Full Press Release Details
Bicycle Therapeutics Announces Interim BT5528
Phase I Clinical Trial Results and Preliminary Results from Ongoing BT8009 Phase I Clinical Trial
-A recommended BT5528 Phase II dose (RP2D) range
has been established at 6.5-8.5mg/m2 every other week; expansion cohorts expected to initiate in 2022
CAMBRIDGE, England, & BOSTON,
October 7, 2021 - Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering
a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle )
technology, today provided a clinical update of its wholly-owned, next-generation Bicycle Toxin Conjugates (BTCs), reporting interim
Phase I trial results for BT5528 and preliminary findings from the ongoing dose escalation portion of the of the BT8009 clinical trial.
"We are pleased to provide a clinical update for two of our wholly-owned
BTCs currently undergoing Phase 1 dose escalation trials in late line cancer patients," said Dominic Smethurst, MA, MBChB, MRCP,
MFPM, Chief Medical Officer of Bicycle Therapeutics. "We are delighted to see preliminary anti-tumor activity in both trials and
across two tumor types, as well as to report tolerability profiles that may demonstrate differentiation from antibody-based approaches."
"These data support our belief that the Bicycle platform offers
a potentially differentiated approach to traditional toxin delivery. The data generated from these molecules provide a wealth of information
and insights as we continue to expand the application of our technology and generate additional Bicycle- targeted therapeutics
with the intention of making a meaningful difference to cancer patients," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle
Therapeutics. "We look forward to providing additional clinical data on BT5528 and BT8009 next year, and initiating our Phase I/II
study for BT7480 later this year."
BT5528, a BTC targeting EphA2, a target for which prior antibody-based
approaches have been unsuccessful, has demonstrated preliminary anti-tumor activity. Bicycle has established an RP2D range and is pursuing
enrollment in expansion cohorts
BT8009, a Nectin-4 targeting BTC with a potentially differentiated
profile as compared to a Nectin-4 targeting ADC has shown preliminary anti-tumor activity in the ongoing Phase I portion of its Phase
Bicycle Therapeutics will host a conference call and webcast on Thursday,
October 7 at 3:00 p.m. ET to review the BT5528 trial data being presented at the AACR-NCI-EORTC meeting and provide an update on preliminary
findings from the BT8009 trial. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international) and provide
the Conference ID 2287246. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website,
bicycletherapeutics.com.
About Bicycle Therapeutics
Bicycle Therapeutics (NASDAQ: BCYC) 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.
Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC ) targeting EphA2, and BT8009, a second-generation
BTC targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC
that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Centre for Drug Development of
Cancer Research UK. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in
Lexington, MA. 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 BT5528, BT8009 and BT7480; the
advancement of Bicycle's product candidate pipeline; ; anticipated design of, initiation of, enrollment in and progression of
Bicycle's clinical trials; the availability of data from clinical trials; and the therapeutic potential of Bicycle's
product candidates. 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: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to Bicycle's
abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in
the initiation 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; 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 be delayed and
may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates;
and other important factors, any of which could cause our 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 5, 2021, 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.
VP, Capital Markets & Investor Relations
Consilium Strategic Communications
Sukaina Virji or Mary-Jane Elliott