Bicycle Therapeutics Announces Publication of Article Highlighting Preclinical Data from BT7480 Program in the Journal for ImmunoTherapy of Cancer

Rhea-AI Summary

Bicycle Therapeutics (NASDAQ: BCYC) announced a publication in the Journal for ImmunoTherapy of Cancer featuring preclinical data on BT7480, a tumor-targeted immune cell agonist. This innovative therapy targets Nectin-4 and activates CD137 selectively in tumor environments, enhancing anti-tumor immunity with intermittent use. The findings reveal BT7480’s capability to rapidly alter the tumor immune microenvironment, leading to complete regressions in mouse models. Bicycle aims to commence a Phase I/II clinical trial by year's end, furthering its commitment to cancer treatment innovation.

Positive

• Publication of preclinical data on BT7480 in a reputable journal.
• BT7480 demonstrated ability to induce complete tumor regressions in mouse models.
• Anticipation of starting Phase I/II clinical trial by the end of the year.

Negative

• Potential risks associated with CD137 activation outside of tumors.
• Dependence on successful outcomes from ongoing clinical trials.

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 an article highlighting preclinical data from BT7480, a tumor-targeted immune cell agonist (TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), was published in the Journal for ImmunoTherapy of Cancer (JITC). The article, titled “BT7480, a novel fully synthetic Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™) induces tumor localized CD137 agonism” is available online via this link.

“CD137 is an important co-stimulatory receptor expressed on multiple components of the immune system. CD137 activation can drive anti-tumor immunity but activation outside of the tumor may give rise to toxicity. To that end, we have developed BT7480, a novel, first-in-class Nectin-4/CD137 Bicycle TICA™, that activates CD137 only in the presence of Nectin-4 expressing tumor cells,” said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. “The data published today in JITC describe BT7480’s ability to elicit rapid reprogramming of the tumor immune microenvironment, which leads to complete regressions and anti-tumor immunity with only intermittent drug exposure in syngeneic mouse tumor models. We believe this work supports the clinical investigation of BT7480 for the treatment of cancer, and we look forward to dosing the first patient in our Phase I/II clinical trial which we plan to commence by the end of this year.”

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, and BT8009, a second-generation BTC™ targeting Nectin-4, a well-validated tumor antigen, 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 Bicycle’s anticipated advancement of its product candidates, including BT7480; the advancement of Bicycle’s product candidate pipeline; anticipated design of, initiation of, enrollment in and progression of Bicycle’s clinical trials; the availability of data from clinical trials; and the therapeutic potential of Bicycle’s 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 ; the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that trials may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; 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 Securities and Exchange Commission (SEC) on August 5, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211102005715/en/

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 BT7480 and how does it work?

BT7480 is a tumor-targeted immune cell agonist that activates CD137 specifically in the presence of Nectin-4 expressing tumor cells, enhancing anti-tumor immunity.

Where can I find the published data on BT7480?

The data on BT7480 can be found in the Journal for ImmunoTherapy of Cancer.

When is the Phase I/II trial for BT7480 expected to start?

Bicycle Therapeutics plans to commence the Phase I/II clinical trial for BT7480 by the end of this year.

What are the implications of BT7480's preclinical results?

The preclinical results suggest that BT7480 could offer a new treatment option for cancer by effectively reprogramming the tumor immune microenvironment.

What are the potential risks of using BT7480?

While BT7480 shows promise, there are risks associated with CD137 activation outside of tumors that need to be evaluated.