A Phase 1, Open-Label, 2-Period, Fixed-Sequence Study to Assess the Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance of [14C]-NX-5948 in Healthy Males

This is a Phase 1, 2-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of [14C]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Period 2 will analyze total radioactivity and metabolite profiling.

Start Date01 Nov 2024

Sponsor / Collaborator

Nurix Therapeutics, Inc.

NCT06593457 / Active, not recruitingPhase 1

A Phase 1, 2-Part, Placebo-Controlled, Double-Blinded Study to Assess the Effect of Food and Drug-Drug Interaction of Fluconazole on the Pharmacokinetics of NX-5948

This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study. Part 2 is a single-period PK evaluation study.

Start Date20 Aug 2024

Sponsor / Collaborator

Nurix Therapeutics, Inc.

NCT05131022 / RecruitingPhase 1

A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.

Start Date13 Apr 2022

Sponsor / Collaborator

Nurix Therapeutics, Inc.

100 Clinical Results associated with NX-5948

100 Translational Medicine associated with NX-5948

100 Patents (Medical) associated with NX-5948

Literatures (Medical) associated with NX-5948

30 Mar 2023·Blood

The cat-and-mouse game of BTK inhibition.

Communications

Author: Portelinha, Ana ; Wendel, Hans-Guido

In this issue of Blood, Zhang et al¹ report the preclin. efficacy of a new Bruton tyrosine kinase (BTK) degrader mol. (NRX-0492, a close relativeOf the clin. compounds NX-2127 and NX-5948)² to overcome BTK inhibitor resistance.The authors show that NRX-0492 degrades wild-type and C481 mutant BTK, resulting in significant single-agent activity against chronic lymphatic leukemia (CLL) patient-derived xenografts in vivo.¹A closely related compound, NX-2127,² is now in clin. trials in B-cell malignancies (NCT04830137).

News (Medical) associated with NX-5948

20 Nov 2024

·www.globenewswire.com

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 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 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 Therapeuticsir@nurixtx.com Elizabeth Wolffe, Ph.D.Wheelhouse Life Science Advisorslwolffe@wheelhouselsa.com Media Aljanae ReynoldsWheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

Phase 1

19 Nov 2024

·www.globenewswire.com

Nurix Therapeutics Presents Preclinical Data from Two Autoimmune and Inflammatory Disease Programs, NX-5948 and GS-6791, at ACR Convergence 2024

Nov. 17, 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 preclinical data, including mechanism of action and relevant disease models, from two pipeline programs: NX-5948 and GS-6791. NX-5948 is Nurix’s proprietary, orally available, brain penetrant Bruton’s tyrosine kinase (BTK) degrader, which is being developed for the potential treatment of inflammation and autoimmune diseases in addition to its ongoing Phase 1b trial in patients with B-cell malignancies. GS-6791 is a selective, orally bioavailable degrader of interleukin-1 receptor-associated kinase 4 (IRAK4), which is being developed in collaboration with Gilead Sciences for the potential treatment of rheumatoid arthritis and other inflammatory diseases. These data were presented in two posters at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR), being held November 14–19, 2024, in Washington, D.C. “The preclinical data presented at ACR Convergence underscore the exceptional potential of our targeted protein degradation strategy compared to kinase inhibition for both BTK and IRAK4, which are critical targets in inflammatory and autoimmune diseases, and support continued advancement of these drug candidates into clinical studies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “These programs showcase the capability of Nurix’s DELigase platform to generate potent best-in-class degrader drug candidates with the potential to deliver superior efficacy in several inflammatory diseases.” BTK mediates signaling downstream of the B cell receptor (BCR), toll-like receptors (TLRs), and Fc receptors (FcRs), making it an attractive therapeutic target in antibody-mediated autoimmune and inflammatory diseases. BTK has been shown to have both kinase and scaffold activities that are key to its function. Targeting BTK can reduce the production of new antibodies and mitigate the inflammation induced by existing antibodies, addressing key challenges in inflammatory and autoimmune diseases. In a poster titled: NX-5948, a Clinical-Stage BTK Degrader, Achieves Deep Suppression of BCR, TLR, and FcR Signaling in Immune Cells and Demonstrates Efficacy in Preclinical Models of Arthritis and Other Inflammatory Diseases, data illustrate the potential benefit of the BTK degrader NX-5948, which is equivalent or superior to inhibition of BTK across multiple mechanistic studies and models of inflammatory diseases. In primary B cells, NX-5948 promotes rapid degradation of BTK and more potently suppresses proximal BCR signaling and BCR- and TLR-mediated B cell activation than current BTK inhibitors under development. In a model of established collagen-induced arthritis, oral administration of NX-5948 achieves equal or superior improvement of clinical scores and deeper suppression of plasma cell numbers compared to BTK inhibitors. NX-5948 also demonstrates efficacy in several other models of inflammatory diseases including antibody-induced glomerulonephritis (a model of lupus nephritis), autoimmune lymphoproliferative syndrome (ALPS, a second model of lupus-like disease), passive cutaneous anaphylaxis (a model of allergic response including chronic spontaneous urticaria), and experimental autoimmune encephalitis (a model of multiple sclerosis). IRAK4 plays a critical role in TLR- and interleukin-1 family receptor (IL-1R) signaling to induce inflammatory responses. Like BTK, IRAK4 has both kinase and scaffold functions, the latter of which have been shown to be particularly critical in IL-1 and TLR-mediated signaling across diverse cell types. GS-6791, a targeted protein degrader of IRAK4, provides a differentiated mode of action compared with inhibition of kinase activity. In a poster titled: IRAK4 Degrader GS-6791 Inhibits TLR and IL-1R-Driven Inflammatory Signaling, and Ameliorates Disease in a Preclinical Arthritis Model, data demonstrate that GS-6791 is a potent degrader of IRAK4 in vitro and in vivo across a range of cell types. In PK/PD models GS-6791 inhibits IL-1- and TLR-induced cytokine release and results in deeper reduction of human B cell and synovial fibroblast cytokine responses compared to IRAK4 kinase inhibitors. In a preclinical model of arthritis, orally administered GS-6791 demonstrates robust, dose-dependent efficacy. The poster presentations are available online in the Scientific Resources section of the Nurix Therapeutics website under Posters and Presentations. About NX-5948: NX-5948 is an investigational, orally bioavailable degrader of BTK that is currently being evaluated in a Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies. Additional information on the Phase 1a/b clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022). About GS-6791 (previously NX-0479): GS-6791 is a potent, selective, oral IRAK4 degrader. Degradation of IRAK4 by GS-6791 has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. Nurix’s collaboration partner, Gilead Sciences, is responsible for conducting IND-enabling studies and advancing this program to clinical development. 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.

