Galena Biopharma, Inc. (GALE) Data From Phase Ib Trial Of FBP Peptide Vaccine Is Very Encouraging

Aug. 01, 2013 2:11 PM ETSLS
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As biopharmaceutical company Galena Biopharma continues the dose escalation Phase Ib trial of its FBP peptide vaccine, positive data have been reported from the first 20 enrolled patients.

Similar to the company's NeuVax vaccine for breast cancer, the FBP vaccine provides a key peptide that is recognized by T-cells, driving an immune response against cancer cells. Galena has observed a 59.3% reduction so far in ovarian cancer recurrence rates among patients who have received the vaccine.

Based on the same technology as NeuVax, which is Galena's lead Phase III product candidate and a vaccine for Her2 1/2+ breast cancer, the FBP vaccine provides an immunogenic peptide (E39 peptide of folate binding protein) that is presented by dendritic cells to T-cells specifically in patients who express the human leukocyte antigen-A2 (HLA-A2). This study will enroll approximately 60 patients who have either ovarian or endometrial cancer, and the patients will be tested for their HLA-A2 status. Those testing HLA-A2+ will be randomized to receive, in six monthly intradermal injections, one of three doses of the E39 peptide (100/500/1,000 mcg) plus 250 mcg GM-CSF, which is an immune-activating adjuvant. Together, the peptide and GM-CSF are referred to as the "FBP vaccine." As a control, HLA-A2- patients will be followed as matched cohort controls, but these patients will not receive any additional therapy aside from standard of care. The Phase Ib trial's primary endpoint is to determine safety and dose-limiting toxicities.

Data from the first 20 patients enrolled in the trial show that patients receiving the FBP vaccine have a lower disease recurrence rate - 11.1% contrasted with the 27.3% recurrence rate among patients that did not receive the vaccine. This represents a 59.3% reduction in disease recurrence.

For 36 months, patients will be followed for disease-free status. Throughout the trial, all patients are being monitored for vaccine activity markers, including the telling "DTH" response, which is a swelling at the injection site, and T-cell activity; both have been observed to correlate with survival in patients vaccinated with NeuVax.

These data from the trial are an early glimpse of the FBP vaccine's overall impact, as the trial is presently only one-third enrolled. The company, however, views these preliminary results as very encouraging indicators that the vaccine will continue progressing in clinical development and likely show a trend toward effectiveness.

Though these data represent only an upside to Galena's projections at this point, the company considers these positive preliminary results to be a validation of its vaccine approach. As Galena has seen with NeuVax, highly immunogenic peptide vaccines can stimulate strong immune responses, which may prevent the recurrence of cancer.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit

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