A2 Bio Announces First Patient Dosed in Phase 1 Clinical Trial of A2B530, a Novel Cell Therapy for the Treatment of Colorectal, Pancreatic and Non-small Cell Lung Cancers

First-in-human trial using A2 Bio’s logic-gated Tmod™ platform to provide selective killing of tumor cells while protecting normal cells

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, today announced the first patient has been dosed in the Phase 1 clinical trial of A2B530. The multi-center Phase 1 dose escalation clinical trial, EVEREST-1 (NCT05736731), will enroll patients with colorectal, pancreatic and non-small cell lung cancers. EVEREST-1 will evaluate safety and determine the recommended dose of A2B530.

A2B530 is the first autologous cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform utilizes a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This novel design is aimed to tackle the fundamental challenge in solid tumor cancer medicines - the ability to selectively kill tumor cells and protect normal cells.

“We believe the selectivity of the Tmod platform forms the foundation for a new class of therapeutics for solid tumor cancers, with the goal of killing tumors while avoiding the dose-limiting toxicities associated with well-known cancer targets. Dosing our first patient is a significant milestone for A2 Bio and for patients seeking novel treatment options. This is the first medicine of an innovative pipeline that leverages the selectivity provided by the blocker to provide potentially safer and more efficacious therapeutics for cancer patients,” said Scott Foraker, chief executive officer of A2 Bio.

A2B530 consists of an activator that targets carcinoembryonic antigen (CEA) and a blocker that targets HLA-A*02. CEA is a tumor-associated antigen expressed at high levels in colorectal, pancreatic and non-small cell lung cancers, but also in healthy gut tissues. HLA-A*02 is expressed in normal tissues and permanently lost via genetic deletion in tumor tissues in the patient population eligible for EVEREST-1. A2B530’s dual-receptor design is intended to provide selective killing of tumor tissues that express CEA and have lost the HLA-A*02 gene permanently.

“Dosing our first patient in EVEREST-1 is a key step to provide a precise, novel CAR T therapy to solid tumor patients with colorectal, pancreatic and non-small cell lung cancers. Tmod CAR T is designed to address the fundamental challenge of selectivity in solid tumor targeted therapy: to avoid on-target, off-tumor dose-limiting toxicity. We would like to thank our multiple investigators, clinical sites, patients and their families for their courage and commitment,” said Dr. William Go, chief medical officer of A2 Bio.

Patients for EVEREST-1 are identified through BASECAMP-1 (NCT04981119), the master pre-screening protocol using a next-generation sequencing diagnostic from Tempus to identify patients whose tumors have lost HLA-A*02. Ten sites are open and currently screening patients. BASECAMP-1 is also screening patients who may benefit from future Tmod therapies.

About A2 Bio

A2 Biotherapeutics, Inc. (A2 Bio) is a clinical-stage biotech company developing first-in-class logic-gated cell therapies to address the high unmet need in cancers. A2 Bio invented the proprietary Tmod™ cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells. For more information, please visit the company’s website at www.a2bio.com.

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A2 Bio Announces First Patient Dosed in Phase 1 Clinical Trial of A2B530, a Novel Cell Therapy for the Treatment of Colorectal, Pancreatic and Non-small Cell Lung Cancers