SAN
DIEGO, Nov. 2, 2023 /PRNewswire/ -- Inhibrx, Inc.
(Nasdaq: INBX), a clinical-stage biopharmaceutical company
dedicated to the development of therapeutics for oncology and rare
diseases, today announced preliminary efficacy and safety data from
the Phase 1 trial of INBRX-109 in combination with Irinotecan and
Temozolomide (IRI/TMZ) for the treatment of advanced or metastatic,
unresectable Ewing sarcoma. Inhibrx presented this dataset as of
the data cut of September
8th, 2023 at the Annual Connective Tissue
Oncology Society (CTOS) Conference today.
Among the 13 patients evaluable, which included 7 classical
Ewing sarcoma patients (EWS) and 6 round cell sarcoma patients
(RCS), the observed disease control rate was 76.9%, or 10 out of 13
patients as measured by RECISTv1.1. There were 7 patients who
achieved partial responses (53.8%), 5 of which were observed in
classical EWS patients (71.4%) and 2 of which were observed in RCS
patients (33.3%). Durable clinical benefit was observed in 4
patients (30.8%) who achieved disease control lasting greater than
6 months. As of September 8, 2023,
the longest duration of stable disease was over 10 months and
ongoing and 7 of the 13 patients remained in the study.
Overall, INBRX-109 in combination with IRI/TMZ was well
tolerated. The most common adverse events were diarrhea, nausea and
fatigue, all consistent with the known safety profile of IRI/TMZ.
No grade 3 or higher liver-related events occurred.
"I am encouraged by these initial data in relapsed/refractory
Ewing sarcoma patients. This is a patient population with a high
unmet need and limited effective treatment options," said Dr.
Rashmi Chugh, MD, a Professor of
Internal Medicine in the Division of Hematology/Oncology at
University of Michigan Rogel
Comprehensive Cancer Center. "I look forward to ongoing
recruitment in this cohort of patients and seeing the results of
the further expansion."
About Ewing Sarcoma
Ewing sarcoma, a round cell sarcoma, is a rare, aggressive tumor
that occurs in children and adults. It is frequently metastatic at
diagnosis with a poor prognosis and commonly relapses. Few
effective treatments are available. IRI with TMZ is frequently used
in the relapsed setting but response rates are low.
About INBRX-109
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.
In January 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, which is
currently ongoing. Additionally, in a Phase 1 trial, Inhibrx is
currently investigating INBRX-109 in other indications in
combination with certain chemotherapies, including Ewing
sarcoma.
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. 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-109, and
statements and beliefs regarding the clinical development of
INBRX-109, the potential demand for INBRX-109 and any presumption
that preliminary data will be representative of final data or data
in 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
ir@inhibrx.com
858-795-4260
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