Oncternal Therapeutics Announces Termination of its Clinical Studies and Exploration of Strategic Alternatives
2024年9月12日 - 10:00PM
Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the “Company”) today
announced its decision to discontinue its clinical trials
evaluating ONCT-534, its dual action androgen receptor inhibitor
for the treatment of patients with metastatic castration resistant
cancer, and ONCT-808, its ROR1-targeting autologous CAR T program
for the treatment of patients with aggressive B-cell lymphoma, and
to explore strategic alternatives.
In the current study, interim Phase 1 results of ONCT-534 did
not show clinically meaningful improvements of disease, including
prostate-specific antigen (PSA) levels, in the 20 patients treated
in eight dosing cohorts with various doses and schedules of
administration of ONCT-534. ONCT-534 was generally well tolerated,
with dose limiting toxicity observed in 2 of 3 patients at the
highest dose tested, 1200 mg given orally once per day.
The results with ONCT-808 at an interim Phase 1 analysis showed
anti-tumor activity at every dose tested, including a complete
metabolic response lasting eight months and long-term persistence
of the CAR-T cells, with expected treatment emergent adverse events
for a CAR-T therapy, and one death due to complications of shock at
the highest dose tested.
Based on the available clinical data and capital requirements
for continued development, the Company has decided to terminate
these studies. The Company will focus on exploring strategic
alternatives with the goal of maximizing value for its
stockholders, which may include asset sales, licensing or other
strategic transactions relating to the Company’s development
programs or a merger, reverse merger, acquisition, or other
business combination involving the Company. While this strategic
exploration is ongoing, the Company will discontinue all product
development activities and will take other steps to reduce costs,
including a reduction in its workforce to preserve cash
resources.
“The early results during dose escalation in the Phase 1/2
studies of ONCT-534 in heavily pretreated patients are
disappointing, as the study was supported by extensive preclinical
data and was designed to address important unmet medical needs for
patients with advanced prostate cancer,” said James Breitmeyer,
M.D., Ph.D., Oncternal’s President and CEO. “In light of these data
and the challenging financing environment, we intend to explore
strategic options with the hope of advancing and realizing value
from our pipeline including ONCT-534, ONCT-808, zilovertamab and
ONCT-216.”
About Oncternal TherapeuticsOncternal
Therapeutics is a clinical-stage biopharmaceutical company focused
on the development of novel oncology therapies for the treatment of
patients with cancers that have critical unmet medical need.
Oncternal pursues drug development targeting promising, yet
untapped biological pathways implicated in cancer generation or
progression, focusing on hematological malignancies and prostate
cancer. More information on our company and programs is available
at https://oncternal.com/.
About ONCT-534 ONCT-534 is an investigational
dual-action androgen receptor inhibitor (DAARI) with demonstrated
preclinical activity in prostate cancer models against both
unmutated androgen receptor (AR), and against multiple forms of AR
mutation and aberration. It is a potential treatment for patients
with mCRPC with unmet medical need because of resistance to
androgen receptor pathway inhibitors, including those with AR
amplification, mutations in the AR ligand binding domain (LBD), or
splice variants with loss of the AR LBD. It is being investigated
in Study ONCT-534-101 (NCT05917470) for the treatment of patients
with mCRPC who are resistant to current AR pathway inhibitors.
About ONCT-808ONCT-808 is an investigational
autologous chimeric antigen receptor T (CAR T) cell therapy that
targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1)
using the binding domain from zilovertamab. ONCT-808 has
demonstrated activity in preclinical models against multiple
hematological malignancies and solid tumors and has been shown to
be specific for cancer cells expressing ROR1. Oncternal has
developed a robust and reproducible manufacturing process that has
the potential to reduce the time patients must wait for their
individual CAR T therapy to be produced compared with currently
approved CAR T products. Oncternal has dosed patients under Study
ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive
B-cell lymphoma, including patients who have failed previous CD19
CAR T treatment.
