OncoSec Reports ImmunoPulse May Prolong Survival Based on Analysis of Long-Term Survival Data from Phase I Study in Melanoma
Source: pipeLine Review, December 2014
SAN DIEGO, CA, USA I December 4, 2014 I 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).
Dr. Mai H. Le, Chief Medical Officer at OncoSec, stated, “The data generated from this study provide encouraging evidence that local, intratumoral therapy has antitumor effects in both locally treated and systemic disease. These preliminary findings suggest that patients who respond to intratumoral pIL-12 EP may have improved survival. Although caution must be exercised in interpreting the OS data, these results warrant further investigation.”
Punit Dhillon, Chief Executive Officer at OncoSec, added, “As we continue to advance the research and development of our immuno-oncology platform, the long-term survival data observed in this study are encouraging and provide further validation that intratumoral immunotherapies may provide significant therapeutic benefit. We are grateful to the organizers of the Melanoma Bridge conference for providing the opportunity to share these data, and look forward to presenting our top-line six-month primary endpoint data from our Phase II study as well.”
About OncoSec Medical
OncoSec Medical Inc. is a biopharmaceutical company developing its investigational ImmunoPulse intratumoral cancer immunotherapy. OncoSec Medical’s core technology is designed to enhance the local delivery and uptake of DNA IL-12 and other DNA-based immune-targeting agents. Clinical studies of ImmunoPulse have demonstrated an acceptable safety profile and preliminary evidence of anti-tumor activity in the treatment of various skin cancers, as well as the potential to initiate a systemic immune response without the systemic toxicities associated with other treatments. OncoSec’s lead program evaluating ImmunoPulse for the treatment of metastatic melanoma is currently in Phase 2 development, and is being conducted in collaboration with several prominent academic medical centers. As the company continues to evaluate ImmunoPulse in its current indications, it is also focused on identifying and developing new immune-targeting agents, investigating additional tumor indications, and evaluating combination-based immunotherapy approaches. For more information, please visit www.oncosec.com.