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May 29, 2014

J&J's Janssen Licenses LADD from Aduro in Up to $365M Deal

  • Aduro Bio Tech said today its LADD immunotherapy platform will be used by Johnson & Johnson’s Janssen Biotech unit to develop new treatments for prostate cancer, in a deal that could net Aduro up to $365 million.

    The LADD platform consists of live-attenuated double-deleted—hence the name—Listeria monocytogenes strains engineered to induce a potent innate immune response as well as to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

    Aduro said it granted Janssen an exclusive worldwide license for the treatments, in an agreement facilitated by J&J’s Innovation Center in California. Janssen will oversee all research, development, manufacturing, regulatory and commercialization activities for the licensed products.

    In return, Janssen agreed to pay Aduro up to $365 million in upfront license fees and payments tied to achieving defined but undisclosed development, regulatory and commercialization milestones, if multiple programs advance to commercialization, as well as tiered royalties on worldwide net sales.

    “We believe this is an important validation of our platform strategy and we are excited to have the Janssen development team taking the lead in advancing the prostate cancer program,” Stephen T. Isaacs, Aduro’s chairman, president and CEO, said in a statement. “We look forward to continued progress with our LADD platform in a broad array of other oncology indications, including pancreatic cancer, mesothelioma, non-small cell lung cancer and glioblastoma among others.”

    LADD is J&J’s latest arrow in its proverbial quiver against prostate cancer. J&J already markets the successful Zytiga for the disease, and last year acquired Aragon Pharmaceuticals for up to $1 billion, adding to J&J’s pipeline the Phase II drug candidate ARN-509, a second-generation androgen receptor antagonist now under study as a possible treatment for castration-resistant prostate cancer (CRPC).

    Under a separate agreement with Janssen, Aduro also granted exclusive rights to its GVAX technology for prostate cancer. Aduro’s GVAX portfolio includes vaccines for pancreatic, prostate, colon and breast cancers as well as multiple myeloma.

    According to Aduro, the GVAX vaccines are derived from human cancer cell lines, which are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine.

    Aduro in January trumpeted promising results from a Phase II trial of GVAX in patients with advanced-stage pancreatic cancer, saying patients receiving GVAX and another Aduro drug candidate, CRS-207, achieved 6.1 months of median overall survival, compared to 3.9 months for patients taking GVAX alone. At 24%, the one-year survival probability for the combination was double the 12% recorded for GVAX alone.

    Aduro agreed to license GVAX from BioSante for undisclosed milestone and royalty payments in 2011, three years after two separate Phase III trials involving the vaccines were halted – in one study, after patients receiving the experimental vaccine died faster than those treated with chemotherapy.

    At the time of the failures, GVAX was being developed by Takeda under license from Cell Genesys. Takeda pulled out of that licensing deal in December 2008, while Cell Genesys was bought six months later by BioSante. 


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