NRIX Nurix Therapeutics Inc.

30.06
-0.64  -2%
Previous Close 30.7
Open 30.3
52 Week Low 21.53
52 Week High 52.38
Market Cap $1,341,056,169
Shares 44,612,647
Float 31,307,249
Enterprise Value $1,025,710,262
Volume 194,286
Av. Daily Volume 363,180
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Drug Pipeline

Drug Stage Notes
DeTIL-0255
Cellular therapy
Phase 1
Phase 1
Phase 1 trial to be initiated YE 2021.
NX-2127
B-cell malignancies
Phase 1b
Phase 1b
Phase 1a portion of Phase 1a/1b study reported initial PK and PD data from the first 2 completed cohorts 100 mg and 200 mg (n=6). Data showed BTK levels in peripheral blood significantly decreased in all patients in the trial starting on day 1 and remained suppressed throughout the dosing period. BTK degradation exceeded 80% at steady state in the first dose cohort and exceeded 90% in the second dose cohort, noted October 27, 2021. Trial to move into the expansion share in 1H 2022.
NX-1607
Immuno-oncology indications
Phase 1
Phase 1
Phase 1 initiated, noted October 14, 2021.
NX-5948
B-cell malignancies / graft-versus-host disease
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2021.

Latest News

  1. Food and Drug Administration clears DeTIL-0255 to initiate Phase 1 clinical trial

    Phase 1 clinical trial initiation anticipated by year-end 2021

    SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Food and Drug Administration (FDA) has cleared Nurix's Investigational New Drug Application (IND) for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte (TIL) therapy. DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patient's tumor expanded ex vivo with NX-0255, a small molecule Casitas B lineage lymphoma-b (CBL-B) inhibitor developed…

    Food and Drug Administration clears DeTIL-0255 to initiate Phase 1 clinical trial

    Phase 1 clinical trial initiation anticipated by year-end 2021

    SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Food and Drug Administration (FDA) has cleared Nurix's Investigational New Drug Application (IND) for its lead cell therapy product candidate DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte (TIL) therapy. DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patient's tumor expanded ex vivo with NX-0255, a small molecule Casitas B lineage lymphoma-b (CBL-B) inhibitor developed by Nurix. DeTIL-0255 is a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Based on extensive preclinical characterization, Nurix believes DeTIL-0255 could allow a broader application of TIL therapy in a range of solid tumors. DeTIL-0255 will be the subject of a poster presentation by Nurix at the Society for Immunotherapy of Cancer (SITC) conference held at the Washington Convention Center on Saturday, November 13. DeTIL-0255 complements Nurix's oral CBL-B inhibitor drug candidate, NX-1607, which is currently in a Phase 1a clinical trial.

    "Given the favorable phenotypic characteristics of TIL developed in our CBL-B inhibitor program, we believe DeTIL-0255 has the potential to be an effective cell therapy for a wide variety of advanced malignancies," said Dr. Robert Brown, Nurix's senior vice president of clinical development. "Our initial clinical focus for DeTIL-0255 will be for patients with gynecological cancers where the unmet medical need is high and where we believe our drug-enhanced TIL approach may help patients."

    The Phase 1 trial of DeTIL-0255 is an open-label, non-randomized clinical trial anticipated to enroll up to 50 patients with gynecological malignancies following a safety run-in. The three expansion cohorts will enroll either patients with recurrent or persistent platinum-resistant epithelial ovarian cancer, patients with recurrent, metastatic, or persistent cervical cancer, or patients with advanced or recurrent endometrial cancer. Nurix is currently working to initiate this trial at multiple sites in the United States that have experience in conducting TIL and other adoptive cell therapy (ACT) trials. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT05107739).

    About Nurix Therapeutics, Inc.

    Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix's extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.

