“We continue to produce compelling data characterizing the preclinical profiles of our novel, fully synthetic immuno-oncology, or IO, candidates,” said
In preclinical models, BT7480 exhibited potent, target-dependent anti-tumor activity, and facilitated the development of immunogenic memory. New data presented at SITC demonstrate that treatment with BT7480 leads to significant modulation of the tumor microenvironment, including immune checkpoints. This finding supports potential dosing of BT7480 in combination with checkpoint inhibitors. At dose levels tested, BT7480 has been shown to be well-tolerated in non-human primates. IND-enabling activities for BT7480 are ongoing.
Based on new data presented at SITC, one of Bicycle’s EphA2/CD137 TICAs demonstrated potent EphA2-dependent activity in both CD137 reporter and primary immune cell assays. As with BT7480, intermittent dosing was associated with robust anti-tumor activity in an MC38 syngeneic mouse model that expresses human CD137. There, complete responder animals became resistant to rechallenge with MC38 tumor cells, implying an immunogenic memory response. Bicycle also showed a potential ability to induce significant modulation of the tumor immune microenvironment, including immune checkpoints. Bicycle announced earlier this year that it has selected an EphA2/CD137 TICA candidate, BT7455.
Together, data to be presented at SITC demonstrate the potential generalizability of the TICA platform, with a Nectin-4/CD137 TICA and an EphA2/CD137 TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC are as follows:
Poster Title: BT7480, a fully synthetic tumor-targeted immune cell agonist (TICA™) induces tumor localized CD137 agonism and modulation of tumor immune microenvironment
Abstract #: 706
Live Q&A:
Poster Title: EphA2/CD137 Bicycle tumor-targeted immune cell agonists (TICAs™) induce tumor regressions, immunogenic memory, and reprogramming of the tumor immune microenvironment
Abstract #: 700
Live Q&A:
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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 and the therapeutic potential and potential advantages of Bicycle’s product candidates, Bicycle’s ability to customize its TICAs, Bicycle’s plans to initiate clinical trials for BT7480 and BT7455, Bicycle’s ability to advance its product candidates through clinical development. 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 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 preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; 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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