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Lift of Partial Clinical Hold on Heat Biologics' (HTBX) HS-410 Much Earlier than Expected; Noble Reaffirms at 'Buy'

February 10, 2016 2:43 PM EST
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Price: $2.83 --0%

Rating Summary:
    8 Buy, 0 Hold, 0 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 13 | Down: 11 | New: 11
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Noble Financial affirms Heat Biologics, Inc. (Nasdaq: HTBX) at Buy with a price target of $16 after the company announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the company’s Phase 2 clinical trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC).

Analyst Rahul Jasuja noted the following:

  • Though we expected removal of the partial clinical hold, this is much earlier than our expectations; as discussed in our previous note, this was likely a documentation error and has been resolved in quick time by the FDA
  • Patients currently on trial will continue to receive HS-410 treatment and new patients will be enrolled in the HS-410 monotherapy arm; following quick resolution of the partial clinical hold we expect data from the Phase 2 bladder cancer trial in 4Q16, as expected
  • Encouraging anti-tumor responses and validation of MoA of clonal expansion of CD8+ T cells were observed in the Phase 1 bladder cancer and Phase 1/2 NSCLC trials; A Phase 1b combination with checkpoint inhibitor (Opdivo) in NSCLC is ongoing
  • HS-410 is based on the ImPACT vaccine platform designed to activate CD8+ T cells; ImPACT is an off-the-shelf allogeneic tumor cell line expressing engineered secreted heat shock protein gp96-Ig that efficiently presents tumor antigens to dendritic cells

For an analyst ratings summary and ratings history on Heat Biologics click here. For more ratings news on Heat Biologics click here.



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