US-based biotechnology company OncoSec has entered a clinical trial collaboration and supply agreement with Merck to begin the Phase II PISCES clinical trial of ImmunoPulse IL-12 and keytruda combination for the treatment of patients with metastatic melanoma.
Keytruda (pembrolizumab) is Merck’s anti-PD-1 therapy, while OncoSec’s ImmunoPulse is an investigational technology developed to increase the local delivery and uptake of DNA-based immune-targeting agents such as IL-12.
Under the agreement, OncoSec will sponsor and fund the study, while Merck will provide keytruda.
The trial will assess the safety and efficacy of the combination in stage III/IV metastatic melanoma patients who are experiencing disease progression after prior treatment with an anti-PD-1 therapy.
OncoSec president and chief executive officer Punit Dhillon said: “This collaboration is supported by our recent clinical data demonstrating the potential ability of ImmunoPulse IL-12 to rescue patients who do not initially respond to anti-PD-1 therapy in melanoma.
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“In addition to our recent fast-track designation for this population, OncoSec is uniquely positioned to meaningfully impact clinical outcomes for patients who do not currently have any other options.
“By working with innovative immuno-oncology leaders, this alliance underpins OncoSec's strategy to combine our ImmunoPulse IL-12 programme with checkpoint inhibitor therapies to advance the care of patients."
ImmunoPulse IL-12 has reportedly shown anti-tumour activity and a favourable safety profile in Phase I and II trials for the treatment of different solid tumours.
OncoSec is further assessing ImmunoPulse IL-12 in patients with triple-negative breast cancer.
The firm is also working towards developing new immune-targeting agents for use with their ImmunoPulse.
Image: Histopathologic image of malignant melanoma. Photo: courtesy of KGH via Wikipedia.