Chimeric Therapeutics (CHM) Study Update summary

Program Overview and Leadership

• CHM CDH17 is the first CDH17 CAR-T cell therapy in clinical trials globally, developed over a decade at the University of Pennsylvania, with four active phase one trials under three FDA INDs at multiple U.S. centers.

• The leadership team has extensive CAR-T and cell therapy experience, with backgrounds at major biotech firms and successful product launches.

Study Background and Design

• Phase 1/2 trial is open for colorectal, gastric, and neuroendocrine cancers at four leading US centers, using a 3+3 dose escalation design with expansion planned for each cancer type.

• Up to 15 patients are planned for Phase 1, with expansion cohorts in Phase 2.

• Manufacturing has achieved 10/10 successful GMP-compliant runs.

Preclinical and Clinical Development

• Preclinical models showed complete eradication of neuroendocrine, gastric, and pancreatic tumor models with no relapse or toxicity in healthy cells.

• Clinical sites include University of Pennsylvania, Sarah Cannon Cancer Center, University of Chicago, and Emory University, with IND clearance in November 2023.