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.
Quanterix partners with leading health networks for Alzheimer's diagnosis advancements
Precision BioSciences reports FDA pre-IND feedback for PBGENE-HBV
VBI to sell manufacturing capabilities and enter new license agreement with Brii Biosciences
Ondine Biomedical's Steriwave shows promise in nasal pathogen reduction
BioSenic expands patent coverage for ATO therapeutic platform
PacBio unveils Nanobind PanDNA kit for enhanced DNA extraction solutions
Sequentify receives funding from Israel Innovation Authority
INOVIO plans BLA submission for INO-3107 as RRP treatment
ImmunityBio secures USD320m investment from Oberland Capital
Poolbeg Pharma prioritises promising RSV drug candidates identified through AI-led analysis
GHIT fund invests JPY500m in antimalarial drug clinical trial
AstraZeneca agrees acquisition of Icosavax
Versameb names new chairman of the board
Kling Bio appoints Dr Stefano Gullà as chief scientific officer