What is NeuVax™ (nelipepimut-S or E75) and how does it work? NeuVax works by turning on the immune system. NeuVax recruits the main components of the cellular immune system to fight cancer by presentation of a T-cell peptide epitope in the context of the peptide-HLA-T-cell receptor complex. When NeuVax is administered, the E75 peptide, a well established T-cell epitope discovered on HER2, binds to the HLA-A2 and HLA-A3 molecules on the surface of tumor cells and Antigen Presenting Cells (APCs). The peptide sends a signal to the immune system by binding in the HLA-peptide-T-cell receptor complex. Circulating T-cells recognize the peptide bound to HLA though T-cell receptors (TCRs) on their surfaces and the T-cells become “educated” and “activated” to target HER2-expressing tumor cells exhibiting the E75 epitope bound to HLA. Furthermore, activation of these T-cells leads to clonal expansion and proliferation of E75-specific “killer T-cells” that circulate through the body, identify and destroy cancer cells that are processing HER2. Mechanism of Action: Active Specific Immunotherapy (ASI) Tumor cells are differentiated from healthy cells by the expression of tumor-associated proteins, also known as “tumor antigens.” HER2/neu is a well established tumor-associated antigen found at various expression levels on the membrane surface of many types of human cancer cells. The human immune system is constantly surveying the body for foreign invaders (foreign proteins) or abnormal self proteins. To aid in this immune surveillance, cellular proteins such as HER2/neu and others are routinely digested or broken down inside the cell into short fragments called peptides and the small peptides are then “displayed” on the cell surface as a means of communicating with the immune system. Differences between the pool of peptides from a tumor cell and a normal cell are revealed on the outside of the cell. Peptides that are presented on or from tumor cells, but that are absent (or present to a far lesser extent) on healthy cells are called tumor-associated peptides (TAPs). Unlike existing monoclonal antibody therapy which requires frequent, ongoing, intravenous (I.V.) infusion, NeuVax can produce continuing activation of the immune system and therapeutic levels of Killer T-cells with a once monthly intradermal (under the skin) dosing schedule that is less expensive and more convenient for both
Sentiment: Strong Buy
Galena Biopharma, Inc. (GALE)
Our first company for investment consideration is Galena Biopharma. The company's primary goal is to develop innovative oncology treatments that address major unmet medical needs dealing with cancer through an immunotherapy approach. For this article, investors should primarily focus on one specific product within their pipeline, NeuVax for the prevention of breast cancer recurrence after standard of care treatments. According to GALE and the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. A further breakdown shows that about 75% of these women have breast cancer tissue that tests positive for some level of Human Epidermal Growth Factor Receptor 2 (HER2) staining. Of that number, only 25% of those patients are eligible for the widely used drug, Herceptin, which is produced by the Roche-Genentech label. GALE's goal would be to use their NeuVax immunotherapy product to target the 50 to 60% of patients that are HER2 negative and are not eligible for Herceptin.
For investors, the science behind such innovative products can be difficult to understand but the marketing potential is a bit more easily understood. Let's find some useful data to help determine if GALE might be a good investment. The Herceptin product by the Roche-Genentech team had revenues of over $6 billion in 2011. Needless to say, NeuVax's potential could be just as huge if it is proved to be a successful product. Of course, investors have to remember that GALE is still a speculative investment, and this is easy to see in their latest second quarter financial statements. For example, the operating loss from continuing operations for the three months ended June 30, 2012 was approximately $5.7 million. For the six month period ended June 30, 2012, the operating loss from continuing operations was $10.1 million. As of June 30, 2012, GALE had cash and cash equivalents of $19.2 million, so there is a small cushion of assets to fund the company for some time. The company believes that their existing cash and cash equivalents should be sufficient to fund operations through at least the second quarter of 2013.
GALE represents an interesting investment possibility in the field of cancer treatments. Let's just hope their breast cancer product can come to market and help investors and patients alike. The company began enrollment in its phase III trial of NeuVax for breast cancer in January of this year. An update on this trial or other progress in its pipeline would be significant catalysts for the company's stock which is trading just under $2, its current resistance level. An entry at a dip in the company's shares or a breakout in a close over $2 could be construed as good possible entry positions. As noted above, the targeted market group is substantial and any positive data from the phase III trial could be a huge share price mover for this $127 million market capitalization biotech
This kind of data plus the ph III enrollment in and on line better results on the way!
This is old but still in the ballpark!
Booster inoculations are well-tolerated and appear to maintain long-term peptide-specific immunity and reduce disease recurrence rates
Booster inoculations are included in the ongoing Phase 3 PRESENT trial
LAKE OSWEGO, Ore., June 4, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, presented data from the Phase 1/2 clinical trial of NeuVax™ (E75) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held June 1-5, 2012 in Chicago, Illinois. The poster entitled, "Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine" (Abstract #2529) was presented on Saturday, June 2, 2012 and was selected for the oral session, "Developmental Therapeutics — Clinical Pharmacology and Immunotherapy."
The Phase 1/2 clinical trials evaluated the NeuVax (E75) vaccine, an HLA A2/A3 restricted HER2/neu (HER2) peptide, mixed with GM-CSF. The trials (SN-33 (Node Positive) and SN-34 (Node Negative)) evaluated a combined 187 patients and have completed a median 60-months of follow-up, with the final patients expected to complete their booster treatments and final follow-up visits by September 2012. The final data analysis is expected to be reported in the fourth quarter of this year.
Initially, patients in the trials were given a series of up to six inoculations of NeuVax dosed once a month. As the trials progressed, the physicians noticed that E75-specific immunity waned after this initial monthly Primary Vaccine Series (PVS) and translated to late recurrences of cancer in some patients. This declining immunity was identified by monitoring the level of CD8 T-cells in each of the patients. Through this evaluation, it became clear that immunological boosters would keep the level of circulating E75-specific CD8+ T cells elevated during the conduct of the trial. As a result of this finding, a voluntary booster program was added to the trials to maintain long-term immunity following the initial monthly PVS.
The booster program offered patients an additional inoculation every six months with a maximum of six boosters. Because the booster program was voluntary, not all women chose to receive the full six additional doses. To date, 53 patients received at least one booster. The results show that, at a median of 60-months, the disease-free survival (DFS) for the booster group (n=53) was 96.2% vs 80.5% in the control group (n=79) (p=0.01); and, the recurrence rate for the booster group was 3.8% vs 18.9% in the control group. This data shows three essential outcomes from the trials:
Booster inoculations are well-tolerated and appear to assist in the maintenance of long-term peptide-specific immunity.
Circulating E75-specific CD8+ T cells and local skin reactions can be re-induced with subsequent inoculations over a time period of up to five years.
Boosted patients have better recurrence rates and improved DFS compared to patients who did not receive vaccine.
"The data presented on Saturday reinforces our Phase 3 trial design and suggests that women will receive the most benefit from NeuVax when their monthly inoculations are followed by booster dosing. We believe this immunity will give these patients protection from their cancer returning," said Rosemary Mazanet, M.D., Ph.D., Executive Vice President and Chief Medical Office. Less
Sentiment: Strong Buy