TVAX Biomedical is actively raising $15m to finance a Phase II registrational study of its glioblastoma multiforme (GBM) candidate TVAX Immunotherapy, CEO Wayne Carter said. The company aims to close the round within 60 days, he added.
The Olathe, Kansas-based company has lined up a number of secondary investors but is still seeking a lead investor, possibly a venture capital firm or family office, to contribute approximately $5m–$8m before closing the round, Carter said.
The current financing round will likely be followed by a final fundraising round or an initial public offering, although the precise details and timeline are yet to be determined, Carter noted. The company has also considered a special purpose acquisition company or a reverse merger as potential future exit strategies, he said. TVAX has raised around $12m in previous fundraising, he added.
The upcoming Phase II will be an unblinded study enrolling 96 patients, with half receiving standard of care (SOC) and half receiving SOC plus the immunotherapy, Carter said. Based on discussions with the FDA, TVAX selected overall survival as the primary endpoint and progression-free survival as a secondary endpoint, he added.
The trial is set to begin shortly after the ongoing financing round closes, Carter said. TVAX Immunotherapy received Fast Track Designation and Orphan Product Designation from the FDA, and the company expects the trial to begin in 2021, according to a 9 December company press release. The clinical team is already in place for the trial, so TVAX is not seeking CRO pitches for this trial, Carter added.
TVAX Immunotherapy is an adoptive T cell therapy in which patients have their cancer surgically removed to develop an individualised cancer vaccine, Carter explained. The vaccine primes their immune system to the neoantigens expressed by the cancer, and after two vaccinations, T cells are collected from the patient’s blood by leukopheresis, he added. These T cells are then activated and expanded before being infused back into the patient to kill their cancer cells, he said.
William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.