A2B694 / A2 Biotherap - LARVOL DELTA

Initial safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)–targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH). (ASCO 2026) - P, P1/2 | "A patient with KRASG12V/STK11 co-mutated NSCLC who had progressed on carboplatin, pemetrexed, and pembrolizumab achieved a complete response (CR) at D90 post-infusion per RECIST 1.1 by central review and had a confirmed CR at D180. We report the first patient with NSCLC to have a CR after CAR T. Overall, A2B694 demonstrated manageable safety and tolerability in patients with advanced solid MSLN-expressing tumors with tumor-associated HLA-A*02 LOH. The maximum tolerated dose has not been reached; dose-escalation continues."

CAR T-Cell Therapy • Clinical • First-in-human • Metastases • Lung Adenocarcinoma • Lung Cancer • Mesothelioma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HLA-A • KRAS • MSLN • STK11

BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials (SITC 2023) - P=N/A, P1/2 | "BASECAMP-1 is an ongoing prescreening study to: 1) Identify patients with tumor-associated HLA LOH and eligible for Tmod CAR T-cell therapy, and 2) Obtain leukapheresis in preparation for the autologous CAR T-cell therapy trials EVEREST-1 (A2B530 targeting carcinoembryonic antigen; NCT05736731) and EVEREST-2 (A2B694 targeting mesothelin). We have identified 52 patients across sites with study-specific disease types with HLA-A*02:01 LOH; of these, 13 are currently being screened, 23 have been found ineligible, and 16 have consented. This demonstrated the feasibility of leveraging a diagnostic during routine clinical workup to identify rare, molecularly defined patients for personalized clinical studies."

CAR T-Cell Therapy • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • HLA-A • MSLN

EVEREST-2: Phase 1/2 Study of Logic-Gated Tmod CAR T A2B694 in Lung Cancer and Other Tumors Expressing MSLN With HLA-A*02 LOH (IASLC-WCLC 2025) - P, P1/2 | "Patient 5 has KRAS G12V / STK11 co-mutated NSCLC adenocarcinoma that progressed on carboplatin, pemetrexed, and pembrolizumab. A2B694 has manageable safety and tolerability in patients with advanced solid MSLN-expressing tumors with tumor-associated HLA-A*02 LOH. The dose-escalation phase continues to enroll patients. All patients exhibited CAR T expansion, and there is an ongoing partial response in a patient with NSCLC."

P1/2 data • Colorectal Cancer • Fatigue • Lung Adenocarcinoma • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • KRAS • MSLN • STK11

EVEREST-2: a phase 1/2 study of A2B694, a logic‑gated Tmod CAR T therapy to treat solid tumors expressing mesothelin (MSLN) with HLA-A*02 loss of heterozygosity: initial safety and efficacy results (SITC 2025) - P | "The patient with KRASG12V/STK11 co-mutated NSCLC who had progressed on carboplatin, pemetrexed, and pembrolizumab achieved a complete response (CR) at D90 post-infusion and had a confirmed CR per RECIST 1.1 by central review at D180. The maximum tolerated dose has not been reached and the dose-escalation phase to determine the RP2D continues.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, NCT06051695Ethics Approval This trial was approved by each site's institutional review board.Abstract 535 Figure 1Request permissionsThe structure of Tmod CAR T cells expressing a MSLN-targeted activator and an..."

Clinical • P1/2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HLA-A • KRAS • MSLN • STK11

Complete Response in a Patient with KRAS/STK11-Mutated NSCLC Treated with A2B694, a Logic-Gated Mesothelin-Targeted Tmod CAR T Therapy to Treat Solid Tumors with HLA-A*02 Loss of Heterozygosity: Initial Safety and Efficacy Results from the EVEREST-2 Study (IASLC-TTLC 2026) - P, P1/2 | "A patient with KRASG12V/STK11 co-mutated NSCLC who had progressed on carboplatin, pemetrexed, and pembrolizumab achieved a complete response (CR) at D90 post-infusion and had a confirmed CR per RECIST 1.1 by central review at D180. We report the first patient with NSCLC to have a CR after CAR T. Overall, A2B694 demonstrated manageable safety and tolerability in patients with advanced solid mesothelin- expressing tumors with tumor-associated HLA-A*02 LOH. The maximum tolerated dose has not been reached and dose-escalation to determine RP2D continues. Figure: A2B694 Levels in Peripheral Blood Over Time (ddPCR) Below not included in word count: Trial registration: ClinicalTrials.gov, NCT06051695 2"

Clinical • First-in-human • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HLA-A • KRAS • MSLN • STK11

A logic-gated chimeric antigen receptor T-cell (CAR T) therapy with an armored, membrane-tethered IL-12 booster in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH): EVEREST-2, a phase 1/2 study. (ASCO 2026) - P, P1/2 | "Early efficacy results include the first ever reported complete response in a patient with non-small cell lung cancer following treatment with a CAR T-cell therapy (A2B694). The phase 1 primary objective is to evaluate the safety and tolerability of A2B543 and identify a recommended phase 2 dose (RP2D). The phase 2 primary objective is to assess overall response rate."

