Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory CLL and SLL
16 Janvier 2024 - 10:01PM
Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage
biopharmaceutical company developing targeted protein modulation
drugs designed to treat patients with cancer and inflammatory
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for
NX-5948, a highly selective degrader of Bruton’s tyrosine kinase
(BTK), for the treatment of adult patients with relapsed or
refractory chronic lymphocytic leukemia or small lymphocytic
lymphoma (r/r CLL/SLL) after at least two lines of therapy,
including a BTK inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2)
inhibitor.
“Fast Track designation for NX-5948 is an important recognition
of the unmet patient need in CLL, particularly in the growing
number of patients whose cancer has progressed following BTK and
BCL2 inhibitor therapy,” said Arthur T. Sands, M.D., Ph.D.,
president and chief executive officer of Nurix. “This designation
follows encouraging safety and efficacy data from our ongoing Phase
1 clinical trial, demonstrating early promise of clinical benefit
with potential for durable outcomes. The receipt of Fast Track
designation is especially timely given our plans to accelerate
enrollment in the Phase 1 trial of NX-5948 with the goal of
enabling a pivotal study for NX-5948 as rapidly as possible.”
The FDA’s Fast Track designation is intended to facilitate and
expedite the development and review of drug candidates to treat
serious conditions and fulfill an unmet medical need. To qualify,
available clinical and non-clinical data need to demonstrate a
therapeutic candidate’s potential to address an unmet medical need.
A therapeutic candidate that receives Fast Track designation may be
eligible for more frequent interactions with the FDA to discuss the
candidate’s development plan and, if relevant criteria are met,
eligibility for Accelerated Approval and Priority Review.
Nurix recently reported positive clinical 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 at the American Society of Hematology (ASH) meeting
held in December 2023. In the ASH presentation, six of seven
patients in the CLL population that received doses ranging from 50
to 200 mg demonstrated clinical benefit with three partial
responses (PR) that were all ongoing as of the October 17, 2023
data cut. NX-5948 was well-tolerated across all doses tested 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.
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. Nurix has
previously reported that NX-5948 is highly potent against a range
of tumor cell lines that are resistant to current BTK inhibitor
therapies, an important consideration in heavily pretreated CLL/SLL
patient populations. Additional information on the ongoing clinical
trial can be accessed at clinicaltrials.gov (NCT05131022).
About Nurix 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 including
inflammatory conditions. 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 plans and strategies for NX-5948,
including Nurix’s plans to accelerate enrollment in the NX-5948
clinical trials; the tolerability, safety profile, therapeutic
potential and other advantages of NX-5948, including its potential
to address a range of BTKi mutations; the planned timing and
conduct of the clinical trial for NX-5948; the planned timing for
the provision of updates and findings from the NX-5948 clinical
trial; and the potential benefits of Fast Track designation.
Forward-looking statements reflect Nurix’s current beliefs,
expectations, and assumptions regarding the future. Although Nurix
believes these expectations and assumptions 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 the Phase 1 clinical
trial for NX-5948 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; (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:
Investors Silinda Neou Nurix
Therapeutics ir@nurixtx.com
Elizabeth Wolffe, Ph.D. Wheelhouse Life Science
Advisors lwolffe@wheelhouselsa.com
Media Aljanae ReynoldsWheelhouse Life
Science Advisors areynolds@wheelhouselsa.com
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