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Galena Biopharma Presents GALE-301 Phase 1/2a Primary Analysis at the American Society of Clinical Oncology Annual Meeting 2016

SAN RAMON, Calif., June 06, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the primary analysis from the Company’s GALE-301 Phase 1/2a clinical trial at the American Society of Clinical Oncology Annual Meeting 2016. GALE-301 is a cancer immunotherapy consisting 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 ovarian and endometrial cancer patients in the adjuvant setting.

The poster, entitled, “The primary analysis of a phase I/IIa dose finding trial of a folate binding protein vaccine, E39 + GM-CSF in ovarian and endometrial cancer patients to prevent recurrence,” demonstrated that the vaccine is well tolerated and immunogenic. In the optimal dose group, the results demonstrate potential clinical benefit for GALE-301 to prevent recurrence in these patients, and that boosters may sustain this effect.

The Phase 1/2a trial began as a dose-escalation Phase 1 trial, transitioning to a Phase 2a comparing expanded dose cohorts with a total of 51 patients enrolled, n=29 in the vaccine group (VG) and n=22 in the control group (CG). After a median follow-up of 16 months, the overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58), with a recurrence rate of only 23.5% in those patients who received booster inoculations. The estimated two-year disease free survival (DFS) is 46.3% in the VG versus 38.1% in the CG (p=0.36). Importantly, in the optimally dosed group (OPT) that received the primary vaccine series (PVS) with 1000 mcg of peptide, there was a significant survival benefit with the estimated 2-year DFS at 73.5% in the VG (n=15), versus 38.1% in the CG (n=22) (p=0.03).

“The GALE-301 data presented today reaffirms our strategy to prevent recurrence of cancer in patients treated with their standard of care therapy who have limited options besides watch and wait,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Although small numbers, in our Phase 1/2a trial we were able to see a statistically significant survival benefit with an estimated two-year disease free survival rate of over 70% in the patients optimally treated with our GALE-301 vaccine.”

Of the 51 patients, all entered the trial with no evidence of disease with 40 enrolled after completion of standard of care treatment for their primary diagnosis and 11 after completion of standard of care treatment for the recurrence of their disease. A further subset analysis was completed comparing the DFS of patients with primary or recurrent disease at enrollment. The survival benefit observed in the optimally dosed group persisted in the primary disease patients (DFS: OPT 66.7% versus CG 36.7%, p=0.02) but not in the recurrent patients (DFS: OPT 33.3% versus CG 22.2%, p=0.96).

“We are currently running trials in ovarian, endometrial and breast cancer patients with both E39 (GALE-301) and the attenuated version of the peptide, E39’ (GALE-302), combined with GM-CSF. These ongoing studies are designed to assess the best vaccination strategy to optimize an FBP-specific anti-tumor immune response and to identify the appropriate patient populations where these agents can have the most clinical benefit. Our results continue to show the strength of the science and will guide the best path forward forward for these compounds,” added COL (ret) George E. Peoples, MD, FACS, Professor (adjunct) of Surgical Oncology at The University of Texas MD Anderson Cancer Center, Founder and Director of Cancer Insight and the Cancer Vaccine Development Program, and co-inventor of the GALE-301 and GALE-302 compounds.

In the Phase 1/2a trial, HLA-A2 positive patients were vaccinated and HLA-A2 negative patients were prospectively followed as a control group. The VG received six monthly inoculations of E39 + 250 mcg GM-CSF as the PVS, followed by two boosters every six months. Of the 29 vaccinated patients, 24 completed the PVS, 17 received one booster, and 14 received two boosters. There were no clinicopathologic differences between groups with primarily grade 1 and grade 2 toxicities. The three most common toxicities were injection site erythema, skin induration and pruritus, which occurred in all vaccinated patients. Immunologic evaluation was performed as a delayed type hypersensitivity (DTH) reaction pre- and post- PVS. Overall, DTH increased pre- to post-PVS in vaccinated patients (5.9+1.5 mm vs 11.7+3.2 mm, p=0.07), with a larger increase seen in the optimally dosed patients (3.8+2.0 mm vs 9.5+3.5 mm, p=0.07) versus those not optimally dosed (7.8+2.1 mm v 11+5.0 mm, p=0.24). Demographic, safety, immunologic, and recurrence data were collected and analyzed using the appropriate statistical tests.

About GALE-301 and GALE-302

GALE-301 and GALE-302 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. GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides in gynecological cancers: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers (ClinicalTrials.gov Identifier: NCT02019524).

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 Program

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302. For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the development of Galena’s product candidates, including GALE-301 and GALE-302, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

NeuVax is a trademark of Galena Biopharma, Inc.

Contact: Remy Bernarda SVP, Investor Relations & Corporate Communications (925) 498-7709 ir@galenabiopharma.com

Source:Galena Biopharma, Inc.