Development History

The concept of treating cancer, in this case colon cancer, by developing patient specific vaccines after diagnosis and surgery has been the result of a 30-year effort by Dr. Michael G. Hanna, Jr. who has been developing cancer vaccines and human monoclonal antibodies during this time. In particular, he was responsible for launching the first approved cancer immunotherapy product TICE BCG for the treatment of superficial bladder carcinoma while working for Akzo Nobel.

1972 – 1983
Dr. Hanna initiated the concept of autologous or patient specific cancer vaccines while at the Oak Ridge National Laboratory working under contact with the National Cancer Institute. This basic research was performed in guinea pigs. He continued to develop this technology as Director of the Frederick Cancer Center for the National Cancer Institute.
1983 – 2000
Akzo Nobel funded his research on OncoVAX® through the Biotechnology Research Institute, which was based in Rockville, MD and directed by Dr. Hanna. During this period, there was a systematic series of clinical trials for dose optimization and regimen optimization concluding with a major randomized, multi-center clinical trial which was completed and later published in The Lancet in 2000. In addition, the Institute was successful in achieving regulatory approval for TICE BCG for the Immunotherapeutic treatment of Carcinoma in-situ and Superficial Papillary Bladder Cancer.
1996 – 1999
Dr. Hanna structured a management buy out/asset acquisition from Akzo Nobel where he acquired OncoVAX® and the Biotechnology Research Institute facilities. The newly formed company was called PerImmune, Inc. PerImmune merged with Seattle-based Intracel Corp. to enhance its capital structure and broaden its product base. The combined companies were headquartered in Rockville and the entity adopted the Intracel name. Dr. Hanna remained as Chairman and Chief Scientific Officer and transferred day-to-day management responsibilities to Intracel’s CEO. The investment group, Intracel Acquisition Holdings, remained as investors and managers of the company from 1998 to 2007 and they presently own 10% of the current company, Vaccinogen, and are positioned to earn significant returns on their investment based on equity and royalties moving forward.
2000 – 2006
The dialogue with the FDA regarding the ultimate approval of OncoVAX® took place and presented many new technical pharmaceutical challenges. The issues resolved were sterility of the product and complete product characterization studies using the methodology of Flow Cytometry. The latter resulted in developing an automated Matrix Associated Potency and Identity assay. A clinical bioequivalence study was conducted and accepted by the FDA suggesting that these manufacturing modifications did not destroy the efficacy of the vaccine. During this time biotechnology companies in general fell out of favor in the market and many failed to meet these new specifications.
2003 – 2006
Additional outside capital was raised via equity and debt rounds totaling $40 million. Concurrent with these raises, different management structures were tried, most without success. The capital plan of the company was unattractive to new outside investors. As inventor and developer of OncoVAX®, Dr. Hanna always retained his position as Chief Scientific Officer and kept the essence of the product in place and moving forward toward success. During this period a licensed cGMP manufacturing facility was built in Emmen, The Netherlands. A pharmacoeconomic analysis of OncoVAX® was completed and published on the use of OncoVAX® in Stage II colon cancer.
May 2006
The FDA granted a Special Protocol Assessment ("SPA")for a 2nd and pivotal Phase IIIb clinical trial.
September 2006
The FDA granted Fast Track designation to OncoVAX® development in the treatment of Stage II colon cancer.
September 2006
32 clinical sites in major hospitals throughout the US, and Europe have been established for this study. With the regulatory risk largely removed as a result of these accomplishments it was determined that the final translational development of this unique and important product would require an additional $25 to $30 million over a 3-year period. These monies would enable the Company to launch commercialization in Switzerland, complete the pivotal Phase IIIb clinical trial and build a large US-based OncoVAX® manufacturing facility.
End of 2006
30 years and over $300 million (USD) of research and development; OncoVAX® is ready for final translational development.
February 16, 2007
Dr. Hanna proposed to form a new corporation (Vaccinogen), acquire all OncoVAX® related assets from Intracel and relieve the current Intracel investors of their payables, overhead and upcoming capital expenditures in order to continue the final translational development of OncoVAX®.
April 15, 2007
Terms were outlined and finalized for Vaccinogen to license and acquire from Intracel all assets of OncoVAX® including but not limited to; intellectual property, exclusive TICE BCG product supply agreement, all manufacturing processes, regulatory approvals and documents, all trademark and critical personnel and all cGMP manufacturing facilities as well as the BV and GmbH subsidiary organizations.
June 27, 2007
Intracel's Board approves the Vaccinogen proposal and both Vaccinogen and Intracel sign the Letter of Intent. Vaccinogen commences the due diligence towards closing the transaction in mid-October.
October 10, 2007
Vaccinogen and Intracel finalize all arrangements pertaining to the license/acquisition agreement for the final translational development of OncoVAX® by Vaccinogen.
October 23, 2007
Vaccinogen finalizes all arrangements to acquire the cGMP manufacturing facility in Emmen, The Netherlands.
November 15, 2007 - Angel level capital raise for Vaccinogen successfully completed.
November 22, 2007 - Vaccinogen enters into a formal distribution agreement with Pro Concepta for the distribution of OncoVAX® in major hospitals throughout Switzerland.
December 1, 2007 - Vaccinogen BV, a Dutch subsidiary, is formed, thus allowing the key manufacturing, quality control and quality assurance experts for OncoVAX® to re-join under Vaccinogen.
December 30, 2007 - Vaccinogen, together with Pro Concepta, officially submitted the registration dossier for Switzerland which enables Vaccinogen to maintain its commercial authorization while it awaits full registration status with Swiss Medic.
January, 2008 - Vaccinogen opens up conversations with several potential distribution partners for OncoVAX® for certain parts of Europe, the Middle East and parts of Asia.
February 13, 2008 - Organon Teknika, a division of Schering-Plough, delivered a supply of BCG that can accommodate the entire clinical trial and up to seven times the currently projected commercial patient volume over the next 12 months.
February 15, 2008 - Vaccinogen hires nine full time certified staff for the Emmen facility.
February 22, 2008 - Vaccinogen enters into a formal distribution agreement with Pharmacenter Hungary for the distribution of OncoVAX® in Hungary, Czech Republic, Slovakia, Poland, Romania, Bulgaria and Slovenia. The roll-out schedule is to take place over two years.
March 1, 2008 - The preparatory work to re-calibrate and validate the equipment in the Emmen manufacturing facility was completed on time and under budget, thus enabling the re-inspection of the facility to take place on time in April.
April 6, 2008 - Vaccinogen GmbH is established thus allowing commercialization in Switzerland to move forward.
April 25, 2008 - The Dutch Ministry of Health officially granted Vaccinogen BV the manufacturing license which enables the Emmen manufacturing facility to produce the OncoVAX® vaccines for both commercial and clinical purposes immediately.