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news.Heat Biologics has started dosing patients in its Phase I/II bladder cancer clinical trial of its investigational biologic product candidate, HS-410.
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HS-410 is designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer.
Dosing in the Phase I/II trial was initiated by clinical investigator Lawrence Karsh at The Urology Center of Colorado in Denver.
Around 93 patients are expected to be enrolled in the trial, which is designed to determine whether vaccination with HS-410 after transurethral resection of bladder tumour (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo.
The multi-centre Phase I/II trial will also evaluate the safety of HS-410 in bladder cancer patients.
HS-410 includes a bladder cancer cell line that has been genetically modified using the company’s ImPACTtechnology platform to secrete a range of bladder cancer antigens bound to a gp96 adjuvant.
The ImPACT Therapy is designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to ‘pump out’ a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called ‘gp96’ to educate and activate a cancer patient’s immune system to recognise and kill cancerous cells.