SAN
DIEGO, Sept. 19, 2023 /PRNewswire/ -- Inhibrx,
Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company
dedicated to the development of therapeutics for oncology and rare
diseases, announced today that Chiesi Farmaceutici S.p.A ("Chiesi")
declined to exercise its option for the ex-North American rights to
develop and commercialize INBRX-101 for the treatment of patients
with emphysema due to Alpha-1 Antitrypsin Deficiency ("AATD").
Inhibrx's delivery of the European Medicines Agency ("EMA")
scientific advice to Chiesi triggered a 60-day option period to
obtain an exclusive license to develop and commercialize INBRX-101
for the treatment of patients with AATD outside of the United States and Canada. On September
18, 2023, Chiesi notified Inhibrx it was declining this
option.
"We believe Inhibrx is now optimally positioned with full global
rights to INBRX-101. This enables broader strategic optionality,
including potentially launching Graft versus Host Disease ("GvHD")
as a first indication in Europe
and Japan. The number of allogeneic transplants in
Europe and Japan are double that of the United States and since GvHD therapies
have a clear reimbursement path in these markets, we see this as a
significant opportunity to help more patients desperately in need,"
said Mark Lappe, CEO of
Inhibrx.
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 ("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.
AATD is an inherited orphan disease affecting an estimated
100,000 patients in the United
States and 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.
Inhibrx is currently conducting the ElevAATe trial, which is
designed as a randomized, controlled, double-blind, head-to-head
superiority study examining INBRX-101 against plasma-derived AAT.
The primary endpoint of the trial is the mean change in the average
functional AAT ("fAAT") concentration as measured by
anti-neutrophil elastase capacity from baseline to average serum
trough fAAT concentration at steady state (Ctrough,ss).
Secondary endpoints are a comparison of the mean change in fAAT
concentration from baseline to fAAT average concentration at steady
state (Cavg,ss), and the percentage of days with fAAT
above the lower limit of the normal range during steady-state
dosing.
The initial read-out from the ElevAATe trial is expected to
occur in late 2024 and the Company plans to meet with the FDA
following completion of that study.
About INBRX-101 and GvHD
Hematopoietic stem cell transplants ("HSCTs") provide an
often-curative option for many patients with hematological and
oncological conditions, with multiple myeloma, Non-Hodgkin
lymphoma, and acute myelogenous leukemia being the most common
diseases requiring an HSCT treatment. GvHD is a significant problem
that can occur post-surgery, usually after an allogeneic
transplant, where the cells donated during the transplant see the
recipient's body as foreign and attack the body.
Strong clinical data and established guidelines for the use of
AAT therapy already exist for acute cases of GvHD. Current clinical
data for plasma-derived AAT therapies for the treatment of GvHD
show promising response rates and favorable safety profiles over
approved therapies, but half-life of the therapies is short and
therefore requires dosing every two to four days. Based on the
observed favorable safety profile of INBRX-101 to date coupled with
its extended half-life, we believe INBRX-101 has the potential for
greater efficacy due to the ability to dose at higher levels less
frequently, while also eliminating the pathogenic risk from
plasma-derived products, which can be life threatening in
immunocompromised patients susceptible to infection.
Inhibrx plans to initiate studies for both acute and chronic
GvHD during the first half of 2024.
About Inhibrx, Inc.
Inhibrx is a clinical-stage biopharmaceutical 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 protein engineering platforms. 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. 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, including any potential accelerated regulatory pathway,
whether a trial is registration-enabling, evaluations and
observations of FDA discussions, statements and beliefs regarding
the current standard of care for AAT and GvHD and the
sustainability of current plasma collection practices, potential
payor reimbursement, future clinical development, application and
dosage of INBRX-101 and any presumption of or implied presumption
of positive results from pre-clinical studies, 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; and other risks
described from time to time 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
filed with the SEC on March 6, 2023
and subsequently filed reports. 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
ir@inhibrx.com
858-795-4260
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