Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the primary analysis from the Company’s GALE-301 Phase 1/2a clinical trial at the American Society of Clinical Oncology Annual Meeting 2016. 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.
The poster, entitled, “The primary analysis of a phase I/IIa dose finding trial of a folate binding protein vaccine, E39 + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence,” demonstrated that the vaccine is well tolerated and immunogenic. In the optimal dose group, the results demonstrate potential clinical benefit for GALE-301 to prevent recurrence in these patients, and that boosters may sustain this effect.
The Phase 1/2a 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 vaccine group (VG) and n=22 in the control group (CG). After a median follow-up of 16 months, the overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58), with a recurrence rate of only 23.5% in those patients who received booster inoculations. The estimated two-year disease free survival (DFS) is 46.3% in the VG versus 38.1% in the CG (p=0.36). Importantly, in the optimally dosed group (OPT) that received the primary vaccine series (PVS) with 1000 mcg of peptide, there was a significant survival benefit with the estimated 2-year DFS at 73.5% in the VG (n=15), versus 38.1% in the CG (n=22) (p=0.03).
“The GALE-301 data presented today reaffirms our strategy to prevent recurrence of cancer in patients treated with their standard of care therapy who have limited options besides watch and wait,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Although small numbers, in our Phase 1/2a trial we were able to see a statistically significant survival benefit with an estimated two-year disease free survival rate of over 70% in the patients optimally treated with our GALE-301 vaccine.”
Of the 51 patients, all entered the trial with no evidence of disease with 40 enrolled after completion of standard of care treatment for their primary diagnosis and 11 after completion of standard of care treatment for the recurrence of their disease. A further subset analysis was completed comparing the DFS of patients with primary or recurrent disease at enrollment. The survival benefit observed in the optimally dosed group persisted in the primary disease patients (DFS: OPT 66.7% versus CG 36.7%, p=0.02) but not in the recurrent patients (DFS: OPT 33.3% versus CG 22.2%, p=0.96).
“We are currently running trials in ovarian, endometrial and breast cancer patients with both E39 (GALE-301) and the attenuated version of the peptide, E39’ (GALE-302), combined with GM-CSF. These ongoing studies are designed to assess the best vaccination strategy to optimize an FBP-specific anti-tumor immune response and to identify the appropriate patient populations where these agents can have the most clinical benefit. Our results continue to show the strength of the science and will guide the best path forward forward for these compounds,” added COL (ret) George E. Peoples, MD, FACS, Professor (adjunct) of Surgical Oncology at The University of Texas MD Anderson Cancer Center, Founder and Director of Cancer Insight and the Cancer Vaccine Development Program, and co-inventor of the GALE-301 and GALE-302 compounds.
In the Phase 1/2a trial, HLA-A2 positive patients were vaccinated and HLA-A2 negative patients were prospectively followed as a control group. The VG received six monthly inoculations of E39 + 250 mcg GM-CSF as the PVS, followed by two boosters every six months. Of the 29 vaccinated patients, 24 completed the PVS, 17 received one booster, and 14 received two boosters. There were no clinicopathologic differences between groups with primarily grade 1 and grade 2 toxicities. The three most common toxicities were injection site erythema, skin induration and pruritus, which occurred in all vaccinated patients. Immunologic evaluation was performed as a delayed type hypersensitivity (DTH) reaction pre- and post- PVS. Overall, DTH increased pre- to post-PVS in vaccinated patients (5.9+1.5 mm vs 11.7+3.2 mm, p=0.07), with a larger increase seen in the optimally dosed patients (3.8+2.0 mm vs 9.5+3.5 mm, p=0.07) versus those not optimally dosed (7.8+2.1 mm v 11+5.0 mm, p=0.24). Demographic, safety, immunologic, and recurrence data were collected and analyzed using the appropriate statistical tests. (Original Source)
Shares of Galena are currently trading at $2.13, up $0.01 or 0.48%. GALE has a 1-year high of $2.39 and a 1-year low of $0.59. The stock’s 50-day moving average is $1.49 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 June 3, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE. Separately, on May 31, Maxim Group’s Jason McCarthy reiterated a Buy rating on the stock .
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 total average return of -12.4% and 7.5% respectively. Bernardino has a success rate of 34.9% and is ranked #3850 out of 3894 analysts, while McCarthy has a success rate of 52.8% and is ranked #484.
Galena Biopharma, Inc. engages as a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. It 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 (fentanyl) sublingual tablets and Zuplenz (ondansetron) oral soluble film.