Viral Gene Announces Breakthrough in Colon Cancer

Philadelphia, PA – October 28, 2016 – Colorectal cancer kills more than 49,000 Americans each year and is the second-leading cause of cancer deaths in the United States. Dr. Scott Waldman, professor and chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, and Dr. Adam Snook, Instructor in that department, with a team from Jefferson’s Departments of Microbiology and Immunology, Dermatology and Cutaneous Biology, and Medical Oncology, have pioneered an innovative vaccine to stop the spread (metastases) of cancers originating in the gastrointestinal tract, including cancers of the colon, rectum, pancreas, stomach, and esophagus.

Targeted Diagnostics & Therapeutics, Inc., a biotechnology company headquartered in Exton, PA, obtained the worldwide exclusive rights to this and other technology from Thomas Jefferson University, in 1994; and since then, has been supporting the work in Dr. Waldman’s laboratory. After 15 years of research, and numerous pre-clinical lab and animal studies to evaluate biological activity and safety, Dr. Waldman filed an Investigational New Drug Application (IND) that was approved by the FDA in 2013. A Phase I clinical trial was successfully completed over a 2-year period in 2015. During Phase I, the vaccine was tested in 10 stage I and II colon cancer patients to determine its safety, tolerability and immunological efficacy.

Viral Gene Inc., was established to obtain funding for, and conduct, the Phase II trial for this vaccine. Viral Gene was granted a worldwide exclusive license and marketing rights for this vaccine technology from Targeted Diagnostics & Therapeutics, Inc. The trial will include patients with the targeted cancers, to assess the vaccine’s efficacy in blocking metastatic disease and improving patient survival. Alpha Holdings, Inc. (117670.KQ), formerly Alphachips Corp., is a Korean-based company that has invested 10 billion Korean Won ($8.7 million) in Viral Gene, to fund the Phase II trial and bring the vaccine to market. Alpha is engaged in the manufacture of system semi-conductors and has a vast product portfolio consisting of integrated circuitry (ICs) for security cameras and encryption, mobile multimedia and communications, wireless and timing controllers, and provides system on chip design (SoC) for Samsung group. Alpha is also Viral Gene’s largest shareholder. Trial completion should take about two years, and both companies plan to conduct a Korean trial for the Asian market under the direction of Dr. Waldman.

In the early 1990s, Dr. Waldman first identified Guanylyl Cyclase C (GCC), a protein shown to be highly accurate in detecting the spread and recurrence of colorectal cancer whether in lymph nodes or blood. The vaccine, which targets GCC, instructs the immune system to recognize and destroy specific metastatic cancer cells.

In addition to the Phase II trial, Viral Gene plans to apply to the FDA for Orphan Drug Status through its Office of Orphan Products Development (OOPD). OOPD’s mission is to advance the evaluation and development of drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases, conditions which affect fewer than 200,000 people, or affect more than 200,000 people but are not expected to recover the costs of developing and marketing a treatment drug. Should orphan drug status be approved and the phase II trial demonstrates efficacy, the vaccine would then fast-track directly to market.

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