Nurix Therapeutics Outlines 2024 Strategic Priorities with Advancement of Targeted Protein Modulation Pipeline in Cancer and Autoimmune Diseases
08 Janvier 2024 - 1:00PM
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 outlined key objectives and anticipated milestones
for 2024 and provided an overview of recent progress in a
presentation at the 42nd Annual J.P. Morgan Healthcare Conference.
“In 2023, Nurix strengthened its leadership position in the
targeted protein modulation field with significant accomplishments
in several key areas of our business,” said Arthur T. Sands, M.D.,
Ph.D., president and chief executive officer of Nurix. “We recently
presented impressive clinical responses from our NX-5948 clinical
trial in leukemia and lymphomas and have implemented plans to
accelerate enrollment with dozens of new clinical trial sites in
the United States, the United Kingdom, and Europe in 2024. We
expanded our pipeline through strategic collaborations, including
the addition of a new class of medicines with our first of its kind
collaboration with Seagen, now Pfizer, to develop Degrader-Antibody
Conjugates for use in cancer. We also made substantial progress in
our existing collaborations, as exemplified by Gilead exercising
its option to exclusively license Nurix’s investigational targeted
IRAK4 protein degrader molecule for rheumatoid arthritis and other
inflammatory diseases. Notably, our strategic collaborations
generated meaningful non-dilutive funding in 2023, which positions
us well financially to progress and expand our pipeline through
important milestones in 2024 and beyond.”
2023 Accomplishments and Business
Highlights
Clinical Stage Pipeline
- Advanced our wholly owned
Bruton’s tyrosine kinase (BTK) degrader programs
and presented positive clinical data at oncology-focused medical
meetings throughout 2023. Most recently, positive data
were presented from Nurix’s novel BTK degrader programs, NX-5948
and NX-2127, at the 65th American Society of Hematology (ASH)
Annual Meeting. A webcast of Nurix’s ASH presentation is available
in the Investors section of the Nurix website under Events and
Presentations.
- NX-5948: is an
orally bioavailable degrader of BTK. Nurix is evaluating daily oral
dosing of NX-5948 in a Phase 1a/1b clinical trial in patients with
relapsed or refractory B-cell malignancies. At the ASH meeting,
Nurix reported data from the dose escalation stage of the trial
demonstrating dose-dependent pharmacokinetics (PK), resulting in
rapid, robust, and sustained BTK degradation in all patients
treated. NX-5948 was well-tolerated across all doses tested from 50
to 450 mg daily. Preliminary efficacy data demonstrated clinical
benefit in six of seven patients with chronic lymphocytic leukemia
(CLL) at doses ranging from 50 to 200 mg. In non-Hodgkin lymphoma
(NHL) patients 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 data cut-off
date. Dose escalation in the NX-5948 trial continues across all
indications and the study is actively enrolling patients in the
United States, the United Kingdom, and the Netherlands. Additional
information on the ongoing clinical trial can be accessed at
www.clinicaltrials.gov (NCT05131022).
-
NX-2127: is a novel orally
bioavailable bifunctional molecule that degrades BTK and cereblon
neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). At the ASH
meeting, Nurix reported data from its Phase 1a dose escalation and
Phase 1b dose expansion cohorts in CLL, mantle cell lymphoma (MCL)
and diffuse large B-cell lymphoma (DLBCL). 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 the
heavily pre-treated patient population including patients with BTK
inhibitor resistance mutations. Durable complete responses (CR)
were reported in two patients with MCL and DLBCL which remained
ongoing for over one year. In patients with CLL, the data
demonstrated an improved overall response rate (ORR) of 41%
compared to 33% ORR presented at ASH 2022. NX-2127 had a manageable
safety profile that was consistent with previous reports for
BTK-targeted and immunomodulatory therapies. Additional information
on the clinical trial can be accessed at www.clinicaltrials.gov
(NCT04830137).
- Expanded Phase 1a dose
escalation trial of NX-1607 to include a combination therapy arm
with Paclitaxel. Nurix’s lead drug candidate from its E3
ligase inhibitor portfolio, NX-1607, is an orally bioavailable
inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) for
immuno-oncology indications including a range of solid tumor types.
Nurix is evaluating NX-1607 in an ongoing Phase 1a dose escalation
trial in monotherapy and in a combination cohort with paclitaxel in
adults in a range of oncology indications at multiple clinical
sites in the United Kingdom and United States. Additional
information on the clinical trial can be accessed at
www.clinicaltrials.gov (NCT05107674).
Research and Corporate
- Advanced internal and
collaboration preclinical pipeline from productive DELigase drug
discovery platform
- Entered into a strategic
collaboration with Seagen (now part of Pfizer) to develop a
portfolio of Degrader-Antibody Conjugates (DACs). DACs are
antibodies that deliver a targeted protein degrader payload to
selectively kill cancer cells. Nurix received a $60 million
upfront payment and has the potential to receive approximately
$3.4 billion in milestone payments plus future royalties.
