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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.
News For HTBX From The Last 14 Days
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February 10, 2016
07:08 EDTHTBXHeat Biologics says FDA lifts partial clinical old on HS-410 Phase 2 trial
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February 4, 2016
10:01 EDTHTBXOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Anglo Platinum (AGPPY) downgraded to Neutral from Overweight at JPMorgan... Buffalo Wild Wings (BWLD) downgraded to Neutral from Buy at Longbow... Changyou.com (CYOU) downgraded to Neutral from Outperform at Credit Suisse... Enbridge (ENB) downgraded to Neutral from Outperform at Credit Suisse... Esterline (ESL) downgraded to Hold at Drexel Hamilton... Franco-Nevada (FNV) downgraded to Neutral from Outperform at Credit Suisse... GoPro (GPRO) downgraded on results, guidance at Sterne Agee CRT... Heat Biologics (HTBX) downgraded to Speculative Buy from Buy at Cantor... Illumina (ILMN) downgraded to Hold from Buy at Canaccord... Intrawest Resorts (SNOW) downgraded to Neutral from Outperform at Macquarie... Match Group (MTCH) downgraded to Equal Weight from Overweight at Barclays... Memorial Resource (MRD) downgraded to Hold from Accumulate at Tudor Pickering... Pacific Biosciences (PACB) downgraded to Neutral from Overweight at Piper Jaffray... Peabody (BTU) downgraded to Underperform from Market Perform at FBR Capital... Peak Resorts (SKIS) downgraded to Underperform from Neutral at Macquarie... PennyMac Mortgage (PMT) downgraded to Market Perform from Outperform at Wells Fargo... Petrobras (PBR) downgraded to Underweight from Neutral at JPMorgan... Sensata (ST) downgraded to Neutral from Overweight at Atlantic Equities... Shutterfly (SFLY) downgraded to Neutral from Buy at BofA/Merrill... Star Bulk Carriers (SBLK) downgraded to Neutral from Speculative Buy at Seaport Global... Synchronoss (SNCR) downgraded at Stifel... Wabtec (WAB) downgraded to Neutral from Buy at Goldman.
07:03 EDTHTBXHeat Biologics downgraded to Speculative Buy from Buy at Cantor
Cantor Fitzgerald downgraded Heat Biologics to Speculative Buy saying the partial clinical hold for HS-410 adds uncertainty. The analyst has a fair value range for shares of $2-$12.
February 3, 2016
07:09 EDTHTBXHeat Biologics reports HS-410 Phase 2 trial placed on clinical hold by FDA
Heat Biologics announced that the company has recently concluded that the cell line on which HS-410 is based had been previously misidentified. Heat has advised the FDA of this conclusion, and the FDA has placed Heat's HS-410 Phase 2 clinical trial on partial clinical hold while they review the updated documentation provided by Heat. Heat believes the partial clinical hold does not relate to concerns regarding the safety of HS-410. All currently enrolled patients can continue receiving HS-410 treatment, or comparator drugs, as per the current study protocol, but no new patients can be enrolled in Heat's open-label, monotherapy arm until the partial clinical hold is lifted. Heat will amend all necessary documents including the related investigator brochure, study protocol and informed consent document. Heat is working diligently in collaboration with the FDA to resume enrollment in its clinical trial. Heat has confirmed that HS-410 drug product has remained consistent throughout all clinical trials and anticipates continuing development of HS-410 for the treatment of non-muscle invasive bladder cancer, or NMIBC, with the existing cell line, contingent upon FDA's removal of the partial clinical hold. All data generated and reported to date remains unchanged, including HS-410's positive safety profile, immune response and shared antigenic profile with patient tumors. Heat anticipates that the partial clinical hold will be resolved quickly and that enrollment timelines for its Phase 2 trial evaluating HS-410 either alone or in combination with standard of care, Bacillus Calmette-Guerin, or BCG, for the treatment of NMIBC will remain materially unchanged. As previously announced, Heat completed enrollment for the trial's randomized, combination arms in October 2015 and continues to expect to report topline efficacy, immune-response and safety data in Q4.

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