OncoSec Medical Incorporated announced the commencement of an investigator-initiated Phase 2 study led by Senior Member and Professor Ahmad A. Tarhini, M.D., Ph.D. of the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate its lead product candidate, TAVO? (interleukin-12 or IL-12 plasmid) immunotherapy as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO? (nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma.

Anti-PD-1 immune checkpoint therapies, such as OPDIVO?, are an established first-line treatment for advanced melanoma, and encouraging clinical data suggest that they have clinically meaningful activity in the neoadjuvant setting as well. This investigator-initiated Phase 2 study has been designed to evaluate whether the addition of TAVO can increase the published anti-tumor response observed with monotherapy OPDIVO?, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors.

Recent trials with anti-PD-1 and anti-PD-1 combinations have shown significant advantages in both relapse free survival (RFS) and overall survival (OS) when administered as neoadjuvant therapy as compared to adjuvant therapy (administered after surgery) alone for metastatic melanoma. The TAVO-specific immunological signatures associated with coordinated innate and adaptive cellular responses were identified in earlier TAVO monotherapy trials and continue to be essential in driving the clinical efficacy in late-stage, anti-PD-1-refractory metastatic melanoma patients. These immunological pathways that sensitize lesions to checkpoint therapy in a late-stage setting are likely to be highly active in an earlier disease setting, which along with TAVO's excellent safety record, provides a strong rationale to leverage this therapeutic combination within the neoadjuvant setting.

"Patients with locally/regionally advanced melanoma present a major challenge for surgical and medical management," said Dr. Tarhini, who is Director, Cutaneous Clinical & Translational Research and Senior Member in the Departments of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center & Research Institute. "Following surgical treatment, these patients continue to have a high risk of relapse and death despite the use of standard adjuvant therapy. Neoadjuvant therapy with an effective immunotherapeutic agent, such as TAVO, combined with the anti-PD-1checkpoint inhibitor nivolumab, has the potential to improve overall outcomes such as operability, pathologic tumor response and long-term disease control. This, combined with the excellent safety and tolerability profile TAVO has demonstrated with hundreds of patients to-date, leaves me very encouraged and eager to evaluate TAVO-nivolumab combination treatment in the neoadjuvant setting."

"This Phase 2 study will highlight the advantages of bringing TAVO into an earlier disease setting. It will be an important validation of the broad utility of TAVO, and is anticipated to build on its excellent safety and efficacy profile to date," said Kellie Malloy Foerter, OncoSec's Chief Operating Officer. "We look forward to collaborating with Dr. Tarhini's team and to supporting other potential investigator-initiated studies that can further the understanding of TAVO's capabilities in treating cancer. We also want to express our appreciation of the patients and their families who participate in clinical trials."