SAN DIEGO, Jan. 4, 2022 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a biotechnology company with four clinical programs
in development and a strong emerging pipeline, today announced
initial results from Part 3 (combination dose escalation) of the
4-part Phase 1 trial of INBRX-106, a novel hexavalent OX40 agonist,
in combination with Keytruda®, in development for the
treatment of patients with solid tumors. Additionally, an
update on single agent data from Part 1 (single agent dose
escalation) and Part 2 (single agent dose expansion) of the trial
was provided.
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In the all-comer Part 3 of this Phase 1 trial, the dose of
INBRX-106 was escalated in combination with Keytruda® in
21 patients with locally advanced or metastatic solid tumors.
INBRX-106 in combination with Keytruda® was observed to
be well tolerated, with predominantly mild or moderate
immune-related toxicities noted. The maximum administered dose of
INBRX-106 was 0.3 mg/kg, at which dose-limiting, immune-related
toxicities such as dermatitis were observed. Accordingly, 0.1 mg/kg
dosed every three weeks was determined to be the maximum tolerated
dose (MTD) of INBRX-106 in combination with
Keytruda®.
Out of five response evaluable patients with tumor types
responsive to immunotherapy in the active dose range of INBRX-106
in combination with Keytruda, two durable partial responses were
achieved in checkpoint inhibitor naïve nasopharyngeal carcinoma and
uveal melanoma patients with duration greater than six months with
treatment ongoing. Additionally, a third checkpoint inhibitor
exposed cutaneous melanoma patient has a double-digit reduction in
tumor volume and duration greater than four months with treatment
ongoing.
Part 2, which was run in parallel with Part 3, is ongoing and
aimed at investigating single agent INBRX-106 dosed at 0.03 mg/kg
in two different dosing schedules in patients with tumor types
responsive to checkpoint inhibitors. Four of ten response evaluable
non-small cell lung cancer (NSCLC) and melanoma patients receiving
INBRX-106 in either Part 1 or 2 of the trial have been on treatment
with INBRX-106 for at least six months. Of those four patients,
three had previous exposure to checkpoint inhibitors and the
fourth, a uveal melanoma patient, was checkpoint inhibitor naïve.
To date, the longest duration on treatment with single agent
INBRX-106 is 90 weeks (approximately 21 months) and ongoing in a
NSCLC patient refractory to Keytruda®.
"We believe the early activity of single agent INBRX-106 and
INBRX-106 in combination with Keytruda® observed in
patients who relapsed or are refractory to checkpoint inhibitors as
well as in patients with tumor types responsive to immunotherapy
that respond poorly to checkpoint inhibitors is very encouraging"
said Mark Lappe, CEO of Inhibrx. "We are pleased to see that
our preclinical data, which demonstrated that hexavalent valency is
required to properly agonize OX40, appear to be translating
clinically."
Part 4 (combination dose expansion) of the trial initiated in a
NSCLC cohort and a basket cohort in patients who relapsed or were
refractory to checkpoint inhibitors, as well as in selected
checkpoint inhibitor naive patient cohorts including cutaneous
melanoma, uveal melanoma, head and neck squamous cell carcinoma and
nasopharyngeal carcinoma. We expect to have initial data from Part
4 of this trial late this year.
About INBRX-106
INBRX-106 is a hexavalent
product candidate agonist of OX40. OX40 is a co-stimulatory
receptor expressed on immune cells that is enriched in the tumor
microenvironment. OX40 ligand is a trimeric protein that activates
OX40 signaling through clustering. We engineered INBRX-106 to
bind and cluster six OX40 receptors and has been shown
preclinically to significantly outperform bivalent antibodies in
co-stimulatory capacity and anti-tumor activity.
The trial for INBRX-106 is a first-in-human, multicenter,
open-label, non-randomized, 4-part Phase 1 trial in patients with
locally advanced or metastatic solid tumors designed to determine
the safety profile and identify the MTD and/or recommended Phase 2
dose of INBRX-106 administered as a single agent or in combination
with Keytruda® (pembrolizumab), a programmed death
receptor-1 (PD-1) checkpoint inhibitor.
About the Inhibrx sdAb Platform
Inhibrx utilizes
diverse methods of protein engineering in the construction of
therapeutic candidates that can address the specific requirements
of complex target and disease biology. A key tool for this effort
is the Inhibrx proprietary sdAb platform, which enables the
development of therapeutic candidates with attributes superior to
other monoclonal antibody and fusion protein approaches. This
platform allows the combination of multiple binding units in a
single molecule, enabling the creation of therapeutic candidates
with defined valency or multiple specificities, potentially capable
of enhanced cell signaling or conditional activation. An additional
benefit of this platform, these optimized and/or multi-functional
entities can be manufactured using the established processes that
are commonly used to produce therapeutic proteins.
Inhibrx is pursuing targets with early validation where other
therapeutics have demonstrated liabilities as well as a portfolio
of sdAb based therapeutic candidates in a variety of indications
for novel targets.
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 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.
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-106, the clinical translatability of
any observed preclinical data and statements and beliefs regarding
the clinical development of INBRX-106 and any presumption of
positive results from Phase 1 clinical trials, including any
implied or presumed positive results, disease control or efficacy
based on initial data observed to date. 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; its ability to obtain any needed clinical trial
supplies from third-party suppliers; 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, 2020 as filed with the
SEC on March 12, 2021, 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. The statements in this press
release are solely those of Inhibrx and its management and do not
represent the views of any third party. The mark "Inhibrx" is
Inhibrx's registered trademark. All other service marks, trademarks
and trade names appearing in this release are the property of their
respective owners. Inhibrx does not intend its use or display of
other companies' trade names, trademarks or service marks to imply
a relationship with, or endorsement or sponsorship of us by, these
other companies.
Investor and Media Contact:
Kelly Deck, CFO
kelly@inhibrx.com
858-795-4260
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