New and effective cancer treatments are constantly being sought. The most common therapies include radiation and drug treatments, many of which are toxic and harmful to normal cells. In addition, tumor cells may simply develop resistance to chemical and radiation treatments, leading to recurrence of chemo- and/or radio-resistant cancers. The immune system, the body's natural defense system against disease, recognizes malignant and normal cells as essentially the same in persons with cancer. Cancer vaccines are designed to 'boost' the immune system so these abnormal cells are recognized as such and eliminated from the body.


ImmuneFx acts by providing a priming action for the immune system. The priming antigen, Emm55, is supplied to the patient's own tumor cells, allogeneic cell lines or en vivo in the form of a DNA plasmid. The cellular machinery expresses the Emm55 antigen on the surface of the tumor cells. The cells are irradiated so that they cannot divide and then returned to the patient. Because the Emm55 antigen is expressed on the surface of the tumor cells, it alerts body's scavenging cells (antigen presenting cells) to the fact that these cells are now foreign. Once this priming action has initiated the immune response, the antigen presenting cells attack the tumor cells, digest them and display all the antigens, those specific to the tumor cells as well as the Emm55 antigen, to T cells which then initiate a response specific to all the antigens. In this way, a strong immune response is directed to the tumor in a way that was not possible before.


The ImmuneFx cancer vaccine capitalizes on the ability of bacterial antigens to evoke a strong immune response and the ability of the patient's immune system to respond to the presence of the bacterial antigens by directing the force of the immune system specifically to the tumor. In addition to the obvious human medical markets, Morphogenesis is also poised to enter the veterinary cancer market for companion animals. Preclinical studies have shown that the vaccine can be produced for and safely delivered to dogs with naturally occurring lymphoma. In all instance, the ImmuneFx vaccine was well tolerated, produced strong humoral, cellular and clinically relevant anti-tumor responses and elicited no toxic side effects.


Phase I human and canine trials for the ImmuneFx vaccine are expected to begin later this year.