About zilovertamabZilovertamab (previously
called cirmtuzumab and UC-961) is an investigational monoclonal
antibody designed to inhibit the function of ROR1. Zilovertamab has
been evaluated in Phase 1/2 Study CIRM-0001 (NCT03088878) in
combination with ibrutinib for the treatment of patients with
mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and
marginal zone lymphoma (MZL), which resulted in 100% progression
free survival (PFS) at 48 months in CLL patients whose tumors
harbored p53 mutation/del(17p), a population underserved by current
treatment options. The U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation to zilovertamab for the treatment
of CLL and MCL. The results of an investigator-sponsored, Phase 1b
clinical trial of zilovertamab in combination with paclitaxel for
the treatment of women with HER2-negative metastatic or locally
advanced, unresectable breast cancer were recently published
(Shatsky 2023). Zilovertamab is being evaluated in an
investigator-initiated Phase 1b study of zilovertamab in
combination with docetaxel in patients with metastatic
castration-resistant prostate cancer (NCT05156905), and an
investigator-initiated Phase 2 clinical trial of zilovertamab in
combination with venetoclax, a Bcl-2 inhibitor, in patients with
relapsed/refractory (R/R) CLL (NCT04501939).
About ONCT-216ONCT-216 (previously called
TK216) is an investigational targeted small-molecule inhibitor of
the E26 transformation-specific (ETS) family of oncoproteins
including fusion proteins. Tumorigenic fusion proteins involving
the EWS protein and an ETS protein can be found in most cases of
Ewing sarcoma. ETS-related translocations or overexpression are
also found in many other tumors such as acute myeloid leukemia
(AML), diffuse large B cell lymphoma (DLBCL), and prostate cancer.
In preclinical models, ONCT-216 was observed to bind to EWS-FLI1,
blocking the interaction between this fusion protein and other
transcriptome proteins such as RNA helicase A, leading to tumor
cell apoptosis and inhibiting tumor growth in animal models. The
U.S. Food and Drug Administration (FDA) has granted Rare Pediatric
Disease Designation, Orphan Drug Designation and Fast Track Status
to ONCT-216 for the treatment of Ewing sarcoma. The results of a
Phase 1/ 2 clinical trial of ONCT-216 in patients with Ewing
sarcoma (NCT02657005) were recently published (Myers 2024).
Forward-Looking Information Oncternal cautions
you that statements included in this press release that are not a
description of historical facts are forward-looking statements. In
some cases, you can identify forward-looking statements by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negatives
of these terms or other similar expressions. These statements are
based on Oncternal’s current beliefs and expectations.
Forward-looking statements include statements regarding:
Oncternal’s ability to complete a strategic transaction or continue
as a going concern even if a strategic transaction is completed;
anticipated benefits of strategic transactions; and Oncternal’s
ability to preserve cash during the strategic alternatives process.
Forward-looking statements are subject to risks and uncertainties
inherent in Oncternal’s business, including: Oncternal may not
realize the benefits expected from the workforce reduction and
discontinuation of product development activities, including its
ability to conserve cash; Oncternal’s ability to retain remaining
key personnel; whether Oncternal will be able to secure and
complete or achieve the anticipated benefits from any potential
strategic transactions on acceptable terms or at all; Oncternal may
use its capital resources sooner than it anticipates, resulting in
a liquidation and dissolution of the Company; Oncternal’s common
stock may be delisted from Nasdaq; and other risks described in
Oncternal’s filings with the U.S. Securities and Exchange
Commission. All forward-looking statements in this press release
are current only as of the date hereof and, except as required by
applicable law, Oncternal undertakes no obligation to revise or
update any forward-looking statement, or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise. All forward-looking statements are
qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
Contact Information:
InvestorsRichard Vincent
858-434-1113rvincent@oncternal.com
Business DevelopmentPablo Urbaneja
415-316-8276
purbaneja@oncternal.com
Oncternal Therapeutics (NASDAQ:ONCT)
過去 株価チャート
から 10 2024 まで 11 2024
Oncternal Therapeutics (NASDAQ:ONCT)
過去 株価チャート
から 11 2023 まで 11 2024