On August 18, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported enrollment of the first patient into the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the anti-tumor activity, safety, and tolerability of the combination of OncoSec’s investigational therapy, ImmunoPulse IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA (pembrolizumab), in patients with unresectable metastatic melanoma (Press release, OncoSec Medical, AUG 18, 2015, View Source [SID:1234507287]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The primary endpoint is the best Overall Response Rate (bORR) of the combination regimen in patients whose tumors are characterized by low numbers of tumor-infiltrating lymphocytes (TILs).

"There is increasing evidence that tumors need to be inflamed and have TILs in order for anti-PD-1 therapies to be most effective," said Mai H. Le, MD, Chief Medical Officer of OncoSec. "Both preclinical and clinical evidence suggest that ImmunoPulse IL-12 can promote tumor immunogenicity. We anticipate that ImmunoPulse IL-12 will increase the proportion of patients who will respond to immune checkpoint inhibitors like KEYTRUDA and that the combination will have synergistic anti-tumor activity."

"This is the first study in the field of immuno-oncology to evaluate the combination of DNA-based interleukin-12 with electroporation and an anti-PD-1/PD-L1 inhibitor," said Punit Dhillon, CEO and President of OncoSec. "We believe the combination of OncoSec’s intratumoral cancer immunotherapy and checkpoint inhibitors has the potential to be a powerful approach in the fight against cancer."

This multi-center, open label, single-arm trial will enroll approximately 42 patients with unresectable, "low-TIL" metastatic melanoma. Alain Algazi, MD, a skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center, is the study’s sponsor and principal investigator. The key endpoints of the study include: best Overall Response Rate by RECIST v1.1 and immune related-Response Criteria (irRC); safety and tolerability; duration of response; 24-week landmark progression-free survival; median progression-free survival; and overall survival.

The treatment schedule for the trial follows the standard schedule for pembrolizumab. Pembrolizumab will be administered systematically once every three weeks and ImmunoPulse IL-12 will be administered on three separate days every six weeks. ImmunoPulse IL-12 employs intratumoral delivery of DNA-based IL-12 followed by electroporation. Merck will supply pembrolizumab, and OncoSec will provide ImmunoPulse IL-12.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov.

About Melanoma
Melanoma is one of the most dangerous forms of skin cancer and accounts for the vast majority of skin cancer deaths.1 When melanoma is caught early enough, surgical excision can be curative in the majority of Stage I and II melanomas. The overall 5-year survival rate for patients with localized melanoma is 98 percent in the United States.1 At later stages, malignant melanoma remains a deadly and frequently difficult to treat cancer. The overall 5-year survival rate for patients falls to 63 percent when the disease reaches the lymph nodes and 16 percent when the disease metastasizes to distant organs.1

Melanoma that has spread to distant sites may be treated with surgery, immunotherapy, chemotherapy and/or radiation therapy.1 Numerous chemotherapy regimens have been tested in melanoma with only modest success and limited overall survival benefit.2 Two approaches – checkpoint inhibitors and targeted kinase inhibitors – have demonstrated improvement in overall survival of patients compared to chemotherapy. 2

While immunotherapy can be extremely effective, the currently approved regimens do not benefit the majority of patients. However, early data of combination approaches with immunotherapies are promising.2 Researchers also continue to focus efforts on targeting pathways of T cell activation.3 The presence of CD8+ T cells seems to correlate with improved prognosis and long-term survival in solid malignancies, such as melanoma,4,5 thus many emerging experimental immunotherapies seek to enhance the tumor’s immunogenicity and increase the anti-tumor CD8+ T cell response.