Developing novel drugs that extend the lives of cancer patients is only one step in the fight against the disease that takes the lives of 7.6 million people each year. The ability to deliver the drugs into the targeted cancer cells with the proper dosage while mitigating damage or side effects to other tissues can be just as important. Unfortunately, delivering the proper medicine efficiently, with the proper dosage, to the targeted area is no simple task. Below are three companies, of various sizes, that are developing targeted delivery platforms to deliver the much needed cancer drugs. And if proven successful and reliable, these delivery platforms will greatly benefit patients… and investors.
Delivering Micro-Doses of Drugs To A Single Cancer Tumor
Celgene Company (CELG) is a large global biopharmaceutical company engaged in developing and commercializing cancer therapies and immune-inflammatory related diseases. Last week, the company announced it has entered into a strategic collaboration agreement with the much smaller, privately held biopharmaceutical company, Presage Biosciences, for Presage's proprietary technology platform to identify novel drug combinations for solid tumor indications. Presage's patented drug array platform is the only technology that allows for simultaneously analyzing multiple cancer drug candidates and drug combinations within a single living tumor. The platform enables the precise placement of multiple micro-dose treatments through the skin and directly into a tumor, which enables drug-specific responses to be measured within an array of multiple drugs. The micro-doses are then studied three-dimensionally, providing the ability to analyze the various drug effects across the span of a living tumor while capturing the heterogeneity of cancer cells to precisely gauge their effect. The end result is a personalized treatment that caters to the specific characteristics of a tumor and allows for faster results leading to the most effective treatment regimen.
According to Celgene's President of Research and Early Development, Thomas Daniel, M.D., in regards to what makes this drug platform different:
Drug development is currently challenged by heavy reliance on in vitro test systems and animal xenografts of little relevance to individual patients. The Presage platform addresses this challenge, permitting rapid assessment of drug candidates and combinations in relevant models, with potential to base critical drug development decisions on in vivo response data.
Celgene has committed $5 million of the $13 million overall investment to research funding and $8 million in equity, which will allow the smaller Presage Biosciences to grow. Twenty- one Presage workers will be measuring tumor responses for drug combinations in mice and dogs, which will help guide Celgene in the selection of programs for the clinic.
This platform has the potential to be another blockbuster in Celgene's vast and impressive pipeline of cancer-fighting drugs, which includes the recently U.S. Food and Drug Administration [FDA] approved, immunomodulatory drug, Pomalyst. Bloomberg expects annual sales of Pomalyst, a drug designed to bolster the body's immune system to destroy cancerous cells and inhibit cancer cell growth in multiple myeloma, could reach $1 billion by 2017. Pomalyst is prescribed when Celgene's own flagship drug, Revlimid, which accounts for almost 66% of the company's sales, or Takeda Pharmaceuticals' drug, Velcade, have failed. In 2012, sales of Revlimid reached approximately $4.2 billion.
CELG, which has a market capitalization of $47.92 billion, has seen its stock rise 45% YTD closing on Thursday, March 14th at $114.28 per share. The company is expected to grow 20% compounded per year, and revenues to climb to $12 billion yearly over the next five years. On Monday, March 11th Bank of America reiterated its buy rating and upped its target price from $113 per share to $127 per share following results of a commissioned statistical analysis Bank of America completed for an ongoing Revlimid study analyzing that there remains an additional 15-20% potential upside to the shares even after the recent run up. CELG has a strong pipeline of drugs on the market and in various stages of development. The company seems to be firing on all cylinders, and should continue to do so in the foreseeable future making the Celgene stock a strong one to own.
Nanoknife - Irreversible Electroporation to Zap Cancer
The second company that has a novel platform to battle cancer when surgery is not an option is AngioDynamics (ANGO). Even though surgery is considered the best option for cancer patients, some tumors are inoperable because they sit next to major organs. In those cases, the option has been chemotherapy. But it has been found that chemotherapy works best when much of the tumor is already removed. Enter ANGO's NanoKnife, a minimally invasive targeted cancer treatment that utilizes irreversible electroporation to kill hard-to-reach tumors and tumor cells in areas that are too dangerous for conventional surgery. The NanoKnife consists of two needles (electrodes), roughly one to two millimeters in diameter, that are guided, via an ultrasound or CT scan, through the skin to the tumor site. Then quick bursts of 3000 volts of electric current zap the tumor, which perforate the tumor cells' membranes killing the cancer cells while leaving normal surrounding tissue viable and untouched. With the cell membranes permanently perforated, chemotherapeutic agents can also be administered to enter the cells and act more effectively on the opened cancer cells. The NanoKnife can be used for both primary tumors or for tumors that have metastasized or spread to other parts or organs of the body in the liver, lungs, kidneys, and pancreas.