    Forward Looking Statement

    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 our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates; the potential advantages of our DELigase® platform and drug candidates; the extent to which our scientific approach and DELigase® platform may potentially address a broad range of diseases; and the timing and success of the development and commercialization of our anticipated drug candidates. Forward-looking statements reflect Nurix's current beliefs, expectations, and assumptions regarding the future of Nurix's business, future plans and strategies, its development plans, its preclinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. 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) risks and uncertainties related to Nurix's ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical and clinical trials; (iii) Nurix's ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix's business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix's ability to protect intellectual property and (vi) other risks and uncertainties described under the heading "Risk Factors" in Nurix's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 16, 2021, Nurix's Quarterly Report on Form 10-Q filed with the SEC on October 14, 2021, 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:Media:
    Jason Kantor, Ph.D.Elizabeth Wolffe, Ph.D.
    Nurix Therapeutics, Inc.Wheelhouse Life Science Advisors
     


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  2. DeTIL-0255 is a drug-enhanced investigational new cell therapy product candidate with potentially superior T cell properties compared to conventional TIL

    Michael T. Lotze, Nurix's chief cellular therapy officer, is awarded Lifetime Achievement award by SITC at its annual meeting

    SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced the presentation of preclinical studies demonstrating that its CBL-B inhibitor, NX-0255, enhances the number and quality of T cells expanded from tumors for use in tumor infiltrating lymphocyte (TIL) therapy. These results will be presented by Nurix in a poster session at the Society for…

    DeTIL-0255 is a drug-enhanced investigational new cell therapy product candidate with potentially superior T cell properties compared to conventional TIL

    Michael T. Lotze, Nurix's chief cellular therapy officer, is awarded Lifetime Achievement award by SITC at its annual meeting

    SAN FRANCISCO, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced the presentation of preclinical studies demonstrating that its CBL-B inhibitor, NX-0255, enhances the number and quality of T cells expanded from tumors for use in tumor infiltrating lymphocyte (TIL) therapy. These results will be presented by Nurix in a poster session at the Society for Immunotherapy of Cancer (SITC) conference held at the Washington Convention Center on Saturday, November 13. Nurix also congratulates Michael T. Lotze, M.D., Nurix's chief cellular therapy officer (CCO), who will be honored at the conference with the 2021 SITC Lifetime Achievement Award.

    "Throughout the history of tumor infiltrating lymphocyte therapy, certain patients with melanoma and several other solid tumor types have experienced extraordinarily durable tumor responses," said Dr. Lotze. "With our small molecule CBL-B inhibitors, we hope to broaden and deepen such responses across a range of solid tumors using our drug-enhanced TIL therapy, DeTIL-0255."

    As a key step toward advancing DeTIL-0255 into the clinic, Nurix performed a series of experiments on human tumors to characterize the effects of CBL-B inhibition using NX-0255 on the production and quality of TIL. Tumor samples were obtained from 16 patients with ovary, colon, lung, head and neck, breast, or vulva carcinomas. Tumors from patients were cultured either in the presence of recombinant human IL-2 (rhIL-2) alone to generate TIL or in combination with NX-0255 + rhIL-2 to generate DeTIL-0255, Nurix's cell therapy clinical candidate. Compared to TIL, DeTIL-0255 demonstrated:

    • Increased T cell expansion (p<0.001);
    • Reduced expression of markers associated with T cell exhaustion such as PD-1, LAG-3 and TIM-3 (p<0.05);
    • Increased cytotoxicity as measured by increased perforin, granzyme B, and the degranulation marker CD107a (p<0.001);
    • Increased 4-1BB, a surrogate marker of tumor reactivity (p<0.05); and
    • Increased T cell receptor diversity (p<0.05)

    Taken together, these findings support advancing DeTIL-0255 into human clinical trials as a potentially superior, drug-enhanced TIL product candidate.

    Nurix's cell therapy programs are headed by Dr. Lotze, whose dedication and contributions to the field of immunotherapy for cancer are to be recognized at the SITC annual meeting with the 2021 SITC Lifetime Achievement Award.

    "We are extremely proud of Michael and thank SITC for recognizing his achievements in the field of immunotherapy for cancer that span many of the critical advances that have had a major impact on the field," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Michael's irrepressible energy and drive to benefit patients with advanced cancer have compelled him to embark on the ambitious task of combining small molecules with cell therapy to create our drug-enhanced cell therapy product candidate, DeTIL-0255, a candidate and concept we believe will bring adoptive cell therapy to the next level."

    Presentation Details

    • Conference: Society for Immunotherapy of Cancer Annual Meeting
    • Title: NX-0255, a Small-Molecule CBL-B Inhibitor, Expands and Enhances Tumor-Infiltrating Lymphocytes for Use in Adoptive Cancer Immunotherapy
    • Abstract number: 98
    • Date: November 13, 2021
    • Presenter: Sarah Whelan, Ph.D.

