Galena Biopharma Inc (NASDAQ:GALE) announced a poster was presented on the Company’s NeuVax™ (nelipepimut-S) investigator-sponsored Phase 2 clinical trial (IST) in high-risk, HER2 3+ patients at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, DC. The Phase 2 trial is a multi-center, prospective, randomized, single-blinded, placebo-controlled trial combining NeuVax and trastuzumab in the adjuvant setting to prevent recurrence in HER2-positive (HER2 3+) breast cancer patients.
The poster, entitled, “Pre-specified interim analysis in a prospective, randomized phase II trial of trastuzumab vs trastuzumab + NeuVax to prevent breast cancer recurrence in HER2+ breast cancer patients,” presented the interim safety analysis that was initiated after enrollment of the 50th patient in the trial (vaccine group (VG) n=22, control group (CG) n=28). The analysis demonstrated that the agent is well tolerated with no increased cardiotoxicity associated with giving NeuVax in combination with trastuzumab.
In the trial, there were no significant clinicopathologic differences between groups. The vast majority of toxicities were grade 1 and there were no related grade 4 or 5 toxicities and no differences in related toxicities between the VG and CG (Grade 1: 96% vs 98.5%; Grade 2: 3.2% vs 1.5%; Grade 3: 0.8% vs 0%, p=0.14). There was no significant reduction in cardiac ejection fraction (EF) pre- to post-treatment in either group (VG: 61.1±5.4% vs 60.1±4.8%, p=0.55; CG: 62.3±5.7% vs 61.9±4.0%, p=0.74) and no notable difference in EF was observed between the baseline (pre-treatment) and the follow-up (post treatment) within the vaccine and control groups (p=0.54).
“As we reported in February, this data was the basis for the Data Safety Monitoring Board (DSMB) to perform a futility analysis and recommend the study continue as planned. Additionally, the DSMB determined that there were no safety concerns,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “The poster presented at AACR provides a more detailed safety analysis of the ongoing IST with NeuVax in combination with trastuzumab in HER2 positive breast cancer patients. We are pleased that the combination of agents are well tolerated and that there is no additive cardio toxicity.”
Dr. Nejadnik continued, “The Phase 2 trial is expected to complete enrollment by the end of this year with immunologic and clinical outcomes data to be reported via the planned primary analysis after 24-months follow-up. This trial in HER2 3+ patients complements our other ongoing IST with NeuVax in combination with trastuzumab in HER2 1+/2+ patients with an interim data analysis also expected by the end of the year.”
The trial is enrolling HLA-A2 and HLA-A3 positive breast cancer patients with stage I-III HER2 positive disease at high risk for recurrence, which is defined as patients not achieving a complete response after trastuzumab-containing neoadjuvant therapy or those undergoing up-front surgery with any node-positive disease (if ER/PR- or ≥4 positive nodes if ER/PR+). Patients are enrolled after surgery, radiation and neo-adjuvant/adjuvant chemotherapy with an approved trastuzumab-containing regimen. Patients are randomized to receive trastuzumab + NeuVax in the VG or trastuzumab + GM-CSF only in the CG. Patients receive vaccinations of NeuVax or GM-CSF intradermally every 3 weeks for 6 total vaccinations (primary vaccine series, PVS) starting with the third dose of trastuzumab maintenance therapy. Starting 6 months after the completion of the PVS, patients receive 4 booster inoculations, one every 6 months. EF is assessed by either echo or MUGA at baseline and serially during treatment. For this analysis, demographic and safety data were collected and analyzed, and the interim safety analysis was initiated after enrollment of the 50th patient.
Shares of Galena are currently trading at $0.623, up $0.031 or 5.33%. GALE has a 1-year high of $49.80 and a 1-year low of $0.21. The stock’s 50-day moving average is $0.65 and its 200-day moving average is $1.24.
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 577% from current levels. Separately, on February 2, Maxim’s Jason McCarthy downgraded the stock to Hold.
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 -6.7% and -10.7% respectively. Bernardino has a success rate of 29% and is ranked #4439 out of 4557 analysts, while McCarthy has a success rate of 36% and is ranked #4467.
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.