OncoSec Medical Inc (NASDAQ:ONCS) shares were down 5.63% on Thursday to $1.52 but recovered 7.28% in after-hours trading to $1.62. The company has a market cap of $29.48 million at 19.16 million shares outstanding. Share prices have been trading in a 52-week range of $1.36 to $3.49.
In a press release yesterday, OnoSec Medical Inc announced key corporate initiatives during the inaugural Investor and Analyst Day in San Diego. These updates included plans for a melanoma combination directed-registration study of OncoSec’s lead product candidate in combination with anti-PD-1 therapy. Aside from that, the company shared details on its preclinical multi-gene plasmid constructs, Tissue-based Real-time Adaptive Controlled Electroporation and its Technology Access Program.
“By focusing our clinical programs on patients who do not respond to anti-PD-1 therapy, we are committed to developing therapies for those in critical need of alternative treatments,” said Punit Dhillon, President and CEO of OncoSec medical inc. “We are pleased to be focused on a registration-directed clinical program with a regulatory path that we hope will lead to a potential FDA approval for our first commercial product in 2019.”
Dhillon added that the favorable anti-tumor activity and safety data garnered from the Investigator Sponsored Trial (IST) Phase II clinical trial combining ImmunoPulse IL-12 and KEYTRUDA provided them with additional confidence to move forward with key regulatory, clinical and commercial efforts aimed at achieving marketing approval for ImmunoPulse IL-12 in anti-PD-1 non-responder advanced melanoma.
“We are changing the way clinicians and scientists think about the use of technology to manipulate cellular activity with the power of DNA construct delivery and activation through our innovative, easy to use, next-generation gene electro-transfer devices,” continued Mr. Dhillon.
He also explained that their development strategy for ImmunoPulse IL-12 will lead to a large market opportunity, and can generate significant value for shareholders. It will also provide a strong foundationfor advancing the company’s next clinical candidate in first-in-human studies in 2018.
The company also highlighted the new Phase II melanoma data that was recently presented at the Society for Immunotherapy of Cancer Annual Meeting. This single-arm, open-label trial assessed the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse IL-12, and Merck’s KEYTRUDA in patients with unresectable metastatic melanoma. A predictive biomarker was used to enroll patients that have a low likelihood of response to an anti-PD1 agent alone, and the purpose of the trial is to assess whether the addition of ImmunoPulse IL-12 can increase response rates in these patients.
OnoSec Medical Inc is a biotechnology company that is focused on designing, developing and commercializing gene therapies, therapeutics and medical approaches to stimulate an anti-tumor immune response for the treatment of cancer. Its lead product candidate, ImmunoPulse IL-12, consists of a plasmid construct encoding the proinflammatory cytokine, IL-12, which is delivered into the tumor through in vivo electroporation.
The company has been pursuing two clinical trials: ImmunoPulse IL-12 monotherapy in patients with metastatic melanoma and ImmunoPulse IL-12 plus pembrolizumab in patients with advanced, metastatic melanoma. Aside from that, OnoSec Medical Inc is pursuing ImmunoPulse IL-12 monotherapy in patients with triple negative breast cancer.