Inhibrx Initiates a Potential Registration-Enabling Phase 2 Study of INBRX-109 in Conventional Chondrosarcoma Patients, ..Cont
June 22 2021 - 7:30AM
InvestorsHub NewsWire
Inhibrx
Initiates
a Potential
Registration-Enabling
Phase 2 Study
of
INBRX-109 in Conventional Chondrosarcoma Patients,
Updates
Data
for Ongoing
Phase 1 Study
and
Announces
Amended
Loan
Agreement
with Oxford
-
Median
progression-free survival (PFS) of 7.6 months
and
disease
control rate
of 87.5%
observed
in conventional chondrosarcoma patients
in
Phase 1
-
Additional
$40M in cash received through the Oxford loan amendment
SAN
DIEGO,
June
21,
2021 -- InvestorsHub
NewsWire -- Inhibrx,
Inc. (Nasdaq: INBX), a biotechnology company with four
clinical programs in development, announced initiation of a
potential registration-enabling
Phase 2 study
of
INBRX-109 in
conventional
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 European Union.
There are currently no therapeutics approved for the treatment
of chondrosarcoma.
In January
2021,
the
U.S. Food and Drug Administration (FDA) granted Fast Track
designation to INBRX-109 for the treatment of patients with
unresectable or metastatic conventional
chondrosarcoma.
Inhibrx
provided
updated
results
from an ongoing
Phase 1
clinical trial evaluating the efficacy and safety of INBRX-109 in
patients with conventional
chondrosarcoma.
Additional
data
will be
presented at the
Annual
Connective Tissue Oncology Society (CTOS) Conference
taking
place on November
10-13,
2021.
-
Disease
control was observed in 14
of
16
patients
(87.5%).
Two patients (12.5%)
achieved partial
responses and 12 of 16 patients (75%)
had
stable disease measured
by
RECISTv1.1.
-
Based
on preliminary results of the ongoing Phase 1 study, the median
progression-free survival (PFS) is 7.6
months,
and
the
median overall survival has not been reached.
-
Three
patients have
exceeded
52
weeks on
treatment
with INBRX-109,
with 62
weeks being the longest
duration of stable
disease observed to
date, with the patient
still on study.
-
The
safety and tolerability profile in
conventional
chondrosarcoma
was
favorable with
only
1 out
of 16 patients experiencing a transient low grade and fully
reversible sign of hepatotoxicity.
-
The
trial is ongoing with an
additional 12 slots
added for patients with IDH1 or IDH2 mutations
to
support ongoing biomarker discovery efforts.
A randomized,
blinded, placebo-controlled, potential
registration-enabling
Phase 2
trial of INBRX-109 in conventional
chondrosarcoma
initiated this
month. The primary
objective of this trial is to evaluate the anticancer efficacy of
INBRX-109, as
measured by PFS per
RECISTv1.1 and assessed by
central independent radiology review. Patients with disease
progression on placebo will be able to crossover to INBRX-109. An
interim analysis will occur after 50% of the
planned
PFS events are
observed.
Additionally, upon
initiation of this
study,
Inhibrx's
loan
agreement with Oxford Finance was amended and $40M
in
additional principal was received by
Inhibrx on June 18,
2021.
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-109, discussions with and beliefs
regarding future action by the U.S. Food and Drug Administration,
and statements and beliefs regarding the future clinical
development of INBRX-109 including
statements indicating that the Phase 2 trial is
registration-enabling 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
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