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Item 8.01 Other Events.
As previously announced, on October 27, 2021, Nurix Therapeutics, Inc. (the “Company”), will present preliminary data from its Phase 1 clinical trial of NX-2127 at the 4th Annual Targeted Protein Degradation Summit (the “TPD Summit”). In connection with the TPD Summit, at 8:30 a.m. ET on October 27, 2021, the Company will hold an investor call and presentation, during which the Company intends to discuss the investor presentation attached as Exhibit 99.1 hereto, which is incorporated herein by reference. Also on October 27, 2021, the Company issued the press release attached as Exhibit 99.2 hereto, which is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are filed herewith and this list is intended to constitute the exhibit index:
| 99.1 | Nurix Therapeutics, Inc. presentation dated October 27, 2021. | |
| 99.2 | Nurix Therapeutics, Inc. press release dated October 27, 2021. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NURIX THERAPEUTICS, INC. | ||||||
| Date: October 27, 2021 | By: | /s/ Arthur T. Sands | ||||
| Arthur T. Sands, M.D., Ph.D. | ||||||
| President and Chief Executive Officer | ||||||
Nurix Therapeutics Blazing a New Path in Medicine First Demonstration of Targeted Protein Degradation of BTK in Hematologic Malignancies: Initial NX-2127 Phase 1a PK/PD Data 4th Annual Targeted Protein Degradation (TPD) Summit October 27, 2021 Exhibit 99.1
Important Notice and Disclaimers This presentation contains information relating to Nurix Therapeutics, Inc. (the “Company,” “we," "us" or "our") and forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our preclinical results and other future conditions. All statements, other than statements of historical fact, contained in this presentation are forward-looking statements, including 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 timing of our planned IND submissions for our 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 extent animal model data predicts human efficacy; and the timing and success of the development and commercialization of our anticipated drug candidates, including our DeTIL and DeCART opportunities. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, performance or events and circumstances could differ materially from those expressed or implied in our forward-looking statements due to a variety of factors, including risks and uncertainties related to our ability to advance our drug candidates; our ability to obtain regulatory approval of and ultimately commercialize our product candidates; the timing and results of preclinical and clinical trials; our ability to fund development activities and achieve development goals; the impact of the COVID-19 pandemic, including the resurgence of cases relating to the spread of the Delta variant, on our business, clinical trials, financial condition, liquidity and results of operation; our ability to protect intellectual property; and other risks and uncertainties described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended November 30, 2020 filed with the Securities and Exchange Commission (the “SEC”) on February 16, 2021, our Quarterly Report on Form 10-Q for the fiscal quarter ended August 31, 2021 filed with the SEC on October 14, 2021, and other filings we make from time to time with the SEC. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal estimates and research are reliable, such estimates and research have not been verified by any independent source. ©Nurix Therapeutics. All rights reserved.
Arthur T. Sands, M.D., Ph.D. Chief Executive Officer 4th Annual Targeted Protein Degradation (TPD) Summit October 27, 2021
Presentation Outline Outline of key questions we plan to address: What is the status of our protein modulation pipeline? What levels of BTK degradation are associated with anti-tumor effects in animal models? What are the initial PK/PD findings from the Phase 1a study of NX-2127 in patients with relapsed/refractory B cell malignancies? ©Nurix Therapeutics. All rights reserved.
