Q & A with OncoSec Medical

Company to Present at SITC 2012 and 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress

SAN DIEGO – October 09, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapies to treat solid tumor cancers, announced the company will be presenting data at two upcoming medical conferences.

Dr. Shailender Bhatia, assistant professor at the University of Washington School of Medicine, will be presenting preliminary clinical data from OncoSec’s ongoing Phase II Merkel cell carcinoma trial at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012), October 26-28, 2012, at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.

The company will also be presenting preliminary clinical data from its ongoing Phase II metastatic melanoma trial to the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress, November 14-17, 2012, at the Hotel Fira Palace in Barcelona, Spain.

Preliminary analyses of both the Merkel cell carcinoma and metastatic melanoma trials will be based on a subset of enrolled subjects, and will evaluate clinical response to at least one cycle of ImmunoPulse treatment.

At the Melanoma/EADO meeting on November 15 at 5:30 PM local Barcelona time, Adil I. Daud, M.D., co-director of melanoma clinical research at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center and lead investigator for OncoSec’s metastatic melanoma trial, along with Axel Hauschild, M.D., professor of dermatology at the University of Kiel, will co-chair an OncoSec-sponsored symposium titled “Electrogenetherapy: Intralesional Immunotherapy Approach for Skin Cancers Using Electroporation.”

The company will provide a complete summary of the data presented at both conferences in upcoming press releases.

 

About SITC 2012

The SITC Annual Meeting & Associated Programs serve as the premier destination for scientific exchange, education and networking in the cancer immunotherapy community. Basic researchers, clinicians, students, postdoctoral fellows and allied health professionals dedicated to improving cancer patient outcomes come together to experience cutting edge research, education and training that serves as the catalyst to advance the field.

About the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress

The World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers is an opportunity for clinicians and researchers who are part of multidisciplinary melanoma centers can interact, learn from one another, establish collaborations and set an agenda for the further evolution of multidisciplinary melanoma care and research. The meeting has been combined with the EADO congress whose focus is on melanoma, cutaneous lymphoma and epithelial skin cancers and is specifically designed to attract young investigators and skin cancer-treating physicians in the field.

About OncoSec Medical Inc.

OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives.  OncoSec’s core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec’s clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers.

This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.     

 

 

metastatic, melanoma, oncosec, medical, gene therapy, clouds, sun, medical trials

 

As the largest organ of the body, the skin protects us from a myriad of conditions, parasites, and other foreign agents. Be that as it may, it is also highly susceptible to different diseases, viruses, and cancers. Different skin types can be more resistant or more susceptible to different conditions. One type of cancer that aggressively attacks the skin is melanoma: the later stage of which is known as metastatic melanoma.

SAN DIEGO, CA, October 2, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapies to treat solid tumor cancers, announced today that the company will be presenting at the 3rd Annual Cancer Immunotherapy: A Long-Awaited Reality conference taking place from 8:00 a.m. to 6:30 p.m. EDT on October 4, 2012, at the New York Academy of Medicine in New York.

Punit Dhillon, President and CEO, will provide an overview of ImmunoPulse, a treatment that uses OncoSec’s patented electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine.

The presentation is expected to begin at 9:15AM ET.

A live and archived webcast of the company’s presentation at the conference hosted by MD Becker Partners LLC will be available at www.regonline.com/mdb2012.

About the 3rd Annual Cancer Immunotherapy: A Long-Awaited Reality Conference

“Cancer Immunotherapy: A Long Awaited Reality” is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy.

 

 

University of Washington To Become Fourth Enrolling Center in Trial 

SAN DIEGO, CA, September 25, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that it has established the University of Washington (UW) as the fourth enrolling site for its Phase II metastatic melanoma clinical trial (OMS-I100). Investigational Review Board (IRB) approval has been received by UW, and investigators are actively recruiting for this clinical trial.