Nurix also retains an option for U.S. profit sharing and
co-promotion on two products arising from the collaboration.
- Advanced Sanofi and
Gilead collaborations and achieved major milestone in Gilead
collaboration with the licensing of NX-0479, an oral IRAK4
degrader. Nurix advanced its ongoing strategic
collaborations with both Sanofi and Gilead, earning
$74 million in preclinical milestones and licensing fees
through fiscal Q3 2023. In March, Gilead exercised its option to
exclusively license Nurix’s oral IRAK4 degrader, which has
potential applications in the treatment of rheumatoid arthritis and
other inflammatory diseases. GS-6791/NX-0479 is the first
development candidate resulting from the 2019 Nurix-Gilead
collaboration to discover, develop and commercialize a pipeline of
innovative targeted protein degradation therapies. Nurix received a
$20 million license fee and could potentially receive up to an
additional $425 million in clinical, regulatory and commercial
milestone payments, as well as up to low double-digit tiered
royalties on product net sales.
- Maintained strong balance
sheet with $329M including funds as of August 31, 2023 and $60
million upfront received from Seagen (now part of Pfizer) in the
fourth quarter of 2023. Based on our current
operating plan Nurix has cash runway into the second half of
2025.
2024 Goals and Catalysts
- Clinical
updates to Nurix’s three wholly clinical stage programs as
described below:
- NX-5948: Nurix
is evaluating NX-5948 in an ongoing Phase 1 clinical trial in
adults with relapsed or refractory B cell malignancies and expects
to define doses for Phase 1b cohort expansion in CLL and NHL and to
present additional clinical data with higher dose levels and longer
treatment duration. The company plans to accelerate Phase 1
clinical trial enrollment to enable pivotal trials. In addition,
Nurix expects to complete ongoing preclinical studies that can
enable an investigational new drug (IND) application for NX-5948 in
autoimmune indications.
- NX-2127: Nurix
expects to resolve the partial clinical hold on the Phase 1
clinical trial to enable the introduction of newly manufactured
drug product into the ongoing Phase 1 clinical trial.
- NX-1607: Nurix
expects to present data from the Phase 1a stage of the monotherapy
and paclitaxel combination cohorts in its clinical trial of NX-1607
in a range of oncology indications, and to define plans and dose(s)
for Phase 1b cohort expansion.
Research and Corporate
- Nurix expects to nominate a
new targeted protein degrader development candidate.
- Nurix plans to present and publish preclinical work on
its wholly owned programs throughout 2024 at appropriate scientific
and medical meetings.
- Research milestones: Nurix expects to achieve
multiple research collaboration milestones throughout 2024 from its
existing collaborations with Gilead, Sanofi, and Pfizer.
- Business Development: Nurix will continue to
prioritize the formation of new drug discovery and development
collaborations to further advance and fund its pipeline.
About NurixNurix 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 future plans, prospects and
strategies, including its plans to expand into therapeutics areas
such as autoimmune and inflammatory disease, its plans to
accelerate enrollment in the NX-5948 clinical trials, and its plans
to pursue an IND application for NX-5948 in autoimmune indications;
Nurix’s future financial or business performance; Nurix’s current
and prospective drug candidates; the planned timing and conduct of
the clinical trials for Nurix’s drug candidates; the planned timing
for the provision of updates and findings from Nurix’s preclinical
and clinical studies; the tolerability, safety profile, therapeutic
potential and other advantages of Nurix’s drug candidates; the
therapeutic potential of Degrader-Antibody Conjugates; the
potential benefits of Nurix’s collaborations, including potential
milestone and sales-related payments; the extent to which Nurix’s
scientific approach, Nurix’s DELigase™ platform and
Degrader-Antibody Conjugates may potentially address a broad range
of diseases; and Nurix’s ability to fund it operating activities
into the second quarter of 2025. 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) risks and uncertainties related to
Nurix’s ability to advance its drug candidates, obtain regulatory
approval of and ultimately commercialize its drug candidates,
including the risk that Nurix may not be able to adequately address
the FDA’s concerns with respect to the NX-2127 clinical trial; (ii)
risks and uncertainties related to the timing and results of
preclinical studies and clinical trials; (iii) risks and
uncertainties related to Nurix’s ability to fund development
activities and achieve development goals; (iv) uncertainties
related to the timing and receipt of payments from Nurix’s
collaboration partners, including milestone payments and royalties
on future potential product sales; (v) the impact of macroeconomic
conditions and global or regional events on Nurix’s business,
clinical trials, financial condition, liquidity and results of
operations; (vi) risks and uncertainties related to Nurix’s ability
to protect intellectual property and (vii) 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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