Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision
medicine company transforming the drug discovery process by
combining leading-edge computational and experimental technologies,
will provide details on the company’s portfolio during its New
Program & Platform event today, June 6, 2024, from 8:00 to
10:00 a.m. ET. As part of the event, the company will disclose
three new programs from its existing pre-clinical pipeline and will
review how the Dynamo™ platform led to these discoveries. The new
programs include two novel programs from its genetic disease
portfolio and a potentially first-in-class NRAS-selective
inhibitor. Both genetic disease programs have the potential to
provide a unique approach to addressing clinically and commercially
validated targets in vascular malformations and Fabry disease. The
new programs announced today do not change cash guidance, which is
expected to fund operations into the second half of 2026.
“Since Relay Therapeutics was founded eight years ago, our
Dynamo platform has been very productive and we have made
significant progress advancing our initial set of programs,
including four that have entered the clinic. We have successfully
created molecules for a variety of targets to-date, have shown
clinical proof-of-concept for two of these programs and are aiming
to start our first Phase 3 study next year with RLY-2608,” said
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay
Therapeutics. “Today, we are very excited to unveil the next set of
innovative programs, which demonstrate the power of our Dynamo
platform, and which we believe will drive the next wave of the
company’s growth. These new programs underscore the breadth of the
platform’s capabilities with expansion beyond precision oncology
into genetic disease and beyond inhibitors to small molecule
chaperones.”
New Programs Potentially Addressing More Than 200,000
Patients in the United States
The New Program & Platform event presentation will highlight
newly disclosed programs in vascular malformations, Fabry disease
and NRAS.
Vascular Malformations
- Vascular malformations are a series
of rare syndromes that occur due to atypical development of
lymphatic and/or blood vessels, which enlarge or form tangles,
pockets or shunting vessels that cause abnormal blood flow. They
can occur in different parts of the body, vary in severity and may
cause symptoms such as pain, swelling, skin discoloration, limb
asymmetry and functional limits. The malformations typically grow
over time, and, depending on what vessel(s) are involved, can
become life-threatening.
- The primary vessel(s) involved
determine the sub-type of malformation, which can include venous
malformations, cerebral cavernous malformations, lymphatic
malformations and PIK3CA-related overgrowth spectrum.
- PI3Kα is the most common driver
mutation among these sub-types, causing an estimated 55 percent of
these vascular malformations.
- In the U.S., an estimated 170,000
people have one of these sub-types driven by a PI3Kα mutation.
- A mutant selective PI3Kα inhibitor
provides the opportunity for greater target coverage, leading to
the potential for improved efficacy and better chronic
tolerability.
- Relay Therapeutics plans to initiate
clinical development of RLY-2608 in vascular malformations in the
first quarter of 2025.
Fabry Disease
- In Fabry disease, a defective gene
(GLA) prohibits the body from producing enough healthy versions of
an enzyme called alpha-galactosidase A (αGal), which is responsible
for breaking down Gb3 (globotriaosylceramide), a fat-like
substance. As a result, harmful levels of Gb3 accumulate in blood
cells and tissues throughout the body, which can lead to a range of
symptoms, including potentially life-threatening ones such as
kidney failure, heart failure and stroke.
- In the U.S., approximately 8,000
people are estimated to have this rare, progressive genetic
disorder.
- Relay Therapeutics has created the
first investigational non-inhibitory chaperone for Fabry disease,
which is designed to stabilize the αGal protein without inhibiting
its activity, thus enabling greater Gb3 clearance across
organs.
- A non-inhibitory chaperone could
potentially serve as a chronic treatment option for people with
Fabry disease, either as a monotherapy or in combination with
enzyme replacement therapy.
- The company expects its
non-inhibitory chaperone to enter the clinic in the second half of
2025.
NRAS
- NRAS is a known oncogene driver that
belongs to the RAS family of signaling proteins. It plays an
important role in cell division, cell differentiation and
programmed cell death. The NRAS protein is responsible for
converting GTP to GDP and is turned “on” when it binds to GTP and
“off” once the GTP is converted to GDP. When mutated, the NRAS gene
creates NRAS proteins that are always “on”, which makes cells grow
and divide uncontrollably and can lead to a number of cancers,
including melanoma, colorectal and non-small-cell lung.
