On August 16, 2022 Prescient Therapeutics (ASX: PTX), a clinical stage oncology company developing personalised cancer therapies, reported that it has entered a manufacturing services agreement with specialist cell therapy manufacturer, Q-Gen Cell Therapeutics (Q-Gen), to produce its OmniCAR cell lines for upcoming clinical trials, with initial work now commenced (Press release, Prescient Therapeutics, AUG 16, 2022, View Source [SID1234618443]).
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As Prescient advances the development of its next-generation OmniCAR programs for acute myeloid leukemia (AML); Her2 positive solid cancers and glioblastoma multiforme, the encouraging progress of the OmniCAR AML program makes it likely be the first OmniCAR program to enter clinical studies.
Manufacturing will take place at Q-Gen’s dedicated Brisbane facility, which produces autologous and allogeneic cell therapies for local and international pharmaceutical companies and academic research groups. Q-Gen is the cell therapy manufacturing arm of the QIMR Berghofer Medical Research Institute and is one of Australia’s leading producers of cell-based medicines. Prescient has commenced the technology transfer process for OmniCAR-T cell manufacturing.
CAR-T therapies involve isolating T cells from a cancer patient and inserting new genetic material into them so that they express a new chimeric antigen receptor capable of recognising cancer cells, before being re-infused into the patient. By contrast, OmniCAR T cells will express a universal immune receptor (SpyCatcher), which can bind with any separate SpyTagged targeting ligand. Thus, OmniCAR cells can potentially address any cancer by incorporating binders to any cancer antigen. This modularity also enables other important and novel characteristics to overcome limitations faced by conventional CAR-T therapies, including post-infusion control of T cell activity and antigen re-direction.
This agreement with Q-Gen covers production and delivery of autologous OmniCAR-T cells for clinical trials. Material conditions of the contract include transduction of T cells with SpyCatcher lentivirus; arming of OmniCAR T cells with SpyTagged binders; and associated quality measures. This agreement will also incorporate CellPryme-M into the manufacturing process of OmniCAR T cells. The agreement lasts up to 5 years, with provision for earlier cessation or extension as per typical commercial terms.
Q-Gen’s General Manager, Andrew Masel, commented "We are excited to be working with Prescient Therapeutics on what we see as a unique cell therapy platform. The team at Q-Gen is looking forward to working closely with Prescient to produce the product for clinical trials here at the QIMR Berghofer Medical Research Institute."
Prescient’s CEO and Managing Director Steven Yatomi-Clarke said, "Prescient is working steadily towards our first in human studies of OmniCAR, which will be an important milestone for the Company. This important agreement secures Prescient’s crucial supply of OmniCAR cells for our clinical trials and ensures we are producing the best possible cell therapy products for doctors and patients living with hardto-treat cancers."
In January Prescient received accreditation by the Office of the Gene Regulator enabling the company to conduct clinical trials in Australia involving gene-edited cells such as OmniCAR.