US-based clinical stage biopharmaceutical firm Heat Biologics has announced its plans to begin patient enrolment in its Phase I/II study of HS-410 in bladder cancer.
The Phase I/II bladder cancer trial 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 trial will enrol approximately 93 patients and will also test the safety of HS-410 in bladder cancer patients. The company expects to begin dosing patients in this month.
HS-410 is a biologic product candidate designed to activate a T-cell mediated pan-antigen immune response against the patient's bladder cancer.
HS-410 consists of a bladder cancer cell line that has been genetically modified using Heat's proprietary immune pan antigen cytotoxic therapy (ImPACT) technology platform.
Heat's ImPACT technology reprograms live cancer cells from a single tumour source to continually secrete gp96, a chaperone protein found in all human cells.
In turn, gp96 chaperones tumour antigens to T-cells to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient's cancer.
Heat's ImPACT technology holds promise for treating a wide variety of different cancers.
Heat Biologics CEO Jeff Wolf said the company is excited to open enrolment on schedule with its Phase I/II study of HS-410 in patients with bladder cancer.
"This is a significant milestone for the company as we remain focused on advancing Heat's proprietary ImPACT therapy into late-stage clinical studies," Wolf said.
The company also anticipates HS-410 to represent a feasible opportunity to address a significant unmet medical need since no new medications were approved by the US Food and Drug Administration (FDA) to treat bladder cancer in more than 25 years.
Image: Histopathology of urothelial carcinoma of the urinary bladder. Photo: courtesy of KGH.