Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical
company developing targeted protein modulation drugs,
today announced that it has initiated the first of
several potential Phase 1b expansion cohorts in its ongoing Phase 1
trial of NX-2127, an orally administered degrader of Bruton’s
tyrosine kinase (BTK) with immunomodulatory activity. The first
expansion cohorts will focus on patients with chronic lymphocytic
leukemia (CLL).
The expansion into CLL is based on recent positive data from
Nurix’s ongoing Phase 1a dose escalation study of NX-2127,
including:
- Meaningful clinical
benefit including multiple confirmed responses by IWCLL criteria
observed in highly pre-treated relapsed/refractory CLL patients
with a median of 6 prior therapies
- Clinical responses
in patients with BTK mutations that confer resistance to current
BTK targeted therapies including both covalent and noncovalent BTK
inhibitors
- All patients show
robust and durable BTK degradation
- All patients show
Immunomodulatory activity mediated through the E3 ligase
cereblon
- Overall biologic
activity in all patients at the 100 mg dose with a favorable safety
profile
“Our decision to advance NX-2127 in patients with CLL is based
on the promising efficacy, safety, pharmacokinetic, and
pharmacodynamic data from the ongoing Phase 1a dose escalation
trial. There is a significant unmet need for a therapeutic approach
with the potential to address the growing problem of relapse due to
the development of BTK inhibitor resistance. We aim to meet that
need and are encouraged by the emerging data demonstrating the
potential of BTK degradation to treat acquired resistance mutations
for both standard of care and newly developed BTK inhibitors,” said
Robert J. Brown, M.D., executive vice president of clinical
development at Nurix. "We look forward to highlighting the
biomarker data and preliminary safety and efficacy data that guided
our decision to expand the trial for CLL patients at Nurix’s
R&D Day, scheduled for May 26th in New York City, and will
provide a full clinical update at a future medical conference in
the second half of 2022.”
The Phase 1b expansion cohorts will include up to 40 CLL
patients enrolled across multiple clinical sites in the United
States. Patients will have received two or more prior regimens
including a BTK inhibitor. All patients will be dosed at 100 mg
orally once daily. The Phase 1a dose escalation portion of the
trial will continue to enroll non-CLL patients at doses ranging
from 50mg to 300mg orally once daily.
Nurix R&D Day
Nurix will host a research & development (R&D) day for
analysts and investors that will be held today May 26, 2022 from
8:00 a.m. to 11:00 a.m. ET in New York City. The R&D Day will
feature a presentation by guest speaker, Anthony Mato, M.D., MSCE,
director of the chronic lymphocytic leukemia (CLL) Program at
Memorial Sloan Kettering Cancer Center, who will provide a
perspective on the clinical experience and unmet need in
hematologic malignancies. The event will include presentations from
Nurix’s management team, who will provide a comprehensive update on
Nurix’s four clinical programs, DELigase® discovery platform and
future development plans.
A live webcast, as well as a replay, will be available in
the Investors section of the Nurix website under Events and
Presentations.
About NX-2127Nurix’s lead drug candidate from
its protein degradation portfolio, NX-2127, is an orally
bioavailable degrader of BTK with immunomodulatory 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 including Ikaros and Aiolos involved in
regulating T-cell function, resulting in immunomodulatory
activity.
About the Phase 1, Study of NX-2127The
multicenter Phase 1 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 is being
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), Waldenstrom
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 clinical-stage 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 StatementThis 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 the
development and regulatory status of Nurix’s drug candidates; the
tolerability, safety profile, therapeutic potential and other
potential advantages of Nurix’s drug candidates; the planned timing
and conduct of the clinical trials for Nurix’s drug candidates; and
the planned timing for the provision of updates and initial
findings from Nurix’s clinical trials and programs. Forward-looking
statements reflect Nurix’s current beliefs, expectations, and
assumptions. 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-2127 and its other drug candidates and receive results on its
expected timelines, or at all; (ii) whether Nurix will be able to
successfully complete clinical development for NX-2127 and its
other drug candidates; (iii) the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; (iv) whether regulatory authorities will be satisfied
with the design of and results from Nurix’s clinical studies; (v)
whether Nurix will be able to obtain regulatory approval of and
ultimately commercialize its drug candidates; (vi) whether Nurix
will be able to fund development activities and achieve development
goals; (vii) the impact of the COVID-19 pandemic on Nurix’s
operations and clinical trials; and (viii) other risks and
uncertainties described under the heading “Risk Factors” in Nurix’s
Quarterly Report on Form 10-Q for the fiscal period ended February
28, 2022, 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: |
Elizabeth Wolffe, Ph.D. |
Brett Whelan |
Wheelhouse Life Science Advisors |
LifeSci Communications |
lwolffe@wheelhouselsa.com |
bwhelan@lifescicomms.com |
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