December 1, 2020

SITC

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Nov 9, 2020–

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 preclinical data for BT7480, a tumor-targeted immune cell agonist (TICA™), and an EphA2/CD137 TICA will be presented during an e-poster session at the Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting on November 9-14, 2020.

“We continue to produce compelling data characterizing the preclinical profiles of our novel, fully synthetic immuno-oncology, or IO, candidates,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “The data presented at SITC provide further evidence of the potential advantages of our TICAs over conventional, biologic-based IO therapies. Our molecules are able to fully engage the local tumor microenvironment with intermittent systemic exposure. Furthermore, because our TICAs are fully synthetic, we can customize each molecule’s pharmacokinetic profile and easily swap tumor-targeting and/or immune cell agonizing Bicycles for a generalizable approach. We believe our TICAs represent a major innovation in precision targeted immune modulation, and we look forward to initiating a clinical trial for our lead IO program, BT7480, in 2021.”

In preclinical models, BT7480 exhibited potent, target-dependent anti-tumor activity, and facilitated the development of immunogenic memory. New data presented at SITC demonstrate that treatment with BT7480 leads to significant modulation of the tumor microenvironment, including immune checkpoints. This finding supports potential dosing of BT7480 in combination with checkpoint inhibitors. At dose levels tested, BT7480 has been shown to be well-tolerated in non-human primates. IND-enabling activities for BT7480 are ongoing.

Based on new data presented at SITC, one of Bicycle’s EphA2/CD137 TICAs demonstrated potent EphA2-dependent activity in both CD137 reporter and primary immune cell assays. As with BT7480, intermittent dosing was associated with robust anti-tumor activity in an MC38 syngeneic mouse model that expresses human CD137. There, complete responder animals became resistant to rechallenge with MC38 tumor cells, implying an immunogenic memory response. Bicycle also showed a potential ability to induce significant modulation of the tumor immune microenvironment, including immune checkpoints. Bicycle announced earlier this year that it has selected an EphA2/CD137 TICA candidate, BT7455.

Together, data to be presented at SITC demonstrate the potential generalizability of the TICA platform, with a Nectin-4/CD137 TICA and an EphA2/CD137 TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC are as follows:

Poster Title: BT7480, a fully synthetic tumor-targeted immune cell agonist (TICA™) induces tumor localized CD137 agonism and modulation of tumor immune microenvironment
Abstract #: 706
Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

Poster Title: EphA2/CD137 Bicycle tumor-targeted immune cell agonists (TICAs™) induce tumor regressions, immunogenic memory, and reprogramming of the tumor immune microenvironment
Abstract #: 700
Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a

…...