KMA.CAR T / HaemaLogiX - LARVOL DELTA

HaemaLogiX Announces Major Milestone with First Patient Successfully Dosed with KMCAR T-Cell (PRNewswire) - "Following an initial infusion, the patient demonstrated that the treatment was well-tolerated, with no serious adverse events. A second patient on the trial has now been enrolled and is set to be treated at a higher dose level."

Trial status • Multiple Myeloma

KOALA: Autologous Chimeric Antigen Receptor (CAR) T-cells Targeting the Kappa Myeloma Antigen (KMA) in Kappa Restricted Multiple Myeloma Patients With Relapsed/Refractory Disease (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Peter MacCallum Cancer Centre, Australia | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology

KOALA trial opens to enrol patients for first‑in‑human KMCAR T‑cell therapy (PharmaTimes)

Enrollment open • First-in-human • Multiple Myeloma

A Novel CAR-T cell therapy targeting kappa myeloma antigen for the treatment of multiple myeloma (IMW 2023) - "Chimeric Antigen Receptor (CAR)-T cell therapy has recently entered the standard of care for relapsed and refractory MM, following the recent FDA-approval of two CAR-T cell products, ide-cel® and cilta-cel®, which target the B cell maturation antigen (BCMA)...The monoclonal antibody, KappaMab (MDX-1097), binds to a conformational epitope on KMA, and has been assessed in phase I, IIa and IIb clinical trials in relapse refractory myeloma patients... Our data demonstrates that anti-KMA CAR-T cell therapy is a novel and potent treatment ready to enter a phase I clinical trial for patients with multiple myeloma."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • IFNG

Novel antigens LMA and KMA are expressed on malignant bone marrow plasma cells from patients at all stages of multiple myeloma and in other plasma cell dyscrasias (IMW 2023) - "KappaMab (formerly MDX-1097) clinical trials have confirmed that normal leukocytes are not depleted by the antibody with no on-target off-tumour effects1-3, and preclinical KMA.CAR T cell data has confirmed the antibody specificity4. KMA or LMA are expressed on PCs at all stages of MM, and all plasmacytomas and AL patient samples. The increased Ag densities of both KMA and LMA compared to BCMA on RRMM BM PCs indicates antigen persistence on a treatment resistant clone. The combination of increased and persistent antigen density and the specificity of these therapeutic antibodies could provide a significant benefit in the treatment of myeloma and PCDs.1."

Clinical • IO biomarker • Amyloidosis • Hematological Disorders • Hematological Malignancies • Monoclonal Gammopathy • Multiple Myeloma • Oncology • Plasmacytoma • NCAM1 • PTPRC • SDC1 • SLAMF7 • TNFRSF17

HaemaLogiX and Peter MacCallum Cancer Centre Announce Myeloma CAR-T Phase I Clinical Trial Agreement (PRNewswire) - "Clinical stage Australian biotech company HaemaLogiX Ltd is pleased to announce it has entered into a co-development agreement with the world leading Peter MacCallum Cancer Centre (Peter Mac) to conduct the first in human Phase I trial of HaemaLogiX's CAR-T immunotherapy, KMA.CAR-T, for kappa-type multiple myeloma....Under the agreement, HaemaLogiX brings its patented KappaMab technology to the collaboration with Peter Mac to develop the technology, method of manufacturing and conduct the trial. The proof of concept trial will be conducted initially in six patients, with the possibility of expanding to twelve patients."

Licensing / partnership • New trial • Hematological Malignancies • Multiple Myeloma • Oncology

Cellular immunotherapy targeting kappa myeloma antigen for the treatment of multiple myeloma (AACR 2023) - "Chimeric Antigen Receptor (CAR)-T cell therapy has recently entered the standard of care for relapsed and refractory MM, following the recent FDA-approval of two CAR-T cell products, ide-cel® and cilta-cel®, which target the B cell maturation antigen (BCMA)...The monoclonal antibody, KappaMab (MDX-1097), binds to a conformational epitope on KMA, and has been assessed in phase I, IIa and IIb clinical trials in relapse refractory myeloma patients (1)...We successfully generated human anti-KMA CAR-T cells with high and stable CAR expression and a predominately memory T cell phenotype...(1) Spencer et al. Blood Cancer Journal (2019) 9:58"

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • IFNG

HaemaLogiX to present final data from anti-KMA CAR-T preclinical studies at AACR (PRNewswire-Asia) - "HaemaLogiX Ltd...announced that its anti-KMA CAR-T cell preclinical development has been completed and is the subject of an abstract accepted for poster presentation at the 2023 Annual Meeting of the American Association for Cancer Research (AACR), held 14-19 April in Orange County. HaemaLogiX's CAR-T is being developed to target Kappa Myeloma Antigen (KMA) a myeloma-specific antigen not found on normal cells. The completed preclinical data demonstrates strong proof of concept to support the use of anti-KMA CAR-T cell therapy for the treatment of patients with myeloma."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology