Shares in Aduro Biotech fell as much as 22 percent Monday after the FDA placed a partial hold on clinical trials utilising the company's Listeria-based immunotherapy construct (LADD) platform. The agency took the action after the drugmaker reported that a blood culture sample taken from an indwelling port of a patient with metastatic pancreatic cancer who exhibited gastrointestinal symptoms tested positive for Listeria.
Aduro said that the strain of Listeria in the infected patient was suspected to be CRS-207, which was awarded breakthrough therapy designation by the FDA in 2014 for the treatment of pancreatic cancer in combination with the company's GVAX Pancreas immunotherapies. The drugmaker noted that the patient subsequently tested negative for infection following antibiotic treatment.
In May, shares in Aduro fell as much as a third after the company said that a Phase IIb study of CRS-207 in patients with previously treated metastatic pancreatic cancer failed to improve overall survival. The therapy is also being investigated in a mid-stage study of patients with pancreatic cancer and early-stage trials in mesothelioma and ovarian cancer.
Aduro indicated that it is working with the FDA to lift the partial hold and resume patient enrolment in the studies. The company's LADD technology platform is based on attenuated strains of Listeria that have been engineered to express tumour-associated antigens to induce specific and targeted immune responses.
In 2014, Johnson & Johnson acquired exclusive rights to certain treatments for lung cancer and other malignancies based on Aduro's LADD platform in a deal potentially worth more than $800 million.
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