AVC-101 / AvenCell Therap - LARVOL DELTA

Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: AvenCell Europe GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • 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

Updated Results from a Phase I Dose Escalation Study of the Rapidly-Switchable Universal CAR-T Therapy UniCAR-T-CD123 in Relapsed/Refractory AML (ASH 2023) - "Repeated dosing of TM in consolidation cycles resulted in robust re-expansion of UniCAR-T with deeper remissions of extended durability. The switchable mechanism provides proven rapid reversal of safety events, enabling higher dose levels."

IO biomarker • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Transplantation • CD123 • IL3RA • NPM1

Dose-escalating Trial With UniCAR02-T Cells and CD123 Target Module (TM123) in Patients With Hematologic and Lymphatic Malignancies (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: AvenCell Europe GmbH | N=45 ➔ 90 | Trial completion date: Jun 2023 ➔ Sep 2025 | Trial primary completion date: Dec 2022 ➔ May 2025

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Phase 1 Dose Escalation Study of the Rapidly Switchable Universal CAR-T Therapy Unicar-T-CD123 in Relapsed/Refractory AML (ASH 2022) - "Standard fludarabine/cyclophosphamide lymphodepletion was given on day -5 to -3 prior to treatment start. No clear correlation was observed between treatment effect or toxicity and cell or TM dose, respectively. The observed effects warrant further investigation and an expansion cohort will be implemented at dose level 16."

IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD123

AvenCell Presents Safety and Efficacy Data from Lead CD123-Directed Universal CAR T Cell Therapy Program at ASH 2022 Meeting (Businesswire) - P1 | N=45 | NCT04230265 | Sponsor: AvenCell Europe GmbH | "AvenCell Therapeutics, Inc...announced updated safety and efficacy data from its lead CD-123-directed Universal CAR T Cell Candidate ('UniCAR')....The oral presentation (#979) included updated data from the first-in-human phase I dose escalation study of AVC-101 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) designed to assess safety and tolerability and identify an MTD. Secondary and exploratory objectives include efficacy, biological activity, and PK....The presentation reports results from 16 heavily pre-treated R/R AML patients with a median of six prior lines of therapies (min-max: 2-9 lines), with nine patients having received a prior allogeneic hematopoietic stem cell transplantation. Median age of patients was 64.5 (range 18-80), with four patients over the age of 70."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

AvenCell to Present New Data from Lead Universal CAR T Cell Therapy Program at 64th American Society of Hematology Annual Meeting and Exposition (Businesswire) - "AvenCell Therapeutics, Inc. announced today that expanded data from its leading Universal CAR T Cell ('UniCAR') Therapy program will be revealed in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting....This presentation will include updated data from the first-in-human phase 1 dose escalation study of AVC-101 in patients with R/R AML, designed to assess safety and tolerability and identify an MTD. Secondary and exploratory objectives include efficacy, biological activity and PK. The abstract reports results as of July 7, 2022 for 14 heavily pre-treated R/R AML patients with a median of three prior lines of therapies (min-max: 1-7 lines), and four patients had received a prior allogeneic hematopoietic stem cell transplantation."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Dose-escalating Trial With UniCAR02-T Cells and CD123 Target Module (TM123) in Patients With Hematologic and Lymphatic Malignancies (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: Cellex Patient Treatment GmbH; Trial completion date: Apr 2022 ➔ Jun 2023; Trial primary completion date: Feb 2022 ➔ Dec 2022

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

[VIRTUAL] Expansion kinetics and cytokine profiles of UniCAR-T-CD123, a rapidly switchable two-component CAR-T therapy, in patients with relapsed/refractory AML (AACR 2021) - "The initial clinical and translational results of UniCAR-T-CD123 represent, to our understanding, a first time evidence for a well-tolerated and effective rapidly switchable CAR-T product. Even though the number of patients treated so far is limited, the data obtained provide clinical proof-of-concept for the opportunity to abrogate side effects by withdrawal of TM123. Enrollment into the Phase IA study is ongoing."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Oncology • CD123 • CSF2 • IFNG • IL2 • IL6 • TNFA

