Nurix Therapeutics Presents Constructive Outcomes from Ongoing Medical Trial of NX-5948 in Sufferers with Relapsed Refractory Power Lymphocytic Leukemia (CLL) on the European Hematology Affiliation...

Goal response charge of 69.2% noticed in closely pretreated affected person inhabitants together with sufferers with BTK inhibitor resistance mutations

Medical responses in CLL sufferers have been speedy and deepening with longer time on therapy

Nurix intends to advance NX-5948 into pivotal trial(s) in 2025

Firm will host a webcast convention at the moment, June 16, 2024, at 9:00 a.m. ET (3:00 p.m. CEST)

SAN FRANCISCO, June 16, 2024 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a medical stage biopharmaceutical firm growing focused protein modulation medication designed to deal with sufferers with most cancers and inflammatory illnesses, at the moment introduced the presentation of up to date medical knowledge for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK), being evaluated in an ongoing Part 1a/b medical trial in adults with relapsed or refractory B-cell malignancies, together with CLL and non-Hodgkin lymphoma (NHL). Dr. Kim Linton, M.B.Ch.B, MRCP, Ph.D., FRCP, senior lecturer on the College of Manchester, a advisor at The Christie NHS Basis Belief and an investigator on the medical trial, offered the info in an oral session on the European Hematology Affiliation Congress, which is being held from June 13–16, 2024, in Madrid, Spain.

“The present outcomes from this examine of superior sufferers are very spectacular for this early stage of improvement and we’re optimistic that NX-5948 has the potential to be an thrilling breakthrough for sufferers with relapsed CLL, significantly in mild of the rising patterns of resistance to the at the moment out there focused therapies,” mentioned Dr. Linton. “As a medical investigator, it’s extremely gratifying to have the ability to provide sufferers who’re refractory to different therapies a as soon as every day, oral drug that may deal with a spread of CLL illness states.”

The information offered at EHA embody security findings for all sufferers within the Part 1a dose escalation examine no matter analysis (n=79) and embody efficacy findings for these sufferers with relapsed or refractory CLL (n=31). Sufferers have been handled with NX-5948 at doses starting from 50 mg to 600 mg as soon as every day by oral administration. NX-5948 was nicely tolerated throughout all doses evaluated with commonest therapy emergent adversarial occasions of purpura/contusion, thrombocytopenia and neutropenia. Among the many efficacy evaluable sufferers with CLL (n=26), NX-5948 therapy resulted in a strong goal response charge (ORR) of 69.2% throughout all doses examined with responses noticed as early as the primary scan (8 weeks) and with many sufferers experiencing deepening of their response with longer time on therapy. All responses remained ongoing as of the April 17 knowledge cutoff. This cohort of CLL sufferers was a closely pretreated inhabitants that had obtained a median of 4 prior strains of remedy (vary = 2–14) together with prior covalent BTK inhibitors (96.8%), prior BCL2 inhibitors (90.3%), and prior non-covalent BTK inhibitors (25.8%). At baseline, a lot of sufferers had mutations related to BTK inhibitor resistance together with mutations in BTK (43.3%) and PLC2G (20.0%). Poor prognostic options have been frequent together with TP53 mutations (46.7%), and two sufferers (6.5%) had central nervous system (CNS) involvement. Responses have been noticed throughout all populations no matter prior therapy, baseline mutations, or CNS involvement.

Dr. Linton additionally offered an up to date case report that detailed the response of 1 affected person who entered the examine with CLL with CNS involvement after having undergone three prior therapies, together with therapy with a BTK inhibitor. After every day therapy with 100 mg, and later 300 mg, of NX-5948, the affected person exhibited a deepening response approaching full response standards by 36 weeks, with elimination of malignant cells within the cerebrospinal fluid (CSF) by 24 weeks.

One other case report offered by the corporate concerned a affected person who had obtained eleven prior strains of remedy, together with all out there BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib). After every day therapy with 200 mg of NX-5948, the affected person achieved a response by week 8 which deepened over time and was ongoing with over 6 months of observe up.

“The responses we’re observing throughout your complete CLL cohort in any respect dose ranges are extraordinarily encouraging. As a subsequent step, we’ll increase the Part 1b portion of the trial throughout a spread of CLL subpopulations to arrange for initiation of pivotal, registration-directed medical analysis in 2025,” mentioned Paula G. O’Connor, M.D., chief medical officer of Nurix. “Whereas we didn’t cowl the medical exercise knowledge from the NX-5948 examine within the numerous subtypes of NHL on this presentation, we’ve got noticed responses throughout subtypes together with full responses in sufferers with superior DLBCL, MCL, MZL, and PCNSL, in addition to constant responses in superior WM. We sit up for presenting extra knowledge from the examine for each CLL and NHL because it matures and to offering additional particulars round our plans for the subsequent stage of improvement of NX-5948.”

