Relay Therapeutics Announces Clinical Trial Collaboration with Pfizer to Evaluate Atirmociclib in Combination with RLY-2608
05 Junho 2024 - 5:05PM
Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision
medicine company transforming the drug discovery process by
combining leading-edge computational and experimental technologies,
today announced a clinical trial collaboration with Pfizer Inc.
(NYSE: PFE) to evaluate atirmociclib, Pfizer’s investigative
selective-CDK4 inhibitor, in combination with RLY-2608 and
fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic
breast cancer.
“We are very enthusiastic to evaluate Pfizer's novel
investigative selective-CDK4 inhibitor atirmociclib in combination
with RLY-2608, the first mutant selective PI3Kα inhibitor,” said
Don Bergstrom, M.D., Ph.D., President of R&D at Relay
Therapeutics. “We believe that combining these two selective agents
– atirmociclib and RLY-2608 – will avoid key off-target toxicity
that comes from hitting CDK6 and wild-type PI3Kα, which has
historically significantly limited use of non-selective agents. The
breast cancer treatment landscape continues to evolve quickly, and
we are pleased that the safety profile RLY-2608 has demonstrated
to-date makes it well-positioned to be part of the next generation
of therapies.”
Under the terms of the agreement, Pfizer will provide
atirmociclib for use in the study and Relay will be responsible for
conducting the study. The RLY-2608 + atirmociclib + fulvestrant
triplet combination is planned to begin by the end of 2024.
About RLY-2608
RLY-2608 is the lead program in Relay Therapeutics’ efforts to
discover and develop mutant selective inhibitors of PI3Kα, the most
frequently mutated kinase in all cancers, with oncogenic mutations
detected in about 14% of patients with solid tumors. RLY-2608 has
the potential, if approved, to address more than 250,000 patients
per year in the United States, one of the largest patient
populations for a precision oncology medicine.
Traditionally, the development of PI3Kα inhibitors has focused
on the active, or orthosteric, site. The therapeutic index of
orthosteric inhibitors is limited by the lack of clinically
meaningful selectivity for mutant versus wild-type (WT) PI3Kα and
off-isoform activity. Toxicity related to inhibition of WT PI3Kα
and other PI3K isoforms results in sub-optimal inhibition of mutant
PI3Kα with reductions in dose intensity and frequent
discontinuation. The Dynamo™ platform enabled the discovery of
RLY-2608, the first known allosteric, pan-mutant, and
isoform-selective PI3Kα inhibitor, designed to overcome these
limitations. Relay Therapeutics solved the full-length cryo-EM
structure of PI3Kα, performed computational long time-scale
molecular dynamic simulations to elucidate conformational
differences between WT and mutant PI3Kα, and leveraged these
insights to support the design of RLY-2608. RLY-2608 is currently
being evaluated in a first-in-human trial designed to treat
patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation.
For more information on RLY-2608, please visit here.
About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicine
company transforming the drug discovery process by combining
leading-edge computational and experimental technologies with the
goal of bringing life-changing therapies to patients. As the first
of a new breed of biotech created at the intersection of
complementary techniques and technologies, Relay Therapeutics aims
to push the boundaries of what’s possible in drug discovery. Its
Dynamo™ platform integrates an array of leading-edge computational
and experimental approaches designed to drug protein targets that
have previously been intractable or inadequately addressed. Relay
Therapeutics’ initial focus is on enhancing small molecule
therapeutic discovery in targeted oncology and genetic disease
indications. For more information, please visit www.relaytx.com or
follow us on Twitter.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding Relay Therapeutics’ strategy, business
plans and focus; the progress and timing of the clinical
development of the programs across Relay Therapeutics’ portfolio,
including the timing of clinical initiation of the RLY-2608 +
atirmociclib + fulvestrant triplet combination; the expected
therapeutic benefits and potential efficacy and tolerability of
RLY-2608, both as a monotherapy and in combination with other
agents, and its other programs; the potential market opportunity
for RLY-2608; and the expected strategic benefits under Relay
Therapeutics' clinical trial collaboration with Pfizer. The words
“may,” “might,” “will,” “could,” “would,” “should,” “plan,”
“anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,”
“predict,” “future,” “project,” “potential,” “continue,” “target”
and similar words or expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, risks associated
with: the impact of global economic uncertainty, geopolitical
instability, or public health epidemics or outbreaks of an
infectious disease on countries or regions in which Relay
Therapeutics has operations or does business, as well as on the
timing and anticipated results of its clinical trials, strategy,
future operations and profitability; the delay of any current or
planned clinical trials or the development of Relay
Therapeutics’ drug candidates; the risk that the
preliminary results of its preclinical or clinical trials may not
be predictive of future or final results in connection with future
clinical trials of its product candidates; Relay Therapeutics’
ability to successfully demonstrate the safety and efficacy of its
drug candidates; the timing and outcome of its planned interactions
with regulatory authorities; and obtaining, maintaining and
protecting its intellectual property. These and other risks
and uncertainties are described in greater detail in the section
entitled “Risk Factors” in Relay Therapeutics’ most recent Annual
Report on Form 10-K and Quarterly Report on Form 10-Q, as well as
any subsequent filings with the Securities and Exchange Commission.
In addition, any forward-looking statements represent Relay
Therapeutics' views only as of today and should not be relied upon
as representing its views as of any subsequent date. Relay
Therapeutics explicitly disclaims any obligation to update any
forward-looking statements. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Contact:Megan
Goulart617-545-5526mgoulart@relaytx.com
Media:Dan
Budwick1AB973-271-6085dan@1abmedia.com
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