On January 05, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO) reported 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 (Press release, Aduro BioTech, JAN 5, 2016, View Source [SID:1234508662]).

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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."

About LADD

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.).

About GVAX

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.