Full Press Release Details
Bicycle Therapeutics Announces Updated Topline
Zelenectide Pevedotin Data and Highlights 2025 Strategic Priorities and Milestones
Updated topline Phase 1 combination data for
zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line
cisplatin-ineligible metastatic urothelial cancer
NECTIN4 gene amplification development strategy
underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in
Emerging radiopharmaceuticals pipeline progressing,
with additional MT1-MMP human imaging data expected in mid-2025 and first EphA2 human imaging data planned for 2H 2025
Expected financial runway into 2H 2027 to support
execution of clinical and strategic priorities
CAMBRIDGE, England & BOSTON, Jan. 13, 2025 - Bicycle Therapeutics
plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic
peptide (Bicycle ) technology, today announced updated topline Phase 1 combination data for zelenectide pevedotin plus
pembrolizumab in previously untreated (first-line) cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The company
also announced recent accomplishments and outlined strategic priorities and anticipated milestones for 2025.
"Bicycle Therapeutics made significant advances across all aspects
of our business in 2024. Notably, we drove important clinical progress of our targeted therapeutics in solid tumors, including greatly
expanding the number of patients who could potentially benefit from our lead therapy zelenectide pevedotin, advanced our emerging pipeline
of novel radiopharmaceuticals and strengthened our financial position and operational capabilities to advance our strategic priorities,"
said CEO Kevin Lee, Ph.D. "We are encouraged by our updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab
in first-line cisplatin-ineligible patients, which we believe continue to demonstrate a differentiated safety profile and encouraging
response rates in patients with poor prognosis and limited treatment options. We believe we are well-positioned to continue our strong
momentum of execution over the course of 2025, which will be another year of important data milestones across our pipeline as we work
to develop potentially transformative treatments that will help patients live longer and live well."
Updated Topline Zelenectide Pevedotin Plus Pembrolizumab Combination
Data in First-Line mUC Highlights
Zelenectide pevedotin, a Bicycle Toxin Conjugate (BTC ),
has significant potential to treat Nectin-4 cancers. As of Jan. 3, 2025, updated topline results from the ongoing Phase 1 Duravelo-1 trial
evaluating zelenectide pevedotin 5 mg/m2 weekly plus pembrolizumab 200 mg once every three weeks in 22 first-line cisplatin-ineligible
patients with mUC showed:
Altogether, these updated data continue to position zelenectide pevedotin
as a potentially promising best-in-class therapy for mUC.
Bicycle Therapeutics is currently conducting the Phase 2/3 Duravelo-2
registrational trial evaluating zelenectide pevedotin plus pembrolizumab versus chemotherapy in first-line mUC (Cohort 1), and zelenectide
pevedotin monotherapy and in combination with pembrolizumab in late-line mUC (Cohort 2). In each cohort, two doses of zelenectide pevedotin
- 5 mg/m2 weekly and 6 mg/m2 two weeks on, one week off - are initially being assessed before a final
2024 Key Accomplishments
2025 Strategic Priorities and Anticipated Milestones
Seek to transform treatment across multiple Nectin-4 associated
cancers with zelenectide pevedotin
Advance emerging Bicycle Radionuclide Conjugates
(BRC ) pipeline and progress strategy for leadership in next-generation radiopharmaceuticals
Advance targeted therapeutics pipeline addressing novel targets
that have historically been challenging to treat
J.P. Morgan Healthcare Conference Presentation and Webcast
Bicycle Therapeutics will highlight these updates and strategic priorities
in a corporate presentation at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 14, 2025, at 5:15 p.m. PT, followed
by a question-and-answer breakout session at 5:35 p.m. PT.
A live webcast of the presentation will be accessible from the Investor
section of the company's website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage pharmaceutical company
developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing
therapeutics. Bicycle molecules 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 Bicycle molecules attractive
candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle Toxin
Conjugate (BTC ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically
undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA ) targeting
Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radionuclide
Conjugates (BRC ) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology
to develop therapies for diseases beyond oncology.
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 www.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 ability to continue its momentum, including with respect to the development
of zelenectide pevedotin, BT5528 and BT7480 as well as potential radiopharmaceutical product candidates; the company's plans to
utilize a NECTIN4 gene amplification strategy in the clinical development of zelenectide pevedotin; Bicycle's strategic goals to
transform treatment across multiple Nectin-4 associated cancers, to become a leader in next-generation radiopharmaceuticals, and to advance
a targeted therapeutics pipeline addressing novel targets that have historically been challenging to treat; the planned initiation of
clinical trials of zelenectide pevedotin in breast cancer, lung cancer, and other cancers; achievement of multiple data milestones during
the course of 2025, and the timing of announcement of data from clinical trials for zelenectide pevedotin, BT5528, BT7480, and human imaging
data for MT1-MMP and EphA2 targeting Bicycle Radionuclide Conjugates; expectations with respect to Bicycle's financial
runway; and the use of Bicycle's technology through various partnerships to develop potential therapies in diseases beyond oncology.
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 research
and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle's product
candidates; the risk that Bicycle may not realize the intended benefits of its technology, partnerships or NECTIN4 gene amplification
strategy; the risk that Bicycle may not achieve any of its clinical development strategies; timing of results from clinical trials; whether
the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials
may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates; the
risk that Bicycle's projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more
cash than anticipated; 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 October 31, 2024, 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.
SVP, Investor Relations and Corporate Communications