“With a rising physique of optimistic medical knowledge, demonstrated exercise within the CNS and a positive security profile, NX-5948 is rising as a best-in-class medication that has the potential to offer an vital therapy possibility for sufferers with CLL and NHL,” mentioned Arthur T. Sands, M.D., Ph.D., president and chief govt officer of Nurix “We intend to maneuver quickly ahead with the aim of initiating pivotal trial(s) with NX-5948 in 2025.”

ConventionName Particulars

On June 16, 2024, at 9:00 a.m., ET (3:00 p.m., CEST), Nurix will host a convention name and webcast to debate knowledge from the NX-5948 medical trial and plans for this system. The stay webcast, with an accompanying presentation, might be accessible beneath the Occasions and Displays web page within the Traders part of the corporate’s web site right here. To take part within the stay convention name please pre-register on-line right here. A replay of the webcast and name might be archived on the Nurix web site for roughly 30 days after the occasion.

About NX-5948

NX-5948 is an investigational, orally bioavailable, mind penetrant, small molecule degrader of BTK. NX-5948 is at the moment being evaluated in a Part 1 medical trial in sufferers with relapsed or refractory B cell malignancies together with power lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL), diffuse massive B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), major central nervous system lymphoma (PCNSL) and Waldenström’s macroglobulinemia (WM). Further data on the continued medical trial may be accessed at clinicaltrials.gov (NCT05131022).

About Nurix

Nurix Therapeutics is a medical stage biopharmaceutical firm targeted on the invention, improvement and commercialization of revolutionary small molecules and antibody therapies primarily based on the modulation of mobile protein ranges as a novel therapy method for most cancers, inflammatory circumstances, and different difficult illnesses. Leveraging in depth experience in E3 ligases along with proprietary DNA-encoded libraries, Nurix has constructed DELigase, an built-in discovery platform, to determine and advance novel drug candidates focusing on E3 ligases, a broad class of enzymes that may modulate proteins inside the cell. Nurix’s drug discovery method is to both harness or inhibit the pure operate of E3 ligases inside the ubiquitin-proteasome system to selectively lower or improve mobile protein ranges. Nurix’s wholly owned, medical stage pipeline consists of focused 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 a number of immune cell varieties together with T cell and NK cells. Nurix is headquartered in San Francisco, California. For added data go to https://www.nurixtx.com.

Ahead-Trying Statements

This press launch comprises statements that relate to future occasions and expectations and as such represent forward-looking statements inside the which means of the Personal Securities Litigation Reform Act of 1995. When or if used on this press launch, the phrases “anticipate,” “consider,” “may,” “estimate,” “anticipate,” “intend,” “could,” “outlook,” “plan,” “predict,” “ought to,” “will,” and comparable expressions and their variants, as they relate to Nurix, could determine forward-looking statements. All statements that replicate Nurix’s expectations, assumptions or projections in regards to the future, apart from statements of historic reality, are forward-looking statements, together with, with out limitation, statements concerning: Nurix’s plans and methods with respect to NX-5948, together with Nurix’s plans with respect to presenting extra knowledge from the NX-5948 medical trial, Nurix’s plans to increase the Part 1b portion of the NX-5948 medical trial throughout a spread of CLL subpopulations, and Nurix’s intention to advance NX-5948 into pivotal trial(s) in 2025; and the potential benefits and therapeutic advantages of NX-5948, together with its potential function within the therapy B-cell lymphomas and CLL involving the CNS. Ahead-looking statements replicate Nurix’s present beliefs, expectations, and assumptions. Though Nurix believes the expectations and assumptions mirrored in such forward-looking statements are affordable, Nurix may give no assurance that they may show to be right. Ahead-looking statements aren’t ensures of future efficiency and are topic to dangers, uncertainties and adjustments in circumstances which can be troublesome to foretell, which may trigger Nurix’s precise actions and outcomes to vary materially from these expressed in any forward-looking assertion. Such dangers and uncertainties embody, however aren’t restricted to: (i) the dangers inherent within the drug improvement course of, together with the sudden emergence of adversarial occasions or different undesirable unwanted side effects throughout medical improvement; (ii) uncertainties associated to the timing and outcomes of medical trials; (iii) whether or not Nurix will be capable to fund its analysis and improvement actions and obtain its analysis and improvement targets; (iv) the influence of financial and market circumstances and world and regional occasions on Nurix’s enterprise, medical trials, monetary situation, liquidity and outcomes of operations; (v) whether or not Nurix will be capable to shield mental property and (vi) different dangers and uncertainties described beneath the heading “Threat Components” in Nurix’s Quarterly Report on Kind 10-Q for the fiscal interval ended February 29, 2024, and different SEC filings. Accordingly, readers are cautioned to not place undue reliance on these forward-looking statements. The statements on this press launch converse solely as of the date of this press launch, even when subsequently made out there by Nurix on its web site or in any other case. Nurix disclaims any intention or obligation to replace publicly any forward-looking statements, whether or not in response to new data, future occasions, or in any other case, besides as required by relevant legislation.

Contacts:

Traders
Jason Kantor, Ph.D.
Nurix Therapeutics
[email protected]

Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
[email protected]

Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]