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Thursday, 07/14/2022 8:27:30 AM

Thursday, July 14, 2022 8:27:30 AM

Post# of 8426
News: On July 8, 2022, Synthetic Biologics, Inc. (the “Company”) was notified of the clearance of the safety evaluation period by the first patient that had been dosed in the investigator sponsored Phase 1 clinical trial evaluating VCN-01 (NCT05057715), an intravenous oncolytic adenovirus, in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) for patients with pancreatic and serious epithelial ovarian cancers. VCN-01 was developed by Synthetic Biologics’ wholly-owned subsidiary VCN Biosciences, SL.



The Phase 1, open-label, non-randomized trial, which is the first clinical trial of VCN-01 being conducted in the US, is designed to evaluate the safety and feasibility of intravenously administered VCN-01 in combination with mesothelin-directed lentiviral transduced huCART-meso cells in a 3+3 dose design for patients with pancreatic or serous epithelial ovarian cancers. VCN-01 will be administered at a single dose of 3.3x1012 vp (cohort 1) or 1 x 1013 vp (cohort 2) followed by a single dose of 5x107 huCART-meso cells on Day 14. The trial may also evaluate the safety of a different sequence of administration for these two investigational products at the same dose levels used in cohort 1.

https://ih.advfn.com/p.php?pid=nmona&article=88593706


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