    About DeTIL-0255

    Nurix's lead cell therapy candidate, DeTIL-0255, is an autologous cell therapy consisting of T cells derived from a patient's tumor expanded in culture with NX-0255 and rhIL-2. DeTIL-0255 is designed to be a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Based on its preclinical characterization, Nurix believes DeTIL-0255 could allow a broader application of TIL therapy. Nurix is currently working to initiate a Phase 1 trial of DeTIL-0255 at multiple sites in the United States that have experience in conducting TIL and other adoptive cell therapy (ACT) trials. Nurix expects to include patients primarily with gynecological tumors who have failed standard of care. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT05107739).

    About Michael T. Lotze, M.D.

    Michael T. Lotze, M.D. has served as Nurix's Chief Cellular Therapy Officer since June 2020. He is a leading clinician scientist with more than 30 years of experience in immunology and clinical medicine, dedicating his efforts to the advancement of translational research, particularly in immunotherapy for cancer including dendritic cell, T cell, and cytokine therapies. Dr. Lotze is the co-inventor of multiple patents in dendritic cell vaccines and antigen discovery, and tumor infiltrating lymphocyte therapy. He previously held leadership roles in the biopharmaceutical industry as the chief scientific officer of Iovance Biotherapeutics and vice president of research at GlaxoSmithKline. Prior to joining Nurix, Dr. Lotze served as professor of surgery, immunology, and bioengineering, vice chair of research within the Department of Surgery and director for Damage Associated Molecular Pattern Molecule (DAMP) Laboratories at the University of Pittsburgh Medical Center Hillman Cancer Center. He was also senior advisor for the Immune Transplant and Therapy Center within the University of Pittsburgh Medical Center Enterprises and serves as associate editor of the Journal of Immunotherapy. Over the course of his career, he has authored more than 500 publications and several books. Dr. Lotze holds an M.D. from Northwestern University and completed his postdoctoral training as a scientist at the National Cancer Institute under Dr. Steven Rosenberg.

    About Nurix Therapeutics, Inc.

    Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix's extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.

    Forward Looking Statement

    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 our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates, preclinical activities, research and development costs, current and prospective collaborations; the potential advantages of our DELigase® platform and drug candidates; the extent to which our scientific approach and DELigase® platform may potentially address a broad range of diseases; the estimated size of the market for our drug candidates; and the timing and success of the development and commercialization of our anticipated drug candidates. Forward-looking statements reflect Nurix's current beliefs, expectations, and assumptions regarding the future of Nurix's business, future plans and strategies, its development plans, its preclinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. 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) risks and uncertainties related to Nurix's ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical and clinical trials; (iii) Nurix's ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix's business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix's ability to protect intellectual property and (vi) other risks and uncertainties described under the heading "Risk Factors" in Nurix's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 16, 2021, Nurix's Quarterly Report on Form 10-Q filed with the SEC on October 14, 2021, 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:Media:
    Jason Kantor, Ph.D.Elizabeth Wolffe, Ph.D.
    Nurix Therapeutics, Inc.Wheelhouse Life Science Advisors


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  3. SAN FRANCISCO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (NASDAQ:NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that Arthur T. Sands, M.D., Ph.D., Nurix's president and chief executive officer, will participate in fireside chats at the following conferences in November:

    • Stifel 2021 Virtual Healthcare Conference
      Tuesday, November 16th, at 3:20-3:50 PM EST
    • Piper Sandler 33rd Annual Virtual Healthcare Conference
      Tuesday, November 30th, at 11:30-11:55 AM EST

    The discussions will be webcast live and may be accessed via a link in the Investors section of the Nurix website under Events and Presentations. Archived copies of the webcasts will be available on the Nurix website for approximately…

    SAN FRANCISCO, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (NASDAQ:NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that Arthur T. Sands, M.D., Ph.D., Nurix's president and chief executive officer, will participate in fireside chats at the following conferences in November:

    • Stifel 2021 Virtual Healthcare Conference

      Tuesday, November 16th, at 3:20-3:50 PM EST

    • Piper Sandler 33rd Annual Virtual Healthcare Conference

      Tuesday, November 30th, at 11:30-11:55 AM EST

    The discussions will be webcast live and may be accessed via a link in the Investors section of the Nurix website under Events and Presentations. Archived copies of the webcasts will be available on the Nurix website for approximately 30 days after the event.

    About Nurix Therapeutics, Inc.

    Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix's extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurix.com.



