Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage
biopharmaceutical company developing targeted protein modulation
drugs designed to treat patients with hematologic malignancies and
solid tumors, today presented positive clinical data from its
orally available degraders of BTK, NX-5948 and NX-2127, which are
being evaluated in separate Phase 1a/1b clinical trials in patients
with relapsed or refractory (r/r) B-cell malignancies, including
CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma
(DLBCL), marginal zone lymphoma (MZL), follicular lymphoma (FL),
primary CNS lymphoma (PCNS), and Waldenström’s macroglobulinemia
(WM). These data were presented in two posters at the 65th American
Society of Hematology (ASH) Annual Meeting and Exposition, which is
being held in San Diego, California.
“Targeting BTK is an established treatment paradigm for patients
with CLL and other B-cell malignancies. BTK degraders represent a
novel next generation therapy for these patients,” said Alexey
Danilov, M.D., Ph.D. Professor and Co-Director, Toni Stephenson
Lymphoma Center, City of Hope National Medical Center and an
investigator on both studies. “CLL patients whose disease
progresses on or after treatment with BTK inhibitors, most often
due to the development of resistance, have no effective treatment
options. The oral availability of BTK degraders, their ability to
target BTK mutations, and their acceptable tolerability highlight
the potential for these agents in the refractory CLL treatment
landscape and potentially in earlier lines of therapy.”
“The emerging efficacy and safety finding from our
differentiated BTK degraders, NX-5948 and NX-2127, highlight the
potential of degraders to become the next dominant class of agents
in the valuable BTK-targeted therapy market,” said Arthur T. Sands,
M.D., Ph.D., president and chief executive officer of Nurix. “This
first clinical disclosure for NX-5948 supports our strategy to
broadly develop NX-5948 in CLL and other non-Hodgkin lymphoma
conditions.”
Nurix reported data from the dose escalation stage of its Phase
1a/1b clinical trial evaluating daily oral dosing of BTK degrader
NX-5948 in patients with r/r B-cell malignancies. These data were
from 26 patients enrolled in cohorts 1-5 (50-450 mg) who had
received a median of four prior therapies (range 2-10, including
BTKi, BCL2i, bispecific antibody or CAR-T therapy) and included
patients with acquired mutations associated with drug resistance.
Dose-dependent pharmacokinetics (PK) were observed, resulting in
rapid, robust, and sustained BTK degradation in all patients
treated once daily with oral NX-5948. In the CLL population that
received doses ranging from 50 to 200 mg, six of seven patients
demonstrated clinical benefit with three partial responses (PR)
that were all ongoing as of the October 17, 2023 data cut,
including one over nine months and three showing stable disease
(SD), with treatment ongoing in two patients. In NHL patients (n=
19) who were treated with doses from 50 to 450 mg, durable
responses were seen across indications, with almost half the
patients continuing to receive treatment as of the cut-off date.
NX-5948 was well-tolerated across all doses tested (50-450 mg) with
no dose limiting toxicities (DLTs) or treatment-related serious
adverse events (SAEs) and no treatment emergent adverse events
(TEAEs) that resulted in drug discontinuation. Importantly, there
were no incidences of atrial fibrillation or hypertension. Dose
escalation continues across all indications and the study is
actively enrolling patients in the United States, the United
Kingdom, and the Netherlands. Additional data with higher dose
levels and longer treatment duration are expected in 2024.
Data from the Phase 1a dose escalation and Phase 1b dose
expansion cohorts (CLL, MCL and DLBCL) of Nurix’s clinical trial of
NX-2127, an orally available degrader of both BTK and cereblon
neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3) were reported in a
second poster presentation. The presentation included data from 54
patients with r/r B-cell malignancies treated once daily with
NX-2127 at doses that ranged from 100 to 300 mg. The patient
population had a median age of 72.5 years (range 50-92 years) and
had received a median of four prior lines of therapy (range 2-11,
including BTKi, BCL2i, IMiDs, bispecific antibodies, or CAR-T
therapy). Among the patients with CLL, 36% had acquired BTK
mutations associated with BTK inhibitor drug resistance prior to
entry in the study. NX-2127 exhibited dose-dependent PK, leading to
robust and sustained degradation of BTK and biologically-relevant
degradation of Ikaros. Treatment with NX-2127 resulted in
encouraging rapid and durable responses in this heavily pre-treated
patient population with complete responses (CR) reported in two
(MCL and DLBCL) of the 17 evaluable NHL patients. These responses
were durable for over one year. Two PRs in other NHL patients (MZL
and FL) were also reported. Among the 27 evaluable patients with
CLL, 11 experienced a PR for an overall response rate (ORR) of
40.7%. This compares favorably to earlier results presented at ASH
2022 showing a preliminary 33% ORR.
