Heat Biologics, Inc. ("Heat
Biologics", "Heat" or the "Company") HTBX, a clinical stage
biopharmaceutical company focused on the development of novel cancer
immunotherapies, announced today that it has amended the Phase 1/2 clinical
protocol for Vesigenurtacel-L (HS-410) in patients with high-risk non-muscle
invasive bladder cancer after transurethral resection of bladder tumor
(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 the third quarter of 2014
and anticipates the Phase 2 study will commence in the fourth quarter of 2014,
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 (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.
Gary Steinberg, M.D., the Lead Principal Investigator for the trial and The
Bruce and Beth White Family Professor and Director of Urologic Oncology at the
University of Chicago Medical Center, commented, "To date, the positive safety
data for Heat's immuno-oncology treatment is promising. There is a clear
rationale for patients to receive treatment with Vesigenurtacel-L earlier in
the disease process and we believe the amended regimen to start treatment
closer to TURBT will better optimize patient outcomes. We are very interested
in advancing into Phase 2 studies so we can begin to assess the response to
Vesigenurtacel-L in high-risk patients in desperate need of viable treatment
options for non-muscle invasive bladder cancer."
Melissa Price, Ph.D., Heat's Vice President of Clinical and Regulatory
Affairs, commented, "We are very pleased to be moving forward with this
revised protocol. After careful consideration for safety, it was important for
us to provide combination therapy at an earlier stage of disease progression
with the optimal standard of care. We strongly believe that the redesign of
the Phase 2 portion of our Vesigenurtacel-L study will produce more meaningful
safety and efficacy results."
The primary endpoint for the Phase 2 bladder study is one-year recurrence-free
survival. The Company expects to complete patient enrollment and dosing in the
third quarter of 2015. Following a twelve-month observation period of all
patients in the trial, Heat expects to report top-line results in the third
quarter of 2016.
For patients and physicians interested in enrollment information for the Phase
1/2 study of Vesigenurtacel-L in patients with high-risk non-muscle invasive
bladder cancer, please visit clinicaltrials.gov and use Identifier
NCT02010203.
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