Bicycle Therapeutics Announces Interim BT8009 Phase I Clinical Trial Results Selected for an Oral Presentation at the 2022 AACR Annual Meeting

Rhea-AI Summary

Bicycle Therapeutics (NASDAQ: BCYC) announced that interim Phase I results from the ongoing Phase I/II trial of BT8009, targeting Nectin-4, will be presented at the 2022 American Association for Cancer Research Annual Meeting in New Orleans from April 8-13. The company will discuss these results in a conference call on April 11, 2022, at 8:30 a.m. ET. Additionally, four abstracts are selected for presentation, including details on BT7480 and BCY6033, highlighting advancements in Bicycle's novel therapeutics.

Positive

• Interim results from the Phase I/II trial of BT8009 to be presented, indicating progress.
• Four abstracts selected for presentation, showcasing the breadth of Bicycle's research.

Negative

• None.

- Four Additional Abstracts Selected as Poster Presentations at the Meeting

- Company to Host Conference Call on Monday, April 11, 2022 at 8:30 a.m. ET

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 interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC™ targeting Nectin-4, has been selected for an oral presentation at the upcoming 2022 American Association for Cancer Research Annual Meeting, being held April 8-13, 2022 in New Orleans, LA. The Company will host a conference call to discuss the data from the presentation on Monday, April 11, 2022 at 8:30 a.m. ET.

Oral Presentation Details

Title: BT8009-100 Phase I/II Study of Novel Bi-Cyclic Peptide and MMAE Conjugate BT8009 in Patients with Advanced Malignancies Associated with Nectin-4 Expression
Abstract #: 7971
Presenter: Meredith McKean, Sarah Cannon Research Institute at Tennessee Oncology
Session Title: Biomarker Advances in Clinical Trials
Date/Time: Sunday, April 10, 2022 at 4:00 p.m. ET

Poster Presentation Details

Title: Development of a CD137 Receptor Occupancy Assay to Support the Phase I/II Study of BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA™)
Abstract #: 5555
Presenter: Heather Cohen, Bicycle Therapeutics
Session Title: Immune Response to Therapies / Immune Monitoring and Clinical Correlates
Date/Time: Monday, April 11, 2022 at 2:30 p.m. ET

Title: Activity of the Erythropoietin-Producing Hepatocellular A2 Receptor (EphA2) Targeting Bicycle® Toxin Conjugate (BTC™) BCY6033 in EGFR Inhibitor Resistant Non-Small Lung Cancer (NSCLC) Patient Derived Xenografts
Abstract #: 333
Presenter: Kenneth Ngo, Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute
Session Title: Biological Therapeutic Agents and Novel Drugs
Date/Time: Sunday, April 10, 2022 at 2:30 p.m. ET

Title: Modeling the cDC1 Ex Vivo and In Vitro: Development and Characterization of a Conventional Dendritic Cell Culture System to Support Drug Discovery
Abstract #: 4230
Presenter: Laura Goodfield, Bicycle Therapeutics
Session Title: Immunomodulatory Agents and Interventions 3
Date/Time: Wednesday, April 13, 2022 at 10:00 a.m. ET

Title: Generation of a Bicycle NK-TICA™, a Novel NK Cell Engaging Molecule Designed to Induce Targeted Tumor Cytotoxicity
Abstract #: 4233
Presenter: Fay Dufort, Bicycle Therapeutics
Session Title: Immunomodulatory Agents and Interventions
Date/Time: Wednesday, April 13, 2022 at 10:00 a.m. ET

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

Conference Call Details

Bicycle Therapeutics will host a conference call and webcast on Monday, April 11, 2022 at 8:30 a.m. ET to review the data being presented. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international) and provide the Conference ID 2775710. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website, bicycletherapeutics.com.

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 Bicycle’s anticipated advancement of its product candidates, including BT5528, BT8009, BT7480 and BT1718, and participation in the AACR Annual Meeting. 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 intentions disclosed in these forward-looking statements as a result of various factors, including: Bicycle’s abilities to meet other anticipated deadlines 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; ; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, and which are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2022, 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/20220308005201/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 are the interim Phase I results of BT8009 presented by BCYC?

The interim Phase I results detail the efficacy and safety of BT8009 targeting Nectin-4, presented at the AACR Annual Meeting.

When is Bicycle Therapeutics' conference call regarding the presentation?

The conference call is scheduled for April 11, 2022, at 8:30 a.m. ET.

What is BT8009 and its significance for BCYC?

BT8009 is a second-generation Bicycle Toxin Conjugate targeting Nectin-4, significant for its potential in treating advanced malignancies.

Where will the AACR Meeting take place in 2022?

The AACR Annual Meeting will be held in New Orleans, LA, from April 8 to April 13, 2022.

How many abstracts did BCYC present at the AACR meeting?

Bicycle Therapeutics has four abstracts selected for presentation at the AACR meeting.