OncoSec Medical Inc (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced enrollment of the first patient into the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the anti-tumor activity, safety, and tolerability of the combination of OncoSec’s investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma. The primary endpoint is the best Overall Response Rate (bORR) of the combination regimen in patients whose tumors are characterized by low numbers of tumor-infiltrating lymphocytes (TILs).
“There is increasing evidence that tumors need to be inflamed and have TILs in order for anti-PD-1 therapies to be most effective,” said Mai H. Le, MD, Chief Medical Officer of OncoSec. “Both preclinical and clinical evidence suggest that ImmunoPulse™ IL-12 can promote tumor immunogenicity. We anticipate that ImmunoPulse™ IL-12 will increase the proportion of patients who will respond to immune checkpoint inhibitors like KEYTRUDA® and that the combination will have synergistic anti-tumor activity.”
“This is the first study in the field of immuno-oncology to evaluate the combination of DNA-based interleukin-12 with electroporation and an anti-PD-1/PD-L1 inhibitor,” said Punit Dhillon, CEO and President of OncoSec. “We believe the combination of OncoSec’s intratumoral cancer immunotherapy and checkpoint inhibitors has the potential to be a powerful approach in the fight against cancer.”
This multi-center, open label, single-arm trial will enroll approximately 42 patients with unresectable, “low-TIL” metastatic melanoma. Alain Algazi, MD, a skin cancer specialist in the Melanoma Center at the UCSF Helen Diller Family Comprehensive Cancer Center, is the study’s sponsor and principal investigator. The key endpoints of the study include: best Overall Response Rate 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.
The treatment schedule for the trial follows the standard schedule for pembrolizumab. Pembrolizumab will be administered systematically once every three weeks and ImmunoPulse™ IL-12 will be administered on three separate days every six weeks. ImmunoPulse™ IL-12 employs intratumoral delivery of DNA-based IL-12 followed by electroporation. Merck will supply pembrolizumab, and OncoSec will provide ImmunoPulse™ IL-12. (Original Source)
Shares of OncoSec Medical closed yesterday at $5.99. ONCS has a 1-year high of $13.20 and a 1-year low of $4.00. The stock’s 50-day moving average is $6.00 and its 200-day moving average is $6.57.
On the ratings front, OncoSec Medical has been the subject of a number of recent research reports. In a report issued on June 22, H.C. Wainwright analyst Mark Breidenbach initiated coverage with a Buy rating on ONCS and a price target of $25, which implies an upside of 317.4% from current levels. Separately, on June 16, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $17.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mark Breidenbach and Jason Kolbert have a total average return of -26.9% and -7.7% respectively. Breidenbach has a success rate of 0.0% and is ranked #3533 out of 3738 analysts, while Kolbert has a success rate of 33.6% and is ranked #3708.
OncoSec Medical Inc is a hybrid device and gene therapy biotechnology company. It is engaged in designing, developing and commercializing medical approaches for treatment of cancer.