NX-2127 had a manageable safety profile that was consistent with
previous reports for BTK-targeted and immunomodulatory therapies.
The most common grade ≥3 TEAEs were neutropenia, which showed
evidence of dose response, hypertension and anemia. Atrial
fibrillation was observed in six patients (11.1%, down from 17%
reported previously), with three patients (5.6%) having grade ≥3
events. Twenty-one patients (38.9%) had serious TEAEs, of which
eight (14.8%) had serious adverse events considered related to
NX-2127 treatment. Two patients experienced DLTs (cognitive
disturbance; neutropenia), and 13 patients developed TEAEs that
resulted in discontinuation of NX-2127. As of the September 15,
2023 cutoff date, treatment was ongoing in 13 patients.
Webcast detailsThe live webcast KOL event,
which will begin at 8:30 p.m. PT (11:30 p.m. ET) on Monday,
December 11, 2023, and the subsequent replay, will be available in
the Investors section of the Nurix website under Events and
Presentations.
About NX-5948NX-5948 is an investigational,
orally bioavailable, small molecule degrader of BTK. NX-5948 is
currently being evaluated in a Phase 1 clinical trial in patients
with relapsed or refractory B cell malignancies. Additional
information on the ongoing clinical trial can be accessed at
clinicaltrials.gov (NCT05131022).
About NX-2127NX-2127 is a novel bifunctional
molecule that degrades BTK and cereblon neosubstrates Ikaros
(IKZF1) and Aiolos (IKZF3). NX-2127 is currently being evaluated in
a Phase 1 clinical trial in patients with relapsed or refractory B
cell malignancies. Additional information on the ongoing clinical
trial can be accessed at www.clinicaltrials.gov (NCT04830137).
About Nurix Therapeutics, Inc.Nurix
Therapeutics is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of innovative
medicines based on the modulation of cellular protein levels as a
novel treatment approach for cancer and other challenging diseases.
Leveraging extensive expertise in E3 ligases together with
proprietary DNA-encoded libraries, Nurix has built DELigase, an
integrated discovery platform, to identify and advance novel drug
candidates targeting E3 ligases, a broad class of enzymes that can
modulate proteins within the cell. Nurix’s drug discovery approach
is to either harness or inhibit the natural function of E3 ligases
within the ubiquitin-proteasome system to selectively decrease or
increase cellular protein levels. Nurix’s wholly owned, clinical
stage pipeline includes targeted protein degraders of Bruton’s
tyrosine kinase, a B-cell signaling protein, and inhibitors of
Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that
regulates activation of multiple immune cell types including T cell
and NK cells. Nurix is headquartered in San Francisco, California.
For additional information visit http://www.nurixtx.com.
Forward-Looking Statements
This press release contains statements that relate to future
events and expectations and as such constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. When or if used in this press release, the
words “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,”
and similar expressions and their variants, as they relate to
Nurix, may identify forward-looking statements. All statements that
reflect Nurix’s expectations, assumptions or projections about the
future, other than statements of historical fact, are
forward-looking statements, including, without limitation,
statements regarding: Nurix’s future plans, prospects and
strategies; the therapeutic potential of BTK degraders; the market
potential of degraders; the tolerability, safety profile,
therapeutic potential and other advantages of NX-5948 and NX-2127;
the planned timing and conduct of the clinical trials for NX-5948
and NX-2127; the planned timing for the provision of updates and
findings from Nurix’s clinical trials; and the extent to which
Nurix’s drug candidates and scientific approach may potentially
address a broad range of diseases. Forward-looking statements
reflect Nurix’s current beliefs, expectations, and assumptions
regarding the future of Nurix’s business, its future plans and
strategies, its preclinical and clinical 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) whether Nurix
will be able to successfully conduct Phase 1 clinical trials for
NX-5948 and NX-2127 and receive results on its expected timelines,
or, at all; (ii) the unexpected emergence of adverse events or
other undesirable side effects during clinical development; (iii)
whether Nurix will be able to successfully complete clinical
development for NX-5948 and NX-2127; (iv) the risk that clinical
trial data are subject to differing interpretations and assessments
by regulatory authorities; (v) whether regulatory authorities will
be satisfied with the results from Nurix’s clinical studies; (vi)
whether Nurix will be able to obtain regulatory approval of and
ultimately commercialize its drug candidates; (vii) whether Nurix
will be able to fund development activities and achieve development
goals; (viii) the impact of macroeconomic conditions and global
events on Nurix’s clinical trials and operations; and (ix) other
risks and uncertainties described under the heading “Risk Factors”
in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter
ended August 31, 2023, 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:
InvestorsSilinda NeouNurix
Therapeuticsir@nurixtx.com
Elizabeth Wolffe, Ph.D.Wheelhouse Life Science
Advisorslwolffe@wheelhouselsa.com
MediaAljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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