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 announce today the anticipated registrational path for
RLY-4008 and three new programs within a growing HR+/HER2- breast
cancer franchise at a virtual analyst and investor event from 8:00
a.m. to 9:00 a.m. ET.
“2022 has proven to be an extremely productive year so far for
Relay Therapeutics and we’re looking forward to sharing updates
across our portfolio today,” said Sanjiv Patel, M.D., Relay
Therapeutics’ president and chief executive officer. “We are
excited to be announcing the anticipated registrational path for
RLY-4008 and the maturation of the data to support that pathway. In
addition, building on the foundation of our PI3Kα franchise, we
will outline a broad commitment to developing comprehensive
treatment options for breast cancer patients. We believe our
platform and approach have the potential to address some of the
hardest-to-treat diseases and are excited to do just that in the
coming years.”
RLY-4008 Regulatory and
Clinical Data Update
Relay Therapeutics conducted an
end-of-phase 1 meeting with the FDA to discuss next steps for the
clinical development of RLY-4008. Based on discussions with the
FDA, the Company has decided to move forward with a single arm
trial design for FGFRi-naïve FGFR2-fusion CCA at 70 mg once daily
to potentially support accelerated approval. The Company also
intends to add additional supportive CCA cohorts to an NDA
submission, including frontline, FGFRi-experienced and FGFR2
mutation and amplification patients that could potentially
facilitate a line and alteration agnostic label if the submission
is approved.
The interim data shared with the FDA
included a data cut-off of April 19, 2022, from the dose escalation
portion of the ongoing study. The interim data included a safety
database of 115 patients, with 58 patients treated with the once
daily (QD) dosing schedule, and 13 of these patients were
FGFRi-naïve FGFR2-fusion CCA patients treated with the once daily
schedule ranging from 20 mg up to 70 mg. Also, in addition to the
17 patients previously disclosed at a twice daily (BID) schedule,
an additional 40 patients were evaluated with an intermittent
dosing schedule, both of which have been deprioritized.
The safety analysis as of the April
19, 2022 cut-off date was consistent with the analysis from the
initial October 2021 data disclosure. Most treatment emergent
adverse events were expected FGFR2 on target, low-grade,
monitorable, manageable, and largely reversible. There were no
observed Grade 4 or 5 adverse events. Notable off-target toxicities
of hyperphosphatemia and diarrhea continued to be clinically
insignificant.
The efficacy analysis from this
interim data on the once daily dosing schedule presented to the FDA
demonstrated confirmed partial responses in eight out of thirteen
(62%) FGFRi-naïve FGFR2-fusion CCA patients across the 20 mg to 70
mg QD cohorts. There were four patients treated at the
registrational trial dose of 70 mg QD as of the April 19, 2022
cut-off date, all of which had confirmed partial responses.
An update from the FGFRi-naïve
FGFR2-fusion CCA patients treated at 70 mg QD across dose
escalation and expansion is expected to be presented at a medical
meeting in the second half of 2022. The entirety of the dose
escalation data is expected to be presented at a medical meeting or
published by the end of the first half of 2023. Lastly, initial
data from the non-CCA expansion cohorts is expected to be presented
in 2023.
Breast Cancer Portfolio and New Targets
Relay Therapeutics today disclosed three new programs from a
growing breast cancer franchise including a selective CDK2
inhibitor, a rationally designed ERα degrader, and a chemically
distinct pan-mutant selective PI3Kα inhibitor (RLY-5836).
- CDK2 is a common cause of resistance to the over 50,000
patients a year in the U.S. on CDK4/6 inhibitors and potentially an
important PI3Kα combination partner. Relay Therapeutics progressed
from first compound synthesized to an advanced CDK2 lead compound
with robust selectivity over other CDK family members in less than
a year. This program is expected to enter the clinic in Q4 2023 or
Q1 2024.
- Leveraging the Dynamo™ platform, Relay Therapeutics has been
able to move from the traditional empirical design of bi-functional
degraders to rationally designed molecules. The company expects to
nominate an ERα degrader development candidate in 2023.
- As a demonstration of Relay Therapeutics’ commitment to PI3Kα
mutant inhibition, the Company has designed a selective and
chemically distinct pan-mutant PI3Kα inhibitor, RLY-5836. RLY-5836
is expected to be ready to enter the clinic in 2023.
Conference Call Information
Relay Therapeutics will host a live webcast and conference call
today beginning at 8:00 am E.T. The virtual analyst and investor
event will be webcast live and may be accessed through 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.
About RLY-4008
RLY-4008 is a potent, selective and oral small molecule
inhibitor of FGFR2, a receptor tyrosine kinase that is frequently
altered in certain cancers. FGFR2 is one of four members of the
FGFR family, a set of closely related proteins with highly similar
protein sequences and properties. Preclinically, RLY-4008
demonstrated FGFR2-dependent killing in cancer cell lines and
induced regression in in vivo models, while minimal inhibition of
other targets was observed, including other members of the FGFR
family. In addition, RLY-4008 demonstrated strong activity against
known clinical on-target resistance mutations in cellular and in
vivo preclinical models. RLY-4008 is currently being evaluated in a
clinical trial in patients with advanced or metastatic
FGFR2-altered solid tumors with a single arm, potentially
registration-enabling cohort for pan-FGFR ("FGFRi") treatment-naïve
FGFR2-fusion CCA. To learn more about the clinical trial of
RLY-4008, please visit here.
About Relay Therapeutics
Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision
medicines 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
disparate technologies, Relay Therapeutics aims to push the
boundaries of what is 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. 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 timing of a
clinical data update for RLY-4008 and the clinical initiation of
Relay Therapeutics’ CDK2 program, ERα program and RLY-5836; the
expected therapeutic benefits of its programs; whether preclinical
or early clinical results of Relay Therapeutics’ product candidates
will be predictive of future clinical trials; Relay Therapeutics’
expectations relating to its current and future interactions with
the FDA, including its belief regarding a potential accelerated
path to registration and label for RLY-4008; expectations regarding
Relay Therapeutics’ operating plan, use of capital, expenses, and
other financial results during 2022 and in the future; and Relay
Therapeutics’ cash runway projection. 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 the ongoing
COVID-19 pandemic, changing macroeconomic conditions or uncertain
geopolitical factors where Relay Therapeutics has operations or
does business, as well as on the timing and anticipated results of
its clinical trials, strategy and future operations; the delay of
any current or planned clinical trials or the development of Relay
Therapeutics’ drug candidates; the risk that the results of its
clinical trials may not be predictive of future results in
connection with future clinical trials; 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:Caroline
Glen617-370-8837cglen@relaytx.com
Media:Dan
Budwick1AB973-271-6085dan@1abmedia.com
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