3 Months After Launching a Phase Ib Trial, Janssen Terminates Collaboration Deal with Aduro Biotech
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The original deal was launched on October 13, 2014 and later amended on November 11, 2015. Under the deal, Aduro gave Janssen an exclusive, worldwide license to research, develop, manufacture, sell and “otherwise exploit” products that have ADU-214, ADU-741 and GVAX Prostate. The terms of the agreement provided Aduro with up to $365 million in upfront license fees and milestone payments, some of which have been paid out. The deal had a potential value of $766 million with high single-digit to low teen royalties. So far, Aduro had received a $30 million upfront payment and a $21 million milestone payment.
Aduro’s LADD platform uses live-attenuated double-deleted Listeria monocytogenes strains of bacteria engineered to stimulate an innate immune response and to express tumor-associated antigens that stimulate tumor-specific T cell-mediated immunity. Its GVAX is a family of vaccines made up of human cancer cell lines genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine. The GVAX portfolio includes vaccines for pancreatic, prostate, colon and breast cancers in addition to multiple myeloma.
Overall, Aduro has three specific tech platforms, all designed to exploit the body’s natural immune system. They are LADD, TING and the B-select monoclonal antibody platform.
On June 7, Aduro initiated a Phase Ib clinical trial of ADU-214 in combination with Opdivo (nivolumab) to treat advanced lung cancer. ADU-214 is based on the LADD tech platform. Janssen was conducting the global trial.
The trial was designed to evaluate the safety and efficacy of ADU-214 in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab). The trial was focused on patients with mesothelin-positive, relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung.
At the time, Stephen T. Isaacs, chairman, president and chief executive officer of Aduro stated, “Based on single agent data from a Phase I dose-escalation study in patients with advanced-stage relapsed or refractory non-small cell lung presented at the 2017 International Association for the Study of Lung Cancer’s World Conference, Janssen made the decision to advance ADU-214 in combination with an anti-PD-1 checkpoint inhibitor. The initial data demonstrated that five out of nine patients treated with single-agent ADU-214 achieved a best response of stable disease, with one patient having received 25 cycles of treatment at the time of data cut off.”
According to Aduro’s 8-K filing with the United States Securities and Exchange Commission (SEC), the termination will be effective on December 24, 2018.
Although the Janssen partnership appears to be over, Aduro still has existing deals with Novartis, Merck, Johns Hopkins University and the University of California, Berkeley (CAL) for its products targeting the STING pathway. STING is a central mediator of innate immunity. When stimulated, it causes the expression of type I interferon, cytokines and T cell recruitment factors, which then active macrophages and dendritic cells, natural killer (NK) cells, and prime tumor-specific T cells.