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Vaccinogen: Revolutionizing Cancer Treatment with OncoVAX®

Vaccinogen is a pioneering research organization dedicated to the development of OncoVAX®, an autologous vaccine that holds the potential to transform the landscape of Colon Cancer treatment.  Our groundbreaking Phase III trial has demonstrated remarkable results. OncoVAX® showcased a significant 20% increase in disease-free survival over a decade for Stage 2 Colon Cancer patients, while reducing the risk of recurrence by 44% for all patients during a comprehensive five-year follow-up period.

This breakthrough in cancer treatment has far-reaching implications, with the potential to save millions of lives globally, not only in colon cancer but also in other adenocarcinomas. By investing in or partnering with Vaccinogen, you can contribute to this life-saving mission.

To propel the development of OncoVAX® further, we are seeking financing or partnership opportunities to complete the pivotal Phase IIIB trial. To successfully accomplish this milestone, an investment of $50M – $100M over a span of three to five years is required. We have already secured Fast Track designation and Special Protocol Assessment from the FDA, enabling us to perform an interim data analysis at 18 months. With these regulatory milestones in place, we anticipate FDA approval within three to four years.

Of particular importance, Vaccinogen holds a patent for our proprietary autologous vaccine technology, which grants us exclusive rights until 2039. This patent, numbered 11-351-235 and issued on 06/07/22, serves as a testament to the uniqueness and competitiveness of our approach.

As we move forward, Vaccinogen stands in a truly unique position. Our primary asset, the patent on “Autologous Vaccines and Methods,” has already yielded successful results in Phase IIIA clinical trials, focusing on minimal residual disease colon cancer. This achievement attests to the safety and efficacy of our approach, garnering further confidence in the potential of OncoVAX®.

To facilitate the critical technology transfer required for manufacturing the vaccines and conducting the Phase IIIB trial across the United States, Canada, and Western Europe, Vaccinogen has formed a consortium with two top-tier companies specializing in contract development and manufacturing (CDMO) and contract research (CRO). By assembling this consortium, we aim to expedite trial enrollment, with the first patient being enrolled within six to nine months of securing funding. Furthermore, this collaborative effort minimizes overhead costs and ensures efficient trial initiation.

In our pursuit of partners, we seek individuals and organizations willing to think outside the box and join us in the development, registration, and commercialization of OncoVAX®. Our vision extends beyond Stage 2 colon cancer, as we envision the potential of OncoVAX® in combination with standard care for more advanced stages of various adenocarcinomas. In fact, our Phase IIIB trial will explore the application of OncoVAX® in Stage 3 colon cancer, utilizing an FDA-approved protocol. Additionally, we foresee the development of Humon Monoclonal Antibodies (HuMabs) within OncoVAX® treated patients, potentially unlocking the ability to create adenocarcinoma vaccines for prevention. The neoepitopes coded by combinations of these HuMabs may very well be the key to unlocking new opportunities in cancer treatment.

By partnering with Vaccinogen, you will be at the forefront of personalized cancer immunotherapeutics, revolutionizing the way we combat this devastating disease. Join us on this extraordinary journey to make a lasting impact on the lives of patients and shape the future of cancer treatment.

Michael G. Hanna Jr. PhD
Founder and Director
Vaccinogen Inc.

Savannah, GA 31411

mghannajr@gmail.com
mghannajrphd@vaccinogen-oncovax.com

About Dr. Hanna

Dr. Michael G. Hanna, Jr. is a distinguished scientist and entrepreneur with a significant contribution to the fields of immunology, cancer research, and biotechnology. He obtained his Ph.D. in experimental pathology and immunology from the University of Tennessee (TN, USA).

From 1974 to 1983, Dr. Hanna served as the Director of the National Cancer Institute at the Frederick Cancer Research Center (MD, USA). During this time, he also lent his expertise in immunology as a consultant to NASA for the lunar receiving laboratory, where he played a crucial role in testing the lunar core powder for potential immunogenic or pathogenic materials.

Continuing his career, Dr. Hanna became the Chief Operating Officer of Organon Teknika/Biotechnology Research Institute and Senior Vice President of Organon Teknika Corporation, a subsidiary of Akzo Nobel, The Netherlands, from 1985 to 1994. One of his notable achievements during this period was the development and approval of TICE BCG, a groundbreaking treatment for carcinoma in situ (CIS) bladder cancer. To this day, TICE BCG remains the standard of care for the prophylaxis of recurrence of superficial bladder cancer and therapy of CIS.

In 1998, Dr. Hanna founded PerImmune Inc., which later merged with Intracel Corp. Under his leadership as President and Chief Executive Officer, the company achieved significant milestones in the biotechnology sector. Dr. Hanna continued to contribute as the Chief Scientific Officer and Chairman of Intracel Resources.

In 2007, Dr. Hanna founded Vaccinogen, where he served as Chairman and CEO. Vaccinogen is a pioneering company specializing in cancer vaccines, particularly the development of OncoVAX. This autologous vaccine is designed to elicit a specific immune response against cancer cells and is currently undergoing Phase 3 clinical investigation for the treatment of colon cancer, melanoma, and renal cell carcinoma.

Beyond his contributions to cancer therapy research and development, Dr. Hanna has made significant strides in the field of biodefense and homeland security. He chaired the Department of Commerce Biotechnology Advisory Committee and actively participated in the Department of Defense Technical Working Group for Biotechnology. One notable achievement was the completion of a Department of Defense contract by PerImmune for manufacturing the current effective therapeutic for Botulinum toxin—an equine heptavalent anti-toxin.

Dr. Hanna’s remarkable career has resulted in over 225 publications in international peer-reviewed journals and book chapters. His groundbreaking research has led to the acquisition of 10 patents related to immunotherapy. He is widely recognized for his contributions, receiving numerous honors and awards. Dr. Hanna has also served on various editorial boards, including that of Human Vaccines & Immunotherapeutics, showcasing his commitment to advancing the scientific knowledge in his field.

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