On September 27, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported data from the Company’s GALE-301 Phase 1/2a clinical trial was presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York, NY (Press release, Galena Biopharma, SEP 27, 2016, View Source [SID:SID1234515437]). 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.

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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 FBPlo patients 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.

About GALE-301

GALE-301 is a cancer immunotherapy that consists 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. 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 11.9 per 100,000 women in the U.S., with an estimated 22,280 new cases and 14,240 deaths in 2016. Approximately 46.2% of ovarian cancer patients are expected to survive five years after diagnosis. Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 195,767 women living with ovarian cancer in the United States.

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 25.4 per 100,000 women in the U.S., with an estimated 60,050 new cases and 10,470 deaths in 2016. Approximately 81.7% of endometrial cancer patients are expected to survive five years after diagnosis. Approximately 2.8% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 – 2013 data). The prevalence data from 2013 showed an estimated 635,437 women living with endometrial cancer in the United States.

Source: National Cancer Institute Surveillance, Epidemiology, and End Results Program