Berkeley, CA (Press Release) – Aduro Biotech, Inc. (NASDAQ: ADRO) today announced that the United States Patent and Trademark Office has issued a new composition of matter patent related to altered APRIL-binding anti­bodies, further enhancing the com­pany’s B-select intellectual property port­folio. Specifically, the granted claims cover BION-1301, Aduro’s first-in-class anti-APRIL anti­body being eval­u­ated in a Phase 1/2 dose escalation trial for the treat­ment of multiple myeloma.

“Blocking APRIL rep­re­sents a unique ap­proach to treating patients with multiple myeloma and we believe BION-1301 has poten­tial to treat a myriad of on­col­ogy indi­ca­tions as well as other auto­immune and inflammatory dis­eases,” commented Stephen Isaacs, chairman and chief exec­u­tive officer of Aduro Biotech. “Ensuring a robust intellectual property position around BION-1301 is in­her­ent to ad­vanc­ing the pro­gram and the claims granted in this particular patent exemplify the novel science behind this exciting pro­gram.”

U.S. patent 9,969,808 adds to pre­vi­ously issued U.S. and inter­na­tional counterpart patents and patent appli­ca­tions that form Aduro’s APRIL patent port­folio. Claims were granted on the basis that BION-1301 enables full blockade of APRIL binding to both its re­cep­tors BCMA and TACI. Preclinical studies have dem­onstrated that blocking APRIL with BION-1301 not only inhibited pro­lif­er­a­tion and sur­vival of multiple myeloma cells but also alleviated drug resistance and immune sup­pres­sion, leading to en­hanced myeloma cell killing.¹ Further pre­clin­i­cal re­search by Aduro and its col­lab­o­rators in­di­cate that blocking APRIL further en­hances anti-BMCA cytotoxic cell killing and that prevention of APRIL binding to TACI may also be a poten­tially im­por­tant mech­a­nism for BION-1301 to inhibit the function of regu­la­tory T cells.²

About APRIL

APRIL (A PRoliferation-Inducing Ligand) is a member of the tumor necrosis factor (TNF) superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA (B cell maturation an­ti­gen) and TACI (Transmembrane Activator and CAML Interactor) to stim­u­late a wide variety of re­sponse­s that promote multiple myeloma growth and sur­vival and sup­press the immune sys­tem so that the tumor cells are pro­tected and sustained in the bone marrow.

About BION-1301

Aduro is cur­rently eval­u­ating BION-1301, its most ad­vanced pro­pri­e­tary B-select mono­clonal anti­body, as a novel ther­apy for multiple myeloma. Despite new treat­ments recently approved in multiple myeloma, this dis­ease remains incurable as patients relapse, or be­come resistant to, cur­rently-available ther­a­pies. In pre­clin­i­cal studies, Aduro has estab­lish­ed that A PRoliferation-Inducing Ligand (APRIL) plays a crucial part in the pro­tective bone marrow tumor microenvironment. In these studies, APRIL, through the B cell maturation an­ti­gen (BCMA), was shown to be critically in­volve­d in the sur­vival, pro­lif­er­a­tion and chemoresistance of multiple myeloma, and upregulates mech­a­nisms of immuno­resistance, in­­clud­ing PD-L1 upregulation. BION-1301, a humanized anti­body that blocks APRIL from binding to its re­cep­tors, has been shown in pre­clin­i­cal studies to halt tumor growth and over­come drug resistance. In addi­tion, BION-1301 also dem­onstrated the ability to inhibit immune sup­pres­sive effects of regu­la­tory T cells via TACI but not BCMA in multiple myeloma blood and bone marrow. BION-1301 is cur­rently being eval­u­ated in a Phase 1/2 clin­i­cal study.

About Aduro

Aduro Biotech, Inc. is an immuno­therapy com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of ther­a­pies that are in­tended to 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 BION-1301, the breadth and strength of our APRIL patent port­folio and our ability to ad­vance our drug devel­op­ment pro­grams. In some cases you can identify these state­ments by for­ward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “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-Q for the quarter ended June 30, 2018, 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.

References:

1. Yu-Tzu Tai et al.. "APRIL and BCMA promote human multiple myeloma growth and immuno­suppression in the bone marrow microenvironment." Blood 127, no. 25 (2016): 3225-3236. Accessed August 16, 2018. doi: 10.1182/blood-2016-01-691162.
2. Liang Lin et al.. "A First in Class APRIL Fully Blocking Antibody Targets Novel Immune Regu­la­tion of APRIL in Multiple Myeloma: Further Therapeutic Implication." Blood 130, no. Suppl 1 (2017): 499. Accessed August 16, 2018. http://www.bloodjournal.org/content/130/Suppl_1/499.

Source: Aduro.