SAN
DIEGO, Jan. 21, 2025 /PRNewswire/ -- Inhibrx
Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a
clinical-stage biopharmaceutical company focused on developing
therapeutics for oncology and rare diseases, today announced
preliminary efficacy and safety data from the Phase 1 trial of
ozekibart (INBRX-109) in combination with FOLFIRI for the treatment
of advanced or metastatic, unresectable colorectal adenocarcinoma
(CRC). These results were presented at the American Society of
Clinical Oncology (ASCO) Gastrointestinal Annual Cancers
Symposium.
Efficacy was assessed in 10 of the 13 patients who received at
least one dose of ozekibart, based on RECIST v1.1 criteria. Results
demonstrated one complete response (CR), three partial responses
(PR), and six cases of stable disease (SD). Durable disease control
lasting ≥180 days was observed in 46.2% of patients, with a median
progression-free survival (PFS) of 7.85 months. All patients had
received at least one prior line of systemic therapy (median: two;
range: 1–6). Notably, the patient achieving a CR had undergone
three prior lines of therapy, and two PRs occurred in patients who
had failed prior FOLFIRI-based treatments.
Ozekibart-related treatment-emergent adverse events (TEAEs) were
reported in 84.6% of patients, with most being grade 1 or 2 in
severity. Grade ≥3 TEAEs were observed in 30.8% of patients. The
most common ozekibart-related TEAEs included nausea, increased
alanine aminotransferase, diarrhea, and fatigue, with the majority
being low-grade.
Encouraged by these preliminary results, Inhibrx has initiated a
new expansion cohort to validate these findings in a more uniform
patient population. The cohort is expected to enroll up to 50
patients, each with two to three prior lines of systemic therapy,
and data are anticipated in Q3 2025.
"We believe these interim results underscore the potential of
ozekibart to provide meaningful clinical benefit for patients with
advanced solid tumors, even in heavily pretreated populations. We
are particularly encouraged by the durable disease control observed
and look forward to further evaluating these findings in our
expansion cohort," commented Josep
Garcia, Chief Clinical Development Officer at Inhibrx.
About Colorectal Adenocarcinoma
Colorectal adenocarcinoma is the third most frequent cancer
globally and the second leading cause of cancer-related death.
According to the WHO, there were nearly 2,000,000 new cases of CRC
in 2020, with nearly 1,000,000 deaths. Effective therapies beyond
the second-line setting are limited. In the U.S., the five-year
relative survival rate in patients with metastatic CRC is 15.7%,
underscoring the need for better treatments.
About ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor
5 (DR5) agonist antibody designed to exploit the tumor-biased cell
death induced by DR5 activation.
In January 2021, the FDA granted Fast
Track designation to ozekibart for the treatment of patients with
metastatic or unresectable conventional chondrosarcoma, and, in
November 2021, the FDA granted orphan
drug designation to ozekibart for chondrosarcoma.
In June 2021, Inhibrx initiated a
randomized, blinded, placebo-controlled, registration-enabling
Phase 2 trial of ozekibart in metastatic, unresectable conventional
chondrosarcoma, which is currently ongoing and expected to read out
in the middle of this year. Additionally, in a Phase 1 trial,
Inhibrx is investigating ozekibart in Ewing sarcoma in combination
with irinotecan/temozolomide.
About Inhibrx Biosciences, Inc.
Inhibrx Biosciences is a clinical-stage biopharmaceutical
company focused on developing a broad pipeline of novel biologic
therapeutic candidates. Inhibrx Biosciences utilizes diverse
methods of protein engineering to address the specific requirements
of complex target and disease biology, including its proprietary
protein engineering platforms. Inhibrx Biosciences was incorporated
in January 2024 as a direct,
wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of
Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx
Biosciences acquired certain corporate infrastructure and other
assets and liabilities through a series of internal restructuring
transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed
a distribution to holders of its shares of common stock of 92% of
the issued and outstanding shares of Inhibrx Biosciences. Following
such transactions, Inhibrx Biosciences' current clinical pipeline
of therapeutic candidates includes ozekibart (INBRX-109) and
INBRX-106, both of which utilize multivalent formats where the
precise valency can be optimized in a target-centric way to mediate
what we believe to be the most appropriate agonist function. Both
programs have key data readouts expected in 2025. For more
information, please visit www.inhibrx.com.
Forward-Looking Statements
Inhibrx cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. These statements are based on Inhibrx's
current beliefs and expectations. These forward-looking statements
include, but are not limited to, statements regarding: Inhibrx's
judgments and beliefs regarding the strength of Inhibrx's pipeline
any future potential safety and efficacy of its therapeutic
candidate, ozekibart; the clinical development of ozekibart,
including expected enrollment in the expansion cohort and data
readouts and the timing thereof; the potential demand for ozekibart
and any presumption that preliminary data will be representative of
final data or data in later clinical trials. Actual results may
differ from those set forth in this press release due to the risks
and uncertainties inherent in Inhibrx's business, including,
without limitation, risks and uncertainties regarding: the
initiation, timing, progress and results of its preclinical studies
and clinical trials, and its research and development programs; its
ability to advance therapeutic candidates into, and successfully
complete, clinical trials; its interpretation of initial, interim
or preliminary data from its clinical trials, including
interpretations regarding disease control and disease response;
results from preclinical studies or early clinical trials not
necessarily being predictive of future results; unexpected adverse
side effects or inadequate efficacy of its therapeutic candidates
that may limit their development, regulatory approval and/or
commercialization; the potential for its programs and prospects to
be negatively impacted by developments relating to its competitors,
including the results of studies or regulatory determinations
relating to its competitors; the timing or likelihood of regulatory
filings and approvals and regulatory developments in the U.S. and
foreign countries; the successful commercialization of its
therapeutic candidates, if approved; an accelerated development or
approval pathway may not be available for ozekibart or other
therapeutic candidates and any such pathway may not lead to a
faster development process; it may not realize the benefits
associated with orphan drug designation, including that orphan drug
exclusivity may not effectively protect a product from competition
and that such exclusivity may not be maintained; the pricing,
coverage and reimbursement of its therapeutic candidates, if
approved; its ability to utilize its technology platform to
generate and advance additional therapeutic candidates; and other
risks described from time to time in the "Risk Factors" section of
its filings with the U.S. Securities and Exchange Commission,
including those described in its Registration Statement on Form 10,
as amended (File No. 001-42031), its Registration Statement on Form
S-1, as amended and supplemented from time to time (File No.
333-280127), and its Quarterly Reports on Form 10-Q, and
supplemented from time to time by its Current Reports on Form 8-K
as filed from time to time. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof, and Inhibrx undertakes no obligation to update
these statements to reflect events that occur or circumstances that
exist after the date hereof. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Investor and Media Contact:
Kelly Deck, CFO
ir@inhibrx.com
858-795-4260
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