- In the U.S., an estimated 28,000
people are diagnosed each year with mutated NRAS solid tumors.
- Existing approved and in-development
treatments either target all RAS proteins (pan-RAS) or target other
downstream parts of the pathway such as RAF and MEK, which leads to
significant off-target toxicity and limits efficacy.
- Relay Therapeutics has created the
first NRAS-selective inhibitor, which has been designed to address
the liabilities of current pan-RAS inhibitors by only binding to
NRAS, while sparing KRAS and HRAS.
- The company expects to initiate
clinical development of its NRAS-selective inhibitor in the second
half of 2025.
Anticipated Milestones
- Breast Cancer
- RLY-2608 + fulvestrant data update
in the fourth quarter of 2024
- RLY-2608 + fulvestrant + ribociclib
initial safety data in the fourth quarter of 2024
- RLY-2608 + fulvestrant +
atirmociclib clinical trial initiation by the end of 2024
- RLY-2608 + fulvestrant potential
Phase 3 trial initiation in 2025
- Genetic Disease
- Vascular malformations: RLY-2608
clinical trial initiation in the first quarter of 2025
- Fabry disease: clinical start in the
second half of 2025
- Precision Oncology
- Lirafugratinib: tumor agnostic data
and regulatory update in the second half of 2024
- NRAS: clinical start in the second
half of 2025
Platform Productivity
Since the founding of Relay Therapeutics in 2016, the company
has built and grown its Dynamo drug discovery platform, which
combines experimental and computational techniques, tools and team
members. Over the last eight years, Dynamo has been very
productive, resulting in eight drug candidates (DCs) and four
Investigational New Drug Applications (INDs), including two
programs that have demonstrated clinical proof-of-concept. By the
end of 2025, Relay Therapeutics expects three new clinical starts
from the additional novel programs announced today. Collectively,
over the first decade of the company’s history, that would be 11
DCs, seven INDs and seven programs that have entered the
clinic.
Cash Runway
The three new programs disclosed today are from Relay
Therapeutics’ existing pre-clinical pipeline. The continued
advancement of these programs has already been accounted for in the
company’s existing cash runway guidance. As of March 31, 2024,
cash, cash equivalents and investments totaled approximately $750
million and are expected to fund the current operating plan into
the second half of 2026.
Event Information
Relay Therapeutics’ New Program & Platform event will begin
at 8:00 a.m. ET and is expected to conclude at approximately 10:00
a.m. ET. The live webcast can be accessed here or on Relay
Therapeutics’ website under Events in the News & Events section
through the following link:
https://ir.relaytx.com/news-events/events-presentations. An
archived replay of the webcast will be available following the
event. It is recommended that participants register at least 15
minutes in advance of the event.
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 updates on the clinical
development of the programs across Relay Therapeutics’ portfolio,
including the expected therapeutic benefits of its programs, and
potential efficacy and tolerability, and the timing and success of
interactions with and approval of regulatory authorities; the
timing of clinical data updates across Relay Therapeutics’
pipeline, including the progress of doublet and triplet
combinations for RLY-2608, the timing of clinical updates for
RLY-2608, and the timing of a clinical data and regulatory update
for lirafugratinib; the timing of clinical initiation of Relay
Therapeutics’ various programs, including a potential pivotal trial
for RLY-2608, clinical development in vascular malformations,
clinical development of Relay Therapeutics’ non-inhibitory
chaperone, and clinical development of its NRAS-selective
inhibitor; the potential of Relay Therapeutics’ product candidates
to address a major unmet medical need; the cash runway projection;
the competitive landscape and potential market opportunities for
Relay Therapeutics’ product candidates; the expected strategic
benefits under Relay Therapeutics’ collaborations; the capabilities
and development of the Dynamo platform, including its
role in identifying product candidates; Relay Therapeutics’ ability
to successfully establish or maintain collaborations or strategic
relationships for its product candidates; expectations regarding
current and future interactions with the U.S. Food and Drug
Administration (FDA); Relay Therapeutics’ ability to manufacture
its product candidates in conformity with the FDA’s requirements;
plans to develop, manufacture and commercialize the current product
candidates and any future product candidates; and the
implementation of Relay Therapeutics’ business model and strategic
plans for its business, current product candidates and any
future product candidates. 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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