SAN
DIEGO, April 25, 2022 /PRNewswire/ -- Inhibrx,
Inc. (Nasdaq: INBX), a biotechnology company with four clinical
programs in development and a strong emerging pipeline, today
announced the formation of a Scientific Advisory Board ("SAB") for
its INBRX-101 program for the treatment of alpha-1 antitrypsin
deficiency ("AATD"). The SAB is comprised of the top global experts
in AATD and will work closely with Inhibrx management to help guide
the development of INBRX-101 to registration and beyond.
"INBRX-101 has the potential to become a best-in-class treatment
for patients with AATD, where very limited progress has been made
over the past two decades," said Dr. Igor
Barjaktarevic. "My hope is INBRX-101 will change the
treatment paradigm for AATD patients and I'm honored to be among
such a distinguished group to help achieve that."
"The prestigious group of scientific and clinical thought
leaders we have assembled to sit on our Scientific Advisory Board
each bring their own unique expertise in AATD and will provide
Inhibrx with relevant and informed counsel as we continue our
development of INBRX-101," said Mark
Lappe, Inhibrx's Chief Executive Officer. "We greatly
appreciate the support of each of these experts."
The founding members of the Inhibrx INBRX-101 SAB are:
Igor Barjaktarevic, M.D.,
Ph.D., is an Associate Professor at the David Geffen School of
Medicine at UCLA and works at Ronald
Reagan Medical Center, both in Los
Angeles, California. He graduated from medical school at the
University of Belgrade in Serbia,
completed his residency in internal medicine at New York University School of Medicine in
New York, and completed his
pulmonary and critical care fellowship at Cornell University at New York Presbyterian
Hospital in New York. Dr.
Barjaktarevic received his Ph.D. in pulmonary immunology in 2016.
His research is focused on chronic obstructive pulmonary disease
("COPD"), AATD, lung nodule/lung cancer and the use of ultrasound
in critical care.
Mark Brantly, M.D., is a
Professor of Medicine and the Vice Chair of Research in the
Department of Medicine at the University of
Florida. He graduated from the University of Florida College of Medicine in
Gainesville, Florida. He completed
his internal medicine residency at Eastern
Virginia Medical School in Norfolk, Virginia and a pulmonary and critical
care fellowship at the National Institute of Health in Bethesda, Maryland. Dr. Brantly specializes in
rare lung disease translational research with a focus on AATD, gene
therapy, pulmonary fibrosis, and alveolar macrophage
function.
Kenneth R. Chapman, M.D., MSc,
FRCPC, FACP, FERS, is a Professor of Medicine at the
University of Toronto in Ontario, Canada and the founder and current
president of Inspiration Research Limited. He serves as the
Director of the Asthma and Airway Centre of the University Health
Network, President of the Canadian Network for Respiratory Care,
and Director of the Canadian Registry for AATD. He received his
Doctor of Medicine from the Faculty of Medicine at the University of Toronto and his Master of Science at
the Institute of Medical Science at the University of Toronto. Dr. Chapman's areas of
expertise are asthma, COPD and airway diseases.
Noel Gerry McElvaney, M.D.,
BCh, BAO, FRCPI, FRCPC is a Professor of Medicine and the
Chairman of the Department of Medicine at the Royal College of Surgeons in Dublin, Ireland. He graduated from the School
of Medicine at the University College in Dublin, Ireland and completed his fellowship
in respiratory medicine at the University of
British Columbia, Vancouver,
Canada. His expertise is in the areas of cystic fibrosis,
AATD, infection, immunity, and lung inflammation. Dr. McElvaney
founded the Alpha-1 Foundation of Ireland in 2001 to provide a patient forum and
to promote awareness of AATD.
Robert A. Sandhaus, M.D.,
Ph.D., FCCP, is a Professor of Medicine at the National Jewish
Health in Denver, Colorado.
He is also the Executive Vice President and Senior Medical Director
of AlphaNet and the Clinical Director of the Alpha-1 Foundation,
two not-for-profit organizations serving the Alpha-1 community. Dr.
Sandhaus received both his medical degree and his Ph.D. from Stony
Brook University School of Medicine in Stony Brook, New York. He completed his
residency in internal medicine at the Beth Israel Hospital in
Boston, Massachusetts and a
pulmonary fellowship at the University of
California, San Francisco in San
Francisco, California. Dr. Sandhaus specializes in pulmonary
medicine and is experienced in AATD, COPD and critical care
medicine.
James Stoller, M.D., M.S.,
is the Chair of the Education Institute at the Cleveland Clinic
Lerner College of Medicine and is an Adjunct Professor of
Organizational Behavior at the Weatherhead School of Management at
Case Western Reserve University, both
in Cleveland, Ohio. He earned his
medical degree from Yale University
School of Medicine and completed his residency at Peter Bent
Brigham Hospital in Boston,
Massachusetts. He completed fellowships in pulmonary disease
and critical care medicine at both Brigham and Women's Hospital in Boston, Massachusetts and Yale University School of Medicine in New Haven, Connecticut, as well as a
fellowship in critical care medicine and anesthesia at Massachusetts General Hospital in Boston, Massachusetts. He specializes in AATD
and COPD.
About AATD and INBRX-101
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 but does not maintain patients in the normal AAT
range and requires frequent and inconvenient once-weekly IV dosing,
while relying on plasma collection practices that might not be
sustainable.
INBRX-101 is a precisely engineered recombinant human AAT-Fc
fusion protein designed to safely achieve and maintain levels of
AAT found in healthy individuals with a favorable safety profile
and the potential for once-monthly dosing.
In October 2021, Inhibrx announced
interim functional PK data from 21 AATD patients in the INBRX-101
Phase 1 clinical trial. 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
AAT levels with observed trough levels exceeding the goal of the
current standard augmentation therapy with plasma-derived AAT.
Interim safety data from 24 patients with AATD showed no
drug-related severe or serious adverse events at doses up to and
including 120 mg/kg single dose and 80 mg/kg multiple 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 observed.
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 single domain antibody, or sdAb, platform. Inhibrx has
collaborations with 2seventy bio (formerly bluebird bio),
Bristol-Myers Squibb and Chiesi, among others. 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-101,
including potential dosing intervals, statements and beliefs
regarding the clinical development of INBRX-101, 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, 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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SOURCE Inhibrx Inc.