Pharma Focus Europe

A2 Bio Commences EVEREST-2 Phase 1 Clinical Trial with Initial Patient Administered Novel Mesothelin Logic-Gated CAR T Therapy

Friday, May 17, 2024

A2 Biotherapeutics, Inc. (A2 Bio) has initiated the Phase 1 clinical trial for A2B694, marking a significant milestone in the development of its innovative cell therapy. This clinical-stage company specializes in creating logic-gated cell therapies for solid tumors, with A2B694 being the latest advancement in this field. The Phase 1 trial, known as EVEREST-2 (NCT06051695), aims to assess the safety and determine the optimal dosage of A2B694 in patients with solid tumors expressing mesothelin, such as ovarian, mesothelioma, pancreatic, colorectal, and non-small cell lung cancer, and who have lost HLA-A*02 expression.

A2B694 represents the second autologous cell therapy utilizing A2 Bio's proprietary Tmod™ platform to enter clinical development. This platform employs a dual-receptor design, comprising an activator targeting tumor cells and a blocker safeguarding normal cells. This innovative approach seeks to selectively eradicate tumor tissues expressing mesothelin while sparing normal cells. By addressing the challenge of distinguishing between tumor and normal cells, A2 Bio aims to overcome limitations seen in conventional solid tumor cancer treatments.

A2 Bio, expressed optimism about dosing the first patient in the trial, highlighting the potential of A2B694 to offer a precise CAR T therapy for patients with limited treatment options. Current therapies for these patients often offer only palliative relief and are constrained by toxicity issues. The company acknowledges the collaborative effort of participating patients, investigators, and clinical care providers in advancing this groundbreaking therapy.

In addition to A2B694, A2 Bio is actively progressing its clinical development of A2B530 and exploring other preclinical programs, leveraging its Tmod™ platform. This ongoing research underscores the company's commitment to expanding its pipeline and exploring new avenues for treating solid tumors.

EVEREST-2 (NCT06051695) represents a seamless Phase 1/2 study for A2B694, designed to evaluate its safety and efficacy. This investigational cell therapy, developed from the Tmod™ platform, employs a dual-receptor system to selectively target tumor cells while sparing normal cells. By recruiting patients with various types of cancer, including lung, colorectal, pancreatic, ovarian, and mesothelioma, the study aims to assess the potential of A2B694 across different tumor types.

A2 Bio's Tmod™ platform stands out for its precision-targeting cellular system, which incorporates both an activator and a blocker to direct immune cells toward tumors while protecting normal tissues. This innovative blocker technology enables personalized and effective targeting of T cells, ensuring that tumors are accurately distinguished from normal cells. By harnessing the power of the immune system in this manner, A2 Bio seeks to revolutionize the treatment landscape for solid tumors.

 

Source: businesswire.com

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