IL-12 Therapy Elicits Encouraging Response Rates in Melanoma

Excerpt:

“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.”

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Immune System-Boosting ImmunoPulse to Be Tested in Triple-Negative Breast Cancer Patients in Pilot Study

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.”


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.”


ASCO 2014: Highlights for People Dealing with Melanoma


Every year, new cancer treatment insights are shared at the American Society of Clinical Oncology (ASCO) Annual Meeting. Here are some of the most notable recent developments in melanoma treatment, gleaned from researchers’ presentations at ASCO last month: Continue reading…


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. 


Melanoma: A 2013 ‘Progress Report’


The past year saw some remarkable advances in melanoma clinical research and treatment. This feature explores the most notable melanoma news of 2013: Continue reading…


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.


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.