FDA Grants Orphan Drug Designation to Aduro’s Mesothelioma Candidate

Today, Aduro Biotech Inc. announced that US health regulators have granted Orphan Drug designation to its novel, immuno-oncology candidate.

The company said that the Office of Orphan Product Development of the US Food and Drug Administration (FDA) granted orphan drug designation to CRS-207, Aduro’s novel immuno-oncology product candidate in development for the treatment of mesothelioma. If the agency approves the drug, CRS-207 would have seven years of limited marketing exclusivity in the US for treatment of mesothelioma. The designation also qualifies Aduro for grant funding to offset the cost of clinical testing and certain tax credits.

“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirck Brockstedt, PhD, senior vice president of research and development of Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”

Aduro is developing CRS-207 for patients with malignant pleural mesothelioma who have not received prior therapy and are not eligible for surgical resection. Currently, patients are being enrolled in a single-arm Phase Ib clinical trial of CRS-207 in combination with standard-of-care chemotherapy.

The company reported interim results at the International Mesothelioma Interest Group Conference in October, stating that the drug demonstrated a 94 percent rate of disease control for the 16 treated, evaluable patients with response data. Specifically, 75 percent had confirmed partial responses and 19 percent experienced stable disease. At the time of the presentation, estimated progression-free survival (PFS) was 7.5 months, with one patient on study for more than 19 months. That patient is currently receiving maintenance therapy with CRS-207 alone following the combination treatment with chemotherapy. Due to positive results, Aduro opened an expansion cohort of up to a total of 40 patients and expects to complete study enrollment in 2015, with top-line results presented next year.

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 (MPM), which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease, accounting for approximately 3,000 cases a year in the US. Based on results from previous studies, expected median PFS is 5.7 months and overall survival (OS) is 12.1 months with combination pemetrexed and cisplatin chemotherapy.

CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induce a potent innate and T cell-mediated adaptive immune response. The drug was engineered to express the tumor-associated antigen mesothelin, which is over-expressed in several cancers, including mesothelioma and pancreatic, non-small cell lung, ovarian and endometrial and gastric cancers.

The FDA already granted orphan drug designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.

Source: Aduro Biotech, Inc.

Last updated: 3/26/15; 10:25am EST


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