By The Life Science Report

Source: Streetwise Reports>   11/20/2017

This immunotherapy firm’s stock recently doubled its Nov. 7 price following lots of news, including a clinical data release, a trial launch and an executive appointment.

The series of recent catalysts for OncoSec Medical Inc. (ONCS:NASDAQ) includes its release of “positive long-term follow-up data,” noted Ram Selvaraju, an analyst with H. C. Wainwright & Co. These results were from its Phase 2 OMS I-102 study, in which the immune stimulator ImmunoPulse IL-12 (pIL-12) was given in combination with Keytruda (pembrolizumab) to 11 melanoma patients unlikely to respond to anti-PD-1 therapy.

The results showed a progression-free survival rate of 57% at 15 months, and all 11 patients achieved duration of response. These data, together with the previously reported best overall response rate of 50% at 24 weeks, suggest “the combo therapy can prime a coordinated innate and adaptive immune response, which could then lead to improved clinical outcomes in patients not responsive to anti-PD-1 therapy alone, in our view,” Selvaraju wrote.

The analyst added that these data also “bode well” for OncoSec’s PISCES/KEYNOTE-695 Phase 2b trial, which it initiated in October. In that study, the same combination of therapies will be administered—ImmunoPulse plus Keytruda—but in a different patient population. These patients have unresectable metastatic melanoma and have progressed or are progressing on an anti-PD-1 therapy. Enrollment of the 48 patients will take place in the United States and Australia, and will be divided into two cohorts, 23 in the first, 25 in the second.

The clinical trial’s primary endpoint is the best overall response rate at 24 weeks. Management has indicated an overall response rate of 30% “would be considered a success for this study,” Selvaraju said. “We believe preliminary interim data could be reported around mid-2018.”

If positive, those interim data “may allow the company to apply for breakthrough therapy designation for pIL-12 in patients who have failed anti-PD-1 monotherapies,” Selvaraju explained.

He reiterated that ImmunoPulse IL-2 has both fast track and orphan status designations. Were the FDA to approve it, and were it to be brought to market, he added, “we note that 5,000–10,000 patients on an annual basis may benefit from this combo therapy with improved response rates.”

Also in October, OncoSec “closed on two registered direct offerings” that yielded $8.2 million at about $1.34 per share, reported Selvaraju.

Finally, the biotech, in early November, appointed Daniel O’Connor as its CEO. “Mr. O’Connor’s expertise in the biotech industry, particularly with regard to areas involving the overlap between immunology and oncology, should serve OncoSec well,” Selvaraju concluded. Most recently, O’Connor was the CEO of Advaxis Inc. (ADXS:OTCBB), also an immuno-oncology company. Prior to that, he worked at ImClone Systems from 2003 to 2008, at which point it was sold to Eli Lilly. There, as senior vice president, general counsel and secretary, he supported the clinical development, launch and commercialization of Erbitux, among other accomplishments.

H.C. Wainwright & Co. maintains its Buy recommendation and $6 per share price target on OncoSec, whose shares are currently trading at around $2.08.

Want to read more Life Sciences Report articles like this? Sign up at www.streetwisereports.com/get-news for our free e-newsletter, and you’ll learn when new articles have been published. To see recent articles and interviews with industry analysts and commentators, visit our Streetwise Interviews page.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following company mentioned in this article is a sponsor of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article.

Additional disclosures about the sources cited in this article

( Companies Mentioned: ONCS:NASDAQ,
)