Seattle, WA (Press Release) – Juno Thera­peutics, Inc. (NASDAQ: JUNO), a bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive cellular immuno­therapies for the treat­ment of cancer, today announced three license agree­ments to ad­vance its pro­gram in multiple myeloma using gamma secretase inhibitors (GSIs) in com­bi­na­tion with BCMA-directed CAR T cells.

Gamma secretase is an enzyme that cleaves a set of transmembrane proteins, in­clud­ing BCMA. Multiple publications have shown that treat­ment with GSIs can in­crease surface ex­pres­sion of BCMA on tumors, particularly multiple myeloma. Increased cell surface BCMA may in­crease potency of a BCMA-directed CAR T ther­apy¹.

“BCMA appears to be an im­por­tant target for treating patients with multiple myeloma and Juno is dedicated to investigating novel ap­proaches to maximize efficacy for these patients. These licenses open up an im­por­tant ap­proach to im­prove the activity and out­comes for CAR T cells targeted at BCMA,” said Sunil Agarwal, M.D., Juno’s Pres­i­dent of Research and Development. “We plan to begin clin­i­cal trials in 2018 combining a gamma secretase inhibitor with our BCMA CAR T prod­uct can­di­dates.”

Through its agree­ment with Eli Lilly and Company, Juno will acquire a license to the GSI known as LY3039478, a prod­uct can­di­date that has been studied in 411 patients and healthy volunteers. Through its agree­ments with OncoTracker and Fred Hutchinson Cancer Research Center, Juno will gain exclusive rights to intellectual property within the field of com­bi­na­tions of GSIs and BCMA-directed engi­neered T cells.

No other terms from these three trans­actions were disclosed.

About Juno

Juno Thera­peutics is build­ing a fully integrated bio­pharma­ceu­tical com­pany focused on devel­op­ing inno­va­tive cellular immuno­therapies for the treat­ment of cancer. Founded on the vision that the use of human cells as thera­peutic entities will drive one of the next im­por­tant phases in med­i­cine, Juno is devel­op­ing cell-based cancer immuno­therapies based on chi­meric an­ti­gen re­cep­tor and high-affinity T cell re­cep­tor tech­nolo­gies to genetically engi­neer T cells to recog­nize and kill cancer. Juno is devel­op­ing multiple cell-based prod­uct can­di­dates to treat a variety of B-cell malig­nan­cies as well as multiple solid tumors and multiple myeloma. Several prod­uct can­di­dates have shown compelling clin­i­cal responses in clin­i­cal trials in refractory leukemia and lym­phoma conducted to date. Juno’s long-term aim is to leverage its cell-based plat­form to develop new prod­uct can­di­dates that address a broader range of cancers and human dis­eases. Juno brings together inno­va­tive tech­nolo­gies from some of the world’s leading research institutions, in­clud­ing the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute (SCRI), the University of California, San Francisco, and The National Cancer Institute. Juno Thera­peutics has an exclusive license to the St. Jude Children’s Research Hospital patented tech­nology for CD19-directed prod­uct can­di­dates that use 4-1BB, which was devel­oped by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital. Juno’s prod­uct can­di­date JCAR017 was devel­oped in col­lab­o­ration with SCRI and others.

About Fred Hutchinson Cancer Research Center

At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and inno­va­tive ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening dis­eases. Fred Hutch’s pioneering work in bone marrow trans­plan­ta­tion led to the devel­op­ment of immuno­therapy, which harnesses the power of the immune sys­tem to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research pro­gram, as well as the clin­i­cal coordinating center of the Women’s Health Initiative and the inter­na­tional headquarters of the HIV Vaccine Trials Network. For more in­for­ma­tion visit www.fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.

About OncoTracker

OncoTracker, Inc. (“OncoTracker”) is a Los Angeles-based medical diagnostics com­pany, with exclusive rights to the recent and patented discovery of a novel blood bio­marker that monitors the tumor burden of patients with multiple myeloma, CLL, B cell lym­phoma and poten­tially other cancers. In addi­tion, OncoTracker has a broad array of tech­nology, intellectual property and prod­ucts related to thera­peutics, monitoring clin­i­cal trials, predicting success of various ther­a­pies and real-time monitoring effectiveness of ther­a­pies in­clud­ing multiple myeloma, other liquid and solid tumors.

Juno’s Forward-Looking Statements

This press release con­tains “forward-looking state­ments” within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, Section 27A of the Se­cu­ri­ties Act of 1933, and Section 21E of the Se­cu­ri­ties Exchange Act of 1934, in­clud­ing state­ments re­gard­ing Juno’s mission, progress, and business plans; the thera­peutic poten­tial of combining JCARH125, or other engi­neered T cells, with GSIs; and Juno’s planned clin­i­cal trials. Forward-looking state­ments are subject to risks and un­cer­tainties that could cause actual results to differ ma­teri­ally from such for­ward-looking state­ments, and reported results should not be con­sidered as an indi­ca­tion of future per­for­mance. These risks and un­cer­tainties in­clude, but are not limited to, risks asso­ci­ated with: the success, cost, and timing of Juno’s prod­uct devel­op­ment activities and clin­i­cal trials; Juno’s ability to obtain regu­la­tory approval for and to com­mer­cial­ize its prod­uct can­di­dates; Juno’s ability to estab­lish­ a commercially-viable manu­fac­tur­ing process and manu­fac­tur­ing infrastructure; regu­la­tory requirements and regu­la­tory devel­op­ments; success of Juno’s com­pet­i­tors with respect to com­pet­ing treat­ments and tech­nolo­gies; Juno’s dependence on third-party col­lab­o­rators and other contractors in Juno’s research and devel­op­ment activities, in­clud­ing for the conduct of clin­i­cal trials and the manu­fac­ture of Juno’s prod­uct can­di­dates; Juno’s ability to attract and retain key scientific, quality control/assurance, manu­fac­tur­ing or man­agement per­son­nel; Juno’s dependence on Celgene for the devel­op­ment and com­mer­cial­iza­tion outside of North America and China of Juno’s CD19 prod­uct can­di­dates and any other prod­uct can­di­dates for which Celgene exercises an option; Juno’s dependence on JW Thera­peutics (Shanghai) Co., Ltd and its affiliates for the devel­op­ment and com­mer­cial­iza­tion of prod­uct can­di­dates in China; Juno’s ability to obtain, main­tain, or protect intellectual property rights related to its prod­uct can­di­dates; amongst others. For a further description of the risks and un­cer­tainties that could cause actual results to differ from those ex­pressed in these for­ward-looking state­ments, as well as risks relating to Juno’s business in general, see Juno’s Quarterly Report on Form 10-Q filed with the Se­cu­ri­ties and Exchange Com­mis­sion on No­vem­ber 1, 2017 and Juno’s other periodic reports filed with the Se­cu­ri­ties and Exchange Com­mis­sion. These for­ward-looking state­ments speak only as of the date hereof. Juno disclaims any obli­ga­tion to update these for­ward-looking state­ments.

The “About Fred Hutchinson Cancer Research Center” and “About OncoTracker” sections of this press release were provided by Fred Hutchinson Cancer Research Center and OncoTracker, re­spec­tive­ly. Juno disclaims all re­spon­si­bil­ity­ for the accuracy of the content of those sections and the websites or other Internet content referenced therein.

Reference

1. Pont M. “Gamma secretase inhibition in­creases recognition of multiple myeloma by BCMA-specific chi­meric an­ti­gen re­cep­tor modified T cells.” Presented at Annual Meeting of the Society for Immunotherapy of Cancer (SITC). No­vem­ber 8-12, 2017. National Harbor, MD.

Source: Juno.