The Deal That Gives Roche Exposure To The Fastest Growing Area Of Cancer Treatment

Submitted by George Riley as part of our contributors program.

On September 10, Swiss drug maker Roche (ROG) announced it had agreed an exclusive licensing deal with Inovio Pharmaceuticals to develop vaccines designed to treat prostate cancer. IN the past experts have claimed that vaccines could not be used in cancer treatment, but Inovio’s research suggests otherwise. Could they have been wrong? If so, what might this deal mean for Roche’s involvement in prostate cancer treatment?

Current Treatment

The current standard of care treatment for prostate cancer is a combination of chemotherapy, radiotherapy and surgery. While relatively effective ? the age standardized five-year relative survival rate is over 80% ? the side effects associated with this combination of therapies can be harmful and debilitating. Consider chemotherapy, for example. Chemotherapy works by introducing highly toxic drugs into a patient’s body. The drugs attack (with the aim of destroying) cancer cells. The problem lies in the drugs detection system. Most chemotherapy drugs are designed to attack cells that multiply at a rapid rate, like cancer cells. In the human body, by adult age, most cells are relatively inactive, but there are some that continue to reproduce rapidly throughout life; hair cells, nail cells and stomach lining cells for example. The chemotherapy drugs attacking these cells produce the side effects most commonly associated with treatment; hair loss and nausea.

INO-5150

The treatment that Roche has taken over the development of is built around a DNA vaccine called INO-5150. DNA vaccines are genetically engineered DNA strands designed to illicit an immune response. How do they work? DNA vaccines are not unlike standard viral vaccines in the way they function. First, the DNA strand is inserted into the patient’s skin or muscle cells. Once inside it causes these cells to produce antigens specific to the cancer. These antigens are then picked up by a type of cell called an antigen presenting cell, which in simple terms is just a transport mechanism, and carried to the lymph nodes. Once at the lymph nodes, antibodies that prevent future infection and a specific type of immune cell called a killer T-cell are stimulated. The T-cells travel through the body and attack the cancer cells, and the antibodies prevent further infection.

The benefits of treatment in this manner are two-fold. First, only the cancerous cells are attacked. This drastically reduces the side effects associated with treatment. Second, the treatment can have a proprietary effect in preventing return of the tumors.

Electroporation

While the advantages of INO-5150 seems clear, the vaccine itself is not the only thing that Roche stands to benefit from with this licensing agreement. Perhaps more important is Inovio’s novel delivery technology. DNA vaccinations are notoriously difficult to introduce to the human physiological system because of the immune response they illicit. Orally, and intravenously, the human immune system will attack and destroy the vaccine long before it has a chance to work. The technology that Inovio, and now Roche, uses to deliver the DNA vaccine overcomes this problem. It is referred to as electroporation. Electroporation uses micro pulsed electricity to temporarily break down a cell’s membrane. Once the membrane is broken the DNA vaccine can travel directly into the cell and become encapsulated when the membrane reforms.

Clinical Trials

INO-5150 is currently undergoing clinical trials. Data from studies on Macaque monkeys suggested that the immune response generated by the vaccine were the highest generated by any type of Prostate specific antigen based immunotherapy in animals. The treatment is reported to be moving into phase I/II clinical trials in the near future.

The Market

The benefit Roche stands to gain from exposure to the prostate cancer treatment market is clear. Prostate cancer is by far the most common male cancer in the United States, with 1 in 6 men being diagnosed with the disease during their lifetime. Statistics suggest over 230,000 new cases will be diagnosed this year in the US. Analysts valued the market at approximately $26B in 2011, and expect it to grow to $50B by 2017. The fastest growing segment of the market is expected to be drug therapeutics (under which DNA vaccination falls), forecast to be worth $18B by 2017.

Alternatives

While INO-5150 looks promising it is important to remember that the treatment is still undergoing clinical trials and as such is far from becoming commercially available. It could be a number of years before Roche, and in turn Roche’s stock price, garners any benefit from the therapy. It is also important to recognize that there are alternatives to both DNA vaccine treatment and electroporation delivery that presents Roche and Inovio with strong competition.

One such competitive therapy uses cytokines in place of the DNA vaccine to illicit the immune response. Cytokines interact with the human immune system to control and regulate its reaction to disease. Interleukin 12 (IL-12) is a cytokine that many believe is an effective way to treat certain types of cancer. It works by signaling the immune system to attack the tumor, causing regression. IL-12 is used in traditional chemotherapy, but is extremely toxic and can only be used in small doses, which reduces its efficacy. OnocSec Medical, Inc. (ONCS) is currently conducting late stage trials of an electroporation treatment that uses IL-12. Introduction of the cytokine directly into cancerous cells using electroporation means that a much lower dose is required to produce much improved efficacy.

As an alternative to electroporation, liposomal delivery of certain drugs can serve to increase their efficacy in treating cancer. Doxil (Liposomal Doxorubicin) is a drug that originally gained FDA approval in 1995 for the treatment of ovarian cancer. In May this year Sun Pharmaceutical Industries received FDA approval for production of a generic version of the drug. While not specifically designed to treat prostate cancer, the liposomal delivery system can be applied to many other drugs.

On top of this, the competition electroporation stands to face from liposomal delivery might be about to get stronger. Liposomes are essentially a fatty layer that encapsulates the drug in question. The encapsulation reduces the systemic decomposition of the drug and increases its bioavailability. The problem currently is that producing liposomal drugs can be costly and time consuming. This is set to change however, with the introduction of a new type of liposome called QuSomes. QuSomes was developed by Dr. Brian Keller, chief scientific officer at BioZone Pharmaceuticals, Inc. (BZNE). The name QuSomes is a contraction for “quick liposomes”, and refers to the instant formation of a liposome upon introduction to water. The process has not yet been applied to cancer therapeutics, but is currently being tested with a number of other drugs including Propofol. Opko Health, Inc. (OPK), of which renowned biotech investor Dr. Philip Frost is Chairman and CEO, recently acquired exclusive rights to the QuSomes technology for ophthalmic use. Dr. Philip Frost is also the founding shareholder, and a senior advisor to, BioZone. If QuSomes is proven to be effective in the administration of drugs such as Propofol it could revolutionize liposomal delivery, and make its application to cancer therapy more effective and less time consuming.

Conclusion

The drug and its delivery system are yet to gain FDA approval, and there are a number of competing treatments also under development, so investor caution is paramount. Having said this, if successful, Roche’s taking over of the development of INO-5150 could offer the company a promising exposure to the rapidly growing drug therapy cancer treatment market.