On October 16, 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) product platform, reported that new translational data for BT1718 and preclinical data for BT5528 and BT8009 will be presented during poster sessions at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 26-30, 2019 in Boston, MA (Press release, Bicycle Therapeutics, OCT 16, 2019, View Source [SID1234542316]).

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New translational data will be presented for BT1718, the Company’s lead Bicycle Toxin Conjugate (BTC) product candidate, which define enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial with BT1718. The Phase I/IIa study, sponsored by Cancer Research UK, is currently in Phase I dose escalation in patients with advanced solid tumors who have not been pre-selected for MT1-MMP status. Once a recommended once-weekly Phase II dose is established, the Company expects to initiate the Phase IIa expansion, which will include patients determined to be MT1-MMP-postive based on a prespecified tumor membrane H-score. Initially, patients will be enrolled into two expansion cohorts, one in squamous lung cancer and the other in an all-comers "basket" cohort. Depending on results from these first two cohorts, additional cohorts may be initiated.

"We are creating a pipeline of Bicycle Toxin Conjugates, which selectively deliver toxin payload to tumors in a manner we believe is unique and differentiated to that of antibody drug conjugates," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We intend to maximize chances of success in the clinic for these innovative medicines by applying well-validated translational approaches to inform tumor type selection and patient enrollment criteria. As the data to be presented supports, we believe we have developed a compelling rationale for the design of the Phase IIa part of the ongoing trial and look forward to advancing BT1718 into the expansion cohorts, following dose selection."

Additional preclinical data will also be presented for Bicycle’s other BTC programs, BT5528 and BT8009, which show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively.

Details on Bicycle’s presentations at AACR (Free AACR Whitepaper)-NCI-EORTC are as follows:

Session Title: Poster Session A
Location: Level 2, Hall D
Poster Presentation Title: MT1-MMP Immunohistochemistry (IHC) analysis of tumor microarrays (TMAs) using a novel scoring system guides patient selection for BT1718 expansion cohorts
Abstract #: A047
Date & Time: October 27, 2019, 12:30 p.m. – 4:00 p.m. ET

Session Title: Poster Session C
Location: Level 2, Hall D
Poster Presentation Title: BT5528, a Bicycle Toxin Conjugate targeting EphA2: mechanism of action and clinical translation
Abstract #: C066
Date & Time: October 29, 2019, 12:30 p.m. – 4:00 p.m. ET

Session Title: Poster Session C
Location: Level 2, Hall D
Poster Presentation Title: BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, shows target selectivity, and efficacy in preclinical large and small tumor models
Abstract #: C061
Date & Time: October 29, 2019, 12:30 p.m. – 4:00 p.m. ET

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

About BT1718

BT1718 is a Bicycle Toxin Conjugate being developed by Bicycle Therapeutics that targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which has an established role in cell invasion and metastasis, is linked to poor outcomes and is over-expressed in many solid tumors. BT1718 has demonstrated promising target-dependent efficacy in preclinical models, including both cell- and patient-derived xenografts that are resistant to treatment with standards of care. In addition, it shows only a subset of the toxicities typically associated with other highly potent cancer treatments.