Aduro Biotech And Protein Potential LLC Present Data Demonstrating Novel Vaccine Offers 100% Protection In Malarial Model

BERKELEY, Calif. and ROCKVILLE, Md., Oct. 28, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) and privately-held Protein Potential LLC today announced the presentation of preclinical data demonstrating that a two-component vaccine regimen protected 100 percent of mice challenged with a rodent malaria parasite. The vaccine stimulates an immune response that targets the circumsporozoite protein (CSP) antigen of Plasmodium falciparum (Pf), the parasite responsible for nearly all malaria deaths. One of the two components utilizes Aduro’s LADD technology which stimulates primarily a cellular response to CSP. The second is composed of Protein Potential’s recombinant PfCSP antigen (rPfCSP) which stimulates primarily a humoral response. The combination of cellular and humoral responses is believed to be essential for long-lasting protection against malaria.

“The Plasmodium falciparum parasite is able to adapt to the human host and evade its immune response very effectively and to date, the most effective subunit, recombinant vaccine prevents infection by malaria parasites in only 30-50% of those immunized,” commented B. Kim Lee Sim, Ph.D., president and chief scientific officer of Protein Potential. “In order to be broadly adopted by travelers and the military, a vaccine must provide more than 80% protection against infection for at least six months. There is a significant need for more effective vaccines for malaria and we believe the data shared today represent a very positive first step. We look forward to IND-enabling studies and clinical testing in humans.”

Aduro and Protein Potential obtained a Small Business Innovative Research (SBIR) grant from the National Institutes of Health to explore the development of a malaria vaccine that protects against Plasmodium falciparum. The vaccine is engineered to target two different stages of the parasite life cycle, thereby preventing infection, disease, and transmission. The data presented today, in a poster entitled ‘Inducing Both Protective Antibodies and CD8 T Cells by Prime-boost with Live Attenuated Vaccine,’ demonstrate that all immunized mice were completely protected against sporozoite challenge with a transgenic rodent malaria parasite, which expressed PfCSP in place of P. berghei CSP. The combination vaccine induced very high levels of antibodies against the malaria parasite as well as robust CD8+ and CD4+ T cell responses. The high titers of inhibitory antibodies, as assessed by inhibition of liver stage development, confirmed the functional immune response.

“The Centers for Disease Control estimate that the global economic burden of malaria is over $12 billion annually,” said Tom Dubensky, Ph.D., chief scientific officer of Aduro. “With more than 200 million cases annually and close to half of the world population at risk for contracting malaria, there is a desperate need to develop new vaccines that prevent the spread of this disease. Importantly, this is a significant validation of our LADD technology platform to provide protective CD8 T cell immunity in an infectious disease indication. We look forward to a continued collaboration with Protein Potential.”

About LADD

LADD is Aduro's proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent humoral immune response and express antigens to induce infectious disease T cell-mediated immunity. Currently used in Aduro’s immuno-oncology portfolio, the LADD technology platform has potential to be applied broadly to indications where the immune system must mount a response, including in infectious disease.

About Malaria

Malaria is an infectious disease and one of the most severe public health problems worldwide. According to the World Health Organization, there are approximately 200 million cases and almost 600,000 deaths annually due to malaria. Half of the world’s population (3.4 billion people) live in areas at risk of malaria transmission, with a majority of cases and deaths in sub-Saharan Africa. Infected female Anopheles mosquitoes spread the Plasmodium parasites to people through their bites, which occur primarily between dusk and dawn. All international travelers, and young children, pregnant women and immune-compromised people living in malarious regions are at increased risk for contracting malaria.

About Protein Potential

Protein Potential’s R&D program is focused on vaccine development for infectious diseases including Plasmodium falciparum and Plasmodium vivax malaria, anthrax, plague, and shigellosis. Protein Potential combines expertise in protein expression, process development, and documentation with the technical know-how to transition candidate vaccines through large-scale cGMP manufacturing. In addition, the company develops and conducts assays required to release vaccines for clinical use and assess the immunogenicity of candidate vaccines in human subjects. Protein Potential’s Products and Services group provides high quality recombinant proteins and DNA constructs to corporate, government, and academic clients. The company’s administrative, laboratory, and production facilities are located in Rockville, Maryland. Additional information about Protein Potential is available at the company’s web site

About Aduro

Aduro Biotech, Inc. (Nasdaq:ADRO) is a clinical-stage immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro’s cyclic dinucleotide (CDN) platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit .

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our technology and the potential for developing a malaria vaccine. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in the most recent Form 10-Q which is on file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264

Media Contact:
Angela Bitting
925 202 6211

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