Oncosec Medical (ONCS) Says ImmunoPulse Combo Phase 3 Data Will Be Present at STIC Meeting

October 13, 2016 6:05 AM EDT

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OncoSec Medical Incorporated (Nasdaq: ONCS) announced that new clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the combination of OncoSec's investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck's KEYTRUDA® (pembrolizumab) in patients with unresectable metastatic melanoma and a low likelihood of response to an anti-PD1 alone will be presented at an oral poster presentation at the upcoming Society for Immunotherapy of Cancer ("SITC") Annual Meeting to be held on November 11-13, 2016, in National Harbor, MD.

In August 2016, OncoSec announced the publication of a research assay in the Journal of Clinical Investigation that can be used as a predicative biomarker in melanoma patients. The assay shows that patients with a low frequency of CD8-positive inflamed tumors (that are PD-1 high and CTLA-4 positive) would pre-dispose them to low response rates to PD-1 inhibitor therapy alone. The Company is using this biomarker assay to pre-qualify patients in this ongoing combination study based on quantification of these type of CD8 cells. In the trial, patients deemed to be likely low responders were treated with a combination of systemic pembrolizumab and intratumoral ImmunoPulse® IL-12 during the trial period. This presentation will provide an interim update of 15 treated patients.

The key endpoints of the study include: best overall response rate (ORR) 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.

Eligible patients were concurrently treated with pembrolizumab and ImmunoPulse® IL-12 during the trial period.

Details of the presentation are as follows:

Abstract Title: Phase II Study of Intratumoral plasmid Interleukin 12 (pIL-12) with Electroporation in Combination with Pembrolizumab in Stage III/IV Melanoma Patients with Low Tumor Infiltrating Lymphocytes (Abstract #203921) Lead Author: Alain Algazi, MD, Clinical Instructor, Department of Medicine (Hematology/Oncology), UCSFPoster Number: 466Date and Time: November 11, 2016 at 12:15 pm EDT (Oral poster presentation to be defined)Location: Prince George's Exhibition Hall AB, Gaylord National Resort & Convention Center

For more information about this trial, please visit: https://clinicaltrials.gov/ct2/show/NCT02493361?term=pIL-12&rank=3



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Comments

Phase 2b, not phase 3 data
John Joe on 2016-10-31 11:40:12
Mark as Spam | Reply to this comment

They will be presenting interim phase 2b data, not phase 3 data.


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