©Nurix Therapeutics. All rights reserved. Nurix’s Wholly-Owned Targeted Protein Modulation Pipeline: Both Degradation and Ligase Inhibition Programs Currently Enrolling Drug Candidate Target / Delivery Therapeutic Area Discovery Lead Optimization Preclinical Phase 1 Phase 2 Phase 3 Protein Degradation Chimeric Targeting Molecule (CTM) Portfolio NX-2127 BTK + IMiD activity Oral B-cell Malignancies NX-5948 BTK Oral B-cell Malignancies and Autoimmune Diseases Commence in H2 2021* KINASE-CTM3 T Cell Kinase T-cell Malignancies and Autoimmune Diseases COVID-CTM Intracellular SARs COV-2 proteins Anti-viral Ligase Inhibition Portfolio NX-1607 CBL-B Oral Immuno-oncology DeTIL-0255 CBL-B (NX-0255) ex vivo Adoptive Cell Therapy (ACT) Commence in H2 2021* LIGASE-INH2 Undisclosed Immuno-oncology * All timing based on calendar-year periods and represents corporate goals set in January 2021 Enrolling Enrolling
DELigase® Enables Efficient Chimeric Targeting Molecule Discovery and Design ©Nurix Therapeutics. All rights reserved. CTM DNA Barcode Binders from DEL are joined via a linker to construct CTMs CTM recruits E3 ligase to target protein, triggering ubiquitin transfer and degradation Target E3 Ligase Target proteins and E3 ligases are screened using DEL 1 2 3 4 Ubiquitin BB2 BB3 BB1 Billions of proprietary DNA-Encoded Library (DEL) compounds BB = Chemical Building Blocks
Nurix’s BTK Degrader Portfolio: A Differentiated Approach to B-Cell Malignancies BTK is standard of care target however mutational escape represents a major unmet need BTK inhibitors are approved for CLL/SLL, mantle cell lymphoma, Waldenstrom's macroglobulinemia, marginal zone lymphoma, with sales of $7.1 billion in 2020 Next generation BTK inhibitors continue to be susceptible to mutational escape Opportunities to meet unmet need with BTK degraders differentiated action Catalytic nature of targeted protein degraders provide a new MOA with fundamentally different PK/PD from inhibitors Unique dual activity: NX-2127 combines the activities of BTK degradation and IMiDs which may be beneficial across a range of hematologic malignancies, particularly in NHL/ DLBCL Durability Can Be Years CLL and MCL Patients Respond to Targeted Agents None Approved for Certain Forms of NHL Resistance Mutations Validation Opportunities BTK Inhibitors NX-2127: BTK degrader with IMiD activity. Developing across multiple B-cell malignancies (CLL, MCL, WM, MZL, DLBCL, FL) NX-5948: BTK degrader without IMiD activity. Developing for targeted B-cell malignancies and autoimmune diseases. ©Nurix Therapeutics. All rights reserved. BTK, Bruton tyrosine kinase; IMiD, Immunomodulatory imide drugs; DLBCL, Diffuse large B cell lymphoma; CLL, Chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma; MCL, Mantle cell lymphoma; WM, Waldenstrom's macroglobulinemia; MZL, Marginal zone lymphoma; FL, Follicular lymphoma; NHL, non-Hodgkin lymphoma
NX-2127 Degrades Both BTK and IMiD Neosubstrate Aiolos NX-2127 shows potent BTK degradation in TMD8 cells (human DLBCL cell line) NX-2127 degradation of Aiolos in human T cells occurs at a similar potency to lenalidomide and pomalidomide ©Nurix Therapeutics. All rights reserved. BTK Degradation in TMD8 Cells Aiolos Degradation in T Cells
NX-2127 Potently Inhibits Growth of Ibrutinib-Resistant Tumor Cell Lines NX-2127 retains potent growth inhibition relative to BTK inhibitors in a tumor cell line carrying the C481S mutation Degradation of BTK with NX-2127 may offer a therapeutic option for patients who develop resistance to BTK inhibitors NX-2127 also shows superior activity to BTK inhibitors in wild-type TMD8 cells ©Nurix Therapeutics. All rights reserved.
TMD8 Tumors Increasing BTK Degradation Correlates with Significant Tumor Growth Inhibition N/A: Not applicable; TGI: tumor growth inhibition. Treatment Oral gavage dose (mg/kg) % BTK degradation in circulating B cells % BTK degradation in TMD8 tumor tissue % TGI vs Vehicle (Day 24) P value vs Vehicle Vehicle 0 0.0±3.2 0.0±1.8 N/A 0 NX-2127 10 69.3±1.5 79.8±1.4 58% 0.0492 30 80.2±1.8 83.7±1.3 74% <0.0001 90 90.8±0.4 90.4±1.4 100% <0.0001 Ibrutinib 30 N/A N/A 62% 0.0004 Circulating B cells Tumor Growth ©Nurix Therapeutics. All rights reserved.
BTK Degradation with Once Daily Oral Dosing of NX-2127 in Non-Human Primates All dose levels achieve BTK degradation consistent with anti-tumor effects in mouse model At steady state once daily, oral dosing of NX-2127 maintains suppression of BTK protein levels throughout the dosing period Day 19 Day 1 ©Nurix Therapeutics. All rights reserved.
