AVC-201 / AvenCell Therap - LARVOL DELTA

FIRST-IN-CLASS SWITCHABLE ALLOGENEIC CAR-T THERAPY FOR CD123+ AML – RESULTS FROM THE PHASE IA REVSTAR-123 (AVC-201-01) STUDY (EHA 2026) - P1 | "Lymphodepletion (LD) consisted of Fludarabine (Flu) and Cyclophosphamide (Cy) administered over 3 days...One DLT was observed: a Grade 2 IEC-HS (pt #12), successfully managed via on/off switch mechanism, Anakinra, and Dexamethasone...Left: Swimlane, clinical responses of evaluable patients (#1, #3, #6, #9 were inevaluable/drop-outs). Right: RevCAR pharmacokinetics summary, expansion and persistence for all dosed patients, per dose level (n=17)."

CAR T-Cell Therapy • IO biomarker • Late-breaking abstract • P1 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Immunology • CD123 • HLA-B • IL3RA • TP53

AvenCell Therapeutics to Report Phase 1a Results of First-in-Class Switchable Allogeneic CD123 CAR-T Therapy for AML in Late-Breaking oral presentation at EHA 2026 (PRNewswire)

Late-breaking abstract • P1 data • Acute Myelogenous Leukemia

Allogeneic CAR-T therapy AVC-201 in AML positive for CD123 (ASH 2025) - P1 | "AvenCell has previously demonstrated clinicalproof-of-concept using a switchable autologous CD123-directed CAR-T cell product (AVC-101; EudraCT2019-001339-30, NCT04230265), showing rapid mitigation of acute toxicities, effective repeated CAR-T cellexpansion, durable clinical responses, and a favorable safety profile...Lymphodepletion (LD) consists offludarabine and cyclophosphamide for three days... AVC-201 has shown a favorable safety and tolerability profile, with no dose-limiting toxicitiesobserved so far. The RP2D has yet to be established. Repeated administration of the targeting modulehas led to clinically meaningful anti-leukemic activity, including a CRi in a heavily pretreated patient with asignificant disease burden at baseline."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • CD123 • HLA-B • IL3RA

Functional Characterization and Optimization of Switchable Allogeneic Chimeric Antigen Receptor T Cells for Targeting CD19 and CD20 in B Cell Malignancies (ASH 2023) - P1 | "A summary of functional characterization data will be presented at the meeting with a focus on the lack of predictability of certain in vitro models and underlying hypotheses. Insights from these studies are now flowing into preclinical development of a novel switchable allogeneic CAR-T cell product candidate targeting CD19 and CD20 in B cell malignancies engineered to fully overcome graft-versus-host disease as well as graft rejection by host T and NK cells."

CAR T-Cell Therapy • Graft versus Host Disease • Hematological Malignancies • Immunology • Oncology • Transplant Rejection • CD123 • IL3RA

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: AvenCell Europe GmbH | N=37 ➔ 80 | Trial completion date: Jun 2026 ➔ Jan 2028 | Trial primary completion date: Dec 2025 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • IL3RA

AvenCell Raises $112 Million in Series B; Funding Led by Novo Holdings (PRNewswire) - "This latest financing will support ongoing clinical validation of AvenCell's proprietary, switchable universal CAR-T cell therapy platform that generates CAR-T cells that can rapidly be turned 'Off' and 'On' even after they are administered to a patient. The universal platform was developed to more safely and effectively treat a wide range of hematologic malignancies compared to conventional cell therapies. Current clinical assets utilizing AvenCell's universal platform include AVC-101, a highly-differentiated autologous CAR-T cell candidate, and AVC-201, a CRISPR-engineered allogeneic CAR-T cell candidate....In addition, AvenCell has several pipeline candidates entering the clinic over the next two years."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies

Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123 (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: AvenCell Europe GmbH | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Combination therapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • IL3RA

Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123 (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: AvenCell Europe GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • IL3RA

AvenCell Announces First Patient Dosed in a Phase IA Study with lead product candidate AVC-201, a Novel Allogeneic CD123-Directed Switchable CAR-T Investigational Therapy for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia and other CD123 Hematological Malignancies (PRNewswire) - "AvenCell Therapeutics, Inc...today announced that it has dosed the first patient in a Phase IA study with AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125)....The phase 1 study, which includes up to 37 patients, will be conducted at multiple sites in Germany and the Netherlands. The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AvenCell Therapeutics Announces EMA Approval of Clinical Trial Application (CTA) for AVC-201, a Novel Allogeneic CD123-Directed Switchable CAR-T Investigational Therapy for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia and other CD123 Hematological Malignancies (PRNewswire) - "AvenCell Therapeutics...announced that the European Medicines Agency (EMA) has approved the company's Clinical Trial Application (CTA) application for AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125)....The phase 1 study, which includes up to 35 patients, will be conducted at multiple sites in Germany. The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123 (clinicaltrials.gov) - P1 | N=37 | Not yet recruiting | Sponsor: AvenCell Europe GmbH

New P1 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology