Colby Pharmaceutical Company Announces Dramatic Results: Novel Technology Increases Influenza Vaccine Protection for Elderly Rhesus Monkeys

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The results show that Colby’s JVRS-100 adjuvant, when used in combination with an influenza virus vaccine, generates enhanced immunity and superior protection of elderly monkeys when challenged with live human flu virus (relative to the vaccine alone).

Colby Pharmaceutical Company (CPC) announces ground-breaking results demonstrating that two inoculations of Colby’s JVRS-100 adjuvant, in combination with Fluzone influenza vaccine, enhance the efficacy of this vaccine in elderly rhesus macaque monkeys and protect these immunized primates against the live influenza virus.

This research was performed in collaboration with investigators at the University of California, the Davis Center for Comparative Medicine, and the California National Primate Research Center. A resulting manuscript, “The effectiveness of influenza vaccination of elderly rhesus macaques is dramatically improved by addition of a cationic lipid/DNA adjuvant,” has now been published in the Advanced Access edition of the Journal of Infectious Diseases. The Journal of Infectious Disease has also included an accompanying editorial entitled, “Towards improved influenza vaccines.”    

The editorial concludes that, “Overall, there is a great need to develop better influenza vaccines for the elderly and other vulnerable groups. The work described by Carroll et al provides another promising approach moving towards human efficacy trials.”

The studies were coordinated by Colby’s VP of Research, Jeff Fairman, Ph.D., in collaboration with Professor Chris Miller, D.V.M., Ph.D., University of California, Davis. Timothy Carroll, PhD, is a postdoctoral scholar at the Center for Comparative Medicine, University of California, Davis, working in Dr. Chris Miller’s lab on eliciting broadly protective antibodies in the rhesus macaque model for human influenza. He also recently presented additional studies at the California National Primate Research Center, entitled, “A whole inactivated H3N2 Influenza A virus vaccine adjuvanted with a cationic lipid/DNA complex (CLDC) protects rhesus macaques from heterosubtypic H1N1 Influenza A virus challenge.”

The Journal of Infectious Disease publication reports the most recent results from Colby’s lead cationic lipid-DNA complex (CLDC), JVRS-100. JVRS-100 has now been shown to be an important adjuvant to enhance immune response [humoral (IgG and IgA)] against human influenza vaccine. The results show that Colby’s JVRS-100 adjuvant, when used in combination with an influenza virus vaccine (the Fluzone 2006-2007 seasonal influenza virus vaccine, (including influenza A/New Caledonia/20/99(H1N1) antigen), generates enhanced immunity and superior protection of elderly Rhesus Macques monkeys when challenged with live human flu virus (relative to the Fluzone vaccine alone).

“The Colby data that was just published in the Journal of Infectious Disease clearly shows the remarkable enhancement of immunity from the JVRS-100 added to the human influenza vaccine Fluzone, as measured by the anti-influenza immune responses. There was a dramatic decrease in virus infection in the monkeys inoculated with the JVRS-100 vaccine. Influenza viral replication was completely, or nearly completely, undetectable,” stated David B. Lewis, M.D., an immunologist at Stanford University and Chairman of the Colby Scientific Advisory Board.

In addition, it is remarkable that after a live flu virus challenge, only the JVRS-100 immunized monkeys had significantly lower levels of virus replication (p<0.01) relative to the control animals who were not immunized with JVRS-100. For example, peak levels of the flu virus were 100-fold lower in the respiratory tract secretions of elderly rhesus monkeys inoculated with Fluzone vaccine with the JVRS-100 added, as compared to the Fluzone vaccine alone monkeys.

Colby’s Chief Executive Officer, David Zarling, Ph.D., MBA, remarked that, “This newly published data, from Colby’s recently completed NIH National Institute of Allergy and Infectious Diseases (NIAID)-funded team, is compelling and timely. These well-controlled experiments clearly demonstrate that the JVRS-100 adjuvanted flu vaccine is ready to go to the next level in clinical development.” He added, “Colby is seeking vaccine partners for the next phase of development of our JVRS-100 vaccine portfolio.”

“Improving the effectiveness of influenza vaccination for the elderly is a critical public health need,” stated Dr. Robert Malone, M.D., M.S., an internationally recognized vaccine expert. He added that, “Dr. Chris Miller and his colleagues at the Center for Comparative Medicine are among the best non-human primate immunologists and vaccine researchers in the world, and I have confidence in their research findings. In these collaborative studies, Colby has now advanced the CLDC adjuvant to the point that JVRS-100 merits expedited human clinical testing when formulated with pandemic influenza and other respiratory virus vaccine candidates.”

Colby is also clinically developing JVRS-100 CLDC as a stand-alone immune activator drug for cancer patients and, in addition, as an immune activating adjuvant, especially in combination with the influenza vaccine for a seasonal human flu and a pre-pandemic H5N1 vaccine. Colby has developed both therapeutic and preventative applications for JVRS-100, primarily for those medical situations where generation of a robust and durable immune response would be challenging, as in elderly or other immune-compromised individuals.

David Zarling will be discussing Colby Pharmaceutical Company at the East Meets West CEO Conference at the Four Seasons Hotel, San Francisco, CA on January 12, 2014 at 1PM PDT.

About Colby

Colby is developing and selling drug candidates from its pipeline of targeted biologic and small molecules. This includes the JVRS-100 CLDC (Cationic Lipid DNA Complex) biopharmaceutical and small molecule targeted drugs that affect immunity. In 2011, Colby focused its biologics product development on JVRS-100 CLDC as a stand-alone therapy in cancer, as well as JVRS-100 CLDC as an adjuvant in combination therapy with specific infectious-virus or infectious-bacteria vaccines and via systemic, intra-lymphnodal, or other administration routes of JVRS-100, in combination with vaccine antigens. The Colby management team has significant licensing and product development experience, having sold two anti-inflammatory CPC-clinical drug candidates in 2011, as well as one late-preclinical CPC-drug candidate in 2010. The company encourages inquiries to dzarling(at)colbypharmaceuticals(dot)com regarding potential partnering, licensing and/or investment.

Colby Contact 1 (650) 333-3150
dzarling(at)colbypharmaceuticals(dot)com
5941 Optical Court, Suite 207, San Jose, CA, 95138

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