ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address
mechanisms of therapeutic resistance, today announced it has
entered into an exclusive license agreement with Voronoi, Inc., an
innovative drug discovery company dedicated to advancing novel
therapeutics. ORIC secured exclusive rights worldwide excluding the
People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC
Territory) for the development and commercialization of ORIC-114, a
brain penetrant, orally bioavailable, irreversible inhibitor
designed to selectively target epidermal growth factor receptor
(EGFR) and human epidermal growth factor receptor 2 (HER2) with
high potency against exon 20 insertion mutations. ORIC expects to
initiate a global Phase 1/2 tumor-agnostic trial in genetically
defined cancers during the second half of 2021.
“ORIC-114 is well aligned with our mission of
overcoming cancer resistance by leveraging our expertise in
precision oncology and key tumor dependencies, and it puts us in
position for three INDs or equivalents next year,” said Jacob
Chacko, M.D., president and chief executive officer of ORIC.
“ORIC-114 fits with our team’s success in developing therapies for
tumor-agnostic mutations, including in patients with brain
metastases, and will leverage our team’s prior experience in the
pioneering development of entrectinib for genetically defined
cancers. We believe Voronoi’s highly selective and brain penetrant
inhibitors targeting exon 20 insertion mutations may address an
area of significant unmet medical need for which no FDA-approved
therapies exist today.”
“We are thrilled to be partnering with ORIC to
further develop our potential best-in-class EGFR/HER2 exon 20
inhibitor program,” said Daekwon Kim, chief executive officer of
Voronoi. “With ORIC’s focus on developing targeted cancer therapies
and their team’s prior experience in leading efforts for multiple
global regulatory approvals for mutant NSCLC and tumor-agnostic
indications, ORIC is an ideal partner to further the development of
this program.”
Under the terms of the agreement, in exchange
for an exclusive license to develop and commercialize Voronoi’s
EGFR and HER2 exon 20 inhibitor program in the ORIC Territory, ORIC
paid to Voronoi a one-time payment comprising $5 million in cash
and $8 million in shares of ORIC common stock. The number of shares
issued to Voronoi was based on a price of $28.24 per share,
representing a premium of 25% to the 30-day trailing
volume-weighted average trading price of ORIC’s common stock. In
addition, ORIC will pay Voronoi success-based payments of up to
$111 million in development and regulatory milestones and up to
$225 million in sales milestones with respect to the first licensed
product. If ORIC pursues a second licensed product, ORIC would pay
Voronoi up to an additional $272 million in success-based
milestones. ORIC will also pay tiered mid-single-digit to low
double-digit royalties based on annual net sales in the ORIC
Territory. ORIC will be responsible for development activities and
expenses in the ORIC Territory.
Webcast and Conference Call
ORIC will host a webcast and conference call
today, October 19th, at 4:30 p.m. ET. To participate in the
conference call, please dial (833) 651-0991 (domestic) or (918)
922-6080 (international) and refer to conference ID: 8129902.
Please join the conference call at least 15 minutes early to
register. A live webcast will be available in the Investors section
of the company's website at www.oricpharma.com. The webcast will be
archived for 60 days following the presentation.
About ORIC-114
and Exon 20 Insertion
Mutations in EGFR and
HER2
The ErbB receptor tyrosine kinase family is
involved in key cellular functions, including cell growth and
survival. Epidermal growth factor receptor (EGFR, or ErbB1) and
human epidermal growth factor receptor 2 (HER2, or ErbB2) exon 20
insertion mutations are observed across multiple solid tumors,
including NSCLC, breast, gastrointestinal, bladder and other
cancers. EGFR exon 20 insertion mutations are observed in
approximately 2% of all patients with NSCLC and have a worse
prognosis than patients with NSCLC driven by other EGFR mutations.
HER2 exon 20 insertion mutations are observed in approximately 1.5%
of all patients with NSCLC. Approximately one-third of patients
with exon 20 insertion mutations may develop brain metastases,
which contributes to poor prognosis.
ORIC-114 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 demonstrates strong anti-tumor
activity in an EGFR-driven intracranial lung cancer model.
Currently, there are no medicines approved by the FDA to treat
tumors with EGFR or HER2 exon 20 insertion mutations. ORIC expects
to initiate a global Phase 1/2 tumor-agnostic trial of ORIC-114 in
genetically defined cancers in the second half of 2021.
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-114’s
effectiveness in brain penetrance and selectivity against exon 20
insertion mutations of EGFR and HER2, the potential benefits of and
activity under the license agreement between ORIC and Voronoi;
development plans underlying ORIC-114, including initiation of a
global Phase 1/2 tumor-agnostic trial of ORIC-114 in genetically
defined cancers in the second half of 2021; the potential
best-in-class nature of the EGFR and HER2 exon 20 inhibitor
program, including ORIC-114; the potential advantages of ORIC’s
product candidates; statements by ORIC’s president and chief
executive officer; and statements by Voronoi’s 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-944, ORIC-533,
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 license
agreement; risks related to the effect of the announcement of the
transaction on ORIC’s business relationships, 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, including
Voronoi, 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 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.cominfo@oricpharma.com
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