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Tuesday, 11/29/2016 5:54:29 PM

Tuesday, November 29, 2016 5:54:29 PM

Post# of 97237
Holding HTBX into data release tomorrow. From the abstract:

Results: Vesigenurtacel-L treatment was well tolerated with no vaccine-related SAEs; primary AEs were mild, most commonly transient injection site reactions. AE profiles (number and severity of AEs) were similar across the treatment arms indicating that vesigenurtacel-L does not significantly alter the known safety profile of BCG. Composite RFS across all arms (prior to the unblinding event at 1-year) was 84.6%, with a 6-month complete response rate in CIS patients of 87.5%. Vesigenurtacel-L antigen expression showed prominent overlap with patient tumors. Additionally, IHC may define a responder and non-responder phenotype by baseline levels of TIL and PD-L1.
Conclusions: The combination of vesigenurtacel-L and BCG is well-tolerated with preliminary evidence of synergistic effect and immunologic responses that are consistent with vaccine mechanism of action. Vesigenurtacel-L warrants further investigation as a potential treatment for NMIBC.

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