CAR T-Cell Therapy • Clinical • Metastases • P1/2 data • Idiopathic Arthritis • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • HLA-A • IL12A • MSLN

EVEREST-2 Study Arm 1: Efficacy and Safety Update for A2B694 (Businesswire) - "As of January 5, 2026, 13 patients were enrolled in phase 1: eight women and five men, with a median age of 59 years; 11 were non-Hispanic White and two were Hispanic/unknown race. Tumor types included ovarian (n = 3), pancreatic (n = 3), NSCLC (n = 1), colorectal (n = 4), gastro-esophageal (n = 1), and mesothelioma (n = 1). A2B694 dose groups were 1×108 (n = 3), 2×108 (n = 4), 4×108 (n = 5), and 6×108 plus low-dose IL-2 (n = 1) cells...Lymphodepletion prior to administration of A2B694 was well-tolerated by all patients, with expected transient cytopenias...No deaths were attributed to A2B694, and no patient has discontinued the study due to adverse events."

P1/2 data • Colorectal Cancer • Gastroesophageal Cancer • Mesothelioma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

A2 Biotherapeutics to Highlight Progress of CAR T-Cell Clinical Programs in Three Poster Presentations During the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting (Businesswire) - "A2 Bio will present two posters from the ongoing phase 1/2 EVEREST-2 study: The first provides the safety and efficacy of A2B694, a logic-gated mesothelin (MSLN)-targeted Tmod chimeric antigen receptor T-cell (CAR T) therapy. The second is a trials-in-progress poster about A2B543, which uses the same logic-gated construct as A2B694 but also includes a membrane-tethered IL-12 booster. A third poster describes modules based on IL-12 and other molecules that boost potency and preserve selectivity of Tmod-based precision cell therapies."

Clinical data • Trial status • Solid Tumor

EVEREST-2: A seamless phase 1/2 study of A2B694, a logic-gated Tmod CAR T-cell therapy, in patients with mesothelin-expressing solid tumors with human leukocyte antigen-A*02 loss of heterozygosity (AACR 2025) - P, P1/2 | "The first patient was enrolled on EVEREST-2 in April 2024. Dose escalation is ongoing."

CAR T-Cell Therapy • Clinical • First-in-human • IO biomarker • P1/2 data • Colorectal Cancer • Hematological Malignancies • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

EVEREST-2: A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov) - P1/2 | N=474 | Recruiting | Sponsor: A2 Biotherapeutics Inc. | N=230 ➔ 474

Enrollment change • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • HLA-A • MSLN

A2 Biotherapeutics Presents Initial Safety and Efficacy Data from Ongoing Phase 1/2 EVEREST-2 Study, Including First Report of a Complete Response to CAR T-Cell Therapy in a Patient with NSCLC (A2 Bio Press Release) - "A2B694 was detected post-infusion in peripheral blood and showed cell expansion in all treated patients, and was also detected in multiple tumor biopsies. In one patient, A2B694 was detected in a tumor biopsy collected on day 42, but not in the concurrently collected blood sample, demonstrating that A2B694 can infiltrate the tumor microenvironment and persist for weeks, even when undetectable in the peripheral blood."

P1/2 data • Colorectal Cancer • Mesothelioma • Non Small Cell Lung Cancer • Pancreatic Cancer

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 Biotherapeutics…announced the presentation of early efficacy and safety data from the EVEREST-2 study (NCT06051695) during the IASLC 2025 World Conference on Lung Cancer (Businesswire) - "Tumor types included three patients with ovarian cancer; one patient with pancreatic cancer; and one patient with non-small cell lung cancer....Lymphodepletion was well tolerated by all patients, with no clinically significant cytopenias. All patients had at least one adverse event (AE); the most common AEs were decreased appetite (n=3, 1 serious), and fatigue (n=3). There were no dose-limiting toxicities, cytokine release syndrome, or related neurotoxicity, and no new safety signals after 8.9 months of follow-up."

P1/2 data • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

EVEREST-2: Initial data of the logic-gated Tmod chimeric antigen receptor T-cell (CAR T) therapy A2B694 for patients with solid tumors associated with mesothelin (MSLN) expression and with human leukocyte antigen (HLA) loss of heterozygosity (LOH). (ASCO 2025) - P, P1/2 | " As of January 15, 2025, 5 participants (median age: 60 years; range, 50-84) have enrolled on EVEREST-2 and received A2B694 at DLs 1-2; participants had ovarian cancer (n = 3), pancreatic cancer (n = 1), and non-small cell lung cancer (n = 1) and had received a median of 4 prior lines of therapy (range, 1-7). The logic-gated approach was successful at reducing toxicity seen with prior MSLN-targeted CAR T therapies, and A2B694 showed successful CAR T expansion and tumor infiltration. The maximum tolerated dose has not been reached, and results from the dose-escalation phase continue to determine the RP2D."

