Bavarian Nordic unveils key Phase 2 study results for BN-Brachyur
Category: #health  By Pankaj Singh  Date: 2019-06-06
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Bavarian Nordic unveils key Phase 2 study results for BN-Brachyur

Phase 2 trial was designed with the aim to observe combination of BN-Brachyury and radiation therapy in chordoma patients

Bavarian Nordic A/S, a Denmark-based biotechnology company, has recently announced that the Data and Safety Monitoring Board has confirmed a partial response in one of the first patients with chordoma enrolled and treated with the combination of radiation treatment and BN-Brachyury at the first evaluation timepoint.

This reportedly meets the initial pre-defined activity threshold for the first stage of the Phase 2 trial, due to which enrolment will be expanded to recruit another 19 patients, whereas the first 10 patients would continue to be treated and evaluated accordingly.

Apparently, the proof of concept of Phase 2 trial was designed with the aim to observe if combining the current standard of care, radiation therapy, with BN-Brachyury will result in a clinically meaningful objective response rate, which is measured as a percentage of patients with a reduction in tumor size within 12 months of radiation therapy. Under this timeframe, historical controls display an ORR of less than 5% with radiation alone.

Sources familiar with the matter mentioned that under the first stage of study, enrolment of 10 patients had been done between November 2018 and January 2019. After that, the study will now advance into stage 2, extending recruitment to a total of 29 patients with a goal of achieving objective responses in 4 patients, corresponding to a ~14% ORR for all patients recruited for the study to be considered a success.

According to President and Chief Executive Officer of Bavarian Nordic, Paul Chaplin, the company has shared the first Phase 2 data from its existing immuno-oncology pipeline, and also the first data signifying clinical activity of combining the company’s targeted immunotherapy with standard of care.

Chaplin added that the swift progression of this trial could possibly offer final results faster than expected and hopes this initial finding has confirmed in a greater number of patients, with BN-Brachyury expected to improve treatment options for patients with chordoma.

Source Credit: http://www.bavarian-nordic.com/investor/news/news.aspx?news=5645 



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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