ORIC Pharmaceuticals Announces Initiation of Expansion Cohorts in Phase 1b Study of ORIC-101
December 21 2020 - 6:30AM
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address
mechanisms of therapeutic resistance, today announced the
initiation of the Part II dose expansion portion of the Phase 1b
study of ORIC-101, a potent and selective glucocorticoid receptor
(GR) antagonist, in combination with Abraxane (nab-paclitaxel) for
the treatment of advanced solid tumors.
“We are pleased to announce continued progress
of our GR program with the selection of the recommended Phase 2
dose of ORIC-101 in combination with Abraxane triggering the
initiation of multiple expansion cohorts in cancers with high unmet
medical need,” said Jacob Chacko, M.D., president and chief
executive officer of ORIC. “I am grateful to the patients and their
families, investigators, and our employees who have helped us reach
this important milestone.”
The Phase 1b clinical study of ORIC-101 in
combination with nab-paclitaxel is a non-randomized, multicenter,
open-label study conducted in two parts, intended to establish the
recommended Phase 2 dose (RP2D), safety, pharmacokinetics,
pharmacodynamics, and preliminary antitumor activity when
administered to patients with advanced or metastatic solid
tumors.
In the Part I dose escalation portion of the
study, five cohorts of patients across multiple solid tumors were
enrolled to evaluate ORIC-101 doses ranging from 80 to 240 mg
administered orally in both intermittent and continuous once daily
dosing regimens, in combination with either 75 or 100 mg/m2
nab-paclitaxel. Following the completion of the dose escalation
portion of the study, the RP2D was determined to be 160 mg of
ORIC-101 continuous once daily dosing and 75 mg/m2 of
nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle, without
requirement for prophylactic granulocyte-colony stimulating factor.
The selection of RP2D was based upon the totality of safety,
pharmacokinetic and pharmacodynamic data demonstrating a
well-tolerated regimen that achieved ORIC-101 exposures leading to
demonstrable target engagement and GR inhibition.
For the Part II dose expansion portion of the
study, up to 132 patients are expected to be enrolled across four
cohorts, including pancreatic ductal adenocarcinoma, ovarian
cancer, triple negative breast cancer, and other advanced solid
tumors. Patients in the dose expansion portion of the study will be
required to have previously progressed on a taxane-containing
regimen, with retrospective analysis of GR expression and other
potentially predictive biomarkers.
The company also announced dose escalation
remains ongoing with ORIC-101 in combination with Xtandi
(enzalutamide) with no dose-limiting toxicities observed to
date. The Phase 1b clinical study of ORIC-101 in
combination with enzalutamide is a non-randomized, multicenter,
open-label study to establish the RP2D, safety, pharmacokinetics,
pharmacodynamics, and preliminary antitumor activity when
administered to patients with metastatic prostate cancer. Dose
exploration has been conducted in three cohorts to date, with 240
mg of ORIC-101 and 160 mg of enzalutamide both administered
continuously once daily currently ongoing.
About ORIC-101
ORIC-101 is a potent and selective small
molecule antagonist of the glucocorticoid receptor, which has been
linked to resistance to multiple classes of cancer therapeutics
across a variety of solid tumors. Preclinical in vitro
and in vivo data suggest ORIC-101 is able to address key resistance
mechanisms of multiple classes of cancer treatments, including
taxanes and androgen receptor modulators. Based on preclinical and
clinical studies, ORIC-101 is expected to have reduced drug-drug
interaction liabilities than other glucocorticoid receptor
antagonists. Currently, there are no glucocorticoid receptor
antagonists approved by the FDA for the treatment of cancer.
Following the successful completion of two Phase 1a trials in over
50 healthy volunteers, ORIC initiated two separate Phase 1b trials
of ORIC-101 in combination with (1) Xtandi (enzalutamide) in
metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in
advanced or metastatic solid tumors.
About ORIC Pharmaceuticals,
Inc.
ORIC Pharmaceuticals is a clinical stage
biopharmaceutical company dedicated to improving patients’ lives by
Overcoming Resistance In Cancer. ORIC’s lead product
candidate, ORIC-101, is a potent and selective small molecule
antagonist of the glucocorticoid receptor, which has been linked to
resistance to multiple classes of cancer therapeutics across a
variety of solid tumors. ORIC-101 is currently in two separate
Phase 1b trials of ORIC-101 in combination with (1) Xtandi
(enzalutamide) in metastatic prostate cancer and (2) Abraxane
(nab-paclitaxel) in advanced or metastatic solid tumors.
ORIC’s other product candidates include (1) 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, (2)
ORIC-944, an allosteric inhibitor of the polycomb repressive
complex 2 (PRC2) via the EED subunit, being developed for prostate
cancer, and (3) 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. Beyond these four 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.
Cautionary Note Regarding
Forward-Looking Statements
This 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, progress related to ORIC’s Phase 1b
clinical study of ORIC-101 with Abraxane (nab-paclitaxel),
including expectations related to initiation of expansion cohorts
and patient enrollment. 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 ORIC-101 or any other product
candidates; the potential for clinical trials of ORIC-101 or any
other product candidates to differ from preclinical, preliminary or
expected results; negative impacts of the COVID-19 pandemic on
ORIC’s operations, including clinical trials; ORIC’s ability to
enroll patients in its ongoing and future clinical trials;
operating results and business generally; 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, 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
final prospectus filed with the Securities and Exchange Commission
(the “SEC”) on November 13, 2020, 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
Officer dominic.piscitelli@oricpharma.cominfo@oricpharma.com
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