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Researchers Submit Patent Application, "Vaccine Adjuvant, Vaccine Composition and Method for Preparing a Vaccine Adjuvant", for Approval

June 30, 2014



By a News Reporter-Staff News Editor at Cancer Vaccine Week -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors PAN, I-Horng (Hsinchu City, TW); LU, I-Haung (Taipei City, TW); YAO, Hsin-Jan (Yunlin County, TW); WU, Hsin-Chieh (Hsinchu City, TW); LIN, Chi-Chien (Nantou City, TW), filed on December 9, 2013, was made available online on June 19, 2014 (see also Industrial Technology Research Institute).

The patent's assignee is Industrial Technology Research Institute.

News editors obtained the following quote from the background information supplied by the inventors: "Vaccine is capable of starting a humoral immune response and then producing antibodies, or activating lymphocytes, such as cytotoxic T cells through a cellular immune response to resist the invasion of a pathogenic organism and prevent occurrence of disease (Cavallo F et al., Vaccination for treatment and prevention of cancer in animal models. Adv Immunol. 2006. 90:175-213. Review). Although vaccines have the effect of activating a subject's immune system, in clinical use, it is often found that the vaccine cannot perform the desired effect in some populations whose auto-immune systems are too weak, such as the aged and children, and thus the addition of the proper amount of vaccine adjuvant is needed. Furthermore, addition of a vaccine adjuvant also has the effect of promoting the immune system to recognize an antigen, and the antigen can be more effectively used through promoting the immune response to decrease the vaccine dosage and vaccine frequency. Therefore, the addition of a vaccine adjuvant not only can decrease the cost of the vaccine, but it can also increase the immune efficiency of the vaccine.

"According to the functions of adjuvants, adjuvants can be classified into two groups. Adjuvants belonging to the first group are used for absorbing antigens and assisting antigens to be phagocytized by cells, such as aluminum salts and M59 emulsifying agent, etc. (O'Hagan D T, Wack A, Podda A. MF59 is a safe and potent vaccine adjuvant for flu vaccines in humans: what did we learn during its development? Clin Pharmacol Ther. 2007 December; 82(6):740-4; 4. Clapp T, Siebert P, Chen D, Jones Braun L. Vaccines with aluminum-containing adjuvants: optimizing vaccine efficacy and thermal stability. J Pharm Sci. 2011 February; 100(2):388-401); adjuvants belonging to the other group are immune regulatory factors, such as CFA-mycobacteria, etc. (Hoft D F, Blazevic A, Abate G, Hanekom W A, Kaplan G, Soler J H, Weichold F, Geiter L, Sadoff J C, Horwitz M A. A new recombinant bacille Calmette-Guerin vaccine safely induces significantly enhanced tuberculosis-specific immunity in human volunteers. J Infect Dis. 2008 Nov. 15; 198(10):1491-501). The main function of a vaccine adjuvant is enhancing the immune activity of an antigen and the immune protective effect, however it has been confirmed that common aluminum salt adjuvants have selectivity for vaccines. Accordingly, the development of a new vaccine adjuvant is needed to promote antigen specificity of the vaccine or the anti-tumor and anti-infection ability of the vaccine."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "The disclosure provides a vaccine adjuvant, comprising: a polysaccharide derived from Antrodia camphorata (also named Antrodia cinnamomea or Taiwanofungus camphoratus) fruiting body, wherein the molecular weight of the polysaccharide is greater than 100 K Da.

"The disclosure also provides a vaccine composition, comprising: the vaccine adjuvant as mentioned above; and an antigen or DNA encoding the antigen.

"The disclosure further provides a method for preparing a vaccine adjuvant, using a polysaccharide derived from Antrodia camphorata (also named Antrodia cinnamomea or Taiwanofungus camphoratus) fruiting body.

