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News

Immunotherapy emerging as major cancer treatment

Aethlon Medical : 29 October, 2013  (Technical Article)
Aethlon Medical responds to article on the use of immunotherapy in the battle against malignant tumours
Immunotherapy emerging as major cancer treatment


Last week, the Wall Street Journal published an informative article on the emergence of cancer immunotherapies designed to augment the immune system's ability to recognize and combat malignant tumours.  The oncology community is embracing this new treatment paradigm based on mounting clinical evidence that immunotherapies can produce long-term responses across multiple tumour types when combined with traditional therapies.  As per the article, industry analysts project that immunotherapies could represent half of all cancer treatments within the next 10 years.  The opportunity in lung cancer alone was referenced as a $6 billion opportunity.



At least five major drug companies are advancing candidates, including Bristol-Myers Squibb, whose drug Yervoy is already approved for melanoma.  Drug mechanisms that inhibit the PD-1 molecular pathway, which cancer cells hijack to evade destruction by the body's immune system, are a primary target in the emerging immunotherapy pipeline. The article also balanced the compelling promise of these candidates with the reality that PD-1 inhibitors and other immunotherapies face significant administration and cost hurdles.  Much of the concern is associated with the challenge of stacking an immunotherapeutic drug on top of the toxicity of established therapies such as radiation, chemotherapy, targeted cancer agents or other PD-1 inhibitors.  Beyond this challenge, the cost of combining such therapies could prove to be prohibitive considering that Yervoy alone costs $120,000 for four doses administered over 12 weeks.



From an Aethlon Medical perspective, the Wall Street Journal article serves to reinforce our vision that a medical device can deliver immunotherapeutic benefit to both established and candidate cancer therapies, and do so economically and without added drug toxicity.



Our device strategy targets a survival mechanism deployed by tumours to evade and defeat the immune system of cancer patients.  This mechanism, which is not addressed by drug therapies, is the seretion of exosomes by cancerous tumours.  Researchers have discovered that tumours release these particles to trigger the death of cancer fighting immune cells and facilitate the spread of metastasis.  Additionally, the systemic elimination of exosomes may represent a novel strategy to inhibit the PD-1 molecular pathway.  To date, researchers have demonstrated that the Aethlon Hemopurifier® can capture exosomes underlying lymphoma, melanoma, ovarian, and breast cancer. If you are not familiar with the Hemopurifier, it is a first-in-class medical device that targets the rapid elimination of life-threatening infectious viruses and tumour-secreted exosomes from circulation.  



Based on the recent approval (after 5+ years of effort) of an investigational device exemption (IDE) by FDA, we are preparing to initiate the first U.S. studies of Hemopurifier therapy in Hepatitis-C (HCV) infected individuals.  In studies previously conducted overseas, Hemopurifier therapy was demonstrated to accelerate viral load depletion in hardest-to-treat HCV patients receiving standard-of-care drug therapy.



As a result of crossing the IDE approval threshold, we opened the door to advance relationships with medical institutes that have clinical interest in expanding Hemopurifier indications to include various forms of cancer.



When we initiated our first cancer research activities, we were making two intuitive yet forward-looking bets.  The first was that exosomes would emerge to become a vital therapeutic target.  The second was a belief that novel immunotherapies would rethink the landscape for treating cancer.  Today, tumour-secreted exosomes are well-documented therapeutic targets and cancer immunotherapies are expected to take center stage in the cancer treatment arena. There is growing hope that the marriage of traditional cancer therapies with next-generation immunotherapies may someday allow cancer to become a manageable condition much like HIV-infection is managed through a cocktail of treatment mechanisms.  At Aethlon Medical, our role is to provide the oncology community with a therapeutic tool that counters the immunosuppressive impact of exosomes without adding drug toxicity to companion cancer therapies.  



In closing, I am providing the scientific viewpoint of Dr. Douglas Taylor on the potential implications of Hemopurifier® therapy in cancer care.  Dr. Taylor is credited with the discovery of tumour-secreted exosomes and is a leading published author on the topic.  He is also one of the newest members of the Aethlon family as he has accepted the position of Chief Scientific Officer at our Exosome Sciences diagnostic subsidiary.  The following is a statement from Dr. Taylor:



Evidence indicates that molecules, such as programmed cell death-1 (PD-1) and CTLA-4, are exploited by tumours to suppress patient immune surveillance, allowing the progression of cancers. These molecules and their ligands negatively regulate anti-tumour immune responses, particularly CD8+ effector T cells. Treatment of activated T cells with anti-PD-L1 antibodies reduce T cell proliferation, which correlates with attenuated IL-2 secretion.  In vitro cytotoxicity studies and in vivo growth inhibition can be restored utilizing anti-PD-L1 antibodies or by genetic silencing of PD-1. The expression of PD-L1 on tumour cells inhibits anti-tumour immunity through engagement of PD-1 on effector T cells. Expression of PD-L1 on tumours is correlated with reduced survival in many tumour types.



Due to the role of these molecules in immune regulation and correlation with cancer outcomes, these pathways are being targeted for immunotherapy. Bristol Myers' experimental PD-1 inhibitor Nivolumab and Merck's candidate, MK-3475, block the PD-1/PD-L1 interaction, allowing the immune system to react with the tumour cells. Yervoy targets a similar checkpoint, inhibiting the CTLA-4 pathway. Unlike genetically targeted drugs, which disrupt mutations that fuel tumour growth, the new agents treat the immune system. Current interest in targeting these molecular pathways raises a concern that their normal function acts as to modulate the immune system to prevent attacks on healthy cells. Studies in murine models deficient for PD-1 developed dilated cardiomyopathy and congestive heart failure and that expression of PD-1 may also prevent autoimmune diseases. Based on the critical role of PD-1 and CTLA-4, targeting their expression may be problematic resulting in serious side effects on the host. However, an essential component of the activity of such molecules may be due to their presence on exosomes released by tumour cells. We previously demonstrated the presence of these immunoregulatory molecules on tumour-derived exosomes and their ability to suppress T cell activation and proliferation (Taylor et al. Clinical Cancer Research, 9: 5113-5119, 2003). Thus, a reasonable approach that does not result in systemic toxicity would be the removal of these immunoregulatory molecules. Consequently, the ability of the Hemopurifier to remove these circulating exosomes may provide a superior approach to treat these patients without the generalized inhibition of the respective molecular pathways.


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