OncoSec Medical Inc (NASDAQ:ONCS) reported the commencement of patient dosing in PISCES and KEYNOTE-695, the firm’s global, multi-center, registration-based open-label Phase IIb clinical study. The trial will assess the combination of ImmunoPulse® IL-12 and pembrolizumab in people with unresectable metastatic melanoma who are progressing or have progressed on an anti-PD-1 treatment.
Sharron Gargosky, the Chief Clinical & Regulatory Officer of OncoSec Medical, reported that there remains a considerable unmet medical requirement in oncology for people in whom the current PD-1 therapies don’t work. Based on the promising data they showcased at SITC, they consider the combination of pembrolizumab and ImmunoPulse IL-12 may provide a differentiated plan to reshaping the tumor microenvironment by changing immunologically cold tumors to hot. They look forward to the sustained development of this study and to sharing data next year.
The Phase IIb, multicenter trial of intratumoral tavo with electroporation in conjunction with intravenous pembrolizumab will register around 48 subjects with a histological diagnosis of melanoma with growing locally advanced or metastatic ailment stated as Stage III or Stage IV. The main objective is defined as the Best Overall Response Rate.
OncoSec’s prior Phase II OMS I-102 combination trial of pembrolizumab and ImmunoPulse® IL-12 in 22 subjects unlikely to respond to anti-PD-1 treatment showcased a 50% BORR and a 41% complete response rate. Additionally, the study demonstrated a 57% progression free survival rate at 15 months and 100% duration of response. In clinical trials so far, intratumoral tavo has been well tolerated and has showcased a favorable safety profile.
PISCES/KEYNOTE-695 marks as the second combination trial performed with pembrolizumab and, if it is a success, could form the foundation for a BLA under the faster approval pathway. Melanoma can be defined as a type of skin cancer that starts in skin cells named melanocytes. As the cancer advances, melanoma becomes extreme tough to treat once it goes beyond the skin.