A2B395 / A2 Biotherap - LARVOL DELTA

Denali-1: a seamless phase 1/2 study of A2B395, a logic‑gated, allogeneic, Tmod chimeric antigen receptor T-cell (CAR T) therapy, in patients with triple-negative breast cancer and other EGFR-expressing solid tumors with HLA-A*02 loss of heterozygosity (LOH) (SABCS 2025) - "Abstract is embargoed at this time."

CAR T-Cell Therapy • Clinical • P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • EGFR • HLA-A

DENALI-1: a seamless phase 1/2 study of A2B395, a logic‑gated, allogeneic, Tmod CAR T therapy, in patients with EGFR‑expressing solid tumors with human leukocyte antigen‑A*02 loss of heterozygosity (SITC 2025) - P | "Dose escalation is ongoing (figure 2).Acknowledgements The authors would like to thank the patients, their families, and their caregivers for participating in this trial; the screeners, clinical research coordinators, study nurses, data managers, and apheresis teams at each study site; and A2 Bio. Medical writing support was provided by Jennifer M. Kulak, PhD, of ApotheCom (Yardley, PA) and funded by A2 Bio.Trial Registration ClinicalTrials.gov, NCT06682793Ethics Approval This trial was approved by each site's institutional review board.Abstract 585 Figure 1Request permissionsLogic-Gated CAR T With the Goal to Reduce Toxicity: MSLN (Activator) and HLA-A*02 (Blocker) [6]Abstract 585 Figure 2Request permissionsDENALI 1 dose escalation study design"

Clinical • P1/2 data • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • B2M • EGFR • HLA-A • MSLN

A2 Biotherapeutics, Inc…announced the acceptance of four abstracts for presentation during the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 5-9, 2025, in National Harbor, Md. (Businesswire) - "A2 Bio will present posters detailing early safety and efficacy from the ongoing phase 1/2 EVEREST-2 study and an enrollment update for the ongoing DENALI-1 study."

P1/2 data • Trial status • Colorectal Cancer • Mesothelioma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A2 Bio Announces First Patient Dosed in DENALI-1 Phase 1/2 Clinical Study of A2B395, a Novel Allogeneic Precision CAR T Cell Therapy for Patients with Solid Tumors that Express EGFR (Businesswire) - "A2 Biotherapeutics...announced dosing of the first patient in the DENALI-1 (NCT06682793) clinical study. DENALI-1 is a multicenter phase 1/2 dose-escalation clinical study to evaluate the safety and efficacy of A2B395, an allogeneic logic-gated CAR T cell therapy, in participants with solid tumors that express EGFR and have lost HLA-A*02 expression."

Trial status • Solid Tumor

Logic-gated, allogeneic Tmod chimeric antigen receptor T-cell (CAR T) therapy targeting epidermal growth factor receptor (EGFR) in advanced solid tumors with human leukocyte antigen (HLA) loss of heterozygosity (LOH): DENALI-1 trial. (ASCO 2025) - P, P1/2 | "The dose-expansion phase will confirm RP2D and collect biomarker data. Phase 2 will assess overall response rate per RECIST v1.1."

CAR T-Cell Therapy • Metastases • Dermatology • Genito-urinary Cancer • Graft versus Host Disease • Hematological Malignancies • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • B2M • EGFR • HLA-A

DENALI-1: A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: A2 Biotherapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A2 Biotherapeutics Closes $80 Million Series C Financing to Advance Clinical Development of Its Precision Cell Therapies Using Its Proprietary Tmod Technology Platform (Businesswire) - "A2 Biotherapeutics...announced the closing of its $80 million Series C financing round, supported by a syndicate of investors that includes The Column Group and Samsara BioCapital. Proceeds will fund the company’s three clinical development programs and advancement of its pipeline of CAR-T cell therapies based on its proprietary Tmod platform technology."

Financing • Solid Tumor