Company Update (NASDAQ:GALE): Galena Biopharma Inc Presents GALE-301/GALE-302 Phase 1b Data at the Society for Immunotherapy of Cancer Conference 2016

GALEGalena Biopharma Inc (NASDAQ:GALE) committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today announced that data from Galena’s GALE-301/GALE-302 clinical program was presented at the Society for Immunotherapy of Cancer Conference 2016 in National Harbor, Maryland. 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 showed no evidence of disease at enrollment. This trial augments the Phase 1/2a trial with single-agent GALE-301 in ovarian and endometrial cancers.

Previous trials have demonstrated that although boosting vaccinations help to maintain long-lasting immunity, attenuated peptides may be a better choice for boosting because over-stimulation with an immunogenic peptide may lead to cytotoxic T lymphocyte (CTL) exhaustion and death. This phenomenon is known as antigen-induced cell death. The presentation, entitled, “Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Booster Vaccines (E39 and E39′) in Breast and Ovarian Cancer Patients,” reported the peptide-specific immune response to E39 and E39′ after different combinations of vaccination and boosting.

Both E39 and E39′ are well tolerated with all related adverse events at grade 1 or grade 2. Though numbers were small, patients boosted with the attenuated peptide showed increased CTL response to boosting regardless of significant residual immunity (SRI) resulting from the primary vaccination series (PVS). While this data needs to be confirmed with a larger sample size, this is consistent with the theoretical advantage of boosting with an attenuated peptide, which is expected to induce less antigen-induced cell death of CTLs.

“This data set on our FBP-targeted agents GALE-301 and GALE-302 provides critical information to understand how different booster regimens may impact the outcome for patients,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Cancers are different in their level of over-expression of FBP. High expressors, such as ovarian cancer, are more likely to develop tolerance and may need a higher dosage or more antigen stimulation with a stronger vaccine such as GALE-301 to overcome the tolerance and be effective. On the other hand, ninety percent of patients enrolled In this Phase 1/2a trial were breast cancer patients with lower FBP expression who have less tolerance and may benefit from a more attenuated antigen such as GALE-302, or alternatively from a lower dosage of the immunodominant antigen vaccine such as GALE-301. This will lead to the desired balance with maximum effect, while preventing CTL exhaustion and antigen induced CTL death.  We expect the final data set from this trial to be presented next year.” (Original Source)

Shares of Galena Biopharma are up nearly 2% in pre-market trading Monday. GALE has a 1-year high of $49.80 and a 1-year low of $0.19. The stock’s 50-day moving average is $0.31 and its 200-day moving average is $0.88.

On the ratings front, GALE stock has been the subject of a number of recent research reports. In a report issued on October 20, Maxim analyst Jason McCarthy reiterated a Buy rating on GALE, with a price target of $1.00, which implies an upside of 376% from current levels. Separately, on October 11, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $2.00.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Vernon Bernardino have a yearly average loss of 12% and 19.7% respectively. McCarthy has a success rate of 28% and is ranked #4077 out of 4209 analysts, while Bernardino has a success rate of 26% and is ranked #4103.

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. 

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