Bicycle Therapeutics Selected to Participate in FDA Program to Expedite Commercial Manufacturing Readiness of BT8009 for Metastatic Bladder Cancer
19 October 2023 - 10:00PM
Business Wire
Program intended to facilitate CMC development
for selected therapies with expedited clinical development
timeframes to help patients get access sooner
Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company
pioneering a new and differentiated class of therapeutics based on
its proprietary bicyclic peptide (Bicycle®) technology, today
announced that BT8009, the company’s lead investigational therapy
in development to treat metastatic bladder (urothelial) cancer, has
been selected to participate in the Chemistry, Manufacturing and
Controls (CMC) Development and Readiness Pilot (CDRP) Program
recently launched by the U.S. Food and Drug Administration (FDA).
BT8009 is one of up to nine products selected for the first year of
the CDRP Program, which the FDA created to facilitate CMC
development for therapies with expedited clinical development
timeframes based on the anticipated clinical benefits of earlier
patient access to the therapy. Through the CDRP Program, Bicycle
Therapeutics plans to work closely with the FDA to facilitate CMC
development and expedite commercial manufacturing readiness of
BT8009.
“We are honored to participate in the inaugural cohort of the
FDA’s CDRP Program,” said Mike Hannay, D.Sc., FRPharmS, senior vice
president and head of CMC at Bicycle Therapeutics. “We look forward
to working closely with the FDA to ensure the commercial
manufacturing readiness for BT8009 keeps pace with its expedited
clinical development. We welcome the guidance we will receive
through more frequent and dedicated CMC discussions with the FDA,
and in turn we hope the agency will become more familiar with our
novel Bicycle® technology and its sophisticated manufacturing
process.”
“At Bicycle Therapeutics, we are pioneering an entirely new
class of drugs with the goal of treating cancer and many other
diseases. We believe BT8009 has the potential to be a
transformative therapy for patients with metastatic bladder cancer,
which is underscored by its selection for the FDA’s CDRP Program in
addition to its Fast Track designation and recently announced
expedited development plan and registrational pathway,” said CEO
Kevin Lee, Ph.D. “On behalf of our entire team, I would like to
thank the FDA for their continued collaboration as we work with
urgency to develop and deliver this promising therapy to
patients.”
In September, Bicycle Therapeutics announced its plan to
expedite development of BT8009 in metastatic bladder cancer
following alignment with the FDA on the therapy’s Phase 2/3
registrational trial, called Duravelo-2. The innovative trial
design allows for the potential accelerated approval of BT8009 in
untreated (first-line) and previously treated (second-line plus)
metastatic bladder cancer. The company plans to initiate the
Duravelo-2 trial in the first quarter of 2024.
About BT8009 BT8009 is an investigational Bicycle Toxin
Conjugate (BTC™) targeting Nectin-4, a well-validated tumor antigen
with elevated levels of expression in multiple tumor types,
including bladder (urothelial) cancer. It is currently being
evaluated in a Phase 1/2 clinical trial enrolling patients with
Nectin-4 expressing advanced solid tumors. BT8009 will be evaluated
in the Phase 2/3 Duravelo-2 trial, a global, multi-center, adaptive
study designed to assess the safety and efficacy of the therapy for
metastatic bladder cancer.
About Bicycle Therapeutics Bicycle Therapeutics is a
clinical-stage biopharmaceutical company developing a novel class
of medicines, referred to as Bicycles, for diseases that are
underserved by existing therapeutics. Bicycles are fully synthetic
short peptides constrained with small molecule scaffolds to form
two loops that stabilize their structural geometry. This constraint
facilitates target binding with high affinity and selectivity,
making Bicycles attractive candidates for drug development. The
company is evaluating BT5528, a Bicycle Toxin Conjugate (BTC™)
targeting EphA2; BT8009, a BTC targeting Nectin-4, a well-validated
tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and
agonizing CD137, in company-sponsored Phase 1/2 trials. In
addition, BT1718, a BTC that targets MT1-MMP, is being investigated
in an ongoing Phase 1/2a clinical trial sponsored by the Cancer
Research UK Centre for Drug Development. Bicycle Therapeutics is
headquartered in Cambridge, UK, with many key functions and members
of its leadership team located in Cambridge, Mass. For more
information, visit bicycletherapeutics.com.
Forward Looking Statements This press release may contain
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by words such as “aims,”
“anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will” and variations of these words or
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding Bicycle
Therapeutics’ anticipated advancement of its product candidates,
including the timing of initiation and design of the Duravelo-2
Phase 2/3 clinical trial and potential accelerated approval of
BT8009; the anticipated progression of Bicycle Therapeutics’
clinical trials; anticipated clinical and other benefits of Bicycle
Therapeutics’ participation in the CDRP Program, including
potential earlier patient access to BT8009; the ability of the
company to expedite commercial manufacturing readiness for BT8009
including ensuring that commercial manufacturing readiness for
BT8009 keeps pace with its clinical development; and BT8009’s
potential to be a transformative therapy for patients with
metastatic bladder cancer. Bicycle Therapeutics may not actually
achieve the plans, intentions or expectations disclosed in these
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
disclosed in these forward-looking statements as a result of
various factors, including: uncertainties inherent in the
initiation, progress and completion of clinical trials and clinical
development of Bicycle Therapeutics’ product candidates; challenges
or delays in the development and preparation of the commercial
manufacturing readiness of BT8009; availability and timing of
results from clinical trials; whether the outcomes of preclinical
studies will be predictive of clinical trial results; whether
initial or interim results from a clinical trial will be predictive
of the final results of the trial or the results of future trials;
the risk that trials may have unsatisfactory outcomes; potential
adverse effects arising from the testing or use of Bicycle
Therapeutics’ product candidates; and other important factors, any
of which could cause Bicycle Therapeutics’ actual results to differ
from those contained in the forward-looking statements, are
described in greater detail in the section entitled “Risk Factors”
in Bicycle Therapeutics’ Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on August 3, 2023, as
well as in other filings Bicycle Therapeutics may make with the SEC
in the future. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Bicycle
Therapeutics expressly disclaims any obligation to update any
forward-looking statements contained herein, whether because of any
new information, future events, changed circumstances or otherwise,
except as otherwise required by law.
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Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Sarah Sutton Argot Partners media@bicycletx.com
212-600-1902
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