SAN
DIEGO, April 26, 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 it has initiated a
registration-enabling trial for INBRX-101, an optimized recombinant
human AAT-Fc fusion protein, for treatment of patients with
emphysema due to alpha-1 antitrypsin deficiency (AATD).
Additionally, the Company announced that the U.S. Food and Drug
Administration (FDA) has lifted the partial clinical hold on
studies evaluating its death-receptor 5 (DR5) agonist,
INBRX-109.
INBRX-101
The ElevAATe trial is designed as a randomized, controlled,
double-blind, head-to-head superiority study examining INBRX-101
against plasma-derived AAT (pdAAT). The study design is as follows:
36 patients dosed every three weeks with INBRX-101 at 120 mg/kg, 36
patients dosed every four weeks with INBRX-101 at 120 mg/kg, and 18
patients dosed weekly with pdAAT at the FDA-approved dose. The
treatment period is 32 weeks and will be conducted at approximately
35 sites in the United States,
Australia and New Zealand.
The primary endpoint of the trial is the mean change in the
average functional AAT (fAAT) concentration as measured by
anti-neutrophil elastase capacity (ANEC) 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. A bronchoscopy sub-study of
approximately 30 patients will also run at designated sites.
The initial read-out from the ElevAATe trial is expected to
occur in late 2024.
INBRX-109
In March 2023, the Company
announced the pause in patient enrollment for the INBRX-109 (DR5
agonist) trials as a result of the pre-defined stopping rules built
into the Phase 2 protocol. This did not impact active patients who
were already on treatment and remained on the trial. With data from
over 200 patients dosed with INBRX-109 to date, the Company was
able to more precisely identify elderly individuals with fatty
liver disease as the at-risk population for severe liver toxicity.
As a result, the Company amended its protocol to include the
Hepatic Steatosis Index (HSI) as part of the screening
criteria.
In April 2023, the FDA lifted the
partial clinical hold. Patient enrollment is expected to resume
next month. Phase 1 combination cohorts are expected to begin
reading out by the end of 2023 and data from the
registration-enabling trial in unresectable or metastatic
conventional chondrosarcoma is expected during the second half of
2024.
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. 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 INBRX-109 and Chondrosarcoma
INBRX-109 is a precision-engineered, tetravalent death receptor
5 (DR5) agonist antibody designed to exploit the tumor-biased cell
death induced by DR5 activation.
Chondrosarcoma is an orphan bone cancer with approximately 2,800
new patients diagnosed annually in the
United States and the EU. There are currently no
therapeutics approved for the treatment of chondrosarcoma.
In 2021, the FDA granted Fast Track designation to INBRX-109 for
the treatment of patients with unresectable or metastatic
conventional chondrosarcoma and orphan-drug designation to
INBRX-109 for chondrosarcoma in the
United States.
In June 2021, Inhibrx initiated a
randomized, blinded, placebo-controlled, registration-enabling
Phase 2 trial of INBRX-109 in conventional chondrosarcoma. This
trial, in addition to the additional Phase 1 cohorts examining
INBRX-109 in combination with certain chemotherapies, are currently
ongoing.
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. 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. 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 candidates,
INBRX-101 and INBRX-109, 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 the
sustainability of current plasma collection practices, future
clinical development, application and dosage of INBRX-101 or
INBRX-109 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
kelly@inhibrx.com
858-795-4260
View original content to download
multimedia:https://www.prnewswire.com/news-releases/inhibrx-initiates-a-registration-enabling-trial-of-inbrx-101-in-aatd-and-announces-lift-of-partial-clinical-hold-on-inbrx-109-dr5-agonist-trials-301807980.html
SOURCE Inhibrx Inc.
