SAN DIEGO, Oct. 12, 2021 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a biotechnology company with four clinical programs
in development and an emerging pre-clinical pipeline, today
announced interim results from a Phase 1 clinical trial evaluating
the safety and pharmacokinetics of INBRX-101, an optimized
recombinant human AAT-Fc fusion protein, in patients with alpha-1
antitrypsin deficiency, or AATD.
Interim functional PK data from this multi-country multi-center
Phase 1 study are from 21 patients with AATD, all with the ZZ
mutation of the SERPINA1 gene, the underlying cause of AATD.
Interim safety data are from 24 patients with AATD. There were no
drug-related severe or serious adverse events at doses up to and
including 120 mg/kg single dose and 80mg/kg multi-dose.
Drug-related adverse events were predominantly mild with a few
moderate events and all were transient and reversible. No signs of
neutralizing anti-drug antibodies have been seen.
Dose related increases in maximal and total INBRX-101 exposure
occurred across the entirety of the tested single ascending dose
range of 10 to 120 mg/kg.
Data from the first multiple ascending dose cohort of INBRX-101
at 40 mg/kg IV every three weeks showed the expected accumulation
of functional alpha-1 antitrypsin, or AAT, levels with observed
trough levels exceeding the goal of the current standard
augmentation therapy with plasma-derived AAT.
Functional AAT and bronchoalveolar lavage data from patients to
be administered three INBRX-101 doses of 80 or 120 mg/kg IV every
three weeks are expected in the first half of 2022.
"These initial data demonstrate the potential of INBRX-101 to
significantly improve treatment for patients with AATD by
maintaining them in the normal range of functional AAT and reducing
infusions from 52 annually to possibly as few as 12 annually," said
Mark Lappe, CEO of Inhibrx.
The Company will host a live webcast presentation today at
5:30 a.m. PT to further discuss the
results.
About the Conference Call
Investors may join via the web:
https://www.webcaster4.com/Webcast/Page/2560/43178 or may
listen to the call by dialing (1-877-870-4263) from locations in
the United States or
(1-412-317-0790) from outside the United
States. Please refer to Inhibrx, Inc. when calling in.
Following the webcast, the presentation may be accessed through a
link on the "Investors" section of Inhibrx's website at
https://inhibrx.investorroom.com/events-and-presentations. The
webcast will be available for 60 days following the event.
Following the presentation, Inhibrx will update its corporate
presentation within the "Investors" section of its website at
www.inhibrx.com.
About INBRX-101 and AATD
INBRX-101 is a precisely engineered recombinant human AAT-Fc
fusion protein designed to safely achieve and maintain levels of
alpha-1 antitrypsin, or AAT, found in healthy individuals with the
potential for once-monthly dosing.
Alpha-1 antitrypsin deficiency, or AATD, is an inherited orphan
disease affecting an estimated 100,000 patients in the United States. AATD is characterized by
deficient levels of the AAT protein, which causes loss of lung
tissue and function and decreased life expectancy.
Plasma-derived AAT is the current standard of care and does not
maintain patients in the normal AAT range, requires frequent and
inconvenient once-weekly IV dosing, and relies on plasma collection
practices that might not be sustainable.
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 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 observed
safety and efficacy to date of its therapeutic candidate,
INBRX-101, discussions with and beliefs regarding future action by
the U.S. Food and Drug Administration, statements and beliefs
regarding the current standard of care for AAT and the
sustainability of current plasma collection practices, future
clinical development, application and dosage of INBRX-101 and the
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 in Inhibrx's
filings with the U.S. Securities and Exchange Commission (the
"SEC"), including under the heading "Risk Factors" in Inhibrx's
Annual Report on Form 10-K for the year ended December 31,
2020, as filed with the SEC. 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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