    Contacts:

    Investors:Media:
    Jason Kantor, Ph.D.Elizabeth Wolffe, Ph.D.
    Nurix Therapeutics, Inc.Wheelhouse Life Science Advisors


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  4. Robust BTK target degradation achieved in all patients treated to date

    Greater than 90% degradation of BTK was achieved at the 200 mg dose of NX-2127

    These data represent the first proof of mechanism of targeted protein degradation in patients with hematologic malignancies

    Nurix to host a conference call today at 8:30 a.m. ET

    SAN FRANCISCO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced initial data demonstrating clinically meaningful degradation of Bruton's tyrosine kinase (BTK) in patients with relapsed or refractory B cell malignancies, including in a chronic lymphocytic leukemia (CLL) patient with significant mutations…

    Robust BTK target degradation achieved in all patients treated to date

    Greater than 90% degradation of BTK was achieved at the 200 mg dose of NX-2127

    These data represent the first proof of mechanism of targeted protein degradation in patients with hematologic malignancies

    Nurix to host a conference call today at 8:30 a.m. ET

    SAN FRANCISCO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced initial data demonstrating clinically meaningful degradation of Bruton's tyrosine kinase (BTK) in patients with relapsed or refractory B cell malignancies, including in a chronic lymphocytic leukemia (CLL) patient with significant mutations in the BTK gene associated with resistance to standard of care BTK inhibitors. These results will be presented by Nurix's president and chief executive officer Arthur T. Sands, M.D., Ph.D., and Nurix's senior vice president of clinical development Robert J. Brown, M.D., at the 4th Annual Targeted Protein Degradation (TPD) Summit at 11:45 a.m. ET today, October 27, 2021. The slides for this presentation will be made available in the investor section of the company's website.

    "The initial data from our study are the first proof-of-mechanism of targeted protein degradation in patients with hematologic malignancies," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The concept of degrading BTK as a new therapeutic strategy in hematologic cancer has taken an important step forward, and the NX-2127 program has hit an exciting milestone in its clinical development."

    Initial PK and PD data from the first two completed cohorts of 100 mg and 200 mg, which included a total of six patients, showed BTK levels in peripheral blood significantly decreased in all patients in the trial starting on day 1 and remained suppressed throughout the dosing period. BTK degradation exceeded 80% at steady state in the first dose cohort and exceeded 90% in the second dose cohort. Such levels of BTK degradation have been associated with anti-tumor effects in preclinical animal models. For example, in a preclinical lymphoma model, BTK degradation of 80% in the peripheral blood was associated with 74% tumor growth inhibition, and BTK degradation of 90% was associated with 100% tumor growth inhibition.

    The clinical data presented includes a notable case study with early evidence of clinical activity in the first patient enrolled (Cohort 1, n=1 at 100 mg dose). Patient 1 is a 78-year-old male diagnosed with CLL who had received 2 prior lines of therapy including most recently ibrutinib. Genetic analysis of CLL cells from this patient prior to initiation of NX-2127 revealed a BTK mutation in 68% of leukemic cells with multiple mutations at site C481 which has been associated with resistance to ibrutinib. Patient 1 remains on study now over 4 months, allowing for two disease assessments at prespecified periods which showed that the patient has thus far achieved a partial response with improved clinical parameters.

    "Patients with relapsed and refractory B cell malignancies continue to require new drugs and new modalities to address their unmet medical need, and we believe that NX-2127 may offer a novel mechanism to block uncontrolled B cell signaling and tumor growth with the further potential to overcome acquired resistance to current treatments," said Robert J. Brown, M.D., senior vice president of clinical development. "The safety profile of NX-2127 to date is encouraging and we look forward to completing the dose escalation portion of the study and moving into the expansion phase in selected cancers in the first half of 2022."

    The Phase 1a dose escalation portion of the Phase 1a/1b trial is ongoing with enrollment of patients with a variety of relapsed or refractory B cell malignancies. The trial is evaluating once daily oral NX-2127 starting at a dose of 100 mg. Pharmacokinetic (PK) and pharmacodynamic (PD) measurements are taken at multiple time points on day 1 and throughout the dosing period. NX-2127 dosed orally once daily was tolerated, and there were no dose limiting toxicities (DLTs) observed at the 100 mg and 200 mg dose levels, with the 300 mg dose now open for enrollment. NX-2127 appears to be well-tolerated at this early stage with a safety profile that is consistent with its known mechanisms of action. Five of six patients remain on NX-2127 for durations ranging from 4 to 19 weeks. One patient with Waldenstrom's macroglobulinemia discontinued treatment after two weeks due to progressive disease.

