FDA grants orphan drug designation for Aduro’s immuno-oncology product candidate

Aduro Biotech has received orphan drug designation from US Food and Drug Administration (FDA) for its immuno-oncology product candidate CRS-207 to treat mesothelioma.

Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen.

CRS-207 is a product candidate developed based on the firm’s live-attenuated and double-deleted (LADD) Listeria monocytogenes immunotherapy platform, which induce a potent innate and T cell-mediated adaptive immune response.

It was engineered to express the tumour-associated antigen mesothelin that is over-expressed in many cancers such as mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

Aduro Biotech research and development senior vice-president Dr Dirk Brockstedt said: “This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer.
“Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen.”

“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 Ib study later this year.”

The approval provides the company with seven years of limited marketing exclusivity for the product in the US, in addition to qualifying it for grant funding to reduce the cost of clinical testing.

The CRS-207 was developed to treat patients with malignant pleural mesothelioma who have not received prior therapy and are not eligible for surgical resection.

Patients are currently being enrolled in a single-arm Phase Ib clinical trial for CRS-207 in combination with standard-of-care chemotherapy.

According to the company, interim results announced at the International Mesothelioma Interest Group Conference in October 2014 demonstrated a 94% rate of disease control for the 16 treated and evaluable patients with response data.

Based on these results, the company opened an expansion cohort of up to a total of 40 patients and plans to complete enrollment in the study this year with results being presented in 2016.

The firm received orphan designation for CRS-207 and GVAX Pancreas to treat pancreatic cancer