Bicycle Therapeutics Announces Continuous Clinical Progress and Leadership Team Updates

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CAMBRIDGE, England, & BOSTON – (COMMERCIAL THREAD) – Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new differentiated class of therapeutics based on its proprietary bicyclic peptide (Bike®), today announced continued progress in its ongoing Phase I / II clinical trials for BT8009, BT5528 and BT7480.

“Last quarter, we published interim clinical results from ongoing trials of two of our Bike toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced that the first patient received a dose in the phase I clinical trial of BT7480, our first immune cell agonist targeting tumors to enter the clinic. In our trial of BT8009, we are pleased to confirm preliminary activity and see that these patients remain on trial. We look forward to presenting the interim results of BT8009 Phase I at a medical meeting and launching the BT5528 expansion cohorts this year, ”said Kevin Lee, Ph.D., CEO. “We are also pleased with our progress in advancing BT7480 into the ongoing Phase I clinical trial and look forward to sharing further details regarding the potential of Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted therapies in oncology.

Bike Conjugates of toxins® (BTC) BT8009 and BT5528

In the ongoing Phase I portion of the Phase I / II clinical trial of BT8009, a second generation BTC ™ targeting Nectin-4, four of 11 patients previously had a partial response according to the Response Assessment Criteria in Solid Tumors (RECIST) version 1.1, of which one in four (25%) in the 2.5 mg strength / m2 dose and three in seven (43%) at 5.0 mg / m2 cohorts. The four patients previously reported as responders have since received at least one subsequent analysis, and all have been confirmed as ongoing RECIST 1.1 responses. One patient within 5.0 mg / m2 cohort, which previously exhibited a partial response with 89% tumor reduction, now received two subsequent analyzes, each of which showed that the total tumor volume had been reduced by 100%, constituting a confirmed complete response. The four patients previously reported as having a RECIST 1.1 clinical response remain on treatment. The tolerance profile of 2.5mg / m2 and 5.0 mg / m2 cohorts remains consistent with that reported previously.

Dose escalation in the phase I trial of BT8009 is still ongoing, with patients currently receiving a dose of 7.5 mg / m2 weekly or every two weeks. Bicycle intends to present the interim results of Phase I of the ongoing clinical trial at a medical meeting this year.

The Phase I / II trial of BT5528, Bicycle’s second-generation BTC targeting EphA2, is also underway, with plans remaining on track to launch expansion cohorts this year, with a recommended phase dose. II expected of 6.5 mg / m2 Every other week.

Bike tumor-targeting immune cell agonist ™ (Bike TICA ™) BT7480

Bicycle has also launched a Phase I clinical trial of BT7480, a new fully synthetic product. Bike TICA targeting Nectin-4 and agonizing CD137, in Q4 2021, and dose escalation in this trial remains ongoing. BT7480 and others Bike TICAs, including a new molecule that engages NK cells, were featured in four posters at SITC in November 2021.

Updates from the management team

Bicycle is also announcing the expansion and transition of its management team. Michael Skynner, Ph.D., Chief Operating Officer (COO) of the Company, has been appointed to the newly created role of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing Bicycle’s proprietary phage display discovery growth. platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who was Vice President, Human Resources and Communications at the company since January 2021, has assumed the role of COO. . Mr. Milnes previously headed human resources and communications at multinational energy and minerals companies. Dr Skynner and Mr Milnes are both based in the UK.

“We are delighted to announce our recent leadership appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the role of COO. Mike has been an invaluable contributor to Bicycle’s success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical advancements, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline; and identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic goal. I have no doubts that Mike can help us achieve these goals. Dr Lee added: “I am equally excited about Alistair’s appointment as COO and believe his operational experience and track record of identifying, recruiting and retaining key talent within large multinational companies will be determinants to guide Bicycle in our next phase of growth.

About bicycle therapy

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a new class of drugs, called Bicycles, for diseases that are underserved by existing therapies. Bikes are short, fully synthetic peptides constrained by scaffolds of small molecules 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 reviews the BT5528, a second generation Bike Conjugate toxin (BTC ™) targeting EphA2; BT8009, a second generation BTC targeting Nectin-4, a well validated tumor antigen; and BT7480, a Bike TICA ™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I / II trials. Additionally, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I / IIa clinical trial sponsored by the Cancer Research UK Center for Drug Development. Bicycle is headquartered in Cambridge, UK with many key functions and members of its management team located in Lexington, MA. For more information visit biketherapeutics.com.

Forward-looking statements

This press release may contain forward-looking statements made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as “objectives”, “anticipate”, “believe” , “Could,” “estimates”, “expects”, “forecasts”, “objective”, “intention”, “may”, “foresees”, “possible”, “possible”, “research”, “Will fly” and variations of such words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements contained in this press release include, without limitation, statements regarding the discovery, development and potential commercialization of potential product candidates using Bicycle technology; Bicycle’s anticipated advance of its product candidates, notably BT5528, BT8009 and BT7480; advancing Bicycle’s product candidate pipeline; anticipated design, launch of expansion cohorts and progression of Bicycle clinical trials; the availability of clinical trial data; the therapeutic potential of Bicycles in oncology and other applications; and Bicycle’s ability to accelerate its product pipeline and identify potentially innovative applications of its technology beyond oncology. Bicycle may not achieve any plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements due to various factors, including: risks to the launch of the clinical trial site, recruitment and follow-up of patients, as well as for Bicycle’s ability to meet other planned 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 expected benefits of its technology; the availability and timing of clinical trial results; whether the results of preclinical studies will be predictive of the results of clinical trials; whether the initial or intermediate results of a clinical trial will predict the final trial results or the results of future trials; the risk that trials will be delayed and fail to perform satisfactorily; potential adverse effects resulting from the testing or use of Bicycle’s product candidates; the risk that Bicycle may not be able to identify other product candidates or additional applications of its technology; and other important factors, each of which could cause Bicycle’s actual results to differ from those contained in forward-looking statements, are further described in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on the Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 4, 2021, as well as in other documents that Bicycle may file with the SEC in the future. All 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 new information, future events, changes in circumstances or otherwise, except as required by law.


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