June 3, 2013

Galena Biopharma Provides Product Pipeline Update at the ASCO 2013 Annual Meeting

  • In completed Phase 1/2 trials of NeuVax™ (nelipepimut-S), patients who exhibit robust in vitro immunologic response have lower recurrence rates.
  • NeuVax companion diagnostic, the Leica Bond Oracle HER2 IHC assay, improves the accuracy of HER2 protein expression levels and patient targeting.
  • FBP (folate binding protein) peptide immunotherapy demonstrates excellent safety, robust immunologic responses, and preliminary efficacy in ovarian and endometrial patients in ongoing Phase 1/2a study.

LAKE OSWEGO, Ore., June 3, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced two publications at the American Society of Clinical Oncologists (ASCO) 2013 Annual Meeting taking place May 31-June 4 in Chicago, Illinois. The Company also provided an update on the ongoing Folate Binding Protein (FBP-E39) Phase 1/2 clinical trial.

NeuVax™ (nelipepimut-S) continues to demonstrate durable response rates

The NeuVax poster presentation entitled: "Biomarker Correlation to Clinical Response in Phase I/II Trials of the Adjuvant Breast Cancer Vaccine, NeuVax (nelipepimut-S or E75)" examined the relationship between in vitro immunologic response (IR) and clinical recurrence (CR) after five years of follow-up in patients with breast cancer. The study looked at the levels of E75 specific T-cells as measured by the dimer assay and correlated the IR with clinical benefit, or lack of recurrence. The dimer assay is a a way of counting E75-specific killer T cells that are induced by the NeuVax vaccine. The vaccine was administered in the adjuvant setting to prevent recurrence in breast cancer patients rendered disease-free following standard-of-care therapy.  Evaluable patients (n=187) combined both the SN-33 (node-positive) and SN-34 (node negative) patients from the Phase 1/2 NeuVax  trials.   In the study, the majority of the recurrences occur in women that had lower absolute levels of NeuVax-specific T cells or more modest increases in their NeuVax-specific T cells. 

The study concluded that in completed phase 1/2 trials of NeuVax, patients who exhibit robust in vitro IR have lower recurrence rates. This finding suggests that nelipepimut-specific CTL clonal expansion is a valid biomarker for CR in patients treated with NeuVax.  In the SN-33 trial, the 60-month Landmark Analysis demonstrated a 5.6% recurrence rate with NeuVax vs. a 25.9% recurrence rate in the control arm—a recurrence reduction of 78.4%.

"NeuVax works by stimulating the body's own immune system, via cytotoxic T lymphocytes (CTLs), to seek out and destroy micrometastatic cancer cells that may be circulating or deposited in a patient's body after they are deemed clinically disease-free. The data presented today demonstrates there is a correlation between the these NeuVax-specifc CTLs stimulated by the vaccine, and a reduction in recurrence of breast cancer in the women tested," said COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center. 

NeuVax Companion Diagnostic Increases Accuracy

Also published in abstract number #e11509, were preliminary results from Leica Biosystems entitled, "Bond Oracle™ HER2 IHC assay for identifying low to intermediate HER2-expressing breast cancer." Galena has partnered with Leica to develop a companion diagnostic for HER2 screening in women with breast cancer. In Galena's Phase 3 PRESENT study, Leica's Bond Oracle™ HER2 IHC System is under evaluation to reliably identify IHC HER2 1+ and 2+ cases by correlating to independent analytical measures of HER2 expression. To date, no companion diagnostic test is validated to differentiate HER2 at these levels of expression.

Testing by Leica Biosystems is ongoing to demonstrate the relationship between HER2 receptor load, HER2 copy number, and HER2 IHC status on four-assay control breast cancer cell lines. Testing is also underway to  show that HER2 mRNA expression correlates with IHC staining with the BOND Oracle HER2 IHC Assay in breast cancer tissue samples.   The testing will hopefully demonstrate that the Bond Oracle HER2 IHC assay can improve the discrimination of HER2 protein expression (IHC 1+, 2+) in breast cancer tumors and can be used to  identify patients for new treatments in development, such as NeuVax.

"Improvements in the determination of HER2 expression in the low to intermediate range will help define the patients that can best benefit from treatment with NeuVax," stated Rosemary Mazanet, M.D., Ph.D., Executive Vice President & Chief Medical Officer. "In addition, the NeuVax data presented today by Dr. Peoples demonstrates that we are able to boost a woman's immune system via her own CTLs and have a positive impact in preventing recurrence of her breast cancer." 

FBP (folate binding protein), HLA-A2 restricted peptide (E39) immunotherapy demonstrates excellent safety, robust immunologic response, and preliminary efficacy in ovarian and endometrial patients in Phase 1/2a study.

Galena provided an update on the first portion of the phase 1/2a FBP (E39) clinical trial which has enrolled 20 patients to date. E39 + GM-CSF is being administered in the adjuvant setting with the goal of preventing recurrences in high-risk, endometrial (EC) and ovarian cancer (OC) patients rendered disease-free with standard-of-care therapy. The phase 1/2a trial is being performed initially as a 3x3, dose-escalation, safety trial enrolling EC and OC patients with tumors expressing any level of FBP. HLA-A2+ patients are enrolled into the vaccine group (VG) while HLA-A2- patients are being followed prospectively as the untreated control group (CG). Six monthly intradermal inoculations (R1-R6) of 100/500/1000mcg of E39 + 250 mcg GMCSF (immunoadjuvant) are administered to the VG during the primary vaccine series (PVS). Local reactions (LR) are measured as the orthogonal mean (OM), after each inoculation. IR in the VG is assessed in vivo by delayed type hypersensitivity (DTH) test, measured as the OM. DTH is measured pre-vaccination (R0) and after the PVS (R6).

The study arms are well-balanced with no differences in age, grade, stage III, or node positivity status between groups. Overall, E39 was well-tolerated and the study to date has demonstrated a 11.1% recurrence rate with E39 vs. a 27.3% recurrence rate in the control group—a recurrence reduction of 59.3%.

Dr. John S. Berry IV, MD, associate principal investigator concludes: "E39 is an immunogenic peptide derived from FBP/FOLR-alpha, which is emerging as a potential target for cancer immunotherapy given its high expression in a number of malignancies and low expression in normal human cells. Early results from our phase 1/2a trial suggest the E39 vaccine is well-tolerated and elicits a strong in vivo immunologic response that may provide clinical benefit."

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (P revention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter, investigator-sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 negative (IHC 1+/2+ or FISH < 2.2) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

About Folate Binding Protein (FBP)

Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides like E39 that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF).   Galena's FBP vaccine, E39, is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

About Leica Biosystems

Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients' lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica's easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Further information can be found at www.LeicaBiosystems.com

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at 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 relating to Galena's expectations for commercialization of Abstral® and the development of Galena's NeuVax™ product candidate. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the possibility that Galena's commercialization of Abstral may be delayed or prove unsuccessful. Galena's business and operations and the development of its product candidates also are subject to the risks and uncertainties identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the three months ended March 21, 2013 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.

CONTACT: Remy Bernarda

         Senior Director, Communications

         (503) 405-8258

         rbernarda@galenabiopharma.com


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