SAN
DIEGO, Nov. 16, 2022 /PRNewswire/ -- Inhibrx,
Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company
dedicated to the development of therapeutics for oncology and rare
diseases, today announced updated efficacy and safety data from the
ongoing Phase 1 INBRX-109 expansion cohorts for the treatment of
chondrosarcoma. Inhibrx presented this dataset as of May 2022 at the Annual Connective Tissue Oncology
Society (CTOS) Conference today, which included matured data on the
original chondrosarcoma cohort and initial data from an additional
cohort of chondrosarcoma patients with the isocitrate dehydrogenase
(IDH) mutation. Additionally, Inhibrx announced further updated
results from this dataset as of November
2022.
Among the 33 patients evaluable as of November 8, 2022, the observed disease control
rate was 87.9%, or 29 out of 33 patients as measured by RECISTv1.1,
with two patients achieving partial responses (6.1%) and 27
patients achieving stable disease (81.8%). Disease control was
observed in patients with and without IDH1/IDH2 mutations. Of those
achieving stable disease 55.6% had decreases from baseline in tumor
size. Clinical benefit was durable, 14 of 33 patients (42.4%) who
achieved disease control had a clinical benefit lasting greater
than 6 months, and the longest duration of stable disease is 20
months. To date, the median progression-free survival (PFS) is 7.6
months, and five patients remain on study.
Treatment-related adverse events (AEs) were reported in less
than 5% of the patients with the most common being increased
alanine aminotransferase (ALT), increased aspartate
aminotransferase (AST), and increased blood bilirubin and fatigue.
There were no grade 4 or 5 events reported among patients with
treatment-related AEs.
About Chondrosarcoma
Chondrosarcoma is a rare malignant bone tumor of
cartilage-producing cells and usually arises in the pelvis or long
bones. Although chondrosarcoma is considered rare with an estimated
annual incidence of 1 in 200,000, it is the most common primary
bone cancer found in adults. Surgical resection is the only
curative treatment and patients with unresectable or metastatic
disease have a poor prognosis. There are currently no approved
therapies for unresectable or metastatic chondrosarcoma.
About INBRX-109
INBRX-109 is a precision-engineered, tetravalent death receptor
5 (DR5) agonist antibody designed to exploit the tumor-biased cell
death induced by DR5 activation.
In 2021, the FDA granted Fast Track designation to INBRX-109 for
the treatment of patients with unresectable or metastatic
conventional chondrosarcoma and orphan-drug designation to
INBRX-109 for chondrosarcoma in the
United States.
In June 2021, Inhibrx initiated a
randomized, blinded, placebo-controlled, potential
registration-enabling Phase 2 trial of INBRX-109 in conventional
chondrosarcoma, which is currently ongoing.
About Inhibrx, Inc.
Inhibrx is a clinical-stage biotechnology company focused on
developing a broad pipeline of novel biologic therapeutic
candidates in oncology and orphan diseases. Inhibrx utilizes
diverse methods of protein engineering to address the specific
requirements of complex target and disease biology, including its
proprietary sdAb platform. Inhibrx has collaborations with 2seventy
bio (formerly bluebird bio), Bristol-Myers Squibb and Chiesi, among
others. 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
and its investigators' judgments and beliefs regarding the strength
of Inhibrx's pipeline, any future potential or observed to date
safety and efficacy of its therapeutic candidate, INBRX-109, and
statements and beliefs regarding the clinical development of
INBRX-109 including statements indicating that the Phase 2 trial is
registration-enabling, potential benefits of the orphan
drug-designation and any presumption of positive results from Phase
1 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, which may not be consistent
with final data or results; the timing or likelihood of regulatory
filings and approvals; the successful commercialization of its
therapeutic candidates, if approved; 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; the implementation of its
business model and strategic plans for its business and therapeutic
candidates; its ability to successfully manufacture therapeutic
candidates for clinical trials and commercial use, if approved; its
ability to contract with third-party suppliers and manufacturers
and their ability to perform adequately; the scope of protection it
is able to establish and maintain for intellectual property rights
covering its therapeutic candidates; its ability to enter into
strategic partnerships and the potential benefits of these
partnerships; its estimates regarding expenses, capital
requirements and needs for additional financing and financial
performance; its expectations regarding the impact of the COVID-19
pandemic on its business; and other risks described from time to
time in the "Risk Factors" section of its filings with the U.S.
Securities and Exchange Commission, or the SEC, including those
described in its Annual Report on Form 10-K for the year ended
December 31, 2021 as filed with the
SEC on February 28, 2022, as well as
its Quarterly Reports on Form 10-Q, and supplemented from time to
time by its Current Reports on Form 8-K. 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.
This press release contains estimates and other statistical data
made by independent parties and by Inhibrx. This data involves a
number of assumptions and limitations, and you are cautioned not to
give undue weight to such estimates.
Investor and Media Contact:
Kelly Deck, CFO
kelly@inhibrx.com
858-795-4260
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