Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Heat Biologics, Inc. (HTBX) recently announced that it has dosed the ninth and final patient required for the phase I part of its phase I/II clinical study on experimental biologic candidate, vesigenurtacel-L (HS-410).
The candidate is being evaluated for the treatment of high-risk, non-muscle invasive bladder cancer.
Vesigenurtacel-L is being developed using the company’s proprietary Immune Pan Antigen Cytotoxic Therapy (ImPACT) based allogeneic cell lines which are designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer.
The study will evaluate whether vaccination with HS-410, post transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) is able to delay disease recurrence compared to placebo.
Heat Biologics expects to initiate the phase II part of the trial during the fourth quarter of 2014, a quarter sooner than expected.
Meanwhile, Heat Biologics recently modified the phase I/II study treatment regimen. The regimen will now include a more robust dose-response analysis. The company also expects an expedited advancement into phase II trials following the completion of enrollment of a single cohort of phase I data.
Heat Biologics expects patient enrollment and dosing in the phase II study on vesigenurtacel-L for the treatment of bladder cancer to be completed in the third quarter of 2015. Top-line recurrence-free survival results are expected in the third quarter of 2016.
Apart from HS-410, Heat Biologics’ oncology pipeline also includes HS-110, which is being evaluated for the treatment of non-small cell lung cancer. We are encouraged by the company’s progress with its oncology pipeline so far.
Heat Biologics currently carries a Zacks Rank #2 (Buy). Other better-ranked stocks in the health care sector include Shire (SHPG), Sucampo Pharmaceuticals (SCMP), and Pacira Pharmaceuticals (PCRX). All three carry a Zacks Rank #1 (Strong Buy).
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