- BT8009 is the third program designed to explore the potential of Bicycles® as next-generation tumor-targeting agents
- BT8009 targets Nectin-4, a well-validated tumor antigen shown to be overexpressed in several common tumor types
“BT8009 is one of a new class of tumor-targeting agents that we believe represent the next generation of treatments for solid tumors. With a molecular weight 50-100 times smaller than that of a typical antibody drug conjugate, or ADC, and the anticipated ability to fully penetrate tumors with precision, we believe Bicycles® may have significant advantages over antibody-based approaches to tumor antigen targeting, a hypothesis supported by results from our preclinical studies,” said
The Phase I/II multi-center, open-label trial will evaluate BT8009 administered once weekly. Enrollment is ongoing in the Phase I dose escalation of BT8009 given as a monotherapy, and the Company plans to evaluate BT8009 dosed in combination with an immune checkpoint inhibitor in future Phase I dose escalation cohorts. The Phase I portion of the trial is primarily designed to assess the safety and tolerability of BT8009, and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, Bicycle expects to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical activity of BT8009 in patients with Nectin-4-positive tumors.
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 BT8009 or any of Bicycle’s other product candidates or programs; the expected design of Bicycle’s clinical trials, including the anticipated Phase II dose escalation portion of Bicycle’s clinical trial of BT8009; the safety, tolerability or efficacy of BT8009; 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 initiation and completion of clinical trials and clinical development of Bicycle’s 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 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
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