Vaccinogen Announces Filing of Oncavert® Patent Application

Establishing a Concept and Pathway to the Development of an Adenocarcinoma Prevention Vaccine

Jun 16, 2016

BALTIMORE, June 16, 2016 /PRNewswire/ -- Vaccinogen, Inc. (OTC.QB: VGEN), a cancer immunotherapy development company, today announced a significant intellectual property milestone with the filing of its Oncavert® patent application. 

The Oncavert® patent application relates to methods for characterizing antigenic determinants, which broadly define adenocarcinomas with the guidance of human monoclonal antibodies (HuMabs) reactive to such epitopes. One aspect involves characterization of the critical antigenic determinants (epitopes) with a high degree of inter- and intra-tumor incidence across a broad range of adenocarcinomas. The patent application also relates to the physical recapitulation of the epitopes, generating a cohort of specific peptides, which may be useful for vaccinating humans against a wide range of adenocarcinomas using a limited number of homogeneous tumor antigens.  Vaccinogen currently has a cohort of antibodies demonstrating known specific cross reactivity with colon tumors and more broadly with a representative variety of adenocarcinomas. The Oncavert® research plan is to expand the cohort by developing more HuMabs from future OncoVAX® treated patients and skin testing the epitopes and or the peptides in other OncoVAX® immunized patients.

Michael G. Hanna Jr., Ph.D., Vaccinogen's Founder, Director, Chairman Emeritus, and discoverer of OncoVAX® and co-discoverer of Oncavert®, stated, "No current tools exist in our cancer treatment armamentarium that can match the specificity of long-term immune surveillance. By way of comparison, if patients were to present with smallpox today, modern medicine can provide little more than supportive care. However, by appropriately training the immune system to prevent infection, we have eradicated the problem from our species. By focusing on prevention, rather than treating advanced disease, smallpox has been completely eliminated as well as similar infectious agents such as pox, polio, measles, guinea worm disease among others.  With Oncavert®, we believe cancer will soon follow."

With Oncavert®, Vaccinogen's migration into prevention of cancer is based on its decades-long position that patient-specific immunotherapy and targeting cancer specific antigens prior to widespread metastasis is essential.  Vaccinogen is now declaring that timing is appropriate to pursue cancer immuno-prevention. Vaccinogen's patient specific active immunotherapy, OncoVAX®, causes an agnostic immune system to create and affect an immediate clinical benefit and establish long-term immune surveillance to prevent cancer recurrence.  In addition, certain unique, broadly reactive antibodies are created.

Vaccinogen's view has been that adenocarcinomas are multi-clonal with inter- as well as intra-genomic heterogeneity. Therefore, a single protein product targeted approach to treatment is extremely problematic. However, for early intervention, the specific antibody homogeneity uncovered during OncoVAX® treatments has become the basis for Oncavert®, which Vaccinogen believes may provide a pathway for developing a generic adenocarcinoma prevention vaccine.

Dr. Hanna continued, "Evaluating and characterizing the humoral and cell-based responses within its previous and upcoming clinical trials, Vaccinogen intends to identify the molecular determinants most suitable to accomplish treatment of occult disease which leads to metastasis and the resources to develop Oncavert® as a prophylactic adenocarcinoma vaccine."

Andrew L. Tussing, Chairman & Chief Executive Officer of Vaccinogen, concluded, "We at Vaccinogen are grateful to Oncavert®'s co-inventors, Drs. Michael Hanna and Jason Howard for their outstanding breakthrough work.  We find ourselves in an exciting time in cancer immunotherapeutic research.  This renaissance is occurring in parallel with advancements in technology designed to identify and exploit these pathways for clinical gain. As a field, we must grasp this opportunity and broaden our focus from curing cancer to preventing cancer."

About Vaccinogen, Inc.
Vaccinogen, Inc. is a cancer vaccine company planning to clinically test OncoVAX®, a treatment designed to prevent the recurrence of stage II colon cancer and potentially other solid tumors. It is a patented process intended to leverage a patient's own live tumor cells to launch a broad immune response against minimal residual disease. Vaccinogen believes that OncoVAX®, at an optimal dose and regimen, is the first colon cancer vaccine to demonstrate effectiveness in preventing cancer recurrence after surgical resection by addressing the diversity of cancer cells inherent to each patient's tumor. This approach has been shown in clinical trials to possess the 4 P's necessary for patient specific active immunotherapy, Personalized, Precision, Potency and PreventionNon-detectable metastasis has been prevented after surgery in the majority of treated patients. Five clinical studies of OncoVAX®, including a statistically significant phase III trial with the optimum dose and regimen, have been completed. Vaccinogen has also secured an option agreement to acquire a high-throughput, single-cell screening and analysis system known as DiCAST, which the company expects to use to screen patient-derived biological samples in order to accelerate its human monoclonal antibody (HuMab) program for the development of next-generation cancer vaccines and immunotherapies. More information is available at www.vaccinogeninc.com.

Forward Looking Statement
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipates", "believe", "plan", "intend", "expect", "likely", "may", "should", "will" and similar references to future periods. Vaccinogen has based these forward-looking statements largely on its expectations and projections about future events and trends affecting the financial condition and/or operating results of our business. Forward-looking statements involve risks and uncertainties; particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and the risks associate with the company's continuing efforts to obtain adequate funding to pursue its goals.  In addition, these forward-looking statements involve risks and uncertainties outlined in our most recent periodic reports filed with the Securities and Exchange Commission. There are important factors that could cause actual results to be substantially different from the results expressed or implied by these forward-looking statements. Therefore, you should not rely on these forward-looking statements. Vaccinogen does not undertake any obligation to update this forward-looking information

SOURCE Vaccinogen, Inc.

For further information: Jason Rando /Joshua Drumm, Ph.D., Tiberend Strategic Advisors, Inc., 212-375-2665 / 2664, jrando@tiberend.com, jdrumm@tiberend.com


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