Whitefish, MT / May 15, 2014 / The cancer drug business is ablaze lately as pharmaceutical companies of all sizes are targeting a multitude of mechanisms of action to develop what they hope to be the next blockbuster cancer therapy. Immuno-oncology programs, namely PD-1 and PD-L1 inhibitors, are being held in high regard as the next generation of cancer therapies as Roche (OTCQX: RHHBY) races towards an FDA decision with MK-3465 for patients with advanced melanoma who did not respond to Bristol-Myers Squibb's (NYSE: BMY) Yervoy. Roche is making headlines not just with MK-3465, releasing data ahead of the May 30 start of this year's American Society of Clinical Oncology (ASCO) meeting, showing that its immune therapy drug MPDL3280A shrunk tumors in 10 of 20 bladder cancer patients. Pfizer (NYSE: PFE) is looking to consolidate some of its developmental pipeline through potentially the biggest biotech acquisition in history, offering more than $100 billion to buy AstraZeneca (NYSE: AZN). AstraZeneca's MedImmune unit is partnered with Pfizer, working on development of an anti-CTLA-4 combination therapy. MedImmune expanded its pipeline this week by inking a pact with Incyte (NASDAQ: INCY) to couple its MEDI4736 with Incyte's INCB24360 in a PD-L1-targeting regimen.
Also in the immunological space, Celldex Therapeutics (NASDAQ: CLDX) saw its shares surge 27 percent on Wednesday after the company reported striking a deal with Bristol-Myers to collaborate on the clinical development of BMY's PD-1 investigational drug nivolumab in combination with Celldex's CD27-targeting drug candidate varlilumab. Separate from the Celldex agreement, BMY bombarded Wall Street with five announcements on nivolumab, boasting good results for treating renal cancer, lung cancer and more.
The Common Link
The common thread shared by all of these cancer targets is exosomes. Exosomes were historically thought of as simply cellular debris, or "noise" in the cell ecosphere and pathogenesis of disease. However, a growing body of evidence has proven the tiny microvesicles to be integral in cellular communication and transportation, including carrying diseased cells, spreading them throughout the circulatory system. In fact, research shows that exosomes are found in virtually every body fluid (i.e. blood, urine, spinal fluid, etc.) and in excessive numbers when disease is present, creating an opportunity for vastly less invasive procedures in the future to diagnose and treat difficult conditions. The capturing of exosomes has great implications in advancing new therapies for hard-to-treat diseases, including cancer, yet the nascent industry only has limited technologies available today to corral exosomes for research, treatment and diagnostics.
Aethlon Medical (OTCQB: AEMD) is one of the leading players in the business, having developed its flagship product, branded the Hemopurifier(r). The Hemopurifier(r) is a first-in-class extracorporeal hemofiltration device utilizing a carbohydrate-binding protein known as GNA to efficiently capture exosomes in the bloodstream. The potential of the Hemopurifier(r) was recently acknowledged in an article sponsored by the National Institute of Health/National Cancer Institute and published in the journal "Trends in Molecular Medicine" discussing the potential of targeting exosomes as a novel therapeutic strategy. Aethlon was the only company mentioned in the discussion on capturing the extracellular vesicles.
A note to shareholders from Aethlon Chief Executive Officer Jim Joyce on Wednesday provided a broad, yet succinct, look at the industry, while providing clarity on the value of the Hemopurifier to the field of oncology. Within the note, Dr. Annette Marleau, Director of Tumor Immunology at Aethlon, explained,
"In recent years, the scientific community has identified a complement of disease-causing proteins and genes carried in the exosomal cargo, the tumor's essential blueprint. Exosomes are thus major purveyors of aggressive cancer phenotypes, able to provide the comprehensive array of mediators for tumor growth and metastasis, drug resistance, immune suppression, and angiogenesis."
Marleau goes on to detail an extensive list of biotechnology companies and the litany of cancer targets that they are aiming to interrupt with their given treatments, ranging from tumor angiogenesis to programmed cell death proteins to epidermal growth factor receptors and back again. By removing exosomes from the circulatory system, Aethlon's Hemopurifier could provide a significant benefit to any cancer drug, whether currently marketed or in development. Aethlon sees the possibilities to bolster efficacy and lessen toxicity as extrapolated from the note and Marleau's comment,
"We envision that addressing exosomes therapeutically could serve as a strategy for dealing with many of these disease targets simultaneously."
Previous human studies showed the Hemopurifier(r) rapidly depletes viral load in patients infected with hepatitis C and HIV. The data from that trial earned Aethlon an Investigational Device Exemption (IDE) from the FDA to treat end stage renal disease patients with the hepatitis C virus. Considering the recent science surrounding exosomes and cancer therapy targets, Aethlon’s Hemopurifier(r) provides hope for a new treatment paradigm in cancer care.
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