On December 10, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported the start of the Phase 1 study of ADU-214 (also known as JNJ-64041757), a LADD immuno-oncology therapy for the treatment of lung cancer, with the dosing of the first patient in the trial. Janssen Biotech, Inc., Aduro’s license partner for ADU-214, is conducting the multi-center study (Press release, Aduro BioTech, DEC 10, 2015, View Source;p=RssLanding&cat=news&id=2121848 [SID:1234508532]).
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"We are extremely pleased to see the first immuno-oncology therapy resulting from our license agreement with Janssen enter the clinic," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "With more than 200,000 new diagnoses this year and over 400,000 people living with lung cancer in the United States alone, new therapeutics are desperately needed. We believe ADU-214 may offer new hope to patients suffering from this aggressive disease."
The Phase 1 study will evaluate intravenous administration of ADU-214 in patients with advanced or metastatic non-small cell lung cancer. The trial is expected to enroll up to 40 patients, approximately 12 of whom will participate in the dose escalation portion of the trial where two dose levels of ADU-214 will be evaluated for safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity in an additional 30 patients. Additional information may be found at clinicaltrials.gov, using identifier NCT02592967.
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.).