On November 9, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that preclinical data for BT7480, a novel Bicycle tumor-targeted immune cell agonist (Bicycle TICA), and BT7455, an EphA2/CD137 Bicycle TICA, will be presented in four poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, being held in Washington D.C. and virtually on November 10-14, 2021 (Press release, Bicycle Therapeutics, NOV 9, 2021, View Source [SID1234594859]).

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"The totality of the preclinical data to date, including that reflected in these four posters to be presented at SITC (Free SITC Whitepaper), support our decision to explore the clinical development of BT7480 and BT7455, our novel, Bicycle TICAs" said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We are encouraged by these early data and by the potential for these programs to one day provide a new treatment option for patients with cancer."

Preclinical results that will be presented at SITC (Free SITC Whitepaper) support Bicycle’s decision to initiate a Phase I/II clinical trial of BT7480 and its prioritization of potential indications to target. Additionally, Bicycle has developed a pharmacokinetic/pharmacodynamic (PK/PD) modelling framework to predict preclinical biomarker level and tumor growth inhibition in response to changes in the BT7480 dose and dosing schedule. Bicycle found that plasma and tumor drug concentration levels may be associated with tumor growth inhibition. EphA2/CD137 Bicycle TICA results in syngeneic mouse tumor models produced complete anti-tumor responses in vivo. These results reveal that costimulatory molecules that exploit intermittent rather than continuous exposure may promote optimal anti-tumor activity.

Together, pre-clinical data to be presented at SITC (Free SITC Whitepaper) demonstrate the broad potential for Bicycle TICAs, with a Nectin-4/CD137 Bicycle TICA and an EphA2/CD137 Bicycle TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC (Free SITC Whitepaper) are as follows:

Poster Title: Quantitation of CD137 and Nectin-4 expression across multiple-tumor types to support indication selection for BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA)
Poster #: 2
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: Establishing the preclinical/translational PK/PD relationship for BT7480, a Nectin-4/CD137 Bicycle tumor-targeted immune cell agonist (Bicycle TICA)
Poster #: 826
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: Generation of a Bicycle NK-TICA, a novel NK cell engaging molecule to enhance targeted tumor cytotoxicity
Poster #: 789
Date and Time: Friday, November 12 at 8 a.m. ET

Poster Title: An integrative approach to optimize a synthetic EphA2/CD137 agonist: balancing potency, physiochemical properties, and pharmacokinetics to achieve robust anti-tumor activity
Poster #: 888
Date and Time: Friday, November 12 at 8 a.m. ET