GALE-301 is well-tolerated and elicits a strong and dose-dependent in vivo immune response; 1000 mcg identified as optimal dose
In the 1000 mcg vaccine dose group (VG), the clinical recurrence rate is 13.3% versus 55% in the control group (CG) (p=0.02), providing for a two-year Disease Free Survival estimate of 85.7% (VG) versus 33.6% (CG), p < 0.02
PORTLAND, OR, USA I September 28, 2015 I Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that data from the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial was presented at the European Cancer Congress 2015 in Vienna, Austria. GALE-301 is Galena's cancer immunotherapy that consists of a peptide (E39) derived from Folate Binding Protein (FBP). GALE-301 is combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) and administered via intradermal injection for the prevention of recurrence in ovarian and endometrial cancers.
Poster #P427 (abstract #2764), entitled "Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine GALE-301 (E39) + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence," provided updated data for all patients who have received at least twelve months of treatment. As presented, the clinical recurrence rate based on all treatment cohorts was 41% in the Vaccine Group (VG) (n=29) versus 55% in the Control Group (CG) (n=22), p=0.41. However, in the 1000 mcg VG cohort (n=15), there have only been two clinical recurrences (13.3% versus 55% CG, p=0.02), and the two-year Disease Free Survival (DFS) estimate is 85.7% (1000 mcg patients) versus 33.6% (CG), p < 0.02, as compared by Kaplan-Meir and Log rank tests.
"This one-year data from our GALE-301 trial is extremely encouraging as it has established the optimal dose while demonstrating clear signs of improvement in the disease free status of women with endometrial and ovarian cancer in the 1000 mcg cohort," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "More than 70,000 women will be diagnosed with ovarian or endometrial cancer this year, and we are focused on preventing their cancer from returning once they receive their initial treatments. Based on the data presented today, we expect to meet with the FDA to discuss a potential path forward to move GALE-301 into a prospective, randomized trial in ovarian and endometrial cancer patients to prevent recurrence."
The clinical trial program for GALE-301 began as a Phase 1 3x3, safety and dose-escalation (100, 500, 1000 mcg of E39) trial and transitioned to a Phase 2a, expanding the optimal dose cohort. Disease-free endometrial and ovarian cancer patients were enrolled after receiving their standard of care therapy. HLA-A2+ patients were vaccinated (VG), and HLA-A2- patients followed prospectively as a CG. Six monthly intradermal inoculations of GALE-301 (E39) + 250 mcg GM-CSF were administered followed by two boosters, one every six months. A total of 51 patients were enrolled: 29 VG and 22 CG. Of the 29 VG patients, 15 received the optimal dose of 1000 mcg, and 14 patients received a suboptimal dose of less than 1000 mcg.
"The data presented at the European Cancer Congress reveal that E39 + GM-CSF is well tolerated and elicits a strong and dose-dependent in vivo immune response. Early efficacy results are promising in the optimally dosed 1000 mcg cohort, with the vaccine exhibiting a very favorable safety profile with primarily Grade 1 and 2 toxicities and no differences in toxicities based on dose," commented Julia Greene, M.D., post-doctoral fellow with the Cancer Vaccine Development Program, and the poster presenter.
Demographic, safety, immunologic, and clinical recurrence data are continuing to be collected. There have been no observable differences in age, grade, stage, or histology between groups (all p≥0.1). In vivo immunologic response is being measured by the delayed type hypersensitivity reaction (DTH) to the E39 peptide. DTH increased pre- to post-vaccination, and the DTH increase was larger in the patients who received the 1000 mcg dose.
GALE-301 is a cancer immunotherapy that consists of a peptide derived from Folate Binding Protein (FBP) and is combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Enrollment has been completed in the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696).
About Ovarian/Endometrial Cancers
New cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015. Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 - 2012 data). The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%.
Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse. Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%. Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.
New cases of endometrial cancer occur at an annual rate of 25.1 per 100,000 women in the U.S., with an estimated 54,870 cases for 2015. Although endometrial cancer represents about 3.3% of all cancers, it represents about 1.7% of all cancer deaths, or an estimated 10,170 deaths in 2015. Approximately 2.8% of women will be diagnosed with endometrial cancer at some point during their lifetime (2010 - 2012 data). The prevalence of endometrial cancer in the U.S. is about 620,000 women, and the five-year survivorship for women with endometrial cancer is 81.7%.
Source: National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy 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. For more information, visit www.galenabiopharma.com.
SOURCE: Galena Biopharma