“Immunopulse IL-12 monotherapy and in combination with pembrolizumab was associated with encouraging response rates and safety data in patients with melanoma who may not respond to anti-PD-1 therapy, according to a press release.
“The findings were presented at the 9th World Congress of Melanoma — A Joint Meeting with the Society for Melanoma Research. The data include a phase 2 Immunopulse IL-12 (OncoSec) monotherapy study with 51 patients and a phase 2 study of the immunotherapy in combination with pembrolizumab, which included 22 patients.”
“Adding the immune stimulator ImmunoPulse IL-12 to pembrolizumab (Keytruda) produced promising activity among patients with melanoma identified as unlikely responders to anti–PD-1 therapies.
“Data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma showed that the combination induced an overall response rate (ORR) of 50% (n = 11) among 22 patients with baseline biomarker data suggesting they would not respond to anti–PD-1 therapy.”
“The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.
“ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).
“ ‘With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,’ Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. ‘Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.’ ”
The gist: A new treatment that has shown promise in other types of cancer will soon be tested in triple negative breast cancer (TNBC) patients. The treatment, called IL-12 ImmunoPulse, delivers instructions for making a protein called IL-12 into a patient’s tumor. The patient’s cells then make IL-12, which boosts the immune system. A small pilot study will take place at Stanford University in California. It will test whether ImmunoPulse has promising effects on the immune system. If it is successful, researchers might try combining the treatment with drugs that are known to be more effective when the immune system is stimulated.
“OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, plans to initiate a pilot study to assess IL-12 ImmunoPulse in patients with Triple Negative Breast Cancer (TNBC). The study will be conducted at Stanford University with Melinda L. Telli, MD, serving as lead investigator.
“This pilot study is designed to assess whether IL-12 ImmunoPulse increases TNBC tumor immunogenicity by driving a pro-inflammatory cascade of events that leads to increases in cytotoxic tumor-infiltrating lymphocytes (TILs). The presence and number of TILs is thought to be a key requirement for promoting the anti-tumor activity of antibodies like anti-PD-1/PD-L1. By driving cytotoxic immune cells into the tumor, IL-12 ImmunoPulse may be an ideal candidate to combine with checkpoint blockade therapies which reported some activity in TNBC.
“Worldwide, TNBC amounts to approximately 200,000 cases each year and accounts for approximately 20 percent of all breast cancer. It is most commonly diagnosed in younger women (less than 40 years) and is characterized by higher relapse rates when compared with estrogen receptor (ER)-positive breast cancers. TNBC is also associated with an increased risk of recurrence, both locally and in distant sites, including the lung and brain. Advanced TNBC remains a significant area of unmet medical need and there is no established standard-of-care. Treatment generally includes chemotherapy, with or without radiation and/or surgery. However, no treatment regimen has clearly demonstrated superiority.”