    Conference Call Information

    Nurix will host a live conference call and webcast on Wednesday, October 27, 2021 at 8:30 a.m. ET. To join the live conference call by telephone, please dial 1 (844) 348-6877 (U.S.) or +1 (253) 336-3591 (International). The conference ID number for the live call is 1837008.

    To access the live webcast, please visit the Investors section of the Company's website and follow the link under Events & Presentations. A replay of the webcast will be available on the Company's website for approximately 30 days.

    Presentation Details

    • Conference: 4th Annual Targeted Protein Degradation Summit
    • Session: Clinical Update on Degraders in the Clinic, Key Learnings & Future Directions
    • Title: Turning Degraders into Drugs – NX-2127 & NX-5948
    • Time: 11:45 a.m. ET
    • Presenter: Arthur T. Sands, M.D., Ph.D., President and CEO

    About NX-2127

    Nurix's lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. NX-2127 harnesses the normal cellular protein degradation mechanism, the E3 ligase-mediated ubiquitin-proteasome pathway, to catalyze degradation of BTK. BTK is an enzyme involved in B-cell development, differentiation and signaling that is critical for proliferation and survival of lymphoma and leukemia cells in many B-cell malignancies. Inhibitors of BTK, such as ibrutinib, are approved for treatment of B-cell cancers, however certain patients cannot tolerate them and in other patients, specific mutations can arise in the BTK protein that confer resistance to these agents, thereby reducing their efficacy. Degradation of BTK has the potential to overcome resistance in patients harboring such mutations in BTK. In addition, NX-2127 catalyzes degradation of transcription factors involved in regulating T-cell function, resulting in T-cell activation in a similar fashion to IMiDs that have demonstrated efficacy in some aggressive B-cell malignancies.

    About the Phase 1, Dose Escalation Study of NX-2127

    The multicenter Phase 1a/1b study is designed to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of orally administered NX-2127 in adult patients with relapsed or refractory B-cell malignancies. The study will be conducted in two parts. The Phase 1a element is a dose-escalation study in which cohorts of patients will receive ascending oral doses of NX-2127 once daily to determine the maximum tolerated dose (MTD) and/or the optimal Phase 1b dose based on safety and tolerability. The second portion of the study, Phase 1b, is a dose expansion phase in which cohorts of patients with specific cancers will receive NX-2127 to further evaluate the safety, and clinical activity of the recommended dose. The study is expected to enroll eligible patients with the following cancers: chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without BTK mutations, Waldenstrom's macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), who have required and received prior systemic therapies. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).

    About Nurix Therapeutics, Inc.

    Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix's extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.

    Forward Looking Statement

    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 our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates, preclinical activities, research and development costs, current and prospective collaborations; the potential advantages of our DELigase® platform and drug candidates; the extent to which our scientific approach and DELigase® platform may potentially address a broad range of diseases; the estimated size of the market for our drug candidates; and the timing and success of the development and commercialization of our anticipated drug candidates. Forward-looking statements reflect Nurix's current beliefs, expectations, and assumptions regarding the future of Nurix's business, future plans and strategies, its development plans, its preclinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. 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) risks and uncertainties related to Nurix's ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical and clinical trials; (iii) Nurix's ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix's business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix's ability to protect intellectual property and (vi) other risks and uncertainties described under the heading "Risk Factors" in Nurix's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 16, 2021, Nurix's Quarterly Report on Form 10-Q filed with the SEC on October 14, 2021, 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:Media:
    Jason Kantor, Ph.D.Elizabeth Wolffe, Ph.D.
    Nurix Therapeutics, Inc.Wheelhouse Life Science Advisors


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  5. Presentation to include initial pharmacokinetic and BTK degradation data

    Company to host conference call at 8:30 a.m. ET on Wednesday, October 27, 2021

    SAN FRANCISCO, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Company will present initial pharmacokinetic and pharmacodynamic data from its first-in-human, Phase 1 dose-escalation trial of NX-2127 in adults with relapsed or refractory B-cell malignancies at the 4th Annual Targeted Protein Degradation Summit. The presentation will begin at 11:45 a.m. ET on Wednesday, October 27, 2021, and will be given by Nurix president and chief executive officer Arthur T. Sands…

