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 the presentation of updated clinical data
for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine
kinase (BTK), being evaluated in an ongoing Phase 1a/b clinical
trial in adults with relapsed or refractory B-cell malignancies,
including CLL and non-Hodgkin lymphoma (NHL). Dr. Kim Linton,
M.B.Ch.B, MRCP, Ph.D., FRCP, senior lecturer at the University of
Manchester, a consultant at The Christie NHS Foundation Trust and
an investigator on the clinical trial, presented the data in an
oral session at the European Hematology Association Congress, which
is being held from June 13–16, 2024, in Madrid, Spain.
“The current results from this study of advanced patients are
very impressive for this early stage of development and we are
optimistic that NX-5948 has the potential to be an exciting
breakthrough for patients with relapsed CLL, particularly in light
of the emerging patterns of resistance to the currently available
targeted therapies,” said Dr. Linton. “As a clinical investigator,
it is highly gratifying to be able to offer patients who are
refractory to other therapies a once daily, oral drug that can
address a range of CLL disease states.”
The data presented at EHA include safety findings for all
patients in the Phase 1a dose escalation study regardless of
diagnosis (n=79) and include efficacy findings for those patients
with relapsed or refractory CLL (n=31). Patients were treated with
NX-5948 at doses ranging from 50 mg to 600 mg once daily by oral
administration. NX-5948 was well tolerated across all doses
evaluated with most common treatment emergent adverse events of
purpura/contusion, thrombocytopenia and neutropenia. Among the
efficacy evaluable patients with CLL (n=26), NX-5948 treatment
resulted in a robust objective response rate (ORR) of 69.2% across
all doses tested with responses observed as early as the first scan
(8 weeks) and with many patients experiencing deepening of their
response with longer time on treatment. All responses remained
ongoing as of the April 17 data cutoff. This cohort of CLL patients
was a heavily pretreated population that had received a median of
four prior lines of therapy (range = 2–14) including prior covalent
BTK inhibitors (96.8%), prior BCL2 inhibitors (90.3%), and prior
non-covalent BTK inhibitors (25.8%). At baseline, a large number of
patients had mutations associated with BTK inhibitor resistance
including mutations in BTK (43.3%) and PLC2G (20.0%). Poor
prognostic features were common including TP53 mutations (46.7%),
and two patients (6.5%) had central nervous system (CNS)
involvement. Responses were observed across all populations
regardless of prior treatment, baseline mutations, or CNS
involvement.
Dr. Linton also presented an updated case report that detailed
the response of one patient who entered the study with CLL with CNS
involvement after having undergone three prior therapies, including
treatment with a BTK inhibitor. After daily treatment with 100 mg,
and later 300 mg, of NX-5948, the patient exhibited a deepening
response approaching complete response criteria by 36 weeks, with
elimination of malignant cells in the cerebrospinal fluid (CSF) by
24 weeks.
Another case report presented by the company involved a patient
who had received eleven prior lines of therapy, including all
available BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib,
and pirtobrutinib). After daily treatment with 200 mg of NX-5948,
the patient achieved a response by week 8 which deepened over time
and was ongoing with over 6 months of follow up.
“The responses we are observing across the entire CLL cohort at
all dose levels are extremely encouraging. As a next step, we will
expand the Phase 1b portion of the trial across a range of CLL
subpopulations to prepare for initiation of pivotal,
registration-directed clinical evaluation in 2025,” said Paula G.
O’Connor, M.D., chief medical officer of Nurix. “While we did not
cover the clinical activity data from the NX-5948 study in the
various subtypes of NHL in this presentation, we have observed
responses across subtypes including complete responses in patients
with advanced DLBCL, MCL, MZL, and PCNSL, as well as consistent
responses in advanced WM. We look forward to presenting additional
data from the study for both CLL and NHL as it matures and to
providing further details around our plans for the next stage of
development of NX-5948.”
“With a growing body of positive clinical data, demonstrated
activity in the CNS and a favorable safety profile, NX-5948 is
emerging as a best-in-class medicine that has the potential to
provide an important treatment option for patients with CLL and
NHL,” said Arthur T. Sands, M.D., Ph.D., president and chief
executive officer of Nurix “We intend to move rapidly forward with
the goal of initiating pivotal trial(s) with NX-5948 in 2025.”
Conference Call Details
On June 16, 2024, at 9:00 a.m., ET (3:00 p.m., CEST), Nurix will
host a conference call and webcast to discuss data from the NX-5948
clinical trial and plans for the program. The live webcast, with an
accompanying presentation, will be accessible under the Events and
Presentations page in the Investors section of the company’s
website here. To participate in the live conference call please
pre-register online here. A replay of the webcast and call will be
archived on the Nurix website for approximately 30 days after the
event.
About NX-5948
NX-5948 is an investigational, orally bioavailable, brain
penetrant, 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 including chronic
lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL),
diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL),
mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary
central nervous system lymphoma (PCNSL) and Waldenström's
macroglobulinemia (WM). 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 small molecules and antibody therapies based on the
modulation of cellular protein levels as a novel treatment approach
for cancer, inflammatory conditions, 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 plans and strategies with respect to
NX-5948, including Nurix’s plans with respect to presenting
additional data from the NX-5948 clinical trial, Nurix’s plans to
expand the Phase 1b portion of the NX-5948 clinical trial across a
range of CLL subpopulations, and Nurix’s intention to advance
NX-5948 into pivotal trial(s) in 2025; and the potential advantages
and therapeutic benefits of NX-5948, including its potential role
in the treatment B-cell lymphomas and CLL involving the CNS.
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) the risks inherent in the drug development process,
including the unexpected emergence of adverse events or other
undesirable side effects during clinical development; (ii)
uncertainties related to the timing and results of clinical trials;
(iii) whether Nurix will be able to fund its research and
development activities and achieve its research and development
goals; (iv) the impact of economic and market conditions and global
and regional events on Nurix’s business, clinical trials, financial
condition, liquidity and results of operations; (v) whether Nurix
will be able to protect intellectual property and (vi) 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 29, 2024, 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:
InvestorsJason Kantor, Ph.D.Nurix
Therapeuticsir@nurixtx.com
Elizabeth Wolffe, Ph.D.Wheelhouse Life Science
Advisorslwolffe@wheelhouselsa.com
MediaAljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Nurix Therapeutics (NASDAQ:NRIX)
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