Galena Biopharma Inc (NASDAQ:GALE) announced data from the Company’s GALE-301 Phase 1/2a clinical trial was presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in New York, NY. The focus of the presentation was on the association between clinical outcomes and folate binding protein (FBP) expression. GALE-301 is administered with the adjuvant granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in disease-free ovarian and endometrial cancer patients.
Poster #B007, entitled, “Improved disease-free survival in endometrial and ovarian cancer patients with low folate binding protein expression after treatment with the E39 peptide vaccine in a phase I/IIa trial,” reported clinical outcomes based on FBP expression level. The data revealed a disease free survival (DFS) benefit in patients with low FBP expression (FBPlo), but not in patients with high FBP expression (FBPhi).
“The results presented today are quite informative to our program as little is known about the effects of FBP expression levels on FBP-directed therapies, including the GALE-301 (E39) vaccine,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “The fact that the low expressors appeared to show a better DFS benefit may be due to immunotolerance from significantly higher endogenous exposure to the FBP antigen. This is also something we explored with our GALE-302, or attenuated version, of the peptide. These findings warrant further study as they may help inform the design and target patient populations for the next clinical trial for our folate binding protein development programs.”
Thirty-eight enrolled patients underwent FBP expression testing, and there were no clinicopathologic differences between the vaccine group (VG n=18) and the control group (CG n=20) or within FBPhi (VG n=10; CG n=9) and FBPlo (VG n=8; CG n=11;) (p≥0.1). There were significantly more primary tumors in FBPlo vs. FBPhi (p=0.027) and median follow up for the study was 16.3 months. While there was no significant difference in overall DFS between the CG and the VG (34.6% vs. 34.6%, p=0.208), in FBPlo patients, there was improved DFS in the VG at 85.7% vs. the CG at 17.5% (p=0.01). There was no such difference in FBPhi patients (VG 13.9% vs. CG 44.4%, p=0.83). Though groups were small, there was a dose-dependent effect in the FBPlo patients receiving 1000mcg (n=4) having improved DFS compared to the <1000mcg patients (n=4) and the CG (n=3) (100% vs. 66.7% vs.17.5%, respectively, p=0.03). Comparing FBPlo and FBPhi patients in the VG, the FBPlopatients had improved DFS (85.7% vs. 13.9%, p=0.052). In the CG, FBPlo patients did worse (17.5% vs. 44.4% in FBPhi, p=0.371).
Disease-free, HLA-A2-positve patients were vaccinated, while HLA-A2-negative patients were followed as untreated controls. The vaccine group received six monthly inoculations of GALE-301+GM-CSF, including either 100, 500, or 1000 mcg of peptide and 250mcg of GM-CSF. FBP expression testing was performed by immunohistochemistry and the results were graded 0-4+ based on the percentage of positively staining cells. Patient’s tumors were then categorized as FBPlo if scored 0-1+ or FBPhi if 2-4+. The patients were monitored for evidence of clinical recurrence through the standard of care follow-up by their treating oncology team. Demographics, FBP expression, and DFS were analyzed using appropriate statistical tests. (Original Source)
Shares of Galena Biopharma are up nearly 13% to $0.385 in pre-market trading. GALE has a 1-year high of $2.49 and a 1-year low of $0.28. The stock’s 50-day moving average is $0.40 and its 200-day moving average is $1.05.
On the ratings front, GALE stock has been the subject of a number of recent research reports. In a report issued on August 16, FBR analyst Vernon Bernardino reiterated a Buy rating on GALE, with a price target of $2.00, which implies an upside of 463% from current levels. Separately, on August 11, Maxim’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $1.00.
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 -12.5% and -3.3% respectively. Bernardino has a success rate of 32% and is ranked #4061 out of 4183 analysts, while McCarthy has a success rate of 37% and is ranked #3741.
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.