Alignment with U.S. FDA on design of Phase 2/3
registrational trial, to be initiated in 1Q 2024
Innovative study design allows for potential
accelerated approval in untreated (first-line) and previously
treated (second-line plus) metastatic bladder cancer
Conference call and webcast today at 8 a.m.
ET
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 the company will proceed with its plan to expedite
development of BT8009 for metastatic bladder (urothelial) cancer
following recent discussions with the U.S. Food and Drug
Administration (FDA). The company has aligned with the FDA on a
Phase 2/3 registrational trial, called Duravelo-2, that has an
innovative design allowing for potential accelerated approval 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.
“We prepared a robust and innovative clinical development plan
for BT8009, with the goal of getting this much-needed therapy to
patients as quickly as possible. We are pleased to have reached
alignment with the FDA on the registrational trial design, dose
selection and clinical trial endpoints that could support potential
accelerated approval in a broad metastatic bladder cancer
population,” said Santiago Arroyo, M.D., Ph.D., chief development
officer at Bicycle Therapeutics. “In preparation for this positive
outcome, we have put in place the clinical infrastructure that will
allow us to start the registrational trial early next year.”
The Phase 2/3 Duravelo-2 trial will assess BT8009 in untreated
metastatic bladder cancer (Cohort 1) and previously treated
metastatic bladder cancer (Cohort 2). In Cohort 1, two doses of
BT8009 plus standard pembrolizumab regimen will be initially
assessed. Following selection of the optimal dose, BT8009 plus
pembrolizumab will be evaluated against chemotherapy. Potential
accelerated approval will be determined by objective response rate
(ORR), and progression-free survival (PFS) will be used to confirm
clinical benefit.
In Cohort 2, two doses of BT8009 as monotherapy will be
initially studied. Following selection of the optimal dose, an
additional arm of BT8009 plus standard pembrolizumab regimen will
be added. Potential accelerated approval for BT8009 monotherapy and
in combination with pembrolizumab will be determined by ORR
compared to historical control data. Discussions with the FDA about
the design of the confirmatory trial for previously treated
metastatic bladder cancer are ongoing.
“At Bicycle Therapeutics, we are committed to using our novel
platform to develop precision targeted therapeutics and improve the
lives of patients who are battling devastating diseases. This is
why, in line with the philosophy of the FDA’s Project FrontRunner
and following the agency’s recent draft guidance on accelerated
approval of oncology therapeutics, we have initially focused on
defining the regulatory path for BT8009 in untreated patients. We
believe today’s announcement is good news for patients, and we are
greatly appreciative of the FDA for their collaboration and
guidance,” said Kevin Lee, Ph.D., chief executive officer of
Bicycle Therapeutics. “As we look to the rest of 2023, we continue
to make progress in our research and development programs and look
forward to providing updates on BT8009, BT5528 and BT7480 later
this year.”
Conference Call and Webcast Information Bicycle
Therapeutics will host a conference call and webcast today,
September 11, 2023, at 8 a.m. ET to review the BT8009 regulatory
update. To access the call, please dial 1-833-816-1408 (U.S.) or +1
412-317-0501 (international) and ask to be joined into the Bicycle
Therapeutics call. A live webcast and replay of the conference call
will be available in the Investor section of the Bicycle website,
bicycletherapeutics.com.
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’s
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’s clinical trials; the
availability of and timing of updates for clinical candidates
BT8009, BT5528 and BT7480; and the therapeutic potential for
Bicycles in bladder cancer and other oncologic indications. Bicycle
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’s product candidates;
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’s product candidates; and other important
factors, any of which could cause Bicycle’s 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’s 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 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230911967115/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Argot Partners Sarah Sutton media@bicycletx.com
212-600-1902
Bicycle Therapeutics (NASDAQ:BCYC)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Bicycle Therapeutics (NASDAQ:BCYC)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024