A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects with Unresectable, Locally Advanced or Metastatic CLDN18.2+ Solid Tumors

November 4, 2023

INTRODUCTION

• The T cell antigen coupler (TAC) is a novel, proprietary chimeric receptor that facilitates the re-direction of T cells to tumor
cells and activates T cells by co-opting the endogenous T cell receptor complex, with the goal of eliciting a safe and durable antitumor
response. In preclinical models, TAC-engineered T cells effectively eradicate tumor cells in vitro and in vivo without
toxicities typically associated with engineered T cell products. TAC01-CLDN18.2 is an autologous T cell product comprising T
cells expressing the CLDN18.2 TAC, which specifically recognizes CLDN18.2+ cells.

• TACTIC-3 (NCT05862324) is an open-label, multicenter phase I/II study that aims to establish safety, maximum tolerated dose
(MTD), recommended phase 2 dose (RP2D), pharmacokinetic profile, and efficacy of TAC01-CLDN18.2 in patients with
CLDN18.2 positive, HER2-negative solid tumors by immunohistochemistry (i.e. gastric, GEJ, esophageal adenocarcinoma,
PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer, and NSCLC) who have measurable
disease after at least 2 prior anti-cancer therapies.

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