A History of Successes

More than 30 years ago, Michael G. Hanna, Jr., Ph.D., Vaccinogen’s founder and CEO, was a pioneer in the concept of individualized targeted therapy – turning a patient’s own cancer on itself. Much of the basic research on the concept was accomplished under his leadership at the National Cancer Institute.

In 1983, Litton Bionetics built an institute for him to carry out this research and develop other innovative treatments and diagnostics. His research institute was later acquired and funded by Akzo Nobel through 1997.

Not only did Dr. Hanna and his team successfully shepherd OncoVAX® through a series of clinical trials, they also developed other break-through products such as the TICE BCG treatment for bladder cancer. TICE BCG was approved by the FDA in 1992 and continues to be the standard of care for bladder cancer today.

Dr. Hanna acquired the OncoVAX® technology and formed PerImmune in 1997. Shortly afterwards, the US FDA began to design its specifications for approving cancer vaccines. While these specifications provided opportunities for significant refinements in the manufacturing process of OncoVAX®, they proved too daunting for most other cancer vaccine companies. In 1998, PerImmune merged with Intracel Corp. In 2007, Dr. Hanna formed Vaccinogen to acquire the OncoVAX®-related assets from Intracel.

More recently, as OncoVAX® completed its earlier clinical trials, Dr. Hanna turned his attention to creating a facility to manufacture it on a large scale basis.

Starting in Q2 2008, patients diagnosed with Stage II colon cancer will be able to receive the OncoVAX® treatment in conjunction with surgery at a variety of hospitals throughout Switzerland on a self-pay basis.

Over the last 3 years, a state-of-the-art manufacturing facility has been built in Emmen, The Netherlands that conforms to Current Good Manufacturing Practices (cGMP), the basic principles, procedures and resources needed to create an environment suitable for the manufacture of high quality products. The plant has received approvals by the Dutch and Swiss health authorities for commercial purposes and can be used for US FDA clinical trials.

Vaccinogen is currently ramping up the commercial applications of OncoVAX® in Switzerland. Starting in Q2 2008, patients diagnosed with Stage II colon cancer will be able to receive the OncoVAX® treatment in conjunction with surgery at a variety of hospitals throughout Switzerland on a self-pay basis. The revenues from this market are largely dependent on the level of patients becoming aware of this new treatment, particularly the segment of the 190,000 Europeans diagnosed with colon cancer each year that are Stage II.

The US FDA has granted Fast Track designation to OncoVAX® development for the prolongation of five year disease free survival in the treatment of Stage II colon cancer since an unmet need for new medical therapies exists in this indication. The FDA has also approved a Special Protocol Assessment ("SPA") of the proposed pivotal Phase IIIb protocol. This study will enroll 560 patients in over 30 sites throughout the USA and Europe. The size of the study was determined assuming a 50% reduction in the OncoVAX®-treated patients of the assumed recurrence rate of 25%. Upon approval for commercialization in the US and Europe, anticipated for 2011/2012, OncoVAX® will begin addressing an unmet medical need for approximately 100,000 patients each year.