Sensei brings on new CMO as it eyes phase 2 immuno-oncology trial | Digital Science
She takes over for Edward Garmey, M.D., an oncology drug development consultant and former chief medical officer at Cerulean Pharma, who was serving as Sensei’s acting CMO since March.
The Gaithersburg, Maryland-based Sensei, previously known as Panacea Pharmaceuticals, is currently awaiting full phase 1 clinical data this fall from its lead immunotherapy candidate, SNS-301, a bacteriophage viral vector that targets an embryonic antigen expressed on the surface of more than 20 different types of adult cancer cells.
In June, alongside the annual meeting of the American Society of Clinical Oncology in Chicago, Sensei published phase 1 data assessing safety and immunogenicity of SNS-301 in patients with biochemically recurrent prostate cancer.
In 12 patients receiving an average of 10 doses over the 15-month study, early results showed that SNS-301 was well tolerated, with a favorable safety profile across all dose levels, the company said. No dose-limiting toxicities were observed at the three evaluated dose levels, and all patients experienced dose-dependent, specific cellular immune responses, including B-cell and T-cell responses.
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In addition, six of eight patients showed improvements in prostate-specific antigen levels, or the amount of time it took for PSA levels to double. Sensei is currently planning to begin enrollment in a phase 2 efficacy trial by the end of the year, which Csiki will help lead as CMO.
At Inovio, Csiki helped advance DNA-based cancer immunotherapies based on T cell vaccines by overseeing clinical programs, strategy and regulatory submissions.
Before that, she served as a senior director of oncology clinical development and as a Keytruda development lead at Merck, as well as a director of clinical development at GlaxoSmithKline, focusing on lymphoma and other oncology programs. Csiki also served as an assistant professor at the Perelman Cancer Center at the University of Pennsylvania, with a translational science laboratory researching thoracic malignancies.