Northwest Biotherapeutics' previous fundraising effort raised $27m (EUR19m) which funded an ongoing Phase III study of it dendritic cell-based vaccine, DCVax, in 312 patients with newly diagnosed Glioblastoma multiforme (GBM).
CEO Linda Powers told BioPharma-Reporter the new funding will “greatly expand production capacity” and will help the company to contract out manufacturing to Cognate Bioservices to supply the whole European market.
She explained that the plan is to increase capacity to support early access programs in the US and Europe, as well as commercialization if the vaccine goes on to win regulatory approval.
Production process
The DCVax production process has changed considerably since the technology was first developed according to Powers, who explained that 10 years ago it took about five months to manufacture product whereas today it takes just eight days to make a batch which provides between three and five years of doses per patient.
“Each dose is put in separate vials and frozen,” and the company has already validated the shelf life and potency of the frozen doses with regulators, she said.
This is the big difference “between us and Provenge [which is manufactured by Denderon] – when they do a run, they only produce one month of treatment for that patient,” she added.
She also said the company already has established manufacturing elsewhere in Germany with Fraunhofer IZI, as well as through a partnership with King’s College in the UK.
“Today it’s a smooth manufacturing process after a decade of honing the manufacturing technology for this,” Powers said.
Medical need
GBM is the most aggressive and lethal form of brain cancer, and is considered an “orphan disease.”
The Phase III trial, which has sparked some negative media for having a primary endpoint of progression free survival, is being run at 50 sites in the US, as well as in England and the company is about to start in Germany after being approved by the regulator there.
Powers explained that the progression free survival endpoint does not fall short of FDA's approval standards for therapies addressing newly diagnosed GBM patients. She noted that the company only has to show a six month difference between treatment and standard of care arms of the trial, which is significantly less than the nearly 1.5 years survival that the company showed in its Phase I/II study.
The company is also conducting a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. NW Bio previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.