May 31, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually. “The data that will be presented at ASCO and EHA this year build on the expansive evidence base supporting the clinical significance and actionability of MRD testing with clonoSEQ within the quickly evolving blood cancer treatment landscape,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “clonoSEQ continues to be the gold standard in MRD assessment, empowering clinicians with the most reliable insights to navigate complex treatment decisions and arming drug developers with a highly sensitive and standardized assay to confidently advance the most promising therapeutics.” MRD status is a powerful predictor of outcomes in blood cancers. Routine MRD testing offers a personalized approach to monitor and evaluate an individual’s response to treatment, identify early signs of relapse before symptoms occur, and inform shared decision-making to optimize care. Beyond clinical applications, clonoSEQ assay technology is used extensively in drug development as a robustly validated tool to understand treatment efficacy and determine depth and kinetics of response. It is also increasingly being used as a primary endpoint in clinical trials. The clinical trial data and real-world evidence to be presented at ASCO and EHA further underscore the clinical benefit of specific and sensitive MRD assessment with clonoSEQ. Highlights include: In a Children’s Oncology Group-led study of pediatric patients with acute lymphoblastic leukemia (ALL), evidence from the largest analysis to date comparing bone marrow MRD assessment to peripheral blood MRD assessment with clonoSEQ showed a strong correlation between blood and marrow, independent of patient risk group. These data support the potential for a less invasive method to monitor MRD and track a patient’s response to therapy in ALL.In various stages of multiple myeloma (MM), real-world evidence and clinical trial results reinforced the clinical significance of sustained MRD negativity and importance of depth of response in predicting patient outcomes, including overall survival (OS) and progression-free survival (PFS), and illustrated how clonoSEQ could inform treatment discontinuation or de-escalation decisions. Follow-up data generated from the University of Chicago prospective MRD2STOP study indicated that MRD testing with clonoSEQ at 10–6 may help identify patients who can safely and effectively discontinue maintenance therapy and sustain MRD negativity off treatment.An MRD analysis from the PERSEUS study, conducted by the Cancer Center Clinica Universidad de Navarra in Spain, compared bortezomib/lenalidomide/dexamethasone (VRd) with or without daratumumab (D) in transplant-eligible patients with newly diagnosed MM. MRD negativity at both 10–5 and 10–6 was associated with improved PFS. Of note, the higher rates of deeper responses (10–6) in the D-VRd/D-R arm were associated with a clinically meaningful benefit of improved PFS.Multiple trials evaluating the safety and efficacy of novel chimeric antigen receptor T cell (CAR-T) therapies demonstrated the value of utilizing clonoSEQ to measure deep responses during or after therapy in often difficult-to-treat patient populations and showed MRD negativity as assessed by clonoSEQ testing is associated with PFS. In patients with chronic lymphocytic leukemia (CLL), data from clinical trials highlighted the use of clonoSEQ to support individualized MRD-guided treatment modification. clonoSEQ-related data to be presented at both ASCO and EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaASCO Oral Presentation6504Obecabtagene Autoleucel (Obe-Cel, AUTO1) In Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Overall Survival (OS), Event-Free Survival (EFS) And The Potential Impact Of Chimeric Antigen Receptor (CAR)-T Cell Persistency And Consolidative Stem Cell Transplantation (SCT) In The Open-Label, Single-Arm FELIX Phase Ib/II StudyFriday, May 313:57–4:09 p.m. CDTEHA Oral PresentationS114Obecabtagene Autoleucel In Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia: Survival And Potential Impact Of CAR-T Cell Persistence And Stem Cell Transplantation In The FELIX StudyFriday, June 143:45–4 p.m. CESTMultiple MyelomaASCO Oral Presentation7505Efficacy And Safety Of Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort DMonday, June 34:24–4:36 p.m. CDTEHA Oral PresentationS205Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort DSaturday, June 154:30–4:45 p.m. CESTASCO Oral Presentation7510Efficacy Of Venetoclax-Dexamethasone (Vendex) V Pomalidomide-Dexamethasone (Pomdex) In Patients (Pts) With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]: Phase 3 CANOVA Study Biomarker Subgroup AnalysisMonday, June 34:24–4:36 p.m. CDTEHA Poster PresentationP912Efficacy Of Venetoclax-Dexamethasone V Pomalidomide-Dexamethasone In Patients With T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+ RRMM]:Phase 3 CANOVA Biomarker Subgroup AnalysisFriday, June 146 p.m. CESTASCO Oral Presentation7502Daratumumab (DARA) + Bortezomib/Lenalidomide/Dexamethasone (VRd) In Transplant-Eligible (TE) Patients (Pts) With Newly Diagnosed Multiple Myeloma (NDMM): Analysis Of Minimal Residual Disease (MRD) In the PERSEUS TrialMonday, June 33:24–3:36 p.m. CDTEHA Oral PresentationS201Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma: Analysis of Minimal Residual Disease in the PERSEUS TrialSaturday, June 1511:45 a.m.