Olema Oncology Announces Expansion of Collaboration Agreement with Novartis
10 Outubro 2023 - 8:00AM
Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq:
OLMA), a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of targeted therapies
for women’s cancers, today announced an amendment to our existing
clinical collaboration and supply agreement with Novartis
Institutes for BioMedical Research, Inc. (“Novartis”) to increase
the size of the ongoing Phase 1/2 clinical study testing
palazestrant in combination with ribociclib to approximately 60
patients.
“The amendment announced today significantly increases the size
of our ongoing Phase 1/2 clinical study testing palazestrant in
combination with ribociclib, in collaboration with Novartis,” said
Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer
of Olema Oncology. “With the Phase 1b dose escalation portion now
successfully completed, we are currently in Phase 2 dose expansion
at the 120 mg dose of palazestrant in combination with 600 mg of
ribociclib. We believe that this expanded study now has the
potential to generate a clinical dataset sufficient to support the
regulatory pathway for a first-line pivotal trial.”
Olema first signed a clinical collaboration and supply agreement
with Novartis in July 2020, the agreement was amended and restated
in January 2022, and focuses on the evaluation of the safety,
tolerability and efficacy of palazestrant in combination with
Novartis’ proprietary cyclin-dependent kinase 4 and 6 (CDK4/6)
inhibitor ribociclib and/or Novartis’ proprietary
phosphatidylinositol 3-kinase (PI3Ka) inhibitor alpelisib in
patients with metastatic ER+ breast cancer. The amendment adds
approximately 30 patients to be enrolled in the cohort expansion
phase of the palazestrant clinical study in combination with
ribociclib.
About Olema OncologyOlema Oncology is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of targeted therapies for women’s
cancers. Olema’s lead product candidate, palazestrant (OP-1250), is
a proprietary, orally-available small molecule with dual activity
as both a complete estrogen receptor (ER) antagonist (CERAN) and a
selective ER degrader (SERD). It is currently being evaluated both
as a single agent in an ongoing Phase 2 clinical trial, and in
combination with CDK4/6 inhibitors (palbociclib and ribociclib) and
a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally
advanced or metastatic ER-positive (ER+), human epidermal growth
factor receptor 2-negative (HER2-) breast cancer. Palazestrant has
been granted FDA Fast Track designation for the treatment of
ER+/HER2- metastatic breast cancer that has progressed following
one or more lines of endocrine therapy with at least one line given
in combination with a CDK4/6 inhibitor. Olema is headquartered in
San Francisco and has operations in Cambridge, Massachusetts. For
more information, please visit us at www.olema.com, or follow us on
Twitter and LinkedIn.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Words such as
“anticipate,” “expect,” “will,” “may,” “goal,” “potential” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These statements
include those related to the timelines for potential clinical
trials of palazestrant (OP-1250) in combination trials, the
potential impact and sufficiency of clinical trial results for
clinical trial timelines for palazestrant in combination trials,
palazestrant’s combinability with other drugs, patient enrollment,
and statements regarding Olema’s partnerships and collaborations.
Because such statements deal with future events and are based on
Olema’s current expectations, they are subject to various risks and
uncertainties, and actual results, performance or achievements of
Olema could differ materially from those described in or implied by
the statements in this press release. These forward-looking
statements are subject to risks and uncertainties, including,
without limitation, those discussed in the section titled “Risk
Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023, and future filings and reports that Olema
makes from time to time with the U.S. Securities and Exchange
Commission. Except as required by law, Olema assumes no obligation
to update these forward-looking statements, including in the event
that actual results differ materially from those anticipated in the
forward-looking statements.
Contact:Geoffrey Mogilner, Vice President, Investor Relations
and Communicationsir@olema.com
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