Galena Biopharma Inc (NASDAQ:GALE) investors have a smile on their faces Friday morning, after the drug maker announced positive data from the Company’s GALE-301 (E39) investigator-sponsored Phase 1/2a clinical trial. The data was given during an oral presentation by Dr. Larry Maxwell at the Annual Meeting on Women’s Cancer 2017 hosted by the Society of Gynecologic Oncology. The presentation was entitled, “Analysis of a Phase I/IIa Trial Assessing E39+GM-CSF, a Folate Binding Protein Vaccine, to Prevent Recurrence in Ovarian and Endometrial Cancer Patients.” GALE-301 is a cancer immunotherapy consisting 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 ovarian and endometrial cancer patients in the adjuvant setting.
“This final data from our early stage clinical trial demonstrates that GALE-301 is well tolerated and we were able to obtain statistically significant disease free survival in a small number of patients treated with the optimal dose,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “The data also showed a meaningful correlation between delayed type hypersensitivity reactions and clinical outcomes indicating that the vaccine is able to generate an immune response. The results of the trial also reiterate our focus on treating patients with primary disease after their initial standard of care treatment where we believe GALE-301 may provide the most benefit. On behalf of the entire Galena team, we would like to thank Dr. Maxwell and Dr. George Peoples whose work on our immunotherapy vaccines targeting FBP have set the stage for potential future trials to prevent ovarian cancer recurrence.”
The trial began as a dose-escalation Phase 1 trial, transitioning to a Phase 2a comparing expanded dose cohorts with a total of 51 patients enrolled, n=29 in the HLA-A2 positive vaccine group (VG) and n=22 in the HLA-A2 negative control group (CG). Forty patients were enrolled after standard of care treatment of primary disease and 11 patients after treatment of recurrent disease (5 in the VG, 6 in the CG). All patients were disease-free at enrollment. Following administration of vaccine, local and systemic toxicities were mild at the completion of the series with no grade 4 or 5 toxicities, and only 1 patient experienced grade 3 toxicity, with the most common local toxicities being induration at the injection site, erythema, and pruritus. Systemic toxicities for the 1000mcg group did not show any significant difference as compared to the <1000mcg group. The most common systemic toxicities were muscle pain, headache, and fatigue.
The final endpoint for the trial was disease free survival (DFS) after two years, or 24 months. The overall DFS for the VG (n=29) was 50% versus 44% for the CG (n=22)(p=0.594). Importantly, the two-year DFS was significantly higher in the optimally dosed 1000mcg group (n=15) with 77% DFS versus 44% DFS in the CG (n=22) patients (p=0.05). Patients with primary disease who received the 1000mcg dose appear to maintain a statistically significant benefit while those with recurrent disease were not. Given the small number of patients in the recurrence group, this finding needs to be confirmed in a larger trial. In the trial, those patients with a lower expression of FBP performed better with an 86% DFS in the VG (n=8) versus 18% in the CG (n=11), p=0.01. This reiterated our prior analysis that high levels of FBP expression associated with more aggressive disease may outpace the immune response and diminish the therapeutic effects of the vaccine. The correlation between delayed type hypersensitivity (DTH) reactions and clinical outcome was also analyzed. DTH was significantly increased from pre- to post-vaccination in the group receiving the optimal dose of 1000 mcg (p=0.03).
The trial was conducted as a prospective Phase 1/2a trial of E39+GM-CSF to prevent recurrence in disease-free ovarian and endometrial cancer patients at high risk for recurrence after standard of care treatments. Eligible patients included patients with primary or recurrent endometrial, ovarian, fallopian tube, or peritoneal cancer. Once enrolled, HLA-A2 positive patients were inoculated with E39+GM-CSF and HLA-A2 negative patients were followed prospectively as matched controls. The primary vaccination series consisted of six total vaccinations, one given every 21-28 days, and the dose escalation scheme consisted of dosing cohorts of 3 patients each receiving one of the following doses: 100μg, 500μg, and 1000μg in addition to 250μg GM-CSF. Two booster inoculations were given, one every six months. In vivo immune monitoring was assessed using DTH measured pre- and post-vaccination. Patients were monitored for evidence of clinical recurrence every 3 months and the pre-specified intention-to-treat analysis was performed at 12 and 24 months after the last patient was enrolled.
Shares of Galena jumped nearly 20% to $0.75 in pre-market trading Friday. GALE has a 1-year high of $4.75 and a 1-year low of $0.16. The stock’s 50-day moving average is $0.90 and its 200-day moving average is $1.22.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on February 6, FBR analyst Vernon Bernardino downgraded GALE to Hold, with a price target of $4.00, which implies an upside of 545% from current levels. On February 2, Maxim’s Jason McCarthy downgraded the stock to Hold as well.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Jason McCarthy have a yearly average loss of -6.1% and -10.7% respectively. Bernardino has a success rate of 29% and is ranked #4414 out of 4558 analysts, while McCarthy has a success rate of 37% and is ranked #4454.
Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs. The company focuses on identifying and advancing therapeutic opportunities to improve cancer care from direct treatment of the disease to the reduction of its debilitating side effects. Its products include Abstral sublingual tablets and Zuplenz oral soluble film.