by Ryan Allway
Access Wire – Cell to cell communication is a cornerstone of maintaining homeostatic health in any multicellular system. There are libraries of research on the exchange of information amongst human cells, such as peptides, chemokines, growth factors and lipids, just to name a few. Comparatively speaking, it has only been in recent years that there is a growing body of evidence regarding the importance of exosomes, specialized nanometer-sized vesicles, in the cellular matrix of the human body. Although they can be derived from different types of cells, promising research is emerging that validates exosomes to be important new therapeutic targets in cancer care.
At present, small molecule therapies are the most widely used approach in cancer treatments. In many cases they are rendered ineffective due to resistance or to debilitating side effects, leaving the oncology landscape extremely challenged to develop new, innovative approaches. Immunotherapy, which uses the body’s immune system to fight tumors, has delivered some very promising advanced data in the last decade, with Dendreon Corporation (DNDN) becoming the first immunotherapy to garner FDA approval in April 2010 as a new treatment for certain men with advanced prostate cancer.
The attractiveness of immunological cancer drugs was exemplified on August 26 when AstraZeneca (AZN) agreed to pay up to $500 million to acquire privately-held Amplimmune, to get its hands on several early-stage novel therapeutics focused on immune-mediated cancer therapies. The deal entails AstraZeneca paying $225 million upfront with promises of up to $275 million more should certain developmental milestones be met.
Perhaps what best demonstrates the value of a potential new immunological cancer therapy is the fact that Amplimmune’s most advanced drug candidate, AMP-514, is still only in the pre-clinical stage with intentions to file an Investigational New Drug application with the FDA by the end of 2013.
The growing efforts of big pharma to find ways to allow the immune system to combat tumors should lend optimism to the millions of cancer sufferers globally and inspire investors to take notice of a burgeoning field in cancer research. How big is the market becoming? According to Research and Markets recent update, there are now 571 companies and partners developing 1,007 immunotherapy candidates across 2,500 different cancer projects.
The fact remains that cancer is a resilient creature that is capable of mutating and developing harsh resistance to cancer therapies. Exosomes have recently been discovered to play multiple roles in muting the effect of cancer therapies, including the programmed cell death of cancer fighting immune cells and the facilitation of drug resistance, which could prove a challenge for any or all of those 1,007 immunotherapy candidates. Further evidence shows that exosome creation can be accelerated in hypoxic conditions, a condition that is supportive of tumor progression, metastasis and angiogenesis.
The point is that the benefit of cancer immunotherapies designed to stimulate the immune response may very well require a synergistic adjunct mechanism to eliminate exosome immune-suppression.
Few companies are targeting the eradication of exosomes like Aethlon Medical Inc. (AEMD). Aethlon’s primary asset is its ADAPT™ System that functions as a pillar for a new class of medical devices that deliver rapid removal of infectious viruses, toxins and disease promoting particles, including exosomes, from the circulatory system. The company’s Hemopurifier® has been validated in overseas clinical trials to substantially reduce viral loads in diseases such as hepatitis C. In October of 2012, the company was granted a U.S. patent that provides Aethlon Medical the exclusive right to remove immune suppressive microvesicular particles, which include but are not limited to exosomes, from the circulation of treated patients. Aethlon recently received an FDA Investigational Device Exemption that allows the company to conduct Hemopurifier clinical trials in the U.S. in end stage renal disease patients with hepatitis C. While that alone should be a catalytic moment for the company, researchers have also discovered that the same Hemopurifier being advanced into hepatitis C studies can capture the exosomes underlying several forms of cancer.
The company has garnered awareness of its technology as related to hepatitis C and its U.S. military contract for the treatment of sepsis, with shares more than doubling in value in 2013, but there seems to be a strong underlying value that has not yet been realized relating to cancer. With this disease, Aethlon’s goal is to improve drug treatment outcomes through an adjunct strategy that can remove cancer-released exosomes without added drug toxicity normally required to expand a cancer treatment regimen.
As mentioned, exosomes are immunosuppressive by nature, meaning that the efficacy could be elevated in the droves of immunology cancer drugs and drug candidates in development. This positions the Hemopurifier as a true adjunct, which might also be attractive to developers of drug candidates that are not demonstrating sufficient efficacy to warrant market approval. Extracorporeal treatment could be the solution. Of course, a combination therapy with traditional chemotherapies is a possibility as well.
As the first device of its kind and a microcosm of the total oncology ecosystem, the Hemopurifier and Aethlon are fighting through headwinds for acceptance. However, the government has taken notice, investors are taking notice and domestic clinical trials for such a prominent disease as hepatitis C should continue to build awareness of the potential of products that emanate from the Aethlon ADAPT pipeline. With some more research quantifying the benefits of removing circulating exosomes, the technology could experience market acceptance in cancer and other indications where exosomes have been discovered to enable disease progression through suppression of the immune system.