SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a biotechnology company with four clinical programs
in development and a strong emerging pipeline, today announced that
the U.S. Food and Drug Administration, or FDA, has granted
orphan-drug designation for INBRX-109 for the treatment of
chondrosarcoma.
"We believe orphan-drug designation underscores the recognition
of INBRX-109 as a promising therapeutic for patients with
metastatic or unresectable chondrosarcoma, a patient community
currently with no other viable options," said Inhibrx Chief
Executive Officer Mark Lappe.
The FDA's Office of Orphan Products Development grants orphan
designation status to drugs and biologics that are intended for the
safe and effective treatment, diagnosis or prevention of rare
diseases, or conditions that affect fewer than 200,000 people in
the U.S. Orphan-drug designation provides certain benefits,
including financial incentives to support clinical development and
the potential for up to seven years of market exclusivity in the
U.S. upon regulatory approval.
About Chondrosarcoma
Chondrosarcoma is an orphan bone cancer with approximately 2,800
new patients diagnosed annually in the
United States and the European Union. There are currently no
therapeutics approved for the treatment of 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 January 2021, the FDA granted
Fast Track designation to INBRX-109 for the treatment of patients
with unresectable or metastatic conventional chondrosarcoma.
In November 2021, Inhibrx provided
updated results from its ongoing Phase 1 clinical trial evaluating
the efficacy and safety of INBRX-109 in patients with conventional
chondrosarcoma. Preliminary disease control was observed in 16 of
the 18 evaluable patients (89%) measured by RECISTv1.1, with two of
the 18 achieving partial responses (11%). Based on preliminary
results of the ongoing Phase 1 trial, the median progression-free
survival (PFS) is 7.4 months, and the median overall survival has
not been reached. Three patients have exceeded 61 weeks on
treatment with INBRX-109, with 77 weeks being the longest duration
of stable disease observed to date.
In June 2021, Inhibrx initiated a
randomized, blinded, placebo-controlled, potential
registration-enabling Phase 2 trial of INBRX-109 in conventional
chondrosarcoma.
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. 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,
discussions with and beliefs regarding future action by the FDA,
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; 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, 2020 as filed with the
SEC on March 12, 2021, 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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SOURCE Inhibrx Inc.