invIOs has secured an Austrian Research Promotion Agency grant to fund up to 45% of its Phase Ib trial for APN401, an autologous cell therapy, for treating solid tumours.
The grant is part of its Austrian Life Sciences Programme 2023 initiative and will be conducted as per the new EU Clinical Trial Regulation.
invIOs is a wholly owned subsidiary of Austria-based Aperion Biologics and focuses on developing cancer therapies using its proprietary EPiC (Enhancement Platform for immune Cells) cell therapy technology platform.
APN401 was developed using the cell therapy platform to target Cbl-b class of proteins, which play an inhibitory role in mediating immune response against cancer cells. The therapy uses the patient’s own peripheral blood mononuclear cells (PBMCs), which are then transfected with short interfering RNA (siRNA) and administered to the patient via an intravenous infusion.
Data from invIOs’s Phase Ia trial demonstrated the feasibility of local manufacturing of APN401 and administering the treatment, all within 24 hours.
Cell therapies are one of the key developmental areas for immuno-oncology drugs, with over 300 candidates in development, as per GlobalData’s assessment.
GlobalData is the parent company of Pharmaceutical Technology.
The Phase Ib clinical trial will evaluate two dosages of APN401 to determine Phase II trial dosage. The recruitment for the trial is already underway with the goal of recruiting up to 12 patients with refractory advanced and metastatic solid tumours.
“This new study aims to show that EPiC can be effective when multiple manufacturing and treatment sites are involved. We look forward to taking this novel, easy-to-administer treatment option to the next phase of development,” said Dr Romana Gugenberger, invIOs’s chief medical and scientific officer.
The trial’s primary endpoint is to define and confirm APN401’s safety profile. The secondary endpoints include measuring overall response rate (ORR), progression-free survival (PFS) and any relevant biomarkers.
Previously presented clinical data for APN401 in two heavily pretreated patients with solid tumours showed disease stabilisation for up to six months.
Austrian Research Promotion Agency is also funding invIOs’ chimeric antigen receptor (CAR)-T cell therapy, INV451, for lung cancer. The therapy is being developed in partnership with Austria-based research institute, Medical University of Innsbruck.
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