GEMoaB Announces Publication of Clinical Data From Ongoing Phase I Study of Their Lead Asset UniCAR-T-CD123 in Relapsed/Refractory AML in "Blood" (PRNewswire) - P1, N=45; NCT04230265; Sponsor: Cellex Patient Treatment GmbH; "GEMoaB...announced the publication of clinical data obtained from the ongoing Phase I study of their rapidly switchable UniCAR platform lead asset, UniCAR-T-CD123, in relapsed/refractory acute myeloid leukemia (rrAML), in the journal 'Blood'...demonstrate that UniCAR-T-CD123 in rrAML is well-tolerated with rapid recovery of hematopoiesis and encouraging early efficacy."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Proof-of-concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML. (PubMed, Blood) - No abstract available

Journal • Acute Myelogenous Leukemia

GEMoaB Announces Clinical Data Presentations on Their Lead Asset UniCAR-T-CD123 in relapsed/refractory AML at the Upcoming EHA-EBMT 3rd European CAR T-Cell Meeting (PRNewswire) - "GEMoaB...announced the acceptance of two presentations on clinical data from the ongoing Phase I study...at the 2021 EHA-EBMT 3rd European CAR T-Cell Meeting, being held from February 4-6...The UniCAR platform promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors...A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123, for the treatment of relapsed/refractory AML, is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors, has been initiated."

P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

GEMoaB Announces Presentation of Translational Data From Ongoing Phase I Clinical Study of Their Lead Asset UniCAR-T-CD123 in Relapsed/Refractory AML at the Upcoming 2021 AACR Annual Meeting (PRNewswire) - P1, N=45; NCT04230265; Sponsor: Cellex Patient Treatment GmbH; "GEMoaB...announced the acceptance of a presentation on translational data obtained from their ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the 2021 AACR Annual Meeting, being held from April 9-14....The data of UniCAR-T-CD123 in rrAML provided as poster presentation at the AACR congress highlight key features of GEMoaB's rapidly switchable universal CAR-T platform UniCAR and focus on expansion kinetics, cytokine profiles and UniCAR-T persistence in heavily pre-treated rrAML patients."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

GEMoaB Announces UniCAR-T-CD123 Data from its Ongoing Phase I Study in Patients with Relapsed/Refractory AML (rrAML) to be Presented at Virtual 3rd EHA-EBMT European CAR T-Cell Meeting (PRNewswire) - P1, N=45; NCT04230265; Sponsor: Cellex Patient Treatment GmbH; "GEMoaB...announced interim data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the Virtual 3rd EHA-EBMT European CAR-T-Cell Meeting, which is held from February 04-06, 2021...UniCAR-T-CD123 has been well tolerated to date with CRS (cytokine release syndrome) grade 1-2; no ICU admissions or dose limiting toxicities have been observed by the cut-off date; UniCAR-T-CD123 dose escalation is ongoing....Phase IA dose-finding studies of the first UniCAR assets UniCAR-T-CD123 in hematological malignancies and UniCAR-T-PSMA in solid tumors are currently recruiting patients."

Cytokine release syndrome • Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

[VIRTUAL] More than a bridging therapy: Targeting CD123 with rapidly switchable universal CAR-T cells for treatment of acute leukemia (AACR-II 2020) - "In summary, in vitro and in vivo evidence suggests that UniCAR-T-CD123 could provide strong efficacy against CD123 expressing hematological malignancies while providing excellent control and ensuring recovery of normal hematopoiesis post treatment. A phase IA dose-finding study is ongoing."

CAR T-Cell Therapy • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123

GEMoaB announces first patient apheresed in a phase ia study with lead product candidate from rapidly switchable universal CAR-T platform (UniCAR) in CD123 positive relapsed/refractory acute leukemias (PRNewswire) - "GEMoaB...announced that it has apheresed the first patient in a Phase IA study with UniCAR-T-CD123...UniCAR-T-CD123 is investigated in late stage, relapsed/refractory Acute Leukemias expressing the CD123 antigen....UniCAR-T-PSMA against CRPC and other PSMA-expressing late-stage solid tumors, is planned to be tested in a Phase I study initiated by H2 2020."

CAR T-Cell Therapy • Enrollment open • New P1 trial