Bavarian Nordic's ongoing phase 2 trial evaluating BN-Brachyury in chordoma shows positive results.
NORDIC BUSINESS REPORT-June 6, 2019-Bavarian Nordic's ongoing phase 2 trial evaluating BN-Brachyury in chordoma shows positive results
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Bavarian Nordic A/S (CPH:BAVA) (OTC: BVNRY), a biotechnology company focused on the development of innovative therapies against cancer and infectious diseases, announced on Wednesday the confirmation by the Data and Safety Monitoring Board (DSMB) of a partial response in one of the first chordoma patients recruited and treated with the combination of BN-Brachyury and radiation treatment at the first evaluation timepoint.
Reportedly, as this meets the initial pre-defined threshold of activity for the first stage of the phase 2 trial, recruitment will be expanded to enrol another 19 patients, while the first 10 patients continue to be treated and evaluated.
According to the company, the proof-of-concept phase 2 trial was designed to determine if the combination of BN-Brachyury and radiation therapy, the current standard of care, results in a clinically meaningful objective response rate (ORR), measured as a percentage of patients with a decrease in tumour size within 12 months of radiation therapy. This is a timeframe during which historical controls show an ORR of less than 5% with radiation alone.
The first stage of the study enrolled 10 patients between November 2018 and January 2019. This study will now advance into stage 2, expanding enrolment to a total of 29 patients with an overall goal of achieving four patients with objective responses, corresponding to an ORR of ~14% for all patients enrolled for the study to be considered successful.
Chordoma is a rare cancer that universally over expresses brachyury and occurs in the base of the skull and spine.
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|Publication:||Nordic Business Report|
|Date:||Jun 6, 2019|
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