Full Press Release Details
Bicycle Therapeutics Announces BT5528 Phase
I Dose Escalation Results in Patients with Advanced Solid Tumors
Anti-tumor activity observed in heavily pre-treated
patients with EphA2-positive ovarian and urothelial cancers; overall response rates of 22% (including one complete response) and 67%,
Emergent safety profile of BT5528 suggests notable
differentiation from current and prior generation EphA2 targeted molecules, with no treatment-related hemorrhage and low grade, low incidence
of peripheral neuropathy, skin rash, and eye disorders
Enrollment in BT5528 expansion cohorts at the
recommended Phase II dose (RP2D) of 6.5mg/m2 every other week remains ongoing
Conference call scheduled for 8:30 a.m. ET
England, & BOSTON, September 7, 2022 - 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 announced Phase I dose escalation top-line results from its Phase I/II trial of BT5528, a BTC targeting EphA2, in patients
with advanced solid tumors.
therapeutic profile from the dose escalation portion of the Phase I/II trial of BT5528 in patients with late-line disease suggests both
differentiated safety and promising activity, most notably in ovarian and urothelial cancers," said Dominic Smethurst, Chief Medical
Officer of Bicycle Therapeutics. "Significant safety concerns seen with antibody drug conjugate (ADC) approaches have limited the
ability to effectively address EphA2, a target which correlates with tumor progression and is overexpressed in many cancers. Based on
BT5528's promising and differentiated safety profile, we hope to demonstrate the true therapeutic potential of this target, this
program and our broader Bicycle Toxin Conjugate (BTC ) platform."
"Smaller size, tumor penetration, pharmacokinetic
and other qualities distinguish BT5528 and other members of our BTC platform from traditional toxin delivery systems and may confer significant
advantages," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Clinical data emerging from our BT5528
study continues to elucidate these potential advantages, and supports the continued, rapid advancement of our Bicycle-targeted therapeutics
platform, all with the ultimate goal of creating unique, impactful medicines that transform the lives of patients. Enrollment continues
on schedule in the expansion portion of this trial, and we anticipate providing further updates next year."
BT5528, a BTC targeting EphA2, a target for
which prior antibody-based approaches have been unsuccessful, has demonstrated anti-tumor activity and differentiated tolerability. Bicycle
has established an RP2D dose (6.5mg/m2 every other week) and is enrolling ongoing expansion cohorts.
Conference Call Details
Bicycle Therapeutics will host a conference call
and webcast today, September 7, 2022, at 8:30 a.m. ET to review the BT5528 trial data. To access the call, please dial (877) 870-4263
(domestic) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined to the Bicycle Therapeutics
call. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website, bicycletherapeutics.com.
About Bicycle Therapeutics
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; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen;
and BT7480, a Bicycle TICA targeting Nectin-4 and agonizing CD137, 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 Cancer Research UK
Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located
in Lexington, Massachusetts. 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 the clinical development of BT5528 or any of Bicycle's
other product candidates or programs; the expected design and anticipated progression of and data readouts from Bicycle's clinical
trials of BT5528; the safety, tolerability or efficacy of BT5528; and the potential benefits of BT5528 or any of Bicycle's other
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 completion of clinical trials and
clinical development of BT5528 and Bicycle's other product candidates; availability and timing of results from clinical trials;
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 and studies may be delayed and may not have satisfactory outcomes; expectations for regulatory approvals
to conduct trials or to market product; 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 4, 2022, 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 may be required by law.
VP, Capital Markets & Investor Relations