ImmunoPulse IL-12 and Keytruda Combo Therapy to be Tested in Phase 2 Trial

ImmunoPulse IL-12 and Keytruda Combo Therapy to be Tested in Phase 2 Trial

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.

2 comments

  1. Jean Stewart says:

    I would like to be in this trial. I believe I will qualify.
    Please email me, if possible.
    I am a patient at Melanoma Pigmented Center at Mass General
    Hospital.
    I am 59, diagnosed at 57
    thru a lymph node. As I have no primary.
    I have not responded to keytruda.
    I am nearing the end of a clinical trial with a synergistic drug, to compliment keytruda, and see if this works. At best I would be stable. As I have a visual on one subcutaneous tumor.
    I am in much pain, many of the tumors are all around my left groin, in the crease where leg attaches to torso.
    I also have a necrotic hole in same area, not only failing radiation, yet I was unlucky to get severe burns to recover from, then I had a seroma blow up and left a hole that was necrotic.
    I had 25 treatments of radiation last Fall. Healed from the red burn. Then on February 2nd 2017, had this hole where the radiation was focused.
    I ended up in a wound clinic from then until just recently. I can deal with the wound myself. I had approx. 30 treatments in the hyperbaric oxygen chamber to help this new set of problems. This lasted until May, and then debreedment every week.
    Now focusing on the melanoma, as May or was it April I found out I was know a stage 4. With new and growing mets in my groin, on my back, in my lungs, and bone of the left femur, near hip.
    I am in much pain. Are others with melanoma in pain like this? We never hear much about pain.
    Are we to pretend it doesn’t exist?
    I am sorry, I was so positive, and a warrior. I just felt if I didn’t have radiation, and had done anything else, I wouldn’t be in this pain. As the real last time before Aprils scans, happened maybe last Oct? Or before my surgery in Aug 2016.
    There was so much time I had to heal from radiation, basically November to May. 6 MONTHS!! To long for such a procedure. I want to help find a way for the non responders to have hope, a chance. As we hear very few stories from non responders.
    I am sorry if this sounds like I only complain. I do not know where to turn. To be in a study that I have been interested in since I heard about it. Also this made much sense to me. And I sure could use this for the tumors all around my left groin. And back. Not sure about the lung or bone in left leg. At least the pain from the tumors around my leg, potentially would be gone.
    Respectfully and honestly, please, please consider if I would be a match for this clinical trial.
    Jean Stewart

    • Alice Melão says:

      Dear Jean, You can try to contact directly the contact person of the trial, has indicated by the info in clinicaltrials.gov. In this case it is Sharron Gargosky, PhD, 858 255 4729, sgargosky@oncosec.com. I hope this information can help you.

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