Clinical Study

21 Oct 2024

·pipelinereview.com

Nurix Therapeutics Presents Positive Results from the Ongoing Clinical Trial of Its BTK Degrader NX-5948 in Patients with Relapsed/Refractory Waldenstrom’s Macroglobulinemia

NX-5948 demonstrated robust clinical activity with objective responses observed in 7 of 9 (77.8%) evaluable Waldenstrom’s patients in the ongoing Phase 1a/1b clinical trial Responses are durable and deepen over time with two patients on treatment for greater than one year Data were presented at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) SAN FRANCISCO, CA, USA I October 19, 2024 I 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 clinical data from its ongoing Phase 1a/1b clinical trial of NX-5948, an orally bioavailable, brain penetrant degrader of Burton’s tyrosine kinase (BTK), in patients with relapsed/refractory Waldenstrom’s macroglobulinemia (WM) at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) which is being held in Prague, Czech Republic October 17–19, 2024. “We are encouraged by the emerging positive data from NX-5948 in patients with Waldenstrom’s macroglobulinemia, which add to the previously disclosed robust clinical activity observed in patients with chronic lymphocytic leukemia,” said Paula G. O’Connor, M.D., chief medical officer of Nurix. “These data support our decision to advance NX-5948 into the ongoing Phase 1b expansion cohort in patients who have previously received at least one prior line of therapy including a BTK inhibitor and patients presenting with Bing-Neel syndrome, a rare form of WM with central nervous system involvement where NX-5948’s ability to penetrate the brain may offer a distinct advantage.” The data presented at IWWM-12 included previously reported safety findings for all patients in the Phase 1a dose escalation study treated with NX-5948 at doses ranging from 50 mg to 600 mg once daily by oral administration regardless of diagnosis (n=79) based on an April 17, 2024 data cut. NX-5948 demonstrated a tolerable safety profile, and the safety profile for patients with WM was consistent with the safety profile for the overall population (WM patient safety data not shown separately). New data from an October 10, 2024 data cut include the baseline characteristics of the first 13 patients with WM enrolled across both the Phase 1a and Phase 1b portions of the trial, clinical response assessments in 9 response-evaluable patients, and duration on study for all 13 patients. Among the 13 WM patients, the median age was 74 years and the median number of prior lines of therapy was 3. All 13 patients previously had been treated with both BTK inhibitors (BTKi) and chemotherapy/chemo-immunotherapy. Three patients (23.1%) had received prior treatment with the non-covalent BTKi pirtobrutinib, and one patient (7.7%) had received prior treatment with a BCL2 inhibitor. Baseline mutation status in MYD88 and CXCR4 was captured from patient records, and eight patients (61.5%) had mutations in MYD88, and two patients (15.4%) had mutations in CXCR4. Among the nine patients who were evaluable for response, seven patients (77.8%) had an objective response and two patients experienced stable disease (22.2%). All seven responses were observed at the first assessment at 8 weeks, and five remain on treatment with two patients on treatment for longer than one year. Responses were observed in patients regardless of their baseline mutations in MYD88 and CXCR4. Two illustrative cases studies of patients treated with NX-5948 were presented. The first case study is a patient with baseline MYD88 and CXCR4 mutations and four prior lines of therapy, including autologous bone marrow transplantation and ibrutinib, who demonstrated a rapid response observed at the first assessment and remained on study at the time of the October 10, 2024 data cut with greater than one year of treatment (currently in cycle 16; 28 days per cycle). NX-5948 treatment resulted in deepening of response over time as measured by reduction in serum IgM levels, a key biomarker of clinical response in WM patients. The second case study is a patient with baseline MYD88 mutation and three prior lines of treatment, having most recently progressed while on zanubrutinib. This patient also experienced a rapid response at the first assessment with decreasing IgM through treatment which was ongoing in cycle 15 at the time of the October 10, 2024 data cut. The IWWM-1 presentation is available in the Scientific Resources section of Nurix website in the Posters and Presentations section. About NX-5948 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. 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 Waldenstrom’s Macroglobulinemia WM is a rare, slow growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal IgM. This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms. In the United States the annual incidence rate is approximately 3 per million or between 1,000 to 1,500 newly diagnosed patients per year. Recommended first-line treatments including chemoimmunotherapy and BTK inhibitor therapy. There are no therapies approved to treat patients after BTKi. Additional therapeutic options are needed. 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 cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com . SOURCE: Nurix Therapeutics

