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 the first findings of
clinical responses in the brain for NX-5948, an orally available,
selective degrader of Bruton’s tyrosine kinase (BTK). The
presentation included case studies for two patients, one with CLL
with CNS involvement and the other with PCNSL, each demonstrating
clinically meaningful responses. The presentation also provided
evidence of measurable drug levels in the CNS of multiple patients
in the ongoing Phase 1 trial who had CNS tumor involvement. These
data were presented by Gwenn M. Hansen, Ph.D., chief scientific
officer of Nurix, as part of the Major Symposium session Molecular
Glues, PROTACs, and Next-Gen Degraders: Discovery and Early
Preclinical Advances at the AACR 2024 Annual Meeting, which is
being held from April 5-10, 2024, in San Diego, CA.
“These data are the first demonstration of clinical activity in
the brain of a targeted protein degrader, opening the door for new
therapeutic strategies to treat leukemias and lymphomas with CNS
involvement,” said Dr. Hansen. “The brain penetration of NX-5948
coupled with the clinical activity and safety profile presented to
date, suggests a potential role in the treatment of B-cell
lymphomas and chronic lymphocytic leukemia involving the CNS which
are notoriously difficult to treat. It also suggests the potential
to use NX-5948 as a therapeutic option for immune indications with
CNS involvement such as multiple sclerosis.”
Dr. Hansen’s presentation included new data from the dose
escalation stage of Nurix’s Phase 1a/1b clinical trial evaluating
daily oral dosing of BTK degrader NX-5948 in patients with relapsed
or refractory B-cell malignancies. Data were presented
demonstrating detection of NX-5948 in the cerebrospinal fluid (CSF)
from all patients with available CSF samples. Case studies were
presented for two of these patients.
In one case study, a CLL patient was enrolled with secondary CNS
involvement whose disease progressed following three prior lines of
treatment, including both a BCL2 inhibitor in combination with
rituximab and a BTK inhibitor (acalabrutinib). This patient, who
presented with malignant cells in the CSF at study entry and the
high-risk cytogenetic marker Del17p, received NX-5948 at a once
daily dose of 100 mg. By week 8, the patient had significant lymph
node reduction and spleen reduction consistent with stable disease.
By week 16, the patient had experienced continued reduction in
lymph nodes and spleen size and improvements in hematologic
measures consistent with a partial response. By week 24, the
partial response was confirmed and the patient no longer had
measurable tumor cells in the CSF. As of March 4th, the patient
remains on treatment in cycle 10 of therapy (>36 weeks).
In the other case study, a patient was enrolled with primary
central nervous system lymphoma (PCNSL) with the high-risk
cytogenic marker of MYC rearrangement and whose disease progressed
after two prior lines of therapy, including high dose multi-drug
chemotherapy with rituximab in the first-line setting, and
ibrutinib in the second line, which yielded a best response of
stable disease. The patient presented with three measurable lesions
in the right temporal lobe and received NX-5948 at the 450 mg once
daily dose. By week 8, the patient experienced complete regression
of all three lesions and demonstrated a complete response (CR). A
subsequent 16 week scan revealed that this patient’s disease had
progressed with the emergence of a new brain lesion.
“These clinical responses seen to date with NX-5948 in patients
with significant brain disease support future exploration of
NX-5948 both as a single agent and in combination with other
therapies that are used for primary and secondary CNS lymphoma and
leukemia,” said Arthur T. Sands, M.D., Ph.D., president and chief
executive officer of Nurix. “The CLL patient with CNS involvement
showed an impressive durable response with NX-5948 as single agent
therapy in this setting. The patient with PCNSL, and an aggressive
NHL histology, showed a rapid, complete response, providing clear
evidence of therapeutic effect in the brain that has the potential
to be augmented through combination therapies to improve durability
of response.”
About Central Nervous System (CNS) Lymphoma
CNS involvement of B cell malignancies span various conditions
including: Primary CNS lymphoma (PCNSL) comprising 4% of all
primary CNS tumors and 4-6% of all extranodal lymphomas; secondary
CNS lymphoma (SCNSL) which represents a risk of ~5% in patients
with diffuse large B cell lymphoma (DLBLC); and CNS involvement in
CLL which albeit rare, presents a poor prognosis in patients with
clinically significant disease.
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. 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 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 the future use of NX-5948 both as a single agent
and in combination with other therapies, 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, its potential as a therapeutic option for immune
indications with CNS involvement, and its potential when used in
combination with other therapies. 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; (iv) whether Nurix will be able to fund its
research and development activities and achieve its research and
development goals; (v) 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;
(vi) whether Nurix will be able to protect intellectual property
and (vii) other risks and uncertainties described under the heading
“Risk Factors” in Nurix’s Annual Report on Form 10-K for the fiscal
year ended November 30, 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:
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
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