INBRX-101 Shows
Favorable Safety Profile in Patients with Alpha-1 Antitrypsin
Deficiency and Demonstrates the Potential to Achieve Normal Alpha-1
Antitrypsin Levels with Monthly Dosing
-
Interim
results from the Phase 1 study show a favorable safety and
tolerability profile with no drug-related severe or serious adverse
events at doses up to and including 120 mg/kg single dose and
80mg/kg multi-dose administered intravenously, or IV.
-
Data
from the single ascending dose cohorts at 10, 40, 80 and 120 mg/kg
revealed the potential to achieve normal AAT levels with monthly
dosing.
-
Data
from the first multiple ascending dose cohort at 40 mg/kg IV every
three weeks showed the expected accumulation of functional AAT
levels with observed trough levels exceeding those achieved by the
current standard of care.
SAN DIEGO, October 12, 2021 --
InvestorsHub NewsWire -- 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.
Key
Functional AAT Levels by Dose
-
The
shaded region represents the normal range of functional AAT in
healthy adults.
-
The
dashed line at 11µM indicates the functional AAT goal of the
current augmentation therapy with plasma-derived AAT.
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Day 21
data from the 120 mg/kg cohort are from the first 2 enrolled
patients with available data.
-
Results
shown are from preliminary, unaudited data.
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 levels over time in AATD patients
administered
40 mg/kg INBRX-101 every three weeks
-
Arrows
indicate INBRX-101 IV dosing.
-
The
shaded region represents the normal range of functional AAT in
healthy adults.
-
The
dashed line at 11µM indicates the functional AAT goal of the
current augmentation therapy with plasma-derived AAT.
-
No
functional AAT sample was collected immediately following the
second dose (Day 21).
-
Results
shown are from preliminary, unaudited data.
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