    Presentation to include initial pharmacokinetic and BTK degradation data

    Company to host conference call at 8:30 a.m. ET on Wednesday, October 27, 2021

    SAN FRANCISCO, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that the Company will present initial pharmacokinetic and pharmacodynamic data from its first-in-human, Phase 1 dose-escalation trial of NX-2127 in adults with relapsed or refractory B-cell malignancies at the 4th Annual Targeted Protein Degradation Summit. The presentation will begin at 11:45 a.m. ET on Wednesday, October 27, 2021, and will be given by Nurix president and chief executive officer Arthur T. Sands, M.D., Ph.D., in an oral session entitled, Clinical Update on Degraders in the Clinic, Key Learnings & Future Directions. The review of initial Phase 1 data will be led by Robert J. Brown, M.D., senior vice president of clinical development.

    Prior to the presentation, at 8:30 a.m. ET on Wednesday, October 27, 2021, the company will host a conference call and webcast to discuss the data. Information on joining the call and webcast is provided below.

    Conference Call and Webcast Details

    Nurix will host a live conference call and webcast on Wednesday, October 27, 2021 at 8:30 a.m. ET. To join the live conference call by telephone, please dial 1 (844) 348-6877 (U.S.) or +1 (253) 336-3591 (International). The conference ID number for the live call is 1837008.

    To access the live webcast, please visit the Investors section of the Company's website and follow the link under Events & Presentations. A replay of the webcast will be available on the Company's website for approximately 30 days.

    About NX-2127

    Nurix's lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. NX-2127 harnesses the normal cellular protein degradation mechanism, the E3 ligase-mediated ubiquitin-proteasome pathway, to catalyze degradation of BTK. BTK is an enzyme involved in B-cell development, differentiation and signaling that is critical for proliferation and survival of lymphoma and leukemia cells in many B-cell malignancies. Inhibitors of BTK, such as ibrutinib, are approved for treatment of B-cell cancers, however certain patients cannot tolerate them and in other patients, specific mutations can arise in the BTK protein that confer resistance to these agents, thereby reducing their efficacy. Degradation of BTK has the potential to overcome resistance in patients harboring such mutations in BTK. In addition, NX-2127 catalyzes degradation of transcription factors involved in regulating T-cell function, resulting in T-cell activation in a similar fashion to IMiDs that have demonstrated efficacy in some aggressive B-cell malignancies.

    About the Phase 1, Dose Escalation Study of NX-2127

    The multicenter Phase 1a/1b study is designed to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of orally administered NX-2127 in adult patients with relapsed or refractory B-cell malignancies. The study will be conducted in two parts. The Phase 1a element is a dose-escalation study in which cohorts of patients will receive ascending oral doses of NX-2127 once daily to determine the maximum tolerated dose (MTD) and/or the optimal Phase 1b dose based on safety and tolerability. The second portion of the study, Phase 1b, is a dose expansion phase in which cohorts of patients with specific cancers will receive NX-2127 to further evaluate the safety and clinical activity of the recommended dose. The study is expected to enroll eligible patients with the following cancers: chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without BTK mutations, Waldenstrom's macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL), who have required and received prior systemic therapies. Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).

    About Nurix Therapeutics, Inc.

    Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix's extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.

    Forward Looking Statement

    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 our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates, preclinical activities, research and development costs, current and prospective collaborations; the potential advantages of our DELigase™ platform and drug candidates; the extent to which our scientific approach and DELigase™ platform may potentially address a broad range of diseases; the estimated size of the market for our drug candidates; and the timing and success of the development and commercialization of our anticipated drug candidates. Forward-looking statements reflect Nurix's current beliefs, expectations, and assumptions regarding the future of Nurix's business, future plans and strategies, its development plans, its preclinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. 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) risks and uncertainties related to Nurix's ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical and clinical trials; (iii) Nurix's ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix's business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix's ability to protect intellectual property and (vi) other risks and uncertainties described under the heading "Risk Factors" in Nurix's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 16, 2021, Nurix's Quarterly Report on Form 10-Q filed with the SEC on October 14, 2021, 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:Media:
    Jason Kantor, Ph.D.Elizabeth Wolffe, Ph.D.
    Nurix Therapeutics, Inc.Wheelhouse Life Science Advisors


    Primary Logo

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