Nurix Therapeutics Announces Partial Clinical Hold For NX-2127 Phase 1 Trial
02 November 2023 - 7:01AM
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 announced that the U.S. Food and Drug
Administration (FDA) has placed a partial clinical hold on U.S.
Phase 1 NX-2127-001 study evaluating NX-2127 in various B-cell
malignancies. Screening and enrollment of new study participants
has been paused. Patients currently enrolled in the clinical study
who are deriving clinical benefit may continue to receive treatment
in accordance with the ongoing study protocol. Nurix is working
with the FDA to resolve the partial clinical hold as soon as
possible.
The partial clinical hold follows the company’s communication to
the FDA of its intention to transition to an improved manufacturing
process. Nurix’s other drug programs are not affected by the
NX-2127 manufacturing process improvement.
“The initial NX-2127 manufacturing process produced a Phase 1
drug product that has yielded important proof-of-concept results
with meaningful clinical responses in patients with advanced B-cell
malignancies,” said Arthur T. Sands, M.D., Ph.D., president and
chief executive officer of Nurix. "While the partial hold is in
effect, we will supply the current drug product for patients who
continue on therapy in the Phase 1 study and will work
expeditiously with FDA to introduce the improved NX-2127
manufacturing process and drug product into our clinical
development plan.”
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 ability to resolve the partial
clinical hold, including the likelihood that the partial clinical
hold will be lifted and the timing of any such resolution; Nurix’s
plans and expectations for discussions with the FDA and the
outcomes from such discussions; Nurix’s plans to transition to an
improved manufacturing process for NX-2127 drug product; Nurix’s
plans to supply current drug product to patients currently enrolled
in the NX-2127 clinical trial; and the impact of the partial
clinical hold on Nurix’s other drug programs. 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) the risk that
the FDA may require Nurix to collect additional data or information
beyond what Nurix currently expects; (ii) the risk that Nurix may
not be able to adequately address the FDA’s concerns with respect
to the NX-2127 clinical trial; (iii) uncertainties relating to
regulatory applications and related filing and approval timelines,
including the risk that the FDA may not remove the partial clinical
hold; (iv) uncertainties regarding Nurix’s ability to comply with
regulatory requirements; (v) the risk that ongoing regulatory
obligations and continued regulatory review may result in
significant additional expense to Nurix or penalties for failure to
comply; and (vi) 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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