OSE announced the halt last week, explaining the decision to pause recruitment temporarily was prompted by “an emerging benefit/risk balance of the experimental treatment."
The firm also said patients already enrolled in Atalante 1 – which is examining Tedopi in people with advanced non-small cell lung cancer who have not responded to first line chemotherapy or second-line checkpoint inhibitor therapy - will continue to receive treatment.
An OSE spokeswoman told us pausing recruitment “should allow several options to be decided according to the observed results: stopping the trial, continuing the planned protocol or continuing in a subset of patients identified in the protocol because there are several different prognostic factors studied.”
Under the current protocol, patients are initially given an injection of Tedopi every three weeks for six cycles. Thereafter they receive the vaccine every two months for a year and finally every three months.
Contract supply
Tedopi is a vaccine composed of 10 epitopes from five tumour associated antigens commonly found in cancers for which the prognosis is poor.
The vaccine is designed to elicit a T cell response.
The active pharmaceutical ingredients (API) for Tedopi – the epitopes – were made by US contractor Portage Pharmaceuticals Limited and formulated by Swiss firm Baccinex.
The paused study is being run by Wales-based contract research organisation Simbec-Orion at sites in the US and Europe.
