CEL-SCI Corporation’s recently announced USPTO approved patent – entitled ‘Method for Inducing an Immune Response and Formulations Thereof’ – will allow the company to extend its intellectual property and expand the application of its LEAPS platform to additional diseases and delivery routes.
SVP of Research, Cellular Immunology at the firm, Daniel Zimmerman, noted that while this patent applied the usage of the platform to infectious diseases “we have a companion case for other conditions we are interested in.”
The LEAPS molecule or conjugate is composed of a peptide antigen known to be critical or very important in that agent's disease process, said Zimmerman. The molecule also has to be immunogenic in certain conditions and has to elicit an effective immune response, whilst remaining highly conserved, he said.
This is then coupled to another peptide derived from the host and known to be important in delivering and evoking the appropriate immune response to control or eradicate the disease agent or process.
This then allows the delivery of this conjugate to the host before infection as a preventative agent or if delivered to the infected host as a therapeutic agent, he noted.
The company recently announced another patent for a particular LEAPS molecule for rheumatoid arthritis, which is supported by $1.5m in grants from the National Institutes of Health (NIH). The LEAPS rheumatoid arthritis candidate is known as CEL-400 and the company intends to file an IND with the FDA upon the completion of preclinical studies.
That patent allows for the extension of the LEAPS technology beyond the company's conventional delivery routes – such as intramuscular or intradermal delivery often using adjuvants – into other non-standard routes of delivery such as utilising dendritic cells or regulatory T-cells, said Zimmerman.
It also allows the combined coupling of LEAPS with drugs or markers which could be used to locate labelled cells, he added.
The Virginia-headquartered company’s most advanced program is a Phase III cancer immunotherapy focused on patients with newly diagnosed head and neck cancer. The Phase III therapy, called Multikine, is a leukocyte interleukin injection which is administered to patients before they have received any other therapy, such as radiotherapy or chemotherapy.