Candel Therapeutics (Advantagene) announced the treatment of the first high grade glioma patients in a study of its Gene Mediated Cytotoxic Immunotherapy (GMCI™; aglatimagene besadenovec plus prodrug) in combination with the checkpoint inhibitor nivolumab and standard of care (SOC) surgery, radiation and temozolomide. Extensive clinical and preclinical data suggests that GMCI and this combination can significantly improve clinical outcomes.
This newest study, BrTK04, is being conducted in collaboration with the Adult Brain Tumor Consortium, composed of eleven of the top clinical institutions in the country, and Bristol-Myers Squibb, manufacturer of nivolumab (Opdivo®). The study chair is Dr. Patrick Wen, Director, Center for Neuro-Oncology at Dana Farber Cancer Center, Harvard Medical School. The primary clinical end-point of BrTK04 is to determine the safety of GMCI, nivolumab, SOC surgery and chemoradiation.
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In BrTK02, a previous phase 2 study of GMCI with SOC, the treatment was well tolerated with an indication of survival benefit as GBM patients with successful surgical outcomes had a median overall survival of 25.1 months compared to 16.3 months for the control group. Data from another recently concluded study at Boston Children's Hospital, under the direction of Dr. Mark Kieran, showed that GMCI can also be safely combined with SOC in pediatric patients. "The data generated with GMCI in the upfront high-grade glioma setting is some of the more compelling clinical data in the field in the last few years. The scientific rationale for the combination of GMCI and nivolumab is sound and is supported by pre-clinical data. When one further considers GMCI's compelling clinical data in various other indications, there is a strong rationale for moving forward with this combination study," stated Dr. Wen.
Additional ongoing clinical studies with GMCI include a Phase 3 in localized prostate cancer and Phase 1/2 studies in prostate, lung and pancreatic cancers. "The application of our GMCI platform in combination with nivolumab further expands Candel's glioma franchise beyond single use application and is an important milestone for the company," said Dr. Estuardo Aguilar-Cordova, Chairman and CEO of Candel Therapeutics. "We are excited for the opportunity to work on a potential new treatment for patients with this devasting disease and we are grateful to our collaborators, the patients participating in this study, and their families."