FDA Grants Fast Track Designation to ImmunoPulse IL-12 for Melanoma


“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.’ ”

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OncoSec Reports ImmunoPulse May Prolong Survival Based on Analysis of Long-Term Survival Data from Phase I Study in Melanoma

The gist: A new treatment called ImmunoPulse has shown promise for improving the long-term survival of metastatic melanoma patients. 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 to kill cancer cells. It was tested in 24 volunteer patients in a clinical trial in 2007. Now, long-term follow-up data has been analyzed. The researchers found that the median length of time patients lived after treatment was 23.9 months.

“OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based cancer immunotherapies, released long-term survival results from its Phase I study in patients with metastatic melanoma, evaluating a single treatment cycle of intratumoral plasmid IL-12 (pIL-12) injection with electroporation (EP). Dr. Robert Pierce, Chief Scientific Officer at OncoSec, a co-author of the abstract presented these data today at the Melanoma Bridge 2014 conference in Naples, Italy.

“The Phase 1 dose-escalation study, which completed enrollment in February 2007 and was first published in the Journal of Clinical Oncology (Daud et al., 2008), established that a single treatment cycle of intratumoral pIL-12 EP, administered on Days 1, 5 and 8, has an acceptable safety profile and is well-tolerated. Escalating concentrations of pIL-12 were administered in cohorts of three patients. No dose-limiting toxicities, treatment-related serious adverse events, or treatment-related Grade 4 or 5 adverse events were reported. Importantly, the study also demonstrated that local intratumoral pIL-12 EP can induce systemic responses, as evidenced by stable disease or objective regression in non-injected, non-electroporated lesions. Moreover, pIL-12 EP monotherapy was shown to achieve objective responses in this initial Phase 1 trial in patients with metastatic melanoma, with three complete responses (CRs) observed after only one treatment cycle.

“OncoSec collected data from long-term follow-up and determined that the median overall survival for the patients in the Phase 1 study was 23.9 months. In addition, a statistically significant difference (p = 0.0054) was observed when comparing overall survival between patients who had a best overall response of at least stable disease or better (median OS = 49.1 months) versus patients who only had disease progression while on study (median OS = 10.9 months).”

UC San Francisco and OncoSec Medical Collaborate to Evaluate Investigational Combination of ImmunoPulse and Anti-PD-1 Treatment

The gist: Two drug companies are teaming up to see wether two melanoma treatments can work better together than either on its own. The treatments are Keytruda (aka pembrolizumab) and ImmunoPulse. Both drugs use a patient’s own immune system to fight cancer.

“OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, has entered a clinical collaboration with the University of California, San Francisco (UCSF), to evaluate the safety, tolerability and efficacy of the combination of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, and OncoSec’s ImmunoPulse (intratumoral IL-12) in metastatic melanoma.

“Recent data suggest that patients who are PD-L1 positive and have increased tumor-infiltrating lymphocytes (TILs) are more likely to respond to anti-PD-1/PD-L1 mAbs compared to patients who are PD-L1 negative. Therefore, therapies that promote TIL generation and PD-L1 positivity may play an important role in augmenting the clinical efficacy of these agents.

“Interleukin-12 (IL-12) is an inflammatory cytokine believed to be a master regulator of the immune system, promoting up-regulation of both the innate and adaptive immune responses. More specifically, IL-12 stimulates the production of another cytokine, interferon gamma (IFN-), which results in the stimulation of antigen processing and presentation machinery, leading to increased TILs and anti-tumor cytotoxic T-cell (CTL) activity.”

OncoSec Medical Presents Positive Phase 2 Interim Data Evaluating ImmunoPulse in Melanoma

“OncoSec Medical Inc. (OTCQB: ONCS), a company developing its ImmunoPulse DNA-based intratumoral cancer immunotherapy, announced interim data from its Phase 2 melanoma study at the American Society of Clinical Oncology’s (ASCO) 50th Annual Meeting in Chicago. The abstract, titled “Systemic anti-tumor effect and clinical response in a Phase 2 trial of intratumoral electroporation of plasmid interleukin-12 in patients with advanced melanoma” (ASCO Abstract #9025), was presented by Adil Daud, M.D., OncoSec’s Chief Clinical Strategist and Principal Investigator of the Phase 2 melanoma study, and selected for discussion during a poster highlights session for melanoma/skin cancers led by Axel Hauschild, M.D., Ph.D.”

