CAMBRIDGE, England & BOSTON / Feb 14, 2023 / 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 monotherapy Phase I dose escalation results of the ongoing Phase I/II trial of BT8009, a novel BTC™ targeting Nectin-4. The results will be presented at the 2023 American Society for Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium on Friday, February 17, 2023 in San Francisco, California. Today at 8:00 a.m. ET, the Company will host a conference call with BT8009 investigator Dr. Capucine Baldini and Dr. Daniel Petrylak to discuss the data being presented.
“We are encouraged by the Phase I dose escalation results as they continue to demonstrate the potential for BT8009 to be best-in-class for the treatment of urothelial cancer based on the observed anti-tumor activity and tolerability profile as well as the potential to treat other tumor types with significant unmet need,” said Kevin Lee, Ph.D., Chief Executive Officer. “Previously, we had reported a confirmed partial response in a non-small cell lung cancer patient and today we are pleased to announce a confirmed partial response in a breast cancer patient. Both of these patients are Nectin-4 positive. We are continuing to move forward with the dose expansion and Phase II portion of the clinical trial and look forward to providing an update by the end of 2023.”
“These data reaffirm the possibility for BT8009 to become a significant new treatment option for patients,” said Capucine Baldini, M.D., Medical Oncologist, Gustave Roussy. “The anti-tumor activity observed to date in heavily pre-treated urothelial, lung and breast cancer patients shows that BT8009’s Nectin-4-targeting properties make it a potentially differentiated treatment option compared to other available treatments.”
“BT009 has the potential to become an important player in the treatment landscape for urothelial cancer and other solid tumors,” said Daniel Petrylak, M.D., Professor of Medicine and Urology, Yale University. “Clinicians need differentiated treatments for patients that can offer lower rates of rash and neuropathy thus leading to longer durations of treatment. Given the preliminary tolerability and response pattern with BT8009 in this Phase I dose escalation, it justifies exploring BT8009 both as a monotherapy and in combination in the ongoing expansion cohorts.”
BT8009, a BTC targeting Nectin-4, has demonstrated anti-tumor activity in heavily pre-treated urothelial, lung and breast cancer patients with signs of differentiation compared to antibody-based approaches. Bicycle established two recommended Phase II doses (RP2Ds) at 5 mg/m2 weekly and 7.5 mg/m2 2 weeks on, 1-week off (over a 21-day cycle). The company is currently focusing its efforts on the 5 mg/m2 weekly dose and enrollment in the expansion cohorts remains ongoing.
Bicycle advancing BT8009 in ongoing expansion cohorts. In November 2022, Bicycle announced the dosing of the first patient in the part B dose expansion portion of the Phase I/II trial. Up to 66 patients will be enrolled in the initial monotherapy expansion cohorts, with the ability to further expand enrollment based on results from these cohorts. These monotherapy cohorts include urothelial cancer patients who are enfortumab vedotin (EV) naïve and those who are EV exposed, as well as cohorts in ovarian, triple negative breast and non-small cell lung cancers. A Phase II trial of BT8009 in combination with pembrolizumab remains on track to commence this year.
Poster Presentation Details
Title: BT8009-100: A Phase I/II Study of a Novel Bicyclic Peptide and MMAE Conjugate BT8009 in Patients with Advanced Malignancies Associated with Nectin-4 Expression, Including Urothelial Cancer
Abstract #: 498
Presenter: Capucine Baldini, M.D., on behalf of the BT8009-100 investigators
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date/Time: Friday, February 17, 3:30 p.m. to 5:00 p.m.; 8:15 p.m. to 9:15 p.m. ET
Conference Call Details
Bicycle Therapeutics will host a conference call and webcast today, February 14, 2023 at 8:00 a.m. ET to review the data being presented. To access the call, please dial (866) 652-5200 (domestic) or (412) 317-6060 (international) and provide the Conference ID 10174689. 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: the potential of BT8009 to target and kill cancer tumor cells; the initiation, progress, and timing of clinical trials of BT8009 and pursuit of additional indications for and further clinical development of this product candidate. Bicycle may not actually achieve the 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 and expectations disclosed in these forward-looking statements as a result of various factors, including: whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that trials and studies may be delayed and may not have satisfactory outcomes; 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 3, 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.
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