“UW now joins the University of California, San Francisco, John Wayne Cancer Institute and Lakeland Cancer Center as our fourth site for the melanoma study,” said Punit Dhillon, President and CEO of OncoSec. “We have enjoyed working with UW and Dr. Shailender Bhatia for the Merkel cell carcinoma program, and look forward to having them join the melanoma trial as well.”

A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be 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 will consist 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 will be moved to the follow-up phase of the study and will be followed for up to five years for safety.

Dr. Shailender Bhatia, principal investigator at UW, commented “We have had experience with this treatment in the Phase II Merkel cell carcinoma study, so we are glad to have the opportunity to now offer this treatment as an experimental therapy to the patients who are suffering from melanoma.”

ImmunoPulse utilizes OncoSec’s proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12. The OncoSec Medical System (OMS) applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells. Phase I data using ImmunoPulse to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53% of patients with distant metastatic lesions demonstrated an objective response, with 15% of these patients having a complete response to the treatment.

For more information about this trial visit: http://clinicaltrials.gov/ct2/show/NCT01502293.

About Melanoma

Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the US are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells which produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, there remains few treatment options for patients with late stage metastatic disease that can extend survival for the broad population.

 

 

Exclusive License Extends Patent Protection for ImmunoPulse Technology

SAN DIEGO – September 11, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse and NeoPulse therapies to treat solid tumor cancers, announced it has secured an exclusive license for specific patented technology from the University of South Florida Research Foundation (USFRF) relating to the delivery of gene-based therapeutics via intratumoral and intramuscular electroporation. This patent is directly related to the ongoing Phase II trials for metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma using the company’s ImmunoPulse therapy, and extends patent protection for the ImmunoPulse technology to the year 2024. Financial terms of this agreement were not disclosed.

OncoSec’s proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, is currently being used to develop the company’s ImmunoPulse and NeoPulse therapies. This platform encompasses patents, technology and other intellectual property for intratumoral methods for delivering drugs and gene-based treatments in humans.

ImmunoPulse involves the application of a brief electric field to the surface of the skin. This temporarily opens pores in the cell membrane, allowing anti-cancer agent DNA IL-12, to be absorbed more efficiently. DNA IL-12, which normally has difficulty penetrating the tumor cell membrane to get inside these cells, has been shown to significantly stimulate the immune system’s T-cells to fight the cancer. The new license from USFRF complements OncoSec’s seminal patents, particularly for the protection of the methods involved in the ImmunoPulse treatment, and specifically for the use of DNA IL-12.

“Our licensing agreement with the USFRF significantly strengthens OncoSec’s intellectual property rights in the area of gene and drug delivery via in vivo electroporation,” said Punit Dhillon, OncoSec’s President and CEO. “We anticipate that the further development of this technology will enhance the ability of ImmunoPulse to address the serious unmet need among patients with skin cancer. OncoSec’s patent portfolio places us in a preeminent position within the field of electroporation-based delivery of gene-based treatments for cancer.”

“OncoSec is the ideal choice to further develop this technology that I and my colleagues pioneered while working at the University of South Florida, and I am pleased they have secured this license,” said Richard Heller, Ph.D., author of the patented technology. “The technology involves short-pulsed electric fields that can deliver plasmid DNA to stimulate the immune system. As a result, it is a natural fit with OncoSec’s ongoing program to develop its ImmunoPulse therapy.”

 

 

SAN DIEGO – September 5, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse and NeoPulse technologies to treat solid tumor cancers, received a new Method of Use and Device patent (Patent Application No. 200780014313.0, “Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection”) for the OncoSec Medical System (OMS) electroporation device platform from the State Intellectual Property Office of the People’s Republic of China. The issuance of this patent has the potential to expand OncoSec’s commercial opportunities for minimally invasive and surgical procedures to treat solid tumors in a very large market such as China.

Punit Dhillon, OncoSec’s President and CEO, commented, “The issuance of this patent is significant, because the Chinese authorities have given the company patent approval for our claims regarding the OMS electroporation device itself, as well as the method of use. These are broad claims, wherein OncoSec now has the ability to deliver various therapeutic agents through its electroporation device, including bleomycin and DNA IL-