HaemaLogiX announces results of collaboration with CellVec

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HaemaLogiX has contracted CellVec, a Singapore-based CDMO that specialises in the development and manufacture of clinical grade lentiviral vector (LV), to manufacture and test the first batch of LV.KMA.CAR for use in in vitro and in vivo studies. CellVec’s LV technology is based on those previously used in clinical studies and was shown to be safe and effective in children with acute lymphoblastic leukaemia (ALL) and in infant B-cell ALL patients (1,2).

CellVec’s proprietary LV platform process has been developed to achieve enhancement in titre, purity and yield. Its newly completed GMP facility is the first in the region to attain PIC/S GMP certification for the manufacture of LV as active pharmaceutical ingredient (API).

HaemaLogiX is an immune-oncology development company researching immune-based treatments that target novel antigens on malignant B cells. The current CAR T cell therapy in development at HaemaLogiX aims to target multiple myeloma, which is an incurable malignancy of bone marrow plasma cells. Treatment with currently approved monoclonal antibodies does not eliminate the myeloma tumor, hence relapses ultimately occur.

In multiple myeloma, the malignant plasma cells secrete either a kappa or lambda light chain restricted monoclonal paraprotein. In addition, myeloma cells express either the kappa myeloma antigen (KMA) or lambda myeloma antigen (LMA) on their cell surfaces. The unique target of our KMA.CAR T cell therapy is KMA on the malignant plasma cells. KMA.CAR T cell therapy offers potential advantages in treating relapsed refractory multiple myeloma because the antigen is specific to the malignant plasma cells and is not found on normal immune cells or organs. In addition, these tumor-directed cytotoxic T cells are able to home to the bone marrow, and may engage to eliminate the malignant plasma cells plus survive in the long term.

CellVec has successfully manufactured a pilot KMA.CAR construct batch for use in in vitro and in vivo studies in Australia. Next steps will include the verification of the CAR T functional activity and evaluating the effectiveness of the KMA.CAR T in vivo.

1. Ghorashian, S., Marijn Kramer, A., Onuoha, S., et al. (2019). Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR. Nat. Med. Sep;25(9):1408-1414. doi: 10.1038/s41591-019-0549-5. Epub 2019 Sep 2.

2. Qasim, W., Zhan, H., Samarasinghe, S., et al. (2017). Molecular remission of infant B-ALL after infusion of universal TALEN gene-edited CAR T cell. Sci Transl Med. Jan 25;9(374):eaaj2013. doi: 10.1126/scitranslmed.aaj2013.

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