ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address
mechanisms of therapeutic resistance, today provided program
updates and announced key milestones for 2021, which are expected
to substantially expand and advance the company’s clinical
pipeline.
“2020 was a transformational year for ORIC during which we
significantly broadened the pipeline via internal discovery and
business development efforts, expanded the team, and strengthened
the balance sheet with the completion of an IPO and follow-on
financing,” said Jacob Chacko, M.D., president and chief
executive officer. “These efforts have positioned us for a dynamic
2021, with our first data from two ongoing trials of our lead
program ORIC-101 and three INDs/CTAs for our other product
candidates, which represents a tremendous amount of development
activity for a company at our stage.”
Program Updates and 2021 Milestones
ORIC-101: Glucocorticoid Receptor (GR)
AntagonistORIC-101 is a potent and selective GR antagonist, with
two distinct mechanisms of action being evaluated in two Phase 1b
trials in combination with: (1) Xtandi (enzalutamide) in metastatic
prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or
metastatic solid tumors.
- The company announced today the
completion of the Part I dose escalation portion of the Phase 1b
trial of ORIC-101 in combination with enzalutamide in metastatic
prostate cancer, by identifying the provisional recommended Phase 2
dose (RP2D) that will be used in the Part II expansion portion of
the trial. The selection of the provisional 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. In the Part I dose escalation portion of the trial,
patients were enrolled to evaluate daily dosing of ORIC-101 with
doses ranging from 80 to 240 mg, in combination with daily dosing
of 160 mg of enzalutamide. In the Part II dose expansion portion of
the trial, up to 48 patients are expected to be enrolled and
treated at the RP2D of 240 mg of ORIC-101 and 160 mg of
enzalutamide on a continuous daily dosing schedule. Patients will
be enrolled independent of GR status, with retrospective analysis
of GR expression and other potentially predictive biomarkers. The
company expects to report interim safety, efficacy, and
translational data from this trial in the second half of 2021.
- The Phase 1b trial of ORIC-101 in
combination with nab-paclitaxel is now enrolling patients in the
Part II dose expansion portion. In December 2020, the company
announced the completion of the Part I dose escalation portion of
ORIC-101 in combination with nab-paclitaxel in solid tumors, the
selection of the RP2D, and the initiation of the dose expansion
portion of the trial. For the Part II dose expansion portion of the
trial, 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 Part II of the trial will be treated at the
RP2D of 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. Eligible patients must have previously progressed on a
taxane-containing regimen and will be enrolled independent of
baseline GR status, with retrospective analysis of GR expression
and other potentially predictive biomarkers. The company expects to
report interim safety, efficacy, and translational data from this
trial in the first half of 2021.
ORIC-533: CD73 Inhibitor ORIC-533 was designed
to be a highly potent, orally bioavailable CD73 inhibitor and has
demonstrated more potent adenosine inhibition in preclinical
studies compared to an antibody approach and other small molecule
CD73 inhibitors. ORIC-533 continues to progress in Investigational
New Drug (IND) enabling studies and the company expects to file an
IND with the Food and Drug Administration (FDA) in the first half
of 2021. Having conducted a preclinical collaboration with an
academic key opinion leader that generated compelling single agent
activity in patient derived model systems in an undisclosed tumor
type, the company plans to pursue a single agent clinical
development path in this indication.
ORIC-944: PRC2 Inhibitor ORIC-944,
in-licensed in August 2020, is a potent and selective allosteric
inhibitor of polycomb repressive complex 2 (PRC2), that targets its
regulatory embryonic ectoderm development (EED) subunit and has
demonstrated single agent efficacy in multiple
enzalutamide-resistant prostate cancer models in preclinical
studies. The company plans to conduct IND enabling studies and then
file an IND with the FDA in the second half of 2021, with initial
clinical development as a single agent in treatment-resistant
prostate cancer.
ORIC-114: EGFR/HER2 Inhibitor ORIC-114,
in-licensed in October 2020, is a brain penetrant, orally
bioavailable, irreversible inhibitor designed to selectively target
EGFR and HER2 with high potency against exon 20 insertion
mutations. ORIC-114 has demonstrated greater brain exposure in
preclinical studies compared to other compounds being developed
against exon 20 mutations and has shown strong antitumor activity
in an EGFR-driven intracranial lung cancer model. The company plans
to conduct IND enabling studies and then file a Clinical Trial
Application (CTA) in South Korea in the second half of 2021.
Discovery PipelineIn addition to the four product candidates,
the company is leveraging its resistance platform in pursuit of
multiple discovery research programs that focus on its expertise in
precision oncology, hormone-dependent cancers, and key tumor
dependencies. These programs highlight the company’s medicinal
chemistry and structure-based drug design proficiency to target
drivers of resistance in solid tumors like prostate, breast, and
lung cancer that relapse with innate, acquired or bypass mechanisms
of resistance. The company recently advanced one of these programs
into lead optimization.
Anticipated 2021 Milestones
ORIC anticipates the following milestones in 2021:
- ORIC-101: Report interim safety, efficacy, and translational
data from ongoing combination trial with nab-paclitaxel in the
first half of 2021
- ORIC-101: Report interim safety, efficacy, and translational
data from ongoing combination trial with enzalutamide in the second
half of 2021
- ORIC-533: File an IND in the first half of 2021
- ORIC-944: File an IND in the second half of 2021
- ORIC-114: File a CTA in the second half of 2021
- Present additional preclinical and translational research data
on ORIC-101, ORIC-533, ORIC-944, and ORIC-114 at scientific
conferences in 2021
Financial Guidance
Cash, cash equivalents and marketable securities totaled $293.6
million as of December 31, 2020, which included gross proceeds of
$133.3 million from the follow-on financing completed in November
2020. The company expects its cash, cash equivalents and marketable
securities will be sufficient to fund its current operating plan
into the second half of 2023.
Presentation and Webcast
Jacob Chacko, M.D., president and chief executive officer, will
present a corporate overview at the 39th J.P. Morgan Healthcare
Conference beginning at 12:40 p.m. PT on Tuesday, January 12, 2021.
A live webcast will be available through the investor section of
the company’s website at https://investors.oricpharma.com/. A
replay of the webcast will be available for 90 days following the
event.
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, statements regarding ORIC’s
development plans and timelines; the potential advantages of ORIC’s
product candidates and programs; plans underlying ORIC-101 clinical
trials and development; the expected timing of reporting interim
data from the ORIC-101 clinical trials; plans underlying ORIC-533,
ORIC-944, ORIC-114 or any other programs; the planned IND filings
for ORIC-533 and ORIC-944 and CTA filing for ORIC-114; ORIC’s
anticipated 2021 milestones; the period over which ORIC estimates
its existing cash, cash equivalents and marketable securities will
be sufficient to fund its current operating plan; and statements by
the company’s president and chief executive officer. 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-101, ORIC-533, ORIC-944, ORIC-114 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; the risk of the
occurrence of any event, change or other circumstance that could
give rise to the termination of the Mirati license agreement or the
Voronoi license agreement; 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 November 5, 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.com info@oricpharma.com
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