CAR T-Cell Therapy • Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

EVEREST-2: A seamless phase 1/2 study of A2B694, a logic-gated Tmod chimeric antigen receptor T-cell (CAR T) therapy, in patients with pancreatic cancer (PANC) or other mesothelin (MSLN)-expressing solid tumors and human leukocyte antigen (HLA)–A*02 loss of heterozygosity (LOH). (ASCO-GI 2025) - P, P1/2 | "Two autologous CAR T therapies are currently under investigation: A2B530, targeting carcinoembryonic antigen, in the EVEREST-1 trial, and A2B694, targeting MSLN, in the EVEREST-2 trial, described herein. J Clin Oncol. 2022."

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • HLA-A • MSLN

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

EVEREST-2: a seamless phase 1/2 study of A2B694, a logic-gated Tmod CAR T-cell therapy, in patients with mesothelin-expressing solid tumors with human leukocyte antigen-A*02 loss of heterozygosity (SITC 2024) - P, P1/2 | "a May occur at any point in disease course. CRC, colorectal cancer; D, day; MESO, mesothelioma; NSCLC, non-small cell lung cancer; OVCA, ovarian cancer; PANC, pancreatic cancer; PCLD, preconditioning lymphodepletionDownload figure Open in new tab Download powerpoint Abstract 627 Figure 3 EVEREST-2 phase 1 dose escalation study design"

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Colorectal Cancer • Hematological Malignancies • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

EVEREST-2 Poster Presentation Summary (Businesswire) - "A2 Biotherapeutics...shared progress of its Tmod CAR T-cell clinical programs during the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)....In a poster presentation on November 8, Dr. Molina shared an enrollment update on EVEREST-2 (abstract number 627), a seamless, phase 1/2, open-label, nonrandomized study to evaluate the safety and efficacy of A2B694 in adult patients with solid tumors. EVEREST-2 is the second interventional clinical study sponsored by A2 Bio. The first patient was enrolled in EVEREST-2 in April 2024, and dose escalation is ongoing."

Trial status • Solid Tumor

A2 Bio to Present Safety and Biomarker Data from EVEREST-1 Trial during 2024 Annual Meeting of the Society for Immunotherapy of Cancer (Businesswire) - "A2 Biotherapeutics, Inc...today announced the acceptance of six abstracts for presentation during the 39^th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 8-10, 2024, in Houston....The company will share an oral presentation that details continued progress to enhance the diversity of patients enrolled in its BASECAMP-1 prescreening trial. Additional posters will present safety and biomarker data in the EVEREST-1 trial; continued progress in the ongoing EVEREST-2 clinical trial; and adaptations to boost potency and preserve selectivity of Tmod-based cell therapies."

Biomarker • P1/2 data • Colorectal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

EVEREST-2: A seamless phase 1/2 study of A2B694, a mesothelin (MSLN) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors that show MSLN expression and human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH). (ASCO 2024) - P, P1/2 | "Mol Immunol. 2020."

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatology • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

A2 Bio Highlights Progress of CAR T-Cell Clinical Programs in Three Poster Presentations during the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting (Businesswire) - "A2 Biotherapeutics, Inc...will present updates on three ongoing clinical trials in poster presentations during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. A2 Bio will present two Trials in Progress posters on its first-in-human (FIH) Phase 1/2 studies, EVEREST-1 and EVEREST-2, as well as a poster highlighting how a greater understanding of the structure of Tmod allowed the BASECAMP-1 master prescreening study to increase the ethnic and racial diversity of patients enrolled in its clinical trials....the BASECAMP-1 study population. By expanding enrollment, 16% more Hispanic, 43% more African-American, and 112% more Asian or Pacific Islander patients were identified."

Clinical protocol • Trial status • Oncology • Solid Tumor

A2 Bio Announces First Patient Dosed in EVEREST-2 Phase 1 Clinical Trial of Novel Mesothelin Logic-Gated CAR T (Businesswire) - "A2 Biotherapeutics, Inc...today announced dosing of the first patient in the Phase 1 clinical trial of A2B694. The multi-center Phase 1 dose escalation clinical trial, EVEREST-2...will evaluate safety and determine the recommended dose of A2B694 in patients with solid tumors that express mesothelin, including ovarian, mesothelioma, pancreatic, colorectal and non-small cell lung cancer, and have lost HLA-A*02 expression."

Trial status • Colorectal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A2 Bio to Highlight Progress of CAR T Clinical Programs in Three Poster Presentations at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "A2 Biotherapeutics, Inc...announced the acceptance of three posters for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting May 31-June 4, 2024, in Chicago, Ill. A2 Bio will present two Trials in Progress on its first-in-human Phase 1/2 studies EVEREST-1 and EVEREST-2, and one poster highlighting the BASECAMP-1 master prescreening study protocol’s impact on increasing trial diversity."

Observational data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Rectal Cancer • Solid Tumor

EVEREST-2: A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov) - P1/2 | N=230 | Recruiting | Sponsor: A2 Biotherapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • HLA-A • MSLN

EVEREST-2: A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression (clinicaltrials.gov) - P1/2 | N=230 | Not yet recruiting | Sponsor: A2 Biotherapeutics Inc.

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • HLA-A • MSLN