ORIC Pharmaceuticals to Present Initial Phase 1b Clinical Data for ORIC-533 in Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
03 November 2023 - 12:00AM
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address
mechanisms of therapeutic resistance, today announced a poster
presentation on the initial Phase 1b clinical data for ORIC-533 in
patients with relapsed/refractory multiple myeloma at the 65th
American Society of Hematology Annual Meeting to be held December
9-12, 2023, in San Diego, CA.
Details of the ASH poster presentation are as
follows:
Title: |
Preliminary Results of the Oral CD73 Inhibitor, ORIC-533,
inRelapsed/Refractory Multiple Myeloma (RRMM) |
Abstract #: |
4761 |
Session Name: |
653. Multiple Myeloma: Prospective Therapeutic Trials: Poster
III |
Session Date: |
Monday, December 11, 2023 |
Presentation Time: |
6:00 PM - 8:00 PM PT |
Location: |
San Diego Convention Center, Halls G-H |
|
Abstract Highlights
ORIC-533 is a highly potent and selective, orally bioavailable,
small molecule inhibitor of CD73, currently being evaluated in an
ongoing Phase 1b dose escalation study to determine its safety,
tolerability, and pharmacokinetics and selection of the recommended
Phase 2 dose in patients with relapsed/refractory multiple myeloma.
The study included a heavily pretreated patient population where
all patients were triple-class refractory, 88% were
penta-refractory, and 59% also received prior anti-BCMA/CD3
bispecific therapy or anti-BCMA CAR-T therapy. ORIC-533 was well
tolerated with the vast majority of treatment-related adverse
events (TRAEs) Grade 1 or 2 in severity and with no dose limiting
toxicities, no Grade ≥ 4 TRAEs, and no treatment-related serious
adverse events. ORIC-533 demonstrated good bioavailability and a
plasma half-life of ~24 hours. Strong inhibition of soluble CD73
enzymatic activity was seen across all dose levels. Preliminary
evidence of enhanced CD8+ T-cell activation was seen at the highest
dose levels tested in both the peripheral blood and bone marrow,
and early evidence of single agent clinical activity was observed.
Overall, ORIC-533 demonstrated an acceptable safety profile and
preliminary evidence of immune activation in this heavily
pretreated patient population.
Full abstracts are available for online viewing
via the ASH Annual Meeting website at Hematology.org.
About ORIC-533
ORIC-533 is a highly potent, orally bioavailable small molecule
inhibitor of CD73, a key node in the adenosine pathway believed to
play a central role in resistance to chemotherapy and
immunotherapy-based treatment regimens. ORIC-533 has demonstrated
greater potency in preclinical studies compared to an antibody
approach, as well as other small molecule inhibitors of CD73 and
adenosine receptor antagonists. Preclinical data demonstrated that
ORIC-533 binds CD73 with high affinity and effectively blocks
adenosine-driven immunosuppression in a high AMP environment,
reflective of AMP levels observed in tumors. In preclinical
studies, nanomolar concentrations of ORIC-533 efficiently rescued
cytotoxic T-cell function in the presence of high AMP
concentrations, as well as in ex vivo bone marrow aspirates from
relapsed or refractory multiple myeloma patients.
About ORIC Pharmaceuticals,
Inc.
ORIC Pharmaceuticals is a clinical stage
biopharmaceutical company dedicated to improving patients’ lives
by Overcoming Resistance In Cancer. ORIC’s
clinical stage product candidates include (1) ORIC-114, a brain
penetrant inhibitor designed to selectively target EGFR and HER2
with high potency against exon 20 insertion mutations, being
developed across multiple genetically defined cancers, (2)
ORIC-533, an orally bioavailable small molecule inhibitor of CD73,
a key node in the adenosine pathway believed to play a central role
in resistance to chemotherapy- and immunotherapy-based treatment
regimens, being developed for multiple myeloma, and (3) ORIC-944,
an allosteric inhibitor of the polycomb repressive complex 2 (PRC2)
via the EED subunit, being developed for prostate cancer. Beyond
these three product candidates, ORIC is also developing multiple
precision medicines targeting other hallmark cancer resistance
mechanisms. ORIC has offices in South San Francisco and San Diego,
California. For more information, please go
to www.oricpharma.com, and follow us on X
or LinkedIn.
Cautionary Note Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements as that term is defined in Section 27A
of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements in this press release that are not
purely historical are forward-looking statements. Such
forward-looking statements include, among other things, statements
regarding ORIC-533’s clinical activity or safety profile, which may
materially change as patient enrollment continues or more patient
data become available; ORIC-533’s development plans; the potential
advantages of ORIC-533 and ORIC’s other product candidates; and
plans underlying ORIC’s clinical trials and development. Words such
as “believes,” “anticipates,” “plans,” “expects,” “intends,”
“will,” “goal,” “potential” and similar expressions are intended to
identify forward-looking statements. The forward-looking statements
contained herein are based upon ORIC’s current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results could differ materially from those
projected in any forward-looking statements due to numerous risks
and uncertainties, including but not limited to: risks associated
with the process of discovering, developing and commercializing
drugs that are safe and effective for use as human therapeutics and
operating as an early clinical stage company; ORIC’s ability to
develop, initiate or complete preclinical studies and clinical
trials for, obtain approvals for and commercialize any of its
product candidates; changes in ORIC’s plans to develop and
commercialize its product candidates; the potential for clinical
trials of ORIC-114, ORIC-533, ORIC-944 or any other product
candidates to differ from preclinical, initial, interim,
preliminary or expected results; negative impacts of health
emergencies, economic instability or international conflicts on
ORIC’s operations, including clinical trials; the risk of the
occurrence of any event, change or other circumstance that could
give rise to the termination of ORIC’s license and collaboration
agreements; the potential market for our product candidates, and
the progress and success of competing therapeutics currently
available or in development; ORIC’s ability to raise any additional
funding it will need to continue to pursue its business and product
development plans; regulatory developments in the United States and
foreign countries; ORIC’s reliance on third parties, including
contract manufacturers and contract research organizations; ORIC’s
ability to obtain and maintain intellectual property protection for
its product candidates; the loss of key scientific or management
personnel; competition in the industry in which ORIC operates;
general economic and market conditions; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled “Risk Factors” in ORIC’s Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the “SEC”) on August 10, 2023, and ORIC’s future
reports to be filed with the SEC. These forward-looking statements
are made as of the date of this press release, and ORIC assumes no
obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those projected in
the forward-looking statements, except as required by law.
Contact:Dominic Piscitelli,
Chief Financial Officerdominic.piscitelli@oricpharma.com
info@oricpharma.com
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