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Press Release

Aduro Biotech Presents Early Observations From its Personalized Neoantigen-based pLADD Therapy Clinical Study at European Neoantigen Summit


Posted on: 26 Apr 18

pLADD Therapy Found to Induce Both Innate and Adaptive Immunity

BERKELEY, Calif., April 26, 2018 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today presented preliminary observations from a case study of a patient with metastatic colorectal cancer treated in Aduro’s ongoing Phase 1 study of its personalized neoantigen-based immunotherapy (pLADD). This Phase 1 proof-of-concept study is designed to evaluate the safety and tolerability of pLADD immunotherapy in adults with metastatic colorectal cancer that is microsatellite stable (MSS). Data were presented at the European Neoantigen Summit held in Amsterdam (April 24-26, 2018).

The immunological data presented demonstrated that neoantigens isolated and sequenced from the patient’s tissue samples, and engineered into a personalized immunotherapy, induced neoantigen-specific CD8+ T cells undetectable before pLADD treatment started. In addition to adaptive immunity, pLADD induced an innate response exemplified by gamma delta T cells, also thought to be important for successful immunotherapy. The patient’s neoantigens were selected using state-of-the-art algorithm identification technology developed by Aduro’s collaborator, Hanlee Ji, M.D., associate professor of medicine at the Stanford University School of Medicine. 

“Although early, the immunological data obtained from this case study is encouraging, as it indicates that our pLADD immunotherapy has the potential to induce a sustained, antigen-specific effect on the immune system,” said Andrea van Elsas, Ph.D., chief scientific officer of Aduro. “We believe our pLADD approach could offer a differentiated treatment option to patients with MSS colorectal cancer, who represent the vast majority of the colorectal cancer patient population and who have not been responsive to immune checkpoint inhibitors. In addition, these preliminary observations support our plan to combine pLADD with checkpoint inhibitors, which we believe could enhance the overall response in this patient setting. We look forward to reporting additional immunological data from this Phase 1 trial before the end of 2018.”

Preclinical data presented showed that mouse pLADD strains targeting tumor-specific neoepitopes induced a robust immune response, including induction of cytokines, chemokines, and antigen-specific CD8+ T cells.  In preclinical models of pLADD, remodeling of the tumor microenvironment with an increase in the CD8:Treg ratio was observed. The combination of pLADD with an anti-PD-1 antibody led to a sustained immune response and significantly improved efficacy in these mouse tumor models.  

Clinical Design of Phase 1 pLADD Trial in Adults with Metastatic Corlorectal Cancer
The Phase 1 single-arm clinical trial (see www.clinicaltrials.gov, identifier NCT03189030) is designed to evaluate the safety and tolerability of a personalized immunotherapy using patient-specific neoantigens and Aduro’s proprietary Listeria platform technology. The trial is enrolling patients with metastatic colorectal cancer that is microsatellite stable. 

About pLADD
Personalized LADD, or pLADD, is a second-generation LADD technology that is designed to leverage the immune-activating activity of the Listeria bacterial vector in combination with neoantigens, which are unique, patient-specific tumor markers exclusively expressed in an individual’s tumor cells.  Once administered, pLADD therapies are expected to mobilize the immune system in two ways--first, through the immediate recognition of the presence of Listeria as being foreign, and subsequently, through a specific and customized immune attack on cells containing the tumor neoantigens presented by pLADD. 

To create a patient-specific pLADD therapy, a physician begins by removing tumor cells from the patient.  These cells are analyzed in order to molecularly characterize (sequence) the tumor, including any mutations that are unique to the patient’s own tumor cells. Predictive algorithms for antigen processing are run to identify pertinent tumor antigens. Aduro then creates a pLADD strain engineered to enable the presentation of multiple selected neoantigens in dendritic cells, with the aim of inducing a targeted, robust anti-cancer immune response. 

Aduro received an exclusive license (for use with Listeria based therapetutics) to the proprietary bioinformatics algorithms and computational workflows for neoantigen identification and selection from Stanford University based on technology developed by Dr. Hanlee Ji. The accurate identification of neoantigens, tumor markers that are unique to an individual’s tumor, is believed to be critical in the development of a patient-specific cancer treatment.  Aduro’s LADD technology, which has been shown in clinical studies to remodel the tumor microenvironment, will be used to create a patient-specific immunotherapy that is engineered to enable the presentation of multiple selected neoantigens in dendritic cells, with the aim of inducing a targeted, robust anti-cancer immune response. 

About Aduro
Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that are intended 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 STING Pathway Activator platform is designed to activate the STING receptor in immune cells, resulting in a potent tumor-specific immune response. ADU-S100 is the first STING Pathway Activator compound to enter the clinic and is currently being evaluated in both a Phase 1 monotherapy study as well as a Phase 1b combination study with an anti-PD1 immune checkpoint inhibitor. Aduro’s B-select monoclonal antibody platform, including BION-1301, an anti-APRIL antibody, is comprised of a number of immune modulating assets in research and development. Aduro's pLADD program is based on proprietary attenuated strains of Listeria that have been engineered to express tumor neoantigens that are specific to an individual patient’s tumor. Other Listeria strains for lung and prostate cancers are being advanced by a partner. 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 for our technology platforms, plans, anticipated timing for the commencement and completion of various clinical trials and the announcement of data relative to these trials and the potential for eventual regulatory approval of our product candidates. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “plan,” “anticipate,” “intend,” “could,” “project,” “seek,” “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 ability to obtain and maintain regulatory approval of our product candidates, our ability 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 our quarterly report on Form 10-K for the year ended December 31, 2017, which is on file with the Securities and Exchange Commission. 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.

Contact: Media Contact:
Jennifer LewAljanae Reynolds
Chief Financial Officer510 809 2452
510 809 4816press@aduro.com                                                                                     
GlobeNewswire
globenewswire.com

Last updated on: 26/04/2018

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