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Gradalis Releases New Clinical Data on Cancer Vaccine

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Gradalis this week announced interim data from a phase II trial of its personalized cancer vaccine, dubbed FANG, showing that the therapy elicits an immune response and delays time to disease recurrence in advanced-stage ovarian patients by more than a year compared with those receiving standard of care.

FANG expressed the immunostimulator recombinant human granulocyte-macrophage colony-stimulating factor, which stimulates the immune system. It also expresses bi-functional shRNAs against furin, an enzyme responsible for lysing the components of the protein TGF-beta that are involved in cellular proliferation and differentiation.

According to the company, the trial has enrolled 17 patients with stage IIIc or stage IV ovarian cancer. Twelve patients received FANG plus the standard treatment of tumor removal and chemotherapy. The other five patients received only standard therapy.

At the time of the interim analysis, a positive tumor immune response as measured by enzyme-linked immunospot analysis was observed in 71 percent of those receiving FANG, Gradalis said. “The mean time to recurrence from start of treatment for patients receiving FANG was 470 days and growing, more than 140 percent longer than the group receiving standard of care, which had a mean time to recurrence of 193 days.”

There were no adverse events reported with FANG treatment.

"In this study of women who otherwise have a very poor prognosis, we are seeing a significant delay of recurrence in the FANG treatment group which is increasing daily," Minal Barve, the lead investigator on the study, said in a statement.

Gradalis also released the findings of a follow-up analysis of 32 patients with various late-stage cancers who were enrolled in a phase I trial of FANG. The results showed a median survival of 562 days compared to 86 day median survival for the 23 patients who met study inclusion criteria but elected to undergo other treatment options.

“Based on an analysis of risk factors derived from a database of 1,181 patient assessments from the MD Anderson Clinical Center, the expected survival for patients enrolled in the FANG clinical study was between 6.2 and 8.4 months,” the company said. “Treatment with FANG therefore more than doubled overall survival time to 18.7 months for patients with very advanced cancer who had an otherwise poor prognosis.”

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