Editor’s note: This article describes a promising immunotherapy treatment that boosts a patient’s own immune system to fight melanoma. 

IL-12 Therapy May Shrink Melanomas Not Directly Treated

An experimental immunotherapy that delivers interleukin-12 (IL-12) directly into a melanoma tumor may also shrink tumors elsewhere in the body. Called ImmunoPulse, the treatment entails injecting a tumor with interleukin-12 DNA and delivering electric shocks to make the tumor cells absorb this DNA. These cells then produce IL-12, boosting the immune response against the tumor. In an ongoing phase II trial of 21 people with melanomas that were treated with ImmunoPulse, tumors shrank in 8 of them (38%) and disappeared for at least 6 months in 2 more of them. Moreover, untreated tumors also shrank in about 60%. The possibility of body-wide effects is encouraging because, in contrast to systemic IL-12 therapy, ImmunoPulse treatments have yet to cause serious side effects.

New Immunotherapy May Turn IL-12 On and Off in Melanomas

Doctors may someday be able to adjust interleukin-12 (IL-12) levels in melanomas at will, according to results of an ongoing clinical trial presented at Melanoma Bridge 2013 Conference in Naples, Italy. IL-12 is an immune system protein that can shrink melanomas, but also has nasty side effects. The experimental immunotherapy entails injecting tumors with a virus that does not cause diseas, and that has been engineered to produce the IL-12 when people take a drug called veledimex. In the phase I/II trial of 21 people with melanomas that had been injected with this engineered virus, IL-12 production turned on when they took veledimex and turned off when they stopped. Depending on the dose, veledimex increased IL-12 production by 1,000 to 100,000 times.

Immunotherapy Gene Delivered Via Electrical Shock Shrinks Melanomas

A new immunotherapy shrank most of the melanomas treated in a clinical trial, researchers reported at the 2013 World Cutaneous Malignancies Congress. The results are from a phase II trial that included 13 people and 37 treated tumors. The treatment entailed injecting tumors with DNA containing the gene for an immune system booster called interleukin-12, and then giving the tumor an electrical shock to make it take up the engineered DNA. By 90 days after treatment, 80% of the melanomas had shrunk and nearly half had disappeared completely.

Zapping Melanomas Stimulates Uptake of Immune System Booster

Early results of a phase II clinical trial are encouraging for a new immunotherapy against melanomas. The first step is injecting the melanoma with engineered DNA that contains the gene for interleuken-12, a protein that stimulates the immune system. The next step, called electroporation, is to shock the tumor with 1,300 volts. This opens pores the melanoma cells, letting them take up the engineered DNA. The tumor then produces the immune system booster interleuken-12. In one arm of this multi-center trial, tumors have shrunk in eight of the nine people treated. And tumors often also shrank in parts of the body that weren’t directly treated. This trial is accepting new participants.

DNA-based Immunotherapy for Melanoma Advances in Clinical Trials

A promising new immunotherapy for melanoma is about to start a phase II clinical trial. Called ImmunoPulse, the two-step treatment entails injecting tumors with DNA that encodes an immune system protein called interleukin-12, and then delivering electric shocks to make the tumor cells absorb the DNA. These cells then produce interleukin-12, which boosts the immune response to the tumor. In an early trial of the new treatment on 13 people with melanoma, tumors shrank in all of them and hadn’t grown six months later in about half of them. The new trial will test how well this new immunotherapy controls the injected tumors as well as tumors elsewhere in the body, and results are expected in 6 months to a year, says ImmunoPulse developer OncoSec Medical Inc.