Johnson & Johnson’s Janssen Biotech is terminating a pair of collaborations to develop lung and prostate cancer treatments with Aduro Biotech that were launched in 2014 and could have generated more than $1.182 billion for the Berkeley, CA, immunotherapy developer, Aduro has disclosed.

In a regulatory filing yesterday, Aduro acknowledged that it will regain global rights to develop and commercialize the cancer vaccines ADU-214, ADU-741, and GVAX Prostate for any and all uses, after receiving from Janssen a written notice from Jansen of the terminations, which take effect December 24.

ADU-214, which Janssen named JNJ-64041757, is an immunotherapy based on Aduro’s live, attenuated double-deleted Listeria (LADD) technology platform that is being developed for the treatment of advanced or metastatic non-small cell lung cancer.

On June 7, Aduro said it had launched a Phase Ib study (NCT03371381) assessing ADU-214 in combination with Bristol-Myers Squibb’s marketed cancer immunotherapy Opdivo® (nivolumab) in advanced lung cancer. The study was active but not recruiting patients as of the most recent update September 25 on

ADU-741, which Janssen named JNJ-64041809, is a LADD immunotherapy product candidate indicated to treat prostate cancer. GVAX Prostate is one of Aduro’s GVAX vaccines derived from human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine.

Janssen and Aduro agreed in May 2014 to partner in developing new prostate cancer treatments using Aduro’s LADD immunotherapy platform. Aduro granted Janssen an exclusive global license for those treatments in return for Janssen agreeing to pay Aduro up to $365 million in upfront license fees and payments tied to achieving defined but undisclosed development, regulatory, and commercialization milestones, plus tiered royalties on worldwide net sales.

Aduro acquired GVAX Prostate in 2011 from BioSante Pharmaceuticals (in turn acquired in 2013 by ANI Pharmaceuticals), in a licensing deal covering two cancer vaccine candidates; the other was GVAX Pancreas.

Five months later in October 2014, the companies expanded their collaboration into lung cancer treatments, with Janssen agreeing in return to pay Aduro up to $847 million in upfront fees and payments tied to development, regulatory and commercialization milestones.

Aduro received $30 million upfront and $21 million in milestone payments in 2015 tied to ADU-214, and $12.5 million upfront and $30 million upfront $10 million in milestone payments in 2015 tied to ADU-741 and GVAX Prostate, the company disclosed in its most recent Form 10-Q quarterly filing for the second quarter.

Refocusing on ADU-S100, BIO-1301

Aduro said in yesterday’s filing that it had prioritized advancement of its lead STING pathway activator ADU-S100 and its anti-APRIL antibody BION-1301. The latter is a humanized monoclonal antibody directed against A PRoliferation-Inducing Ligand) antibody (APRIL) being developed for the treatment of relapsed or refractory multiple myeloma, the subject of a Phase I/II study (NCT03340883).

On April 17 at the American Association for Cancer Research Annual Meeting (AACR), held April 14-18 in Chicago, Aduro trumpeted positive preclinical data for ADU-S100, a first-in-class small molecule therapeutic in a Phase I studies targeting the STimulator of INterferon Genes (STING) pathway. The data showed that an optimized dosing regimen of ADU-S100 administered intratumorally activated acute innate immunity as well as adaptive CD8+ T cells needed for systemic and durable antitumor immunity, the company said at the time.

ADU-S100 is the subject of a Phase I study (NCT02675439) alone and in combination with Bristol-Myers Squibb’s marketed cancer immunotherapy Yervoy® (ipilimumab) in advanced/metastatic solid tumors or lymphomas, and a Phase I study (NCT03172936) in combination with Novartis’ PDR001, an anti-PD-1 compound, also in advanced metastatic solid tumors and lymphomas.

Aduro also said it will complete its personalized LADD (pLADD) ongoing Phase I monotherapy trial (NCT03189030), “treating up to a total of 13 subjects in accordance with the current protocol.” The study—which previously envisioned 28 participants—was active but not recruiting patients as of the most recent update September 26 on

Shares of Aduro fell 13% from yesterday’s closing price of $7.18 in market trading this morning, to $6.23 as of 10:20 a.m.

Janssen’s termination of the Aduro collaborations comes nearly two weeks since Aduro announced the departure of Natalie R. Sacks, M.D., as CMO, effective yesterday, without offering an explanation. She will continue to provide counsel to the company as a consultant, Aduro added.

Aduro is the second company with which Janssen has terminated a collaboration in less than a week. On September 27, Janssen and Geron said the companies ended a nearly four-year-old collaboration to develop the blood cancer candidate imetelstat, citing only “a strategic portfolio evaluation and prioritization of assets” within its portfolio.

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