OSE Immunotherapeutics halts recruitment in cancer vaccine trial

By Gareth Macdonald

- Last updated on GMT


Related tags Lung cancer

OSE Immunotherapeutics SA has halted recruitment in a Phase III trial of its cancer vaccine Tedopi (OSE2101). 

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.

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