US-based clinical stage biopharmaceutical firm Heat Biologics has dosed the first patient in its Phase I/II bladder cancer clinical trial of its investigational biologic product candidate, HS-410.
HS-410 consists of a bladder cancer cell line that has been genetically modified using the company’s ImPACTtechnology platform to secrete a wide range of bladder cancer antigens bound to a gp96 adjuvant.
It is designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer.
Dosing in the trial was started by clinical investigator Lawrence Karsh at The Urology Center of Colorado in Denver.
Heat chief executive officer Jeff Wolf said: "This represents a significant milestone for our Phase I/II study and an exciting step forward for Heat’s clinical development programme."
A total of 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 test the safety of HS-410 in bladder cancer patients.
Heat vice-president of clinical and regulatory affairs Melissa Price said: "This year our clinical team will be focused on operational excellence as we advance our lead product candidates, HS-410 for bladder cancer and HS-110 for lung cancer."
Heat Biologics is focused on developing its novel, ImPACT therapeutic vaccines to fight against a wide range of cancers.
The company’s 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.
Image: Histopathology of urothelial carcinoma of the urinary bladder. Photo: courtesy of KGH.