ESO-T01 / Pregene Biotech, AstraZeneca - LARVOL DELTA

AstraZeneca's newest CAR-T play shows first glimpse of clinical activity (Firstwordpharma Press Release) - P1 | N=24 | NCT06691685 | "The four patients in the study received a single infusion of ESO-T01 targeting BCMA, at a starting dose of 2.0 × 108 transduction units....Patient 1 achieved a stringent complete response with resolution of all medullary and extramedullary lesions by the second month; Patient 2 also had a stringent complete response, with complete lesion resolution by day 28. Patients 3 and 4 showed partial responses, with reduced tumour lesions and minimal residual disease negativity in the bone marrow by day 28....All patients experienced Grade 1 cytokine release syndrome (CRS), while patient 4, who had the highest tumour burden in the cerebrospinal fluid, developed Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS)."

P1 data • Multiple Myeloma

Engineering T Cell-Specific Lentiviral Vectors for Safe and Effective In Vivo CAR-T Therapy (ASGCT 2025) - "BCMA CAR-T cells generated using VSV-GI331E TCRαβ VHH ENaBL-T (referred to as ESO-T01) exhibited potent antitumor activity in vitro against target tumor cells. ENaBL-T represents a promising step toward the clinical translation of cost-effective, scalable, and safe in vivo CAR-T cell therapies. Disease Focus of Abstract:Cancer Hematologic"

IO biomarker • Preclinical • Viral vector • Hematological Malignancies • Oncology • CD8

ENaBL, a Novel Lentiviral Vector Platform for In Vivo Engineering of Therapeutic Anti-BCMA CAR T Cells, Shows Effective T Cell Transduction and Tumor Control in a Humanized Murine Model (ASGCT 2025) - P1 | "Chimeric antigen receptor (CAR) T-cell therapies have transformed treatment for B-cell malignancies, though their availability is restricted by manufacturing limitations, logistical demands, long waiting time and high cost of treatment. We have successfully manufactured ENaBL-T encoding a clinically validated BCMA CAR construct (referred to as ESO-T01) at clinical scale using adherent fixed bed bioreactor and first in human testing was initiated in 4Q2024 (NCT06691685). Disease Focus of Abstract:Cancer Hematologic"

CAR T-Cell Therapy • IO biomarker • Preclinical • Viral vector • Hematological Malignancies • Multiple Myeloma • Oncology • CD34 • CD8

EsoBiotec to Present Preclinical Proof-of-Concept Data for Its Off-the-Shelf ENaBL In Vivo Cell Therapy Platform at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (GlobeNewswire) - "EsoBiotec...today announced that it will present pre-clinical proof of concept data validating the company’s T cell targeting Engineered NanoBody Lentiviral (ENaBL) vector, ENaBL-T, for in vivo CAR-T cell therapies. Data from three approved abstracts will be presented as posters at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, taking place in New Orleans, Louisiana, from May 13-17, 2025....Our T cell-targeting ENaBL vector incorporates unique engineering features that we believe are key drivers of the encouraging early clinical activity observed in patients with relapsed or refractory multiple myeloma treated at the lowest dose of ESO-T01. Initial clinical data from this trial are expected to be released in the second half of 2025."

Clinical data • Multiple Myeloma

A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Chunrui Li | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Chunrui Li

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Chromatin Bioscience's synthetic promoter supports EsoBiotec's ESO-T01 CAR-T therapy as it enters the clinic (PRNewswire) - "Chromatin Bioscience is pleased to announce its ongoing collaboration with EsoBiotec, which has successfully advanced its ESO-T01 in vivo CAR-T candidate into clinical trials. ESO-T01 is the first in vivo B-cell maturation antigen (BCMA) CAR-T candidate to reach the clinical stage and utilises a synthetic promoter designed using Chromatin Bio's proprietary promoter design platform, chromatinLENS, exclusively for EsoBiotec as part of its innovative approach to immunotherapy. EsoBiotec's ESO-T01, developed using its ENaBL platform, is a T cell targeted lentiviral vector expressing a BCMA-targeted CAR construct for the treatment of multiple myeloma."

Licensing / partnership • Multiple Myeloma

EsoBiotec Doses First Patient in Investigator Initiated Trial of In Vivo BCMA CAR-T Candidate ESO-T01 for Multiple Myeloma (GlobeNewswire) - "EsoBiotec SA...today announced the first patient has been dosed in an investigator-initiated clinical trial in China of ESO-T01 for relapsed/refractory multiple myeloma. ESO-T01 is an immune shielded lentiviral vector that specifically reprograms T lymphocytes in vivo into highly effective BCMA CAR-T cells....Initial clinical observations with ESO-T01 indicate a favorable safety profile and promising efficacy already at the first dose level of 0.25E+09 transducing unit per patient, with pharmacokinetic characteristics comparable to autologous ex vivo CAR-T therapies....We look forward to sharing initial clinical data in the second half of 2025."

P1 data • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Wuhan Union Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

EsoBiotec Begins Clinical Trial of In Vivo BCMA CAR-T Candidate ESO-T01 for Multiple Myeloma (GlobeNewswire) - "EsoBiotec SA...announced the launch of an Investigator-Initiated Clinical Trial (IIT) in China of ESO-T01, an immune shielded lentiviral vector that reprograms T lymphocytes in vivo into highly effective BCMA CAR-T cells, for the treatment of multiple myeloma....The proof-of-concept, first-in-human IIT is underway and initial clinical data are expected to be presented in the second half of 2025."

P1 data • Trial status • Multiple Myeloma

A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma. (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology