Press Release

- BT7480 has been selected as the Company’s lead immuno-oncology candidate to advance into IND-enabling studies

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Nov. 5, 2019-- Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles®) technology, today announced that new preclinical data from BT7480, a potent tumor-targeted immune cell agonist (TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), will be presented during speaker and poster sessions at the Society for Immunotherapy of Cancer’s (SITC) 2019 Annual Meeting on November 6-10, 2019 in National Harbor, MD.

“Our novel and proprietary Bicycle tumor-targeted immune cell agonists, or TICAs, are fully synthetic approaches engineered to overcome the limitations of other immunomodulatory mechanisms,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “The constrained nature of Bicycles confers high affinity and selectivity and enables us to easily link tumor targeting Bicycles to Bicycles that agonize CD137, providing tumor-specific effects. In preclinical experiments with BT7480, we have shown these characteristics promote rapid tumor penetration and powerful anti-tumor activity. We believe that these features, along with the modular nature of the Bicycle platform, could position Bicycles at the cutting edge of next generation immuno-oncology treatments and we look forward to progressing BT7480 into IND-enabling studies.”

Nectin-4/CD137 TICAs have shown very potent and tumor antigen dependent CD137 agonism in ex vivo experiments using patient-derived lung tumor samples that have intact immune microenvironments. In a Nectin-4 overexpressing syngeneic tumor model, 92% (n=24) of animals dosed with BT7480 experienced complete tumor regressions. Five of the complete responder animals were subsequently re-challenged with the same tumor cell implantation and no tumor growth was observed, implying development of immunogenic memory. In addition to these data on BT7480, the Company will also present preclinical data at SITC on other emergent Bicycle TICA strategies.

Details on Bicycle’s SITC presentations are as follows:

Session Title: Session 2: Novel Platforms and Innovation
Location: Cherry Blossom Ballroom
Oral Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle® peptide induces tumor localized 4-1BB agonism
Presenter: Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics
Date & Time: Wednesday, November 6, 20194:35 p.m. – 4:45 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George's Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle® peptide induces tumor localized 4-1BB agonism
Abstract #: P782
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George's Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted EphA2/4-1BB Bicycle® peptide induces tumor localized 4-1BB agonism
Abstract #: P794
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

The posters will be available on the Publications section of bicycletherapeutics.com following presentation.

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’s lead product candidate, BT1718, is a Bicycle Toxin Conjugate being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. 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 or any of Bicycle’s other product candidates or programs and the therapeutic potential of these 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: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle’s product candidates; availability and timing of results from preclinical studies and clinical trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of BT7480 or other product candidates; risks related to Bicycle’s ability to maintain existing collaborations and realize the benefits thereof; 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, as described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2019, 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 as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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Source: Bicycle Therapeutics plc

Bicycle Therapeutics
Maren Killackey
maren.killackey@bicycletx.com
+1-617-203-8300