–12 p.m. CESTASCO Oral Presentation7504Ciltacabtagene Autoleucel Vs Standard of Care in Patients With Functional High-Risk Multiple Myeloma: CARTITUDE-4 Subgroup AnalysisMonday, June 34:12–4:24 p.m. CDTEHA Poster PresentationP978Ciltacabtagene Autoleucel Vs Standard of Care in Lenalidomide-Refractory Multiple Myeloma: Phase 3 CARTITUDE-4 Subgroup Analysis By Cytogenetic RiskFriday, June 146 p.m. CEST Additional data to be presented at ASCO: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaOral Presentation10014Comparison Of Immunoglobulin High-Throughput Sequencing MRD in Bone Marrow And Peripheral Blood In Pediatric B-ALL: A Report From The Children's Oncology Group AALL1731Monday, June 312:54–1:06 p.m. CDTFollicular LymphomaOral Presentation7015EPCORE NHL1 Follicular Lymphoma (FL) Cycle (C) 1 Optimization (OPT) Cohort: Expanding The Clinical Utility of Epcoritamab in Relapsed o-r Refractory (R/R) FLSunday, June 25:30–5:36 p.m. CDTMultiple MyelomaOral Presentation106Discontinuation of Maintenance Therapy in Multiple Myeloma Guided By Multimodal Measurable Residual Disease Negativity (MRD2STOP)Monday, June 310:01–10:13 a.m. CDTOral Presentation7500Phase 3 Study Results of Isatuximab, Bortezomib, Lenalidomide, And Dexamethasone (Isa-Vrd) Versus Vrd For Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (IMROZ)Monday, June 33–3:12 p.m. CDTOral Presentation7501Phase 3 Randomized Study of Isatuximab (Isa) Plus Lenalidomide And Dexamethasone (Rd) With Bortezomib Versus Isard in Patients With Newly Diagnosed Transplant Ineligible Multiple Myeloma (NDMM TI)Monday, June 33:12–3:24 p.m. CDTPoster Presentation7527Association Of Patient (Pt) Factors And Pharmacodynamic Biomarkers With Progression-Free Survival (PFS) After Idecabtagene Vicleucel (Ide-Cel) In Pts From KarMMa-3Monday, June 39 a.m.–12 p.m. CDTPoster Presentation7535Ciltacabtagene Autoleucel In Patients With Lenalidomide-Refractory Multiple Myeloma: CARTITUDE-2 Cohort A Expansion SubgroupMonday, June 39 a.m.–12 p.m. CDTPoster Presentation7557Effect Of Dose-Adjusted Melphalan On MRD-Negativity To Full Dose Melphalan in Patients With Multiple Myeloma Post-Autologous Stem Cell TransplantMonday, June 39 a.m.–12 p.m. CDTPoster Presentation7560Indirect Comparison of Linvoseltamab Versus Teclistamab For Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)Monday, June 39 a.m.–12 p.m. CDT Additional data to be presented at EHA: Presentation Type and NumberTitlePresentation TimingB-Cell Acute Lymphoblastic LeukemiaPoster PresentationP413Brexucabtagene Autoleucel (Brexu-Cel) As Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia With Marrow Blasts <5%, Including Patients (Pts) With NGS MRD Negative DiseaseFriday, June 146 p.m. CESTChronic Lymphocytic LeukemiaOral PresentationS164Combined Pirtobrutinib, Venetoclax, And Obinutuzumab in First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase 2 TrialFriday, June 143:45–4 p.m. CESTPoster Presentation P1837Postinfusion Resource Use And Cost of Lisocabtagene Maraleucel By Response Status And Prior Lines of Therapy In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia From TRANSCEND CLL 004Friday, June 146 p.m. CESTPoster PresentationP672A Phase 2 Study of Minimal Residual Disease (MRD)-Adapted, Time-Limited Acalabrutinib And Obinutuzumab For The Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): MRD OutcomesFriday, June 146 p.m. CESTFollicular LymphomaOral PresentationS234Epcoritamab Induces Deep Responses in Relapsed Or Refractory (R/R) Follicular Lymphoma (FL): Safety And Pooled Efficacy Data From EPCORE NHL‑1 Pivotal And Cycle (C) 1 Optimization (OPT) FL CohortsSaturday, June 155:30–5:45 p.m. CESTPoster Presentation P1137Undetectable Measurable Residual Disease (MRD) Is Associated With Improved Long-Term Outcome in Patients With Follicular Lymphoma (FL) Treated With Chemo-Immunotherapy: Results From SWOG S0016Friday, June 146 p.m. CESTPoster PresentationP2059Minimal Residual Disease (MRD), Pharmacokinetic (PK), And Pharmacodynamic (PD) Assessment of Epcoritamab 2- Vs 3-Step Step-Up Dosing in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)Friday, June 146 p.m. CESTMultiple MyelomaPoster Presentation P974Daratumumab (DARA)/Bortezomib/Lenalidomide/Dexamethasone (D-VRd) With D-R Maintenance (Maint) In Transplant-Eligible (TE) Newly Diagnosed Myeloma (NDMM): Analysis of PERSEUS Based On Cytogenetic RiskFriday, June 146 p.m. CESTPoster Presentation P943Oral Ixazomib Maintenance Following Autologous Stem Cell Transplant (ASCT) In Patients With Newly Diagnosed Multiple Myeloma (NDMM): Final Overall Survival (OS) Analysis From The TOURMALINE-MM3 StudyFriday, June 146 p.m. CEST About clonoSEQ clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, ALL, and DLBCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary. About Adaptive BiotechnologiesAdaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@adaptivebiotech.com