Initial Results From the Folate Binding Protein Vaccine Phase 1 Trial
Galena Biopharma Announces Initial Results From the Folate Binding Protein Vaccine Phase 1 Trial at the Society for Immunotherapy of Cancer Conference
Galena Biopharma 6 minutes ago
•Folate Binding Protein (FBP) shown to be safe and immunogenic in its Phase 1 trial
•Phase 2a trial expected to initiate by year end
PORTLAND, Ore., Nov. 11, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) Conference 2013 on November 7-10, 2013, in National Harbor, Maryland. The data presented are the results of the Phase 1 portion of the trial for the Folate Binding Protein (FBP) vaccine. FBP is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.
The poster presentation entitled "Phase 1 Trial Results of a Folate Receptor Alpha-directed Cancer Vaccine (E39) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence," showed that the FBP vaccine is both safe and immunogenic. The primary outcome of the Phase 1 trial was to determine safety and the optimal dose, with a secondary outcome to look for an initial efficacy signal and immunological response. The optimal dose was determined to be 500 mcg peptide combined with 250 mcg GM-CSF. FBP proved to be well tolerated, with largely Grade 1 toxicities, primarily consisting of injection site reactions. After a median follow-up of six months, there have been 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrence
After a median follow-up of six months, there have been 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group, although the trial was not powered for any efficacy measurements.
"New approaches are needed for ovarian and endometrial cancer patients who face a high risk of disease recurrence. The initial results from the Phase 1 trial show that the FBP vaccine may be a potential cancer immunotherapy treatment to prevent recurrence in these high risk patient populations," concluded Dr. Erika J. Schneble, San Antonio Military Medical Center, San Antonio, TX who presented the results at the SITC conference.
The Phase 1 component was a 3x3, dose-escalation, safety trial enrolling disease-free endometrial and ovarian cancer, HLA-A2 positive patients into the vaccine group, while HLA-A2 negative patients were being followed prospectively as an untreated control group. Six monthly intradermal inoculations of either 100mcg, 500mcg, or 1000mcg of peptide vaccine + 250 mcg GM-CSF immunoadjuvant were administered during the primary vaccine series. Immunologic responses were assessed by both local reaction after each inoculation and by delayed-type hypersensitivity (DTH) reaction measured pre-vaccination and after the primary vaccine series. Recurrences are determined clinically. Thirty-one patients were enrolled in the Phase 1 trial: 15 in the vaccine group and 16 in the active control group. There were no significant differences in age, grade, stage, or nodal status between groups. Overall, the vaccine was well tolerated with the majority of local and systemic toxicities Grade 1 (maximum local toxicity: 93% Grade 1; maximum systemic toxicity: 60% Grade 1). Local skin reactions increased from the first to the third injections, and then plateaued for the remainder of therapy.
The vaccine appears to pass the safety threshold. The immune response profile of 2 recur vs 4 recur in the control group may not mean too much at phase 1. Hope to hear more during phase 2 when the dosing plan is established.