Aduro nabs FDA 'breakthrough' nod for pancreatic cancer vaccine combo

Aduro CEO Stephen Isaacs

Aduro BioTech's GVAX, a cancer vaccine previously halted in the clinic, is finding new life in a combination treatment that the Berkeley-based company is testing in patients with pancreatic cancer. With a grim overall 5-year survival rate of about 6%, pancreatic cancer has long remained one of the toughest targets in the oncology field.

Aduro was granted a coveted breakthrough therapy designation from the FDA for the combo approach, made up of its CRS-207 and GVAX, which it acquired from Biosante ($BPAX) last year.

The designation was awarded based on findings from a Phase II trial in metastatic pancreatic cancer patients. In a randomized study of 93 patients who failed or refused prior therapy, patients receiving the combination of GVAX Pancreas and CRS-207 cancer vaccines lived 6.1 months compared to those receiving GVAX Pancreas vaccine alone, who lived 3.9 months.

"This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat," Aduro President and CEO Stephen Isaacs said in a company statement. 

GVAX has passed through several hands since it was first developed by San Francisco-based Cell Genesys, which ran into trouble after a 2008 trial of GVAX was halted. Trial data revealed a higher number of deaths among subjects given the drug rather than another treatment. The trial did not bode well for the company's plans to continue the vaccine's development, and soon after, Cell Genesys was taken over by BioSante in 2009.

But GVAX's previous failure seems of little consequence to Johnson and Johnson Innovation center, which inked a licensing deal in May with Aduro to gain exclusive rights to the GVAX technology--which is based on human cancer cell lines that are genetically modified to secrete a specific kind of immune-stimulatory cytokine.

Also in May, Johnson & Johnson nabbed the rights to ABU-741--designed to boost T-cell attack specifically engineered for the treatment of prostate cancer.

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