Galena Biopharma (GALE) Announces Presentation of GALE-301, GALE-302 Data at ASC Clinical Congress 2016

October 20, 2016 7:07 AM EDT

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Galena Biopharma, Inc. (Nasdaq: GALE) announced that Dr. Doreen Jackson delivered a podium presentation on Galena’s GALE-301 and GALE-302 clinical program at the American College of Surgeons Clinical Congress 2016 in Washington, D.C. GALE-301 (E39) and GALE-302 (E39’ – variant of E39) are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. The Phase 1b is a single-center, randomized, single-blinded, three-arm study in patients with breast or ovarian cancer diagnosis who were treated with standard of care and were without evidence of disease. This trial augments the Phase 1/2a trial with single-agent GALE-301 in ovarian and endometrial cancers.

The presentation is entitled, “A Phase Ib Trial Comparing Different Doses/Schedules of a Folate Binding Protein (FBP)-derived Peptide Vaccine, E39, and its Attenuated Version, E39’, to Induce Long-term FBP-specific Immunity in Disease-free Cancer Patients.” In this trial, which enrolled mostly breast cancer patients, who have lower FBP exposure than ovarian patients, the 500mcg dose appears to provide a more optimal immunological response. This differs from the results in ovarian cancer patients, who have much higher FBP expression, with potential secondary immune tolerance, where 1000mcg was the optimal dose. However, E39’ (GALE-302) given after E39 (GALE-301) was able to induce long-term immunity in both dosing cohorts, underscoring the potential importance of attenuated peptides in relatively antigen-naïve patients.

In the patients who received 500mcg of peptide (n=14), delayed-type hypersensitivity (DTH), but not E39-specific cytotoxic T-lymphocytes (CTLs), increased at 1- and 6-months post-primary vaccine series (PVS)(p=0.03 for both). No differences were seen in the patients (n=16) who received 1000mcg of peptide. Comparing the 3 arms in patients who received 500 mcg dosing, only the patients who received E39 followed by E39’ showed increased DTH at 1-month (p=0.013) and 6-months (p<0.0001). In the patients with this same schedule who received 1000mcg of peptide, at 6-months they saw increased DTH (p=0.02) and CTLs (p=0.046). There were no clinicopathologic differences or toxicities greater than grade 2 seen in any of the doses or schedules.

“Similar to the FBP expression levels presented earlier this month from the GALE-301 clinical trial, this GALE-301/GALE-302 data on dosing and treatment schedules is extremely valuable as it highlights the potential utility of the vaccine in different cancer indications as we plan the next path forward for our clinical program targeting FBP,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “This data adds to the body of science for the vaccine and is instrumental in understanding the interaction of our peptides in the treatment landscape. Importantly, the immunologically active doses of the vaccine targeting FBP seem to vary between the breast and ovarian patient populations, and may reflect the implication of the level of FBP expression on the cells. We may consider the use of an attenuated version of this peptide in patient populations with lower FBP expression, since the potency of the FBP vaccine could lead to T-cell burn-out in patients over time.”

Dr. Nejadnik continued, “We would like to congratulate Dr. Jackson who was given an award for ‘Excellence in Research’ by the American College of Surgeons for her work on this program. And, we look forward to her poster presentation in December at the San Antonio Breast Cancer Symposium where she will be providing additional data from this trial in breast cancer patients.”

HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care and without evidence of disease, regardless of FBP expression level. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm (n=14) and 250mcg GM-CSF + 1000mcg of peptide in the second five patients (n=16). Delayed-type hypersensitivity (DTH) and E39-specific CTLs were assessed at one and six months post-PVS. Thirty-nine patients were randomized into three arms with 30 breast (n=27) or ovarian (n=3) cancer patients completing the PVS and assessed for this presentation:

  • E39 (GALE-301) x 6 inoculations (n=10)
  • E39 (GALE-301) x 3 inoculations followed by E39’ (GALE-302) x 3 inoculations (n=10)
  • E39’ (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=10)


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