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Aduro and Merck to evaluate combo of former’s CRS-207 with latter’s Keytruda
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BERKELEY,
Calif.—Aduro Biotech Inc. a biopharmaceutical company with three distinct immunotherapy
technologies, has announced the expansion of its clinical collaboration with Merck & Co. (known as
MSD outside the United States and Canada) to include an additional Phase 2 clinical trial. The companies will investigate the combination of CRS-207,
Aduro’s LADD (live, attenuated double-deleted)-based immunotherapy, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment
of patients with malignant pleural mesothelioma (MPM) whose disease progressed following prior treatment.
Earlier
this year, Aduro announced a Phase 2 clinical
collaboration with Merck, through a subsidiary, to evaluate the combination of CRS-207 with pembrolizumab for the treatment of gastric cancer.
“Data from our ongoing Phase 1 clinical trial of CRS-207 with standard chemotherapy as frontline treatment for
malignant pleural mesothelioma have been very encouraging, including disease control in 94 percent of patients treated with the CRS-207/chemotherapy
combination,” said Dr. Natalie Sacks, chief medical officer at Aduro. “Based on these clinical data, as well as data from preclinical
studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase 2 trial to evaluate the CRS-
207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment.”
The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with
previously treated MPM. The trial is expected to involve approximately 35 patients who have failed one to two prior treatments.
Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and
abdomen. Malignant pleural mesothelioma, which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease and accounts for
approximately 13,000 cases a year in the United States, European Union and Japan. MPM is an aggressive disease with a poor prognosis. Most MPM patients are
not candidates for surgical resection. Currently, there is no U.S. Food and Drug Administration-approved therapy for second- or third-line treatment of
MPM.
LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria
monocytogenes strains that have been engineered to generate an innate immune response and to express tumor-associated antigens to induce tumor-specific
T cell-mediated immunity. CRS-207, the company’s lead LADD product candidate, has been engineered to express the tumor-associated antigen mesothelin,
which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.
Code: E05171701 Back |
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