On December 18, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported top-line results from a Phase 2 clinical study evaluating the targeted immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma, a rare cancer occurring in the base of the skull and spine (Press release, Bavarian Nordic, DEC 18, 2020, View Source,of%20the%20skull%20and%20spine. [SID1234573079]). While the study failed to meet its primary endpoint, it provided evidence of clinical activity.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Phase 2 study enrolled 29 patients, which were treated with a combination of the prime-boost vaccine candidate, BN-Brachyury and the current standard of care, radiation therapy. Whereas radiation has been shown to inflame the tumor, thereby releasing cancer antigens, BN-Brachyury has been designed to teach T cells to attack and kill brachyury-expressing tumor cells. Patients were monitored over a period of 12 months after radiation therapy, a timeframe during which historical controls show an objective response rate (ORR) of less than 5% with radiation alone. The overall goal of the study was to achieve four patients with objective responses, corresponding to an ORR of approximately 14% for all patients enrolled.
Two patients achieving objective responses were observed in the study, as measured by the predefined conventional assessment criteria (RECIST) according to the study protocol. In addition, 19 patients have stable disease, while the rest progressed, or left the study before the assessment was performed. The RECIST criteria assumes tumors are spherical and assesses their size by measuring the tumor diameter. This method may, however, underestimate the chordoma tumor shrinkage, as a retrospective analysis of six of the patients enrolled into the study revealed four of these patients had an objective response when tumor shrinkage was evaluated by a volumetric assessment. These intriguing signs of clinical efficacy are also supported by two chordoma patients that have recorded either a volumetric objective response, or a symptomatic response following the intravenous administration of BN-Brachyury in a separate on-going trial.
While no further studies of BN-Brachyury administered subcutaneously are planned, the signs of clinical efficacy that have been observed support brachyury as a potentially important immunotherapy target, particularly for chordoma. The Company is now looking to adapt ongoing trials to investigate MVA-based vaccines encoding brachyury administered intravenously – a promising approach designed to utilize broader aspects of the immune response while improving T cell activation and function.
"Chordoma is known for its refractoriness to all treatments investigated so far. The observation of some hints of efficacy with our immunotherapy approach is encouraging enough for us to continue with our efforts to develop a new treatment for this highly unmet medical need," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.