The combination of ImmunoPulse IL-12 and the anti-PD-1 therapy Keytruda (pembrolizumab) soon will be tested in a Phase 2 trial for treatment of metastatic melanoma. The study, called PISCES, is part of a clinical trial collaboration between OncoSec Medical, which is ImmunoPulse IL-12’s manufacturer, and Merck.
“We are honored to collaborate with Merck – one of the world’s leading cancer immuno-oncology companies – to help bring innovative cancer treatments to patients with unmet medical needs,” Punit Dhillon, CEO and president of OncoSec, said in a press release.
The ImmunoPulse immunotherapy platform was developed to deliver and promote the expression of interleukin-12 (IL-12) within the tumor microenvironment. IL-12 is a naturally occurring protein that stimulates immune activation, enabling the immune system to target and attack tumors.
Anti-PD-1 immunotherapies are highly effective and widely used in the battle against tumors. However, many patients with solid tumors do not respond to them, which is a major concern.
“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,” said Dhillon.
Indeed, results from a Phase 2 trial (NCT02493361) showed that IL-12 co-treatment improved overall clinical response to anti PD-1 therapy by 40% in melanoma patients not expected to respond to therapy. These results suggested that the combination therapy effectively could change the tumor microenvironment to benefit patients otherwise unlikely to respond to anti-PD-1 monotherapy.
“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,” Dhillon added.
The new Phase 2 trial (NCT03132675) is expected to enroll up to 48 patients with advanced or metastatic melanoma who progressed, or are progressing following an anti PD-1 therapy — Keytruda or Opdivo (nivolumab). The study will address the safety and effectiveness of ImmuoPulse IL-12 injected directly into the tumor, in combination with intravenous Keytruda.
Under the agreement, OncoSec will sponsor and fund the study and Merck will provide Keytruda. Additional details of the collaboration were not disclosed.
“By working with innovative immuno-oncology leaders, this alliance underpins OncoSec’s strategy to combine our ImmunoPulse IL-12 program with checkpoint inhibitor therapies to advance the care of patients,” Dhillon said.