Full Press Release Details
Bicycle Therapeutics Announces Expedited Development
Plan for BT8009 in Metastatic Bladder Cancer
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.
CAMBRIDGE, UK, and BOSTON - September 11, 2023 - 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
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.
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
SVP, Investor Relations and Corporate Communications