OncoSec Medical Announces Positive Preliminary Safety Data in Combination Study

100% of Treated Lesions Demonstrated Complete Regression

SAN DIEGO – October 8, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced positive preliminary animal data demonstrating the benefits of combining the company’s ImmunoPulse with anti-CTLA4 and anti-PD1 antibodies.

Dr. Richard Heller, professor at Old Dominion University, summarized the initial results of this study at the Cancer Vaccines and Gene Therapy Meeting in Philadelphia, Pennsylvania. The study was conducted using a single tumor model where a total of forty mice (eight treatment groups) were treated with either ImmunoPulse alone, or in combination with anti-CTLA4, anti-PD1 or both at varying concentrations. Safety and anti-tumor activity were assessed. Results indicate that all treatment groups showed 100% regression of treated lesions in all mice, and that no mice died as a result of toxicity from treatment. The results from this initial study demonstrate that ImmunoPulse in combination with anti-CTLA4 or anti-PD1 is safe, effective and does not have any contraindicated outcomes. Based on these positive results the company intends to continue testing combination approaches in more aggressive melanoma models that will support further evaluation of this approach in humans.

“Results are encouraging and indicate that using gene electrotransfer to deliver plasmid IL-12 into tumors can be an effective and safe delivery tool. Additional studies are being conducted to demonstrate that the combination may lead to immune responses against distant untreated lesions in mice. We will investigate the anti-tumor response and plan to present these findings in the near future,” commented Dr. Heller.

In addition, Dr. Adil Daud, principal investigator and co-director of melanoma research at the University of California San Francisco School of Medicine reviewed previously presented data from OncoSec’s Phase II melanoma program. In his presentation titled Gene Electrotransfer in Solid Tumors, Dr. Daud discussed that continual analysis of the data so far confirms signals demonstrated in the positive interim immune response data presented earlier in the year.

About the Sponsored Research Agreement with Old Dominion University for Combination Study in Melanoma

In June of 2013, OncoSec signed a Sponsored Research Agreement (SRA) with Old Dominion University (ODU) and the Frank Reidy Research Center for Bioelectrics. Under the agreement, OncoSec and the University agreed to collaborate on nonclinical research focused on developing new technology related to electroporation and delivery of different agents into solid tumors by electroporation. The first research experiment under the SRA was to evaluate the effects of ImmunoPulse in combination with Anti-CTLA4, Anti-PD1 and Anti-PDL-1 in a melanoma mouse model.

 

SAN DIEGO, CA. – (October 4, 2013) OncoSec is pleased to announce that CEO and co-founder, Punit Dhillon, will be speaking at this year’s INTERFACE 2013 Digital Health Summit at the Vancouver Convention Centre located in Vancouver, B.C. The international, three-day conference is a gathering of the minds among some of North America’s leading influencers in health IT, digital health, and the future of medicine.

“I’m delighted to be in the company of such an esteemed group of thinkers,” said Dhillon. “I look forward to sharing my thoughts on the future of cancer treatment as well as hearing from the other speakers about their innovative digital health solutions.”

Dhillon will deliver his talk on Thursday, October 10 at 10:45 AM PT entitled, “Inside the Battle of Making Chemo Obsolete” and will also be participating in a panel discussion on trade and investment in the healthcare industry.  Other conference speakers include Terry McBride of YYoga, Geof Auchinleck of Claris Technologies, and Dr. Steven Steinhubl of Scripps Translational Science Institute.  To learn more about the event or to register, please visit: www.interfacesummit.com

While in Vancouver, Dhillon will also be speaking at the launch event for TiE Young Entrepreneurs, a unique program that helps high school students learn about the challenges and rewards of becoming an entrepreneur. The program provides the students with an opportunity to be mentored by seasoned entrepreneurs, while creating a network of likeminded aspiring entrepreneurs. The TiE Young Entrepreneurs Launch Event is slated for October 12 at SFU Segal Graduate School of Business.

About INTERFACE 2013 Digital Health Summit

INTERFACE 2013 is produced by SANOTRON, Canada’s first technology accelerator focused entirely on digital health solutions that can dramatically reduce costs, significantly improve user experience and quality of life, create new jobs and opportunities, and build a sustainable healthcare system in Canada and worldwide. This is SANOTRON’s second annual summit.

 

SAN DIEGO – October 3, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the 12th Annual BIO Investor Forum.

Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

The presentation will take place on Tuesday, October 8 at 2:30 p.m. PT in the Presidio room at the Palace Hotel in San Francisco, California. The presentation will also be webcast and can be viewed at this link: http://www.veracast.com/webcasts/bio/investorforum2013/79210379405.cfm

A webcast replay will be available one hour after the conclusion of the live event and will expire on January 7, 2014.

