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OncoSec Shares Spike 17% After New Data Defended

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OncoSec Shares Spike 17% After New Data Defended

OncoSec Medical Inc (NASDAQ: ONCS) shares spiked about 20 percent intraday Thursday amid the release of positive mid-stage trial data for its investigational therapy ImmuoPulse IL-12 as a monotherapy and in combination with Pembrolizumab (Keytruda) for treating predicted anti-PD-1 non-responder metastatic melanoma patients.

The data was presented in an oral presentation at the 2017 World Congress of Melanoma.

At the time of writing, shares of OncoSec were up 5.51 percent at $1.34.

When asked his views on the data, STAT News' national biotech columnist Adam Feuerstein said in a tweet, at the outset, the results look neutral or better.

The Trial

OncoSec Medical said the monotherapy and combo studies tested 51 and 22 patients, respectively, with metastatic melanoma. The patients for the combo study were chosen based on their baseline biomarker data, which predicted that they will not respond to anti-PD-1 therapy.

Combo Treatment

On efficacy, the company said in the case of the combo treatment, 50 percent best overall response rate was observed at 24 weeks, while nine achieved response evaluation criteria in solid tumors. The data also demonstrated a coordinated innate and adaptive response, suggesting ImmunoPulse IL-12's synergistic relationship with the anti PD-1.

Commenting on the data, Maxim Group's Jason McCarthy and Jason Kolbert said the data is a positive, given that the expected response rate in this population is only 0-10 percent. The analysts said the focus now is on the registration study with Merck & Co., Inc. (NYSE: MRK).

The analysts noted that the Phase 2b registration study dubbed PISCES/KEYNOTE-695, with Merck is underway. The study evaluates patients who have failed multiple rounds of checkpoint monotherapy, with the primary endpoint of the study being BORR at 24 weeks. The trail is designed as an open-label one and has enrolled 48 patients.

"Good results would translate into a significant incentive for Merck to support the combination," the analysts said.

See also: Attention Biotech Investors, Here's Your PDUFA Primer For October

Monotherapy

As a monotherapy, the therapy achieved 25-34.6 percent BORR by a modified skin RECIST.

In patients treated with ImmunoPulse IL-12 on a 90-day cycle, there were 19.2 percent complete responders, 15.4 percent partial responders and 34.6 percent stable disease, with the total disease control rate of 69.2 percent.

Among patients put on the monotherapy on a six-week cycle, the total disease control.

Safety

The trial results revealed that fewer than 10 percent of patients in both studies reported treatment-related serious adverse events. Additionally, the company said the data also demonstrated that ImmunoPulse IL-12 can trigger key immunologic events, driving a cellular response leading to an inflamed tumor, with increased TIL frequency.

Meanwhile, the monotherapy as well combo treatments converted cold or non-immunogenic tumors to hot or immunogenic, with the effect more pronounced in the latter. This would drive the T-cell into the tumor area for a checkpoint to act upon.

"Collectively, these study findings reinforce the combination of ImmunoPulse IL-12 and pembrolizumab to address a significant unmet medical need in melanoma patients who are unlikely to respond to anti-PD-1 therapies," said Punit Dhillon, CEO and president of OncoSec.

"We look forward to presenting additional data from our ongoing Phase 2 combination study at the upcoming 2017 Society for Immunotherapy of Cancer Annual Meeting, in addition to our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018."

Maxim Group believes it would take a combination therapy to unlock a larger market opportunity. The firm said the next key event for OncoSec is the presentation of data in the first set of patients evaluated in the phase 2b trails, due in the middle of 2018.

The firm has a Buy rating and $5 price target for the shares of OncoSec.

Related Link: The BLUE And The BOLD; Analyst Suggests Pair Trade Ahead Of Year-End Catalysts

 

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