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August 4, 2014
08:24 EDTHTBXHeat Biologics amends bladder cancer protocol for early advancement into Phase 2
Heat Biologics announced that it has amended the Phase 1/2 clinical protocol for Vesigenurtacel-L in patients with high-risk non-muscle invasive bladder cancer after transurethral resection of bladder tumor, or TURBT. The modified treatment regimen facilitates a more robust dose-response analysis and will permit Heat to advance directly into Phase 2 trials following enrollment of a single cohort of Phase 1 data rather than the two cohorts required by the original trial design. Heat expects to complete enrollment of the Phase 1 portion of the study in Q3 and anticipates the Phase 2 study will commence in Q4, one quarter earlier than initially expected. The original Phase 1/2 bladder cancer trial protocol called for evaluation of two doses of monotherapy Vesigenurtacel-L after induction bacillus Calmette Guérin, or BCG, to assess initial safety and determine the best dose to advance to Phase 2. The amended protocol changes the treatment regimen from monotherapy Vesigenurtacel-L following BCG to combination with BCG based on proposed synergy with the combination. This new regimen will start treatment with Vesigenurtacel-L earlier in the disease process and enable concurrent administration of BCG and HS-410 throughout the adjuvant therapy period. Furthermore, the revision advances both doses into Phase 2 to correlate the dose with recurrence rate. Heat's management team worked closely in consultation with its Clinical Advisory Board to develop this combination study with a clinically more meaningful and efficient design. The protocol revision is expected to allow for expedited advancement into Phase 2 and is accompanied by robust safety evaluation during the Phase 2 study. In the first seven patients treated to date, there have been no reported serious adverse events.
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November 14, 2014
07:32 EDTHTBXHeat Biologics reports Q3 EPS (46c), consensus (42c)

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