UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): December 7, 2020
NURIX THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-39398 | 27-0838048 | ||
| (State or Other Jurisdiction of Incorporation or Organization) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 1700 Owens Street, Suite 205 San Francisco, California |
94158 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(415) 660-5320
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, $0.001 par value per share | NRIX | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
On December 7, 2020, Nurix Therapeutics, Inc. (the “Company”) presented at the 62nd American Society of Hematology Annual Meeting and Exposition (the “Presentation”). A copy of the Presentation is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
The information furnished with this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Forward Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1, contains forward-looking statements and information relating to Nurix Therapeutics, Inc. (the “Company,” “we,” “us” or “our”). 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 facts, contained in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, 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 product candidates; the potential advantages of NX-2127; the extent animal model data predicts human efficacy; and the success and timing of our development and commercialization of our product candidates. 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 product candidates; 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 on our business; our ability to protect intellectual property; and other risks and uncertainties described under the heading “Risk Factors” in our final prospectus pursuant to Rule 424(b)(4) filed with the Securities and Exchange Commission (the “SEC”) on July 24, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended August 31, 2020, as well as other SEC filings. 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Exhibit Title or Description | |
| 99.1 | Presentation dated December 7, 2020 | |
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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: December 7, 2020 | By: | /s/ Christine Ring | ||||
| Christine Ring, Ph.D., J.D. | ||||||
| General Counsel | ||||||
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NX-2127, a Degrader of BTK and IMiD Neosubstrates, for the Treatment of B-Cell Malignancies Presenter: Daniel Robbins, Ph. D. drobbins@nurixtx.com Exhibit 99.1
Disclosures All authors of this presentation are current or former employees and shareholders of Nurix Therapeutics. ©Nurix Therapeutics. All rights reserved.
NX-2127 has a dual degradation mechanism of action for two clinically validated targets ©Nurix Therapeutics. All rights reserved. BTK is a tyrosine kinase involved in B cell development, differentiation and signaling BTK inhibitors are approved for treatment of B cell malignancies Mutations to BTK have conferred resistance to approved agents indicating an area of unmet medical need IMiD therapies have shown efficacy in some aggressive B-cell malignancies The dual action of BTK degradation and IMiD activity may provide a unique treatment strategy for relapsed/refractory B-cell malignancies NX-2127 is a novel, hetero-bifunctional, orally administered, Chimeric Targeting Molecule (CTM) that induces the degradation of Bruton’s Tyrosine Kinase (BTK) in cells through recruitment of cereblon (CRBN), a component of the CRL4-CRBN ubiquitin ligase complex The engagement of NX-2127 also catalyzes neosubstrate degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two transcription factors regulating T-cell function Harness (CRBN binder) Hook (BTK binder) Linker NX-2127 Ubiquitin BTK CRBN Catalytic ubiquitination Proteasome BTK A B CRBN BTK Degradation Ikaros Aiolos Catalytic ubiquitination Degradation Proteasome CRBN ubiquitin ligase complex CRBN ubiquitin ligase complex
NX-2127 catalyzes BTK degradation and anti-proliferative activity in cancer cell lines ©Nurix Therapeutics. All rights reserved. NX-2127 catalyzes potent degradation of BTK in DLBCL cell lines (TMD8), including cells with the ibrutinib-resistance mutation BTKC481S NX-2127 catalyzes BTK degradation in Rec-1 and Mino mantle cell lymphoma cell lines NX-2127 potently blocks cell proliferation of BTKC481S TMD8 cells relative to ibrutinib DC50 = half maximal degradation concentration HTRF = Homogeneous Time Resolved Fluorescence A B C
NX-2127 has minimal in vitro effects on platelet aggregation ©Nurix Therapeutics. All rights reserved. NX-2127 does not show significant inhibition of platelet aggregation in an in vitro platelet aggregation assay
NX-2127 catalyzes Aiolos degradation and IL-2 production similar to IMiD drugs ©Nurix Therapeutics. All rights reserved. IMiD Activity: T Cell Activation and IL-2 Secretion IMiD Activity: Aiolos Degradation in Naïve Human T Cells NX-2127 degrades Aiolos with similar potency to that of pomalidomide and lenalidomide NX-2127 exhibits IMiD-like activity by activation and IL-2 production following CD3/CD28 stimulation
Oral Administration of NX-2127 Demonstrates Cancer Growth Inhibition in Mouse Xenograft Tumor Model ©Nurix Therapeutics. All rights reserved. Tumor Growth Inhibition in Xenograft Model of Wild Type Lymphoma Tumor Growth Inhibition in Xenograft Model of Mutant Ibrutinib-Resistant Lymphoma NX-2127 demonstrates comparable tumor growth inhibition to ibrutinib in a xenograft mouse model containing tumors with a wild type BTK NX-2127 shows more potent tumor growth inhibition compared to ibrutinib in a xenograft mouse model containing tumors with the most common human resistance mutation (C481S) in BTK target protein
Oral Dosing of NX-2127 Degrades BTK in Cynomolgus Monkey ©Nurix Therapeutics. All rights reserved. BTK Levels in B cells at Day 19 BTK Levels in B cells at Day 1 NX-2127 induces significant degradation of BTK in 4 hours and more than 90% degradation through 24 hours post dose Once daily, oral dosing of NX-2127 maintains suppression of BTK protein levels throughout the 19-day duration of the study (NX-2127 PK t1/2 = 5.4 h) QD QD QD
Summary and Conclusions NX-2127 catalyzes potent BTK degradation in vitro and results in anti-proliferative effects in human lymphoma cell lines The IMiD activity of NX-2127 is similar to that of IMiD drugs pomalidomide and lenalidomide and results in T-cell activation NX-2127 demonstrates potent BTK degradation in vivo upon oral dosing in cynomolgus monkey and displays anti-tumor effects in both wild-type and C481S mutant mouse xenograft tumor models NX-2127 combines BTK degradation with IMiD activity to provide an attractive therapeutic strategy in the setting of resistance mutations and an expanded set of B-cell malignancies ©Nurix Therapeutics. All rights reserved.
Acknowledgements Chemistry Daisuke Kato Zef Konst Jose Leighton Oliver McConnell Joel McIntosh Ge Peng Josh Taygerly Jeffrey Wu Jeff Mihalic Christoph Zapf Development Timothy Ingallinera Janine Powers Jenny McKinnell Dane Karr Drug Discovery Technologies Eileen Ambing Andrew Sawayama Naimee Mehta Herman Yuen Paul Novick Jose Santos Dahlia Weiss Mario Cardozo Matt Clifton Stefan Gajewski Collaborators NIH NHLBI Adrian Wiestner Sarah Herman Hailey Harris Deyi Zhang Tokyo Medical and Dental University (TMD8 cells) Biology & Lead Discovery Jordan Ye Mark Noviski Austin Tenn-McClellan Szerenke Kiss von Soly Jennifa Gosling Karl Doerner Stephanie Yung Kathleen Boyle Diana Muñoz Steve Basham Preclinical Pharmacology May Tan Anna Kolobova Luz Perez Jennifer Tung Ryan Rountree Jennie Stokes Sasha Borodovsky Project Leadership & Project Management Aileen Kelly Dan Robbins Elsa Tretter Nurix Leadership Arthur Sands Pierre Beaurang Robert Brown Hans Van Houte Cristiana Guiducci Gwenn Hansen Howard Simon Jason Kantor Chris Ring Jean Chang ©Nurix Therapeutics. All rights reserved.