“The totality of the preclinical data to date, including that reflected in these four posters to be presented at SITC, support our decision to explore the clinical development of BT7480 and BT7455, our novel, Bicycle TICAs” said
Preclinical results that will be presented at SITC support Bicycle’s decision to initiate a Phase I/II clinical trial of BT7480 and its prioritization of potential indications to target. Additionally, Bicycle has developed a pharmacokinetic/pharmacodynamic (PK/PD) modelling framework to predict preclinical biomarker level and tumor growth inhibition in response to changes in the BT7480 dose and dosing schedule. Bicycle found that plasma and tumor drug concentration levels may be associated with tumor growth inhibition. EphA2/CD137 Bicycle TICA results in syngeneic mouse tumor models produced complete anti-tumor responses in vivo. These results reveal that costimulatory molecules that exploit intermittent rather than continuous exposure may promote optimal anti-tumor activity.
Together, pre-clinical data to be presented at SITC demonstrate the broad potential for Bicycle TICAs, with a Nectin-4/CD137 Bicycle TICA and an EphA2/CD137 Bicycle TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC are as follows:
Poster Title: Quantitation of CD137 and Nectin-4 expression across multiple-tumor types to support indication selection for BT7480, a Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™)
Poster #: 2
Date and Time:
Poster Title: Establishing the preclinical/translational PK/PD relationship for BT7480, a Nectin-4/CD137 Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™)
Poster #: 826
Date and Time:
Poster Title: Generation of a Bicycle NK-TICA™, a novel NK cell engaging molecule to enhance targeted tumor cytotoxicity
Poster #: 789
Date and Time:
Poster Title: An integrative approach to optimize a synthetic EphA2/CD137 agonist: balancing potency, physiochemical properties, and pharmacokinetics to achieve robust anti-tumor activity
Poster #: 888
Date and Time:
About
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 BT7480, BT7455 and other Bicycle TICAs or any of Bicycle’s other product candidates or programs; the safety, tolerability or efficacy of BT7480 or any other Bicycle TICA product candidate; and the potential benefits of BT7480, BT7455 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 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 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
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Investors:
VP, Capital Markets & Investor Relations
david.borah@bicycletx.com
617-203-8300
Media:
bicycle@consilium-comms.com
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