Though NanoKnife is approved by the FDA for surgical ablation of soft-tissue, concerns have been raised that the company has taken shortcuts in what is generally a long FDA approval process. The reason the company was able to get the NanoKnife s approval without conducting any randomized controlled clinical trials is due to a modification in the law enacted by congress in 1976, that allows for granting regulatory approval to certain medical devices quickly, often with little or no clinical evidence, if the device is similar enough to another already on the market. Therefore, the NanoKnife went from being tested on animals to being approved by the FDA as a cancer fighter. Though the lack of clinical tests, which may account for the less than warm reception and lower than expected sales, does not mean that the NanoKnife is not an effective platform in delivering its cancer treatment. According to a 2011 Australian study published in the Journal Of Vascular Interventional Radiology, the device has shown positive results: The treatment completely destroyed 83% of primary liver tumors.
ANGO has a market capitalization of $388.5 million. The company manufactures and sells surgical and diagnostic devices for vascular access, the treatment of peripheral vascular disease, and for oncology and surgical settings. The Company's devices are used in minimally invasive, image-guided procedures. The stock has maintained a narrow 52-week trading range, trading from a low of $10 to a high of $12.93. On March 8th ANGO's stock dropped over 10% after the company announced lower-than-expected 3rd quarter 2013 net earnings estimated to total approximately $82 million, $7 million below earlier estimates of $89 million. The stock has since bounced back to close on Thursday, March 14th at $11.55 per share. According to President and CEO, Joseph DeVivo:
We're viewing the third quarter top line performance as a temporary setback. It is simply taking us more time to build momentum as we continue to onboard new technologies while our sales force settles in. However, we remain as confident as ever in our strategy for growth, our business model and in the management team we have in place.
Part of Mr. DeVivo's strategy is to have a "big push" to grow internationally, which makes sense considering that today's business is global, and that 85% of the company's revenue still comes from sales in the United States. This is a good little company, and it will take time, patience, and positive results for the NanoKnife to gain more acceptance as an actual treatment for certain cancers; but if ANGO can grow its sales internationally the stock should grow too, though probably a little slower than the market wishes.
OMS Platform - Reversible Electroporation To Zap Cancer
OncoSec Medical Inc. (ONCS.OB), with a market capitalization of $18.21 million, is the smallest of the three companies profiled, but has what might be a big drug delivery platform with its propriety OncoSec Medical System [OMS], which is a reversible electroporation platform that the company uses to treat melanoma and other skin cancers. The difference between irreversible and reversible electroporation is that, with reversible electroporation, after the electric pulse is removed the pores of the affected cells close back up, trapping a chemotherapeutic or DNA-based drug inside the cell.
The OMS platform has a duel-purpose treatment design, dubbed ImmunoPulse and NeoPulse, depending on the therapy being administered. The company appears to now be focusing most of its efforts on its ImmunoPulse, which is currently in three Phase II trials for the treatment of metastatic melanoma, Merkel cell carcinoma, and cutaneous T-cell lymphoma. ImmunoPulse utilizes the DNA plasmid interleukin-12 (IL-12), which is injected directly to the tumor site. After the injection, six needle-like electrodes hooked up to a generator are inserted into the skin around the tumor. Short pulses of 1,300 volts are then administered, and the electric field causes the pores of the cancer cells' membranes to open, allowing the DNA plasmid to enter directly into the open pores. The electric field is then turned off and the cell pores close, trapping the cancer-killing DNA therapy inside the tumor cells allowing for a more effective treatment, while eliminating damage to healthy body systems.
Interestingly, the reversible electroporation has shown to affect a much larger area than just the targeted cells. Researchers have found that the patients' immune systems were attacking cancer cells outside the direct treatment areas, including distant lesions. Interim results of the ImmunoPulse Phase II trial for metastatic melanoma has supported the key findings from the previous Phase I trial, which indicated that ImmunoPulse is able to induce regression or stabilization of local and distant untreated metastases following a single cycle of treatment.
The other reversible electroporation-based therapy that ONCS is developing is NeoPulse, which uses the chemotherapeutic-based drug, bleomycin, a highly effective yet highly toxic anti-cancer drug. With NeoPulse, using the OMS system to directly target the cancerous cells, an effective result was achieved with 1/20th of a traditional dose of bleomycin; and by opening the cell membrane and trapping in the drug, it was shown that bleomycin had its ability to kill tumor cells enhanced by a factor of as much as 4,000. NeoPulse is in Phase II trials in the U.S. for skin cancer. The company's president and CEO, Punit Dhillon, said in an interview late last year that, since the company has only so many resources, he was looking for a partner as a licensing opportunity for NeoPulse. If that occurs it becomes a win-win for ONCS as it will gain a considerable amount of cash and it would allow ONCS to concentrate the company's efforts on continuing to develop ImmunoPulse.
ONCS stock closed on Thursday, March 14th at $0.206 per share. Mr. Dhillon will present at the 25th Annual Roth Conference on Tuesday, March 19th and will provide an overview of the company and its milestones during the presentation. With the OMS system showing positive results in the clinical trials, ONCS appears closer to moving ahead to the next stage. This little company has the potential to make a big impact on the way certain cancer drugs are delivered to targeted cancer tumors, and this is a stock that could move significantly upward this year.
The three companies profiled are of various sizes, and while CELG is by far the safest of the three as an investment, ANGO and ONCS appear to have the potential for a larger percentage gain. They also, as much smaller companies, have a higher investment risk. It is advised to research any small, yet emerging, drug-medical device companies before investing.