SAN
DIEGO, June 30, 2022 /PRNewswire/ -- Inhibrx,
Inc. (Nasdaq: INBX), a biotechnology company with four clinical
programs in development and a robust preclinical pipeline, today
announced the completion of Phase 1 dose escalation of INBRX-105, a
novel targeted 4-1BB agonist, in combination with
Keytruda®. It also reported the funding of an additional
$60 million from its Loan and
Security Agreement, as amended (the "Loan Agreement"), with Oxford
Finance, LLC ("Oxford"), to bring its cash balance to approximately
$176 million as of June 30, 2022.
"We are very encouraged by the results observed in Part 3 and
believe the Part 4 expansion cohorts have been designed to
demonstrate the potential of INBRX-105," commented Mark Lappe, Inhibrx's CEO. "The additional debt
provided by Oxford provides non-dilutive financing and, we believe,
the time needed to mature our programs ahead of various potential
strategic options."
Phase 1 Dose Escalation Results
for INBRX-105 in Combination with Keytruda®
INBRX-105 is a precisely engineered multi-specific therapeutic
candidate based on our single domain antibody ("sdAb") platform
designed to agonize 4-1BB selectively in the presence of programmed
death ligand 1 ("PD-L1"), a protein typically enriched in the tumor
microenvironment and lymphoid tissues.
The study is a first-in-human, multicenter, open-label,
non-randomized, Phase 1 trial in patients with locally advanced or
metastatic solid tumors. This four-part trial is designed to
determine the safety profile and identify the maximum tolerated
dose and the recommended Phase 2 dose of INBRX-105 administered in
combination with Keytruda®, a programmed death
receptor-1 checkpoint inhibitor. Part 3, dose escalation in
combination with Keytruda®, has concluded with a total
of 30 patients enrolled. Patients were not pre-screened for PD-L1
expression. INBRX-105 in combination with Keytruda® was
reasonably well-tolerated and we observed durable responses in
checkpoint-naïve and relapsed refractory patients. These results
informed what we believe to be the optimal dose level for INBRX-105
in combination with Keytruda® in Part 4. Additionally,
single agent responses have been observed at this same dose level
in both checkpoint-naïve and relapsed/refractory patients.
Part 4, dose expansion cohorts of INBRX-105 in combination with
Keytruda®, initiated enrollment in May 2022. This will include a total of
approximately 90 patients in five separate cohorts and we expect to
announce initial data from these cohorts in the first half of
2023.
Additional $60 Million in Debt from Oxford
On June 29, 2022, Inhibrx drew two
additional term loans from its Loan Agreement with Oxford for an
aggregate principal amount of $60.0
million. The two additional term loans were based on the
completion of the following:
- $30 million upon the receipt
of positive topline data from the Phase 1 clinical trial of
INBRX-101, our AAT-Fc fusion protein for the treatment of Alpha-1
antitrypsin deficiency, which we released in May 2022; and
- $30 million upon initiation of
Part 4 of the Phase 1 clinical trial of INBRX-105, our PD-L1x4-1BB
tetravalent conditional agonist.
Inhibrx has one additional $30
million tranche available under the Loan Agreement, which
will be available to fund upon the initiation of a potential
registration-enabling clinical trial of INBRX-101. To date, the
aggregate balance of Inhibrx's outstanding term loans, which mature
in January 2027, is $170.0 million. The repayment schedule provides
for interest-only payments until March
2025 with a potential 12-month extension.
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, 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: any future
potential or observed to date safety and efficacy of its
therapeutic candidate, INBRX-105, the clinical translatability of
any observed preclinical data and statements and beliefs regarding
the clinical development of INBRX-105 and any presumption of
positive results from earlier clinical trials (or earlier parts of
clinical trials) in later clinical trials (or later parts of
clinical trials), including any implied or presumed positive
results, disease control or efficacy based on data observed to
date, beliefs regarding optimal dosage, and evaluations and
judgments regarding Inhibrx's cash position and balance sheet,
statements and judgements regarding its partnership and
relationship with Oxford, and the potential for future strategic
options. 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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