The manufacturing deal with Boehringer fell through after the exchange rate between the Euro and US dollar “became so unbalanced it was no longer cost effective,” John Eldridge, Chief Scientific Officer of Profectus, told Outsourcing-Pharma.com. Prior to the Boehringer partnership, Profectus initially had a manufacturing contract with DSM Biologics until they left the business of manufacturing DNA vaccines, Eldridge added.
He said Boehringer was “a wonderful partner,” but Profectus needed a US-based CMO and Althea passed its audit “with flying colours.”
Under the agreement, Althea will provide gram-scale quantities of cGMP (current Good Manufacturing Practice) plasmid DNA expressing IL-12 (Interleukin 12) to assist Profectus’ ongoing DNA vaccine development efforts. Those efforts are supported by a contract from the US NIH (National Institutes of Health).
As far as the length of the partnership, Eldridge said Althea will be Profectus’ partner “for the foreseeable future for any DNA vaccines.” He noted the difficulty of establishing the right partner and producing a safe and reproducible product.
Profectus’ DNA vaccine work spun out of research from Wyeth in 2008 after about 12 years of development. Profectus kept experienced staff from Wyeth, which was purchased by Pfizer in 2009, as well as two government contracts worth about $90m, one of which is for the plasmid DNA-based vaccines, Eldridge said.
Plasmid DNA Vaccine Development
A Phase I study of the IL-12 adjuvant has just been completed and Eldridge said the findings were recently accepted in the Journal of Infectious Diseases. The forthcoming results show the IL-12 plasmid increases patients’ response rate and enhance immunogenicity, he said.
Profectus has other clinical trials starting up later in the year and all of them will use the IL-12 plasmid as a way to enhance DNA vaccine efficacy. One study funded by the IAVI (International AIDS Vaccine Initiative) in Africa has completed enrolment, and the NIH also recently initiated a follow-on study of DNA priming that has enrolled 73 out of 100 subjects.
Advantages of DNA Vaccines
Calling them “the next generation of vaccines,” Eldridge said DNA vaccines have a number of “practical advantages,” including design simplicity to ease their manufacturing, positive safety profiles and they’re “good at inducing cell-mediated immune response.”
He projected that these vaccines could hit the market within the next 10 years as some are poised to enter Phase II trials soon. DNA-based veterinary vaccines are already on the market so the “utility of DNA vaccines has been proven,” Eldridge said.