A couple of weeks after Tocagen nabbed the FDA’s breakthrough therapy designation for a new treatment for recurring brain cancer, the San Diego-based biotech is trying its hand at an $86 million IPO.
The biotech has gathered some Phase I results for a therapy dubbed Toca 511 & Toca FC. Toca 511 uses a vector to deliver a gene therapy to cancer cells in the brain which converts Toca FC into the cancer agent 5-FU. When it kills cancer cells, they release antigens that then spark an immune response to help amp up the effect of the therapy, according to the company’s S-1.
The Phase I open label study recruited 126 patients, and Tocagen used a snapshot of one group in that study – 43 patients – who demonstrated an average 12.4 month overall survival rate that was 4 months better than the historical control investigators offered for comparison. Subsets and historical controls aren’t ideal, but Phase I dose-escalation studies are rarely ideal.
The biotech recently finished enrolling the Phase II portion of a Phase II/III study to see if it can replicate that result from Phase I. And they plan to try for an accelerated approval with the FDA on mid-stage results.
Cue pages of risk factors related to developing new drugs in general and brain cancer remedies in specific.
Tocagen has been a low-profile player in the biotech business. And it burned through $128 million to get to where it is today, at one point taking an $18 million loan to cover costs. If it can succeed with the IPO in another muted year for new offerings, the biotech plans to trade as $TOCA.
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