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.

Related topics Bio Developments Facilities

Related news

Show more

Related product

Process optimization for mAb commercial manufacturing

Process optimization for mAb commercial manufacturing

Content provided by Catalent | 01-Jun-2023 | Product Presentation

Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring...

Related suppliers