About the BIO Investor Forum

The BIO Investor Forum is a national investor event to explore investment trends and opportunities in life sciences, with a focus on venture-stage growth and emerging public companies as well as those poised to join the growth “watch list” in 2014. The conference delivers a rich program that features corporate presentations and panel debates on the “sweet spots” and growth challenges facing the industry.

 

SAN DIEGO – October 1, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the Cancer Vaccines and Gene Therapy Meeting at The Desmond Malvern Hotel in Philadelphia, Pennsylvania.

Dr. Richard Heller, Professor at Old Dominion University will be presenting pre-clinical data on the use of electroporation to deliver plasmid IL-12 in solid tumors in a presentation titled: Gene Electrotransfer as an Effective Delivery Tool. This presentation will take place on Thursday, October 3 at 3:30 PM ET.

Dr. Adil Daud, principal investigator and co-director of melanoma research at the University of California San Francisco School of Medicine will be presenting an update to OncoSec’s Phase II melanoma immune response data, which will include IL-12 expression findings in a presentation titled Gene Electrotransfer in Solid Tumors. This presentation will take place on Friday, October 4 at 1:00 PM ET.

About the Cancer Vaccines and Gene Therapy Meeting

The Cancer Vaccines and Gene Therapy Meeting will bring together important leaders to present and discuss the latest approaches and technologies used to develop promising anti-cancer therapeutics.

 

SAN DIEGO – September 24, 2013 – OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, today announced its melanoma development strategy. The company plans to continue forward in its development path to seek FDA approval for its ImmunoPulse therapy and outlines key activities in the melanoma program that the company expects to share more details about within the next 12 months.

Phase II Study Expansion
The company plans to move forward with an expansion study of its Phase II trial for metastatic melanoma. The effectiveness of an accelerated treatment cycle will be evaluated, where an additional 10 patients will be enrolled and will receive a second cycle of treatment after three weeks. OncoSec may amend the protocol depending on the study outcomes.

Data Announcement
OncoSec’s Phase II melanoma study completed enrollment on June 18, 2013. Positive immune response data, confirming the systemic effects of DNA IL-12 administered locally with electroporation, was announced at the 8th World Congress of Melanoma meeting in July.
Top-line interim clinical data detailing available objective response rates (complete and partial response rates at Day 180) is expected in the upcoming months.

Combination Study
OncoSec is conducting a research study with Old Dominion University to evaluate the effects of ImmunoPulse in combination with Anti-CTLA-4, Anti-PD-1 and Anti-PDL-1 in a melanoma mouse model. The research study supports the company’s strategy to investigate methods that can potentially improve response rates of front-line therapy. Moreover, a positive outcome from these preclinical studies may result in the ability to expand ImmunoPulse’s reach into a larger melanoma patient population, including those with unresectable metastatic melanoma. Data from this study is expected in early 2014.

Initiation of Phase IIb Study
While OncoSec’s current Phase II studies in metastatic melanoma and Merkel cell carcinoma are coming to a conclusion, the company is preparing for its next phase of development and is setting up for the initiation of a Phase IIb trial. The Phase IIb study will be a randomized, controlled study, providing the company with information for a key inflection point in the development of this program.

Punit Dhillon, President and CEO of OncoSec Medical, said, “With the completion of our last financing, OncoSec expects to be well funded to focus on an aggressive clinical development strategy. In addition to our clinical program, we are focusing resources on a research pipeline that supports the expansion of clinical candidates and explores novel DNA plasmid constructs and cytokines for other cancer indications. We hope to continue strengthening our position in the melanoma landscape and are excited to share our research findings and data this year.”

To view a video of Mr. Dhillon’s vision for the company’s melanoma program, click here.

 

SAN DIEGO – September 20, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the 2013 Aegis Capital Healthcare Conference. The presentation will take place at 9:45am PT on Thursday, September 26 at The Encore at Wynn in Las Vegas, NV.

Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

About the 2013 Aegis Capital Healthcare Conference

This symposium, hosted by Aegis Capital Corp., will feature presentations from industry-leading growth companies in the healthcare sector.

The executives presenting at the conference come from the highest ranks of management and the most innovative aspects of science. They will be offering views into their companies and into the healthcare industry as a whole.  Following corporate presentations, executives will have the opportunity to participate in question-and-answer sessions with fund managers, institutional and private investors, industry analysts, and Aegis Capital’s top-performing brokers.

 

SAN DIEGO – September 19, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors,

today announced that it has closed a registered public offering of 47,792,000 shares of its common stock at $0.25 per share and warrants to purchase up to 23,896,000 shares of common stock at an exercise price of $0.35 per share for four years.

The gross proceeds of the offering was approximately $12 million. Net proceeds, after deducting the placement agent’s fee and other estimated offering expenses payable by OncoSec, was approximately $11.1 million.

OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.

H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction. Maxim Group LLC acted as the financial advisor to OncoSec in connection with the transaction.

Punit Dhillon, President and CEO of OncoSec Medical, said, “This funding further strengthens OncoSec’s treasury and positions the company for future successes as we move the company forward to implement our clinical development strategy for melanoma and Merkel cell carcinoma”.

The securities described above were offered and sold by OncoSec pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission, or the SEC. A final prospectus related to the offering has also been filed with the SEC. Copies of the final prospectus can be obtained directly from OncoSec and at the SEC’s website at www.sec.gov.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of OncoSec’s common stock or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

 

SAN DIEGO – September 16, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced today that it has entered into definitive agreements with institutional investors to purchase approximately $12 million of securities in a registered public offering. OncoSec has agreed to sell to institutional investors an aggregate of 47,792,000 shares of its common stock at $0.25 per share. Additionally, investors will receive warrants to purchase up to 23,896,000 shares of common stock at an exercise price of $0.35 per share for a term of four years.

The gross proceeds of the offering are expected to be approximately $12 million. Net proceeds, after deducting the placement agent’s fee and other estimated offering expenses payable by OncoSec, are expected to be approximately $11.1 million.

OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.

H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction. Maxim Group LLC acted as the financial advisor to OncoSec in connection with the transaction.

The offering is expected to close on or about September 19, 2013, subject to customary closing conditions.

The securities described above are being offered by OncoSec pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission, or the SEC. A prospectus supplement related to the offering will be filed with the SEC. The securities may only be offered by means of a prospectus. Copies of the prospectus and prospectus supplement can be obtained directly from OncoSec and at the SEC’s website at www.sec.gov or by request at H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of OncoSec’s common stock or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

 

SAN DIEGO – September 4, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the Annual Rodman & Renshaw 2013 Global Investment Conference in New York City.

Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

The presentation will take place on Monday, September 9 at 2:25 PM ET at Room 7.02, 7th Floor of the Millennium Broadway Hotel in New York, NY. The presentation will also be webcast and can be viewed at this link: http://wsw.com/webcast/rrshq23/ONCS. The webcast replay will remain available for 90 days following the live presentation.

Data Confirms the Systemic Effects of DNA IL-12 Administered Locally with Electroporation

SAN DIEGO – July 22, 2012 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced interim immune response data from the company’s Phase II study of ImmunoPulse in patients with metastatic melanoma. Findings showed that OncoSec’s ImmunoPulse demonstrated a significant change in tumor immunity following treatment with DNA IL-12 and electroporation. Dr. Adil Daud, principal investigator at the University of California San Francisco, presented the data at the 8th World Congress of Melanoma in Hamburg, Germany.

Blood samples taken at baseline (Day 1) and Day 90 from subjects treated with ImmunoPulse were analyzed. Changes in activated T-cells and regulatory T-cells were quantified. At Day 90 following treatment, it was demonstrated that there was a significant decrease in circulating “exhausted” CD8/PD-1+ (p=0.0017) and CD8/CD69+ (p=0.008) T-cells. PD-1 is expressed in activated exhausted T cells, and blocking PD-1 is an emerging treatment modality for multiple cancers including melanoma. These results demonstrate that plasmid delivery of interleukin-12 (IL-12) can also result in a decrease in exhausted T-cells, which may lead to improvement in clinical outcomes for patients treated with ImmunoPulse.

In addition to changes in circulating T-cells, an increase in NK cell frequency and activation was also observed from baseline. It was also demonstrated that antigen-specific T-cell responses to melanoma were increased with DNA IL-12 while other antibody responses were modulated and appeared to narrow over time. These data confirm the systemic effects of DNA IL-12 administered locally with electroporation.

Punit Dhillon, President and CEO of OncoSec, said: “We are encouraged by these immune data, since they highlight a potential mechanism of action for ImmunoPulse, and demonstrate the biologic activity of this therapy after only a single cycle of treatment.”

Dr. Daud commented: “The statistical significance of these data is impressive and confirms our understanding of the mechanism of action of IL-12. We look forward to understanding further if these changes in immune responses also correlate with positive clinical outcomes. These data will be shared later on this year.”

OncoSec recently announced completion of enrollment for its Phase II melanoma trial. Previously, the company announced that ImmunoPulse demonstrated clinical benefit in both locally treated and untreated distant melanoma lesions, and that the therapy appeared to be safe and well-tolerated, after an interim analysis of safety and efficacy of the first 13 patients.

About the Phase II ImmunoPulse Study

A total of 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma have been enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle consists of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients are moved to the follow-up phase of the study and will be followed for up to five years for safety.

 


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