OncoSec Medical Inc (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today presented preliminary findings from OMS-I130, a Phase II clinical trial of ImmunoPulse™ IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC). These preliminary findings, indicating that ImmunoPulse™ IL-12 may lead to an increase in CD8+ T-cells and ‘adaptive immune resistance’ in HNSCC patients, are consistent with preclinical and clinical data previously reported in other indications. Together, the data from these multiple studies support a rationale for combining ImmunoPulse™ IL-12 with anti-PD-1 blockade therapies.
Robert H. Pierce, MD, Chief Scientific Officer at OncoSec, presented the findings in an oral presentation entitled: “Intratumoral IL-12 Therapy in HNSCC: Can In-Situ Vaccination Solve the Problem of Anti-PD-1 Non-Response?” at the EUROGIN 2016 Conference in Salzburg, Austria. The oral presentation is part of the conference session entitled: “Updates on Immunotherapy Trials in HPV-HNSCC,” chaired by Sara I. Pai, MD, PhD, a faculty member at Massachusetts General Hospital and Harvard Medical School and co-author of the abstract.
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Dr. Pierce described a role for intratumoral immunotherapy in driving anti-tumor CD8+ responses and altering the immune environment to enable tumors to become responsive to anti-PD-1 blockade. Specifically, Dr. Pierce described new cases from the single-agent ImmunoPulse™ IL-12 Phase II HNSCC trial, in which intratumoral electroporation of DNA-based IL-12 drove a CD8+ T-cell response and associated increase in interferon-gamma-related genes in some patients. Moreover, one patient, who went on to receive anti-PD-1 therapy in combination with ImmunoPulse™ IL-12, experienced a significant tumor regression and has an ongoing partial response.
“Although we have treated only four patients to date, these data in patients with head and neck cancer are entirely consistent with our previous studies in melanoma and Merkel cell carcinoma as well as our preclinical models—namely, that in-situ vaccination with plasmid IL-12 can convert low-TIL, poorly-inflamed tumors into high-TIL inflamed tumors. That conversion may augment responses to T-cell checkpoint therapy, such as anti-PD-1 antibodies,” said Dr. Pierce.
The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and Alain Algazi, MD, from the University of California, San Francisco. OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumor activity of ImmunoPulse™ IL-12 in patients with treatment-refractory metastatic and unresectable HNSCC. The trial (NCT02345330) is open, but currently not recruiting patients.
“We have paused enrollment in the HNSCC trial for two main reasons. First, we are currently focusing our internal resources on moving toward a registration trial in melanoma. Additionally, our strategy is aimed at demonstrating that ImmunoPulse™ IL-12 is a rational choice for combination therapy with anti-PD-1/PD-L1 and that ImmunoPulse™ IL-12 will increase the number of patients who will benefit from these treatments,” said Punit Dhillon, President and CEO. “As approval of one or more of the PD-1/PD-L1 antibodies in HNSCC seems likely in the near term, we will explore a combination of our technology with the approved agent at that time.” (Original Source)
Shares of OncoSec Medical are currently trading at $1.70, down $0.05 or -2.86%. ONCS has a 1-year high of $7.51 and a 1-year low of $1.36. The stock’s 50-day moving average is $1.72 and its 200-day moving average is $2.08.
On the ratings front, OncoSec has been the subject of a number of recent research reports. In a report issued on June 6, Maxim Group analyst Jason McCarthy reiterated a Buy rating on ONCS, with a price target of $17, which represents a potential upside of 908.6% from where the stock is currently trading. Separately, on April 20, H.C. Wainwright’s Mark Breidenbach reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Mark Breidenbach have a total average return of 3.7% and -19.3% respectively. McCarthy has a success rate of 46.0% and is ranked #847 out of 3971 analysts, while Breidenbach has a success rate of 25% and is ranked #3800.
OncoSec Medical, Inc. designs, develops, and commercializes medical products for the treatment of cancer. It engages in the discovery and development of novel immunotherapeutic products to improve treatment options for patients and physicians, which intends to treat oncology indications. The company was founded by Avtar S. Dhillon and Punit S. Dhillon on February 8, 2008 and is headquartered in San Diego, CA.