"A detailed description is given in the following embodiments with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

"The embodiments of disclosure can be more fully understood by reading the subsequent detailed description and examples with references made to the accompanying drawings, wherein:

"FIG. 1A shows the preparation process for the polysaccharide from the Antrodia camphorata fruiting body (ACFB01) sample;

"FIG. 1B shows the preparation process for the polysaccharide from the Antrodia camphorata fruiting body (ACFB01>100 K) sample;

"FIG. 2 shows the gel filtration chromatography profile for ACFB01>100 K sample;

"FIG. 3 shows the levels of TNF-.alpha. secreted by mouse bone marrow-derived dendritic cells (BMDCs) treated with the polysaccharide of Antrodia camphorata fruiting body, ACFB01 sample, at different doses, and cell viability;

"FIG. 4A shows the levels of TNF-.alpha. secreted by mouse bone marrow-derived dendritic cells (BMDCs) treated with fractions with different molecular weight of ACFB01 sample;

"FIG. 4B shows the levels of TNF-.alpha. secreted by mouse bone marrow-derived dendritic cells (BMDCs) treated with ACFB01>100 K sample at different doses;

"FIGS. 5A and 5B show the levels of IL-6 and IL-12 secreted by mouse bone marrow-derived dendritic cells (BMDCs) treated with ACFB01>100 K sample at different doses (0-20 .mu.g/ml);

"FIGS. 6A, 6B and 6C show the levels of MCP-1, MIP-1.alpha. and RANTES secreted by mouse bone marrow-derived dendritic cells (BMDCs) treated with ACFB01>100 K sample at different doses (0-20 .mu.g/ml), respectively;

"FIGS. 7A, 7B and 7C show expression conditions of CD40, CD86 and MHC class II of mouse bone marrow-derived dendritic cells (BMDCs) treated with ACFB01>100 K sample (20 .mu.g/ml), respectively;

"FIG. 8A shows the effect of ACFB01>100 K sample on T cell proliferation in vitro;

"FIG. 8B shows the effect of ACFB01>100 K sample on expression levels of Interferon-.gamma./IFN-.gamma. and IL-4 in vitro;

"FIG. 9A shows the effect of ACFB01>100 K sample on T cell proliferation in vivo;

"FIG. 9B shows the effect of ACFB01>100 K sample on expression levels of Interferon-.gamma./IFN-.gamma. and IL-4 in vivo;

"FIG. 10A shows the effect of ACFB01>100 K combined with HER-2/neu DNA vaccine on the tumor of C3/HeN mice injected with MBT-2 tumor cells (bladder cancer cell overexpressing HER-2/neu);

"FIG. 10B shows the effect of ACFB01>100 K combined with HER-2/neu DNA vaccine on the life of C3/HeN mice injected with MBT-2 tumor cells (bladder cancer cell overexpressing HER-2/neu);

"FIGS. 11A and 11B show the effect of ACFB01>100 K combined with HER-2/neu DNA vaccine on activation of T cells of C3/HeN mice injected with MBT-2 tumor cells (bladder cancer cell overexpressing HER-2/neu);

"FIG. 11C shows the effect of ACFB01>100 K combined with HER-2/neu DNA vaccine on expressions of IFN-.gamma. and IL-4 of C3/HeN mice injected with MBT-2 tumor cells (bladder cancer cell overexpressing HER-2/neu); and

"FIG. 12 shows the effect of dendritic cell vaccine pulsed with ACFB01>100 K treatment on tumor of the orthotopic liver cancer model."

For additional information on this patent application, see: PAN, I-Horng; LU, I-Haung; YAO, Hsin-Jan; WU, Hsin-Chieh; LIN, Chi-Chien. Vaccine Adjuvant, Vaccine Composition and Method for Preparing a Vaccine Adjuvant. Filed December 9, 2013 and posted June 19, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=3414&p=69&f=G&l=50&d=PG01&S1=20140612.PD.&OS=PD/20140612&RS=PD/20140612

Keywords for this news article include: Antigen-Presenting Cells, Oncology, Immunology, Bone Marrow, Vaccination, DNA Research, DNA Vaccines, Immunization, Bone Research, Immune System, Bladder Cancer, Cancer Vaccines, Dendritic Cells, Medical Devices, Cell Proliferation, Synthetic Vaccines, Biological Products, Mononuclear Phagocyte System.

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Source: Cancer Vaccine Week