Robert J. Brown, M.D. SVP, Clinical Development 4th Annual Targeted Protein Degradation (TPD) Summit October 27, 2021
NX-2127-001: Phase 1 First-in-Human Clinical Trial Design Two-Part Phase 1 Monotherapy Trial of NX-2127 in Relapsed or Refractory B-Cell Malignancies Dose Escalation Dose escalation Status Complete Dose Expansion CLL with BTK C481 mutation (n≈20) CLL unselected (n≈20) MCL, MZL, WM (n≈20) FL (n≈20) DLBCL (n≈20) Complete Objectives: - Assess safety and tolerability - Identify maximum tolerated dose - Evaluate PK/PD Enrolling Potential Oral daily dosing 100 mg 200 mg 300 mg 400 mg Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 CLL, chronic lymphocytic leukemia; FL, follicular lymphoma; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; WM, Waldenstrom's macroglobulinemia. ©Nurix Therapeutics. All rights reserved.
Study Disposition: Five of Six Relapsed/Refractory Patients Enrolled Remain on Study with NX-2127 Data as of October 18, 2021 Time on study calculated as time from dosing start date to data extraction date NX-2127 Dose Patient Disease Type No. Prior Lines Prior BTK-Targeted Therapy 100 mg 1 CLL 2 Ibrutinib 200 mg 2 CLL 6 Ibrutinib 3 MCL 4 Ibrutinib, acalabrutinib, and pirtobrutinib 4 WM 4 Ibrutinib and pirtobrutinib 5 CLL 3 Ibrutinib 6 SLL 9 Ibrutinib Treatment ongoing Discontinued Time on Study (Weeks) DLT Period 8 Week Disease Assessment 16 Week Disease Assessment ©Nurix Therapeutics. All rights reserved. Progressive Disease 7 Patients Screened, 6 Patients enrolled
Daily Oral Dosing Achieves Steady State NX-2127 Levels by Day 8 Oral daily doses of NX-2127 achieves steady state concentrations by Day 8 Oral daily dosing of NX-2127 demonstrates plasma exposure similar that observed in non-human primates ©Nurix Therapeutics. All rights reserved.
Robust BTK Degradation Observed in All Patients Dosed Regardless of Baseline BTK Protein Levels MFI: geometric mean fluorescence intensity in circulating CD19+ B cells. Patients have varying levels of BTK in B cells at the start of treatment Oral daily treatment of NX-2127 induced a rapid and significant decrease in BTK levels that was sustained throughout dosing ©Nurix Therapeutics. All rights reserved.
Greater Than 90% BTK Degradation Achieved at Steady State at Second Dose Level (200 mg once daily) Cohort 1 patient with >80% BTK degradation at steady state Cohort 2 average >90% BTK degradation at steady state BTK degradation in patients was consistent with results from mouse and primate models BTK % degradation was confirmed by western blot Note: % BTK degradation was not calculated for Patient 5 due to baseline sample not collected ©Nurix Therapeutics. All rights reserved.
BTK Degradation Table of Enrolled Patients Dose Patient % BTK Degraded Baseline Day 2 Day 8 Day 15 Day 22 Day 29 Average Steady State* Day 56 100 mg Patient 1 (CLL) 0 62.8 76.9 78.0 85.5 82.0 81.8 81.4 200 mg Patient 2 (CLL) 0 75.1 90.5 96.1 95.4 96.1 95.9 96.0 Patient 3 (MCL) 0 74.0 92.7 94.6 95.4 92.3 94.1 94.7 Patient 4 (WM) 0 63.6 56.8 91.5 91.5 Patient 5 (CLL) N/A Patient 6 (SLL) 0 6.9 85.1 Cohort 2, Patient 4: Last dose given on Cycle 1 Day 15, discontinued due to disease progression Cohort 2, Patient 5: Baseline sample was not collected due to inclement weather (Hurricane Ida), thus % degradation could not be calculated. *Average steady state is calculated with available % BTK degraded values from Day 15, Day 22 and Day 29 ©Nurix Therapeutics. All rights reserved.
