BERKELEY, Calif., Jan. 05, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that two patents have been issued by the U.S. Patent and Trademark Office covering composition and methods related to its LADD and GVAX immunotherapy technologies.
Patent 9,198,960 claims methods for enhancing an immune response to mesothelin by administering first a “prime” dose of an inactivated tumor cell containing a nucleic acid that encodes granulocyte macrophage-colony stimulation factor (GM-CSF) followed by a “boost” dose of an immunotherapy comprising an attenuated Listeria that encodes an expressible, immunologically active portion of mesothelin. The patent also specifically claims the method for Aduro’s live attenuated double deleted (LADD) platform containing deletions of the actA and inlB genes within Listeria. The nominal expiration date for this patent is July 17, 2027, subject to any extensions that may be available. Aduro has demonstrated in a randomized 93-patient Phase 2a clinical trial in metastatic pancreatic cancer that the claimed prime-boost approach utilizing its LADD and GVAX immunotherapies resulted in significant improvement in overall survival when compared to GVAX alone. The company is currently evaluating this regimen against single agent chemotherapy in the randomized Phase 2b ECLIPSE trial and also in combination with the PD-1 immune checkpoint blocker, nivolumab in the randomized Phase 2b STELLAR trial.
Patent 9,200,057, which is jointly owned with Providence Health & Services, claims compositions containing a bacterium or virus which comprises a nucleic acid encoding at least three copies of an EGFRvIII polypeptide, a tumor-specific neo-antigen, which facilitates both antigen expression levels and immunogenicity. Aduro is collaborating with Providence on an investigator-sponsored trial of its LADD immunotherapy containing EGFRvIII and NY-ESO-1, ADU-623 for which Aduro has exclusive rights, to evaluate treatment of high-grade glioma, a form of brain cancer. The EGFRvIII tumor-associated antigen is also being utilized by Aduro for other exclusively-owned LADD-based vaccine strains directed to additional cancer types. The nominal expiration date for this patent is November 17, 2031, subject to any extensions that may be available.
“These two patents are important expansions of our patent estate, encompassing claims associated with our therapeutic approaches and extending patent coverage into 2031,” said Thomas Dubensky, Jr., chief scientific officer of Aduro. “These newly issued patents are illustrative of our objective to maintain a leadership position and we look forward to continued advancements, including key data announcements from randomized studies this year.”
LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).
GVAX a family of immunotherapies derived from human cancer cell lines that are genetically modified to express granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune system-stimulating cytokine. GVAX Pancreas, the company’s lead approach in this platform, is derived from human pancreatic cancer cell lines and is designed to activate specific T cell immunity to pancreatic cancer antigens, including mesothelin.
Aduro Biotech, Inc. 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’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
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 benefits of patents 9,198,960 and 9,200,057, the potential for CRS-207, GVAX Pancreas and our other product candidates and the potential for eventual regulatory approval, commercialization and launch of our product candidates. 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.
SVP, Corporate Affairs
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Mike BeyerSam Brown, Inc.
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Aduro Biotech, Inc.