Clinical ResultPhase 1Immunotherapy

100 Deals associated with NX-5948

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 1	US	Nurix Therapeutics, Inc.	13 Apr 2022
Chronic Lymphocytic Leukemia	Phase 1	NL	Nurix Therapeutics, Inc.	13 Apr 2022
Chronic Lymphocytic Leukemia	Phase 1	GB	Nurix Therapeutics, Inc.	13 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 1	US	Nurix Therapeutics, Inc.	13 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 1	NL	Nurix Therapeutics, Inc.	13 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 1	GB	Nurix Therapeutics, Inc.	13 Apr 2022
Follicular Lymphoma	Phase 1	US	Nurix Therapeutics, Inc.	13 Apr 2022
Follicular Lymphoma	Phase 1	NL	Nurix Therapeutics, Inc.	13 Apr 2022
Follicular Lymphoma	Phase 1	GB	Nurix Therapeutics, Inc.	13 Apr 2022
Mantle-Cell Lymphoma	Phase 1	US	Nurix Therapeutics, Inc.	13 Apr 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Recurrent Chronic Lymphoid Leukemia	-	NX-5948 50 mg	ckvbdsirqz(fssboadzfk) = Most common TEAEs were: purpura/contusion (44.1%, no Gr≥3); thrombocytopenia (23.5%, 2.9% Gr≥3); petechiae (29.4%, no Gr≥3); fatigue (20.6%, no Gr≥3); neutropenia (17.6%, 14.7% Gr≥3; pts with up to Gr 4 cytopenias were eligible for study participation); rash (23.5%, no Gr≥3, 2.9% SAE); headache (23.5%, no Gr≥3); pulmonary embolism (1 case, not deemed treatment related) oobimrnoxm (fbrhidaekk )	-	09 Dec 2024
ASH2024	Not Applicable	Recurrent Chronic Lymphoid Leukemia	-	NX-5948 100 mg		-	09 Dec 2024
NCT05131022 (GlobeNewswire) Manual	Phase 1	Waldenstrom Macroglobulinemia	79	NX-5948	axxsgbjqoz(mqnygdvjtj) = xpmvlthhze nuwsxohkwg (utmreyapfk ) View more	Positive	19 Oct 2024
NCT05131022 (EHA2024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| B-Cell Malignant Neoplasm	46	NX-5948	zmnnlmlejq(rqekeqxkuy) = none onxwkrgdum (ugnmppxvvq ) View more	Positive	14 May 2024
NCT05131022 (Biospace) Manual	Phase 1	Chronic Lymphocytic Leukemia	7	NX-5948	uovzqkzraa(smsnscthzx) = lzsxstdcgr gjorzbskrw (yxgxtnysqt ) View more	Positive	16 Jan 2024
NCT05131022 (NX-5948-301, ASH2023) Manual	Phase 1	B-Cell Lymphoma Third line	14	NX-5948	azjptlfzse(wzhrfjpzpo) = oowupqvibv zzwfcgehjw (symqvssowb ) View more	Positive	11 Dec 2023

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