The race for a cure draws closer with the recent shift of utilizing immunomodulatory or chemotherapeutic agents alone, to adding immunotherapeutic agents in combination with these agents. Immunotherapeutic agents activate our own immune system to locate, recognize, target, and destroy cancer cells. Over many years of evolution, cancer cells have been able to evade our immune system by the use of biologic camouflage, and therefore our immune system has never been able to attack cancer cells because they were not recognized as foreign material for destruction.
Recent research and development from leading pharmaceutical companies has led to new approaches, utilizing monoclonal antibodies, in creating "true" immunotherapeutic agents. These agents can be broken down into two groups; upstream immunotherapeutic agents, and downstream immunotherapeutic agents. Downstream agents currently developed are; Anti-PD-1, Anti-PD-L1, and Anti-CTLA-4 which I covered in my previous article. These downstream agents are products in the pipelines of; Bristol Myers (BMY), Merck (MRK), and Roche (OTCQX:OTCQX:OTCQX:RHHBY). The only upstream immunotherapy agent is bavituximab, in the pipeline of Peregrine Pharmaceuticals (PPHM). Upstream immunotherapies are far superior to downstream therapies, and in fact downstream immunotherapies have been shown in pre-clinical models to be synergistic when used with bavituximab. New human clinical trials using bavituximab in combination with downstream agents are currently being started, and results are expected to be blockbuster.
According to Peregrine Pharmaceuticals web site; "Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that has demonstrated broad therapeutic potential across multiple oncology indications and represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of tumor cells and cells that line tumor blood vessels, causing the tumor to evade immune detection." This "biologic camouflage" of cancer cells has been supported by over 1500 peer reviewed publications, and has been the recent focus of many scholars in the oncology field.
Bavituximab targets and binds to PS, thereby blocking the cancers immunosuppressive signal, and has been shown to reactivate the body's immune system, restoring its ability to recognize and destroy cancerous tumors. Bavituximab has been shown to nearly double survival over standard of care in second-line breast and second-line lung cancer in phase II studies.
Of special note, many chemotherapeutic agents increase the amount of "flipped" PS in the tumor micro environment, thereby increasing the binding site for bavituximab. Examples of such chemotherapeutic agents include docetaxol, sorafenib and paclitaxcel. Currently, investors and oncologists are anxiously awaiting news of Peregrine Pharmaceuticals' preliminary read out of median overall survival of two IST trials, one combining sorafenib with bavituximab for treatment of liver cancer and the second a breast cancer trial combining paclitaxcel with bavituximab. At last year's ASCO meeting Peregrine Pharmaceuticals presented preliminary data of bavituximab in combination with paclitaxcel and showed complete responses "cures" in 15% of patients to date. Are the complete response numbers growing in the breast cancer trial? Will bavituximab show strong survival benefits when combined with sorafenib for treatment of liver cancer? These are the questions that will be answered soon.
Peregrine Pharmaceuticals has made tremendous progress over the past few months with the bavituximab oncology program, gaining FDA Fast Track status for the treatment of second-line NSCLC. Peregrine Pharmaceuticals was recently featured on CNBC noting their drug bavituximab as the next potential blockbuster drug to treat cancer. CNBC noted that 100% of drugs that recently received priority review from the FDA had gained approval. Peregrine Pharmaceuticals could potentially apply for accelerated approval at anytime, and produce bavituximab for commercialization through its owned subsidiary and in-house bio-manufacturing unit Avid Bioservices, which provides development and biomanufacturing services for both Peregrine and outside customers.
Peregrine Pharmaceuticals has recently increased its cash position to 90 million through a preferred share offering, which is enough to fully fund their phase III "SUNRISE" trial in second line NSCLC. Investors of Peregrine Pharmaceuticals are now focused on the next few weeks with ten conferences scheduled. The conferences will focus on the safety and efficacy of bavituximab, and the potential as the new leader in the immunotherapy space. Topics will cover current clinical trials underway from cancer to HIV, as well as a plenary session on the world stage in Germany. Peregrine Pharmaceuticals has quickly become noticed through the out-reach work of their KOL's (key opinion leaders) Dr. Scott Antonia of the world recognized Moffitt center and Dr. Dimitry Gabrilovich of the Wistar institute, who recently were added to Peregrine Pharmaceuticals staff of medical advisors.
Peregrine Pharmaceuticals is currently not partnered, and owns the licenses to all patents for all agents that bind to PS. Investors are anxiously awaiting news of whether or not Peregrine Pharmaceuticals will receive accelerated approval for bavituximab in 2014, or partner with a large pharmaceutical company then apply for accelerated approval. With accelerated approval of bavituximab in hand the marketing for this next potential blockbuster drug could begin in 2015 and sales of bavituximab for second line NSCLC and possibly breast and liver cancer could exceed 2 billion annually.