WHITEFISH, MT / June 26, 2014 / Probably the most explosive field in biotechnology right now is that of immuno-oncology. The field is predicated on the concept that the body’s immune system can be augmented or taught to modulate cancer without the use of toxic chemotherapy agents and radiation, the standard of care today worldwide. A few years ago, the immuno-oncology research was relatively non-existent, but now it’s one of the hottest around with some big pharmas making it a primary directive. Last year, Merck & Co. (NYSE:MRK) brought back Roger Perlmutter, a man with an extensive background in immunology, for a second tour with the company, this time as EVP and President of Merck Research Laboratories, to shepherd a new path for Merck focused on oncology at the research level with an emphasis on immuno-oncology. Last week, Merck enlisted MorphoSys AG in a partnership to develop therapeutic antibodies against immune checkpoints. The antibody experts at MorphoSys are in high demand, inking development agreements with Celgene (CELG), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS) and more to develop antibodies to support the human immune system against cancer.
Immuno-Oncology Partnering Frenzy Is On
Just a brief look at the recent slew of activity shows that most of the biggest drugmakers in the world are heading down the immunology pathway to develop novel drugs as the next frontier of cancer research. In addition to working with MorphoSys, GlaxoSmithKine just cut a deal in which it will spend $350 million to partner with U.K-based Adaptimmune to study immuno-oncology candidates. Glaxo’s view of the future of cancer – and possibly other indications – is evident given the fact that in April they agreed to sell most of their cancer business to Novartis for up to $16 billion, while spending $7.1 billion to acquire the majority of Novartis’ vaccine business.
Pfizer’s failed $120-billion mega-offer to acquire AstraZeneca (NYSE:AZN) was partly because of Pfizer’s desire to gain control of the British company’s experimental drugs that help the body’s immune system fight cancer. Bristol-Myers Squibb (NYSE:BMY) has made three recent moves to strengthen its immuno-oncology pipeline, including a $1.24-billion deal with CytomX. Incyte (INCY) has been on the move too, forging partnerships with AstraZeneca, Bristol-Myers and Roche (RHHBY) in recent months to develop immunological therapies for cancer.
Cumulatively, AstraZeneca, Merck, Roche and Bristol-Myers Squibb have initiated nearly 80 immune-based clinical studies, lending a great deal of credence to Citigroup analyst Andrew Baum’s forecast that immuno-oncology drugs will be generating $35 billion in annual sales in the mid-term. Right now, immunotherapy drugs only comprise about 3 percent of cancer treatments globally, but Baum thinks that number will surge to 60 percent by 2023.
To put this in perspective, if Baum is correct in his projection, cancer immunotherapy drugs would become the biggest market in medicine, topping even the peak sales of blockbuster drugs for high cholesterol.
The Emerging Importance of Exosomes
Within the immuno-oncology space, there is a tiny vesicle that virtually every scientist had previously cast-off as nothing more than worthless cellular debris that is starting to be the center of growing fanfare. That particle is called an exosome and it’s something that Aethlon Medical Inc. (AEMD) viewed as a potential key in oncology before the rest of the world started to understand it and its importance.
Putting its money where its mouth is, Aethlon established a diagnostic subsidiary, Exosome Sciences, Inc. and recruited Dr. Douglas Taylor as Chief Scientific Officer of the company. Dr. Taylor, who is credited with the discovery of tumor-secreted exosomes, is extensively published on the topic and regarded as one of the world’s foremost experts on exosomes. Think of this move as somewhat akin in relevance to Roger Perlmutter bringing on oncology expert Dr. Roy Baynes as the head of Merck’s new clinical development program.
Researchers are now widely realizing that tumor cells secrete exosomes as a mechanism to suppress immune cells from doing their job of destroying cancerous cells, which supports tumor proliferation. Additional evidence suggests that exosomes have a hand in tumor metastasis by playing a role in multi-drug resistance and serving as a building block for tumors to created their own blood supply. It is also now understood that there is a direct correlation between the number of exosomes in the body and the stage of cancer progression. Simply, few tumor-secreted exosomes suggest that cancer is in early stages and a plethora of these exosomes indicates an advanced stage of the disease.
Further, studies have shown that exosomes transport a variety of cancer targets, including PD-1 (programmed cell death 1) and its ligands, PD-L1 and PD-L2, probably the most talked about targets in cancer as they are known to put the brakes on the immune system. Roche has been cast into the spotlight with news last month that it won the vaunted FDA "Breakthrough Therapy" designation for its PD-L1 drug MPDL3280A. Roche’s research arm Genentech presented promising data on the experimental drug at this year’s American Society of Clinical Oncology conference showing a 43% response rate and evidence of a durable effect in patients with urothelial bladder cancer.
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The Future Research
At the root of all the aforementioned partnering activity is a fascinating trend of biotechs to combine their immunotherapy with another treatment to destroy cancer cells. This creates a particularly compelling situation for Aethlon and its Hemopurifier extracorporeal blood filtration device. Aethlon has demonstrated in clinical studies that the Hemopurifier can rapidly and efficiently reduce or eliminate viral loads in the treatment of HIV and hepatitis C infected patients. Using different affinity agents in the process, the company has now shown in the lab that the Hemopurifier can also capture and remove tumor-secreted exosomes from the circulatory system.
With exosomes acting as a thumb on the immune system, allowing tumors to run rampant, it seems logical that removing that thumb will allow immune cells to attack and kill cancer cells and restore/maintain homeostatic health. Aethlon will need to conduct clinical trials to document the effectiveness of the Hemopurifier in reducing exosome load and further delineate the clinical outcome of exosome depletion as it relates to disease progression, but if it does so successfully it would represent a major breakthrough in oncology. There are several catalysts that can be derived from this clinical research, including Aethlon likely becoming an attractive partner to increase the efficacy of either a traditional small molecule drug or a biologic to treat cancer. It just makes sense that in the quickly growing and competitive space of immuno-oncology, companies looking to gain an edge could benefit from marrying the Hemopurifier with their therapeutic to deliver the most robust efficacy and improve speed in treatment.
Second, cancer is greatly lacking diagnostics, generally having to rely upon biopsies that often do not happen until the disease has progressed, or worse yet, metastasized. Because tumor-secreted exosomes are found in all body fluids and are known to correlate to cancer progression, there is the potential for a non-invasive blood (or even urine) test to identify tumor presence at a much earlier stage.
At what could be considered a blistering pace, relative to typical drug development, the oncology community seems to be approaching a major breakthrough that will overcome the shortcomings of chemotherapy and radiation treatments that are toxic with generally short-lived results. Immuno-oncology regimens are showing themselves to hold a key to durable response rates and it seems that combination therapies and new diagnostic measures are positioning Aethlon and the Hemopurifier in the thick of this transition to new and better ways to treat cancer.
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SOURCE: Emerging Growth LLC