US-based biotechnology company Immunophotonics has dosed the first patient in the Phase II/III clinical trial of inCVAX for the treatment of breast cancer.
inCVAX is developed as a therapeutic cancer vaccine to trigger an immune response against the primary tumour and distant metastases.
It detects tumour antigens directly from the individual tumour and activates the T-cells to attack the cancerous cells.
inCVAX is administered through two injections into an accessible tumour to trigger the anti-tumour immune response against the cancer.
The randomised, controlled clinical Phase II/III trial is being pursued on the basis of a previously undertaken investigator-initiated clinical trial in Peru, which demonstrated the efficacy of the cancer vaccine in reducing both treated tumours and distant, untreated metastases.
The current Phase II/III trial will enrol 246 patients and has been designed to test the efficacy of inCVAX in treating late-stage breast cancer patients.
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Immunophotonics co-founder and president Lu Alleruzzo said: “We were encouraged by the investigator-initiated, first-in-human results and are excited to have initiated this follow-on clinical trial.
“The clinical investigators are eager to enrol patients and we expect to have preliminary results available sometime in Q2-2017.”
The company has stated data suggestive of inCVAX to be used on a broader range of solid tumour indications.
Immunophotonics will make a US Investigational New Drug submission for inCVAX next year while exploring options to use the cancer vaccine for other indications including advanced melanoma.
Image: inCVAX triggers anti-cancer immune response. Photo: courtesy of Immunophotonics / GlobeNewswire.