On December 21, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that the first patient in the Phase 1 study of ADU-741 (also known as JNJ-64041809), a LADD immunotherapy product candidate for the treatment of prostate cancer, has been dosed. Janssen Biotech, Inc., is Aduro’s license partner for ADU-741 (Press release, Aduro BioTech, DEC 21, 2015, View Source [SID:1234508624]). Janssen is conducting the study. Schedule your 30 min Free 1stOncology Demo! "Janssen has deep expertise in the development of therapeutics for prostate cancer and we are extremely pleased with the rapid advancement of ADU-741 into clinical trials," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "ADU-741 represents a highly-specific, multifaceted approach to stimulate the immune system to fight cancer and we believe it may offer a new and unique treatment alternative to improve the outcome of men suffering from metastatic castration-resistant prostate cancer. We are particularly excited about ADU-741, which represents a significant advancement of our LADD technology and utilizes our proprietary methods to express multiple antigens that are relevant to prostate cancer. By engaging in productive agreements with partners like Janssen, Novartis and Incyte, we expand the reach of our novel immuno-oncology platform and offset the development costs of our internal therapies, all of which we pursue for the ultimate goal of bringing new treatments to patients in need."
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The Phase 1 study will enroll approximately 40 patients with metastatic castration-resistant prostate cancer. The initial dose escalation portion of the trial, with two dose levels of ADU-741, will evaluate safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity. Additional information may be found at clinicaltrials.gov, using identifier NCT02625857.
About LADD
LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).