SAN DIEGO -- Vical Incorporated today announced that it has been awarded a three-year, $5.7 million Phase II Small Business Innovation Research (SBIR) grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The grant will partially fund the development of Vical's non-viral DNA vaccine against anthrax, and does not change the company's net loss forecast for 2003.
"We are delighted to receive additional financial support from the NIH for our anthrax vaccine development program," said Vical's president and CEO, Vijay Samant. The company's initial anthrax vaccine research was supported, in part, by an STTR grant from the NIAID, as announced in July 2002. "We continue to make good progress in our anthrax vaccine development program. We have completed preclinical safety studies in rabbits and manufacturing the DNA for the Phase I trial, and we intend to begin human clinical testing in the second half of 2003."
Vical's developmental anthrax vaccine is a cationic lipid/DNA formulation that encodes detoxified forms of both Protective Antigen (PA) and Lethal Factor (LF) anthrax proteins. By targeting both proteins, which combine to form lethal toxin (Letx), the goal is to develop a vaccine that provides broader protection against anthrax than vaccines that target only PA. Preclinical data presented at the American Society of Microbiology (ASM) Biodefense meeting in March 2003, included:
* All PA DNA vaccine formulations stimulated anti-PA immune responses
equal to or greater than the currently licensed vaccine;
* All rabbits immunized with PA DNA vaccine formulations, either alone or
in combination with LF DNA vaccination, survived the inhalation
challenge, indicating protection equivalent to the currently licensed
* All unvaccinated control rabbits died two to four days after challenge,
validating the study procedures and confirming the severity of
inhalation anthrax infection; and
* LF DNA vaccination stimulated anti-LF immune responses and, even when
used alone, provided rabbits with partial protection against the
inhalation challenge, suggesting a potential second means of protection
and supporting its inclusion as a component of a bivalent anthrax
vaccine candidate advancing into human testing.
David C. Kaslow, MD, Vical's chief scientific officer, said, "Our research efforts to date have been encouraging. The challenge study was completed within 10 months of starting research at Vical on anthrax, and the pre-IND meeting with FDA was completed within 12 months of initiating the program. This is a faster pace than the typical development cycle for conventional vaccine technologies. With appropriate guidance from FDA on the new Animal Rule, effectiveness testing could potentially be accomplished using accepted animal challenge models without conducting large clinical efficacy trials in humans before market approval."
Vical researches and develops biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
Source: Vical Incorporated