Bicycle Therapeutics to Present Four Posters Highlighting Preclinical Data from its Bicycle Tumor-Targeted Immune Cell Agonist™ (Bicycle TICA™) Programs at the SITC 36th Annual Meeting

Rhea-AI Summary

Bicycle Therapeutics (NASDAQ: BCYC) announced the presentation of preclinical data for its novel tumor-targeted immune cell agonists BT7480 and BT7455 at the Society for Immunotherapy of Cancer's 36th Annual Meeting from November 10-14, 2021. The preclinical results support the initiation of a Phase I/II trial for BT7480, indicating potential anti-tumor responses in syngeneic mouse models. The data also formed the basis for a pharmacokinetic/pharmacodynamic modeling framework to optimize dosing schedules. These developments position Bicycle Therapeutics favorably in the competitive biotechnology landscape.

Positive

• Presentation of preclinical data for BT7480 and BT7455 supports clinical development.
• Initiation of Phase I/II clinical trial for BT7480 based on promising preclinical results.
• Positive anti-tumor responses observed in mouse models for EphA2/CD137 Bicycle TICA.

Negative

• None.

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)-- 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 that preclinical data for BT7480, a novel Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA), and BT7455, an EphA2/CD137 Bicycle TICA, will be presented in four poster presentations at the Society for Immunotherapy of Cancer’s (SITC) 36^th Annual Meeting, being held in Washington D.C. and virtually on November 10-14, 2021.

“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 Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. “We are encouraged by these early data and by the potential for these programs to one day provide a new treatment option for patients with cancer.”

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: Friday, November 12 at 8 a.m. ET

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: Friday, November 12 at 8 a.m. ET

Poster Title: Generation of a Bicycle NK-TICA™, a novel NK cell engaging molecule to enhance targeted tumor cytotoxicity
Poster #: 789
Date and Time: Friday, November 12 at 8 a.m. ET

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: Friday, November 12 at 8 a.m. ET

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; 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, 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 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 Securities and Exchange Commission (SEC) on November 4, 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.

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Investors:

David Borah, CFA

VP, Capital Markets & Investor Relations

david.borah@bicycletx.com

617-203-8300

Media:

Consilium Strategic Communications

Sukaina Virji or Mary-Jane Elliott

bicycle@consilium-comms.com

Source: Bicycle Therapeutics plc

FAQ

What is the significance of the preclinical data presented by Bicycle Therapeutics for BT7480?

The preclinical data supports the clinical development of BT7480, indicating its potential effectiveness as a tumor-targeted immune cell agonist.

When will the Phase I/II clinical trial for BT7480 commence?

The Phase I/II clinical trial for BT7480 is set to be initiated following the positive preclinical data presented at the SITC annual meeting.

What were the outcomes of the preclinical studies for BT7455?

Similar to BT7480, BT7455 data presented at SITC reinforces its potential as an effective therapeutic candidate in cancer treatment.

What are the next steps for Bicycle Therapeutics regarding BT7480?

Bicycle Therapeutics plans to initiate a Phase I/II clinical trial for BT7480 after the supportive preclinical findings.

What does the pharmacokinetic/pharmacodynamic modeling framework indicate for BT7480?

The modeling framework suggests that drug concentration levels may correlate with tumor growth inhibition, guiding future dosage and treatment strategies.