No Dose Limiting Toxicities Observed in the First Two Cohorts Preferred Term Dose Level (mg) Grade Relatedness Intervention Disposition Neutropenia 100 3 Yes None Resolved Neutropenia 200 3 Yes Yes Resolved Hypertension 200 3 Yes No Resolved Dyspnea 200 3 No No Resolved Pneumonia 200 3 No Yes Ongoing ©Nurix Therapeutics. All rights reserved. NX-2127 appears to be well tolerated at this early stage with a safety profile that is consistent with its known mechanisms of action Full safety data will be presented by our investigators at a later medical meeting All Grade 3 or Greater Adverse Events No deaths No related serious adverse events
Case Study: Patient in Cohort 1 Patient History: 78 year-old male with stage IV CLL Date of Initial Diagnosis: March 2012 Prior Treatments: 1. Rituximab (with solumedrol), 2015 2. Ibrutinib, 2015-2021 Disease at Study Entry: Bone Marrow Involvement: 85.4% Spleen: Enlarged (15.7 cm) Nodal Lesions: Several, largest being 4.2 cm ©Nurix Therapeutics. All rights reserved.
Clinical Response Observed in Patient 1 ª Spleen % change is the percent change to a reference “normal” of 13 cm. b Response for this patient as per International working group on chronic lymphocytic leukemia (iwCLL) c Listed as partial remission in database. DLT: dose limiting toxicity; SAE: serious adverse event; AE: adverse event; ANC: absolute neutrophil count; Hgb: hemoglobin, Plt: platelet count, ALC: absolute lymphocyte count, SPD: sum of product diameters ©Nurix Therapeutics. All rights reserved. Safety Exposure No dose interruptions or modifications DLT’s None SAE’s None Grade 3 or > AE Neutropenia (ANC = 860), resolved without intervention Disease Assessment Time Point Hgb (g/dL) Plt (K/uL) ALC (K/uL) Spleen (cm) Spleen % changeª Lymph Node SPD (cm2) Nodal SPD % Change Responseb Baseline 14.3 112 16.4 15.7 --- 27.1 --- ---- Week 8 13.2 133 36.9 14.8 -33% 13.4 -51% Stable Diseasec Week 16 14.1 114 22.5 14.2 -56% 10.8 -60% Partial remission with lymphocytosis
Preliminary Findings: Robust Degradation of BTK by NX-2127 in All Patients Dosed NX-2127 is well-tolerated to date with no dose-limiting toxicities Safety profile at this early stage is manageable and consistent with mechanisms of action 5 of 6 patients remain on study Dose escalation has advanced to Cohort 3 at 300 mg once daily First demonstration of TPD of BTK in hematologic malignancies Greater than 90% BTK degradation observed in all patients at steady state in Cohort 2 (200 mg) PK/PD was consistent with modeling and preclinical animal studies Clinical response observed in Patient 1 at first dose level of 100 mg once daily BTK degradation exceeded 80% at steady state Patient’s disease expressed 68% mutated BTK, including approximately 50% C481 mutations ©Nurix Therapeutics. All rights reserved.
Conclusions Nurix protein modulation pipeline now has two programs in clinical development: NX-2127 (TPD) and NX-1607 (ligase inhibition) with two more programs advancing Robust BTK degradation demonstrated by NX-2127 in patients validates Nurix’s BTK portfolio approach in targeted protein degradation Preclinical models of PK and BTK degradation have been reliable predictors of degradation mechanism of action in humans Human data from NX-2127 informs future dose selection for NX-5948, Nurix’s BTK degrader that lacks IMiD activity and crosses the blood brain barrier in preclinical studies Nurix anticipates advancing NX-2127 to Phase 1b dose expansion in H1 2022 These initial data support the concept of targeted protein degradation as a potential therapeutic approach in hematologic malignancies ©Nurix Therapeutics. All rights reserved.
Questions and Answers
Exhibit 99.2
Nurix Therapeutics Announces Initial Data from the First Phase 1a Dose Escalation Trial of
NX-2127 in Patients with Relapsed or Refractory B Cell Malignancies
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, CA, October 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.
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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 |
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| • | 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
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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
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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 | |
| jkantor@nurixtx.com | lwolffe@wheelhouselsa.com |
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