– Event to be webcast live on Tuesday, October 4, 2022 at 5:30 a.m. PT –
SAN
DIEGO, Oct. 3, 2022 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a clinical-stage biopharmaceutical company
dedicated to the development of therapeutics for oncology and rare
diseases, announced today that it will host a live webcast
presentation on Tuesday, October 4,
2022 at 5:30 a.m. PT to
announce the regulatory pathway for INBRX-101 for the treatment of
patients with alpha-1 antitrypsin deficiency, or AATD.
Investors may join via the web:
https://app.webinar.net/8GArp0rQd3z or may listen to the call
by dialing (1-877-870-4263). Please refer to Inhibrx, Inc. or
confirmation code 10171898 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 a less frequent dosing interval compared to the
weekly infusion interval of the currently available plasma-derived
AAT therapies.
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.
Augmentation therapy with plasma-derived AAT is the current
standard of care but 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.
Data from the Phase 1 multiple ascending dose study of INBRX-101
at 40, 80 and 120 mg/kg IV every three weeks, showed the expected
accumulation of functional AAT levels and the ability to achieve
fully normal functional AAT levels in severely deficient AATD
patients. Based on PK modeling, accumulation is expected to
continue following subsequent doses and reach steady state after a
total of approximately five to six consecutive doses, administered
every three or four weeks.
Treatment was well tolerated with no severe or serious adverse
events related to the study drug. Drug-related adverse events were
predominantly mild and those few that were moderate in severity
were all transient and reversible, with minimal or no symptomatic
care. No safety-related or PK/PD-related signs of neutralizing
anti-drug antibodies were observed.
In March 2022, the FDA granted
orphan-drug designation for INBRX-101 for the treatment of
AATD.
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 observed
safety and efficacy to date of its therapeutic candidate,
INBRX-101, discussions with and beliefs regarding future action by
the FDA, evaluations and observations of FDA discussions,
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 any presumption of or implied presumption of positive results
from pre-clinical studies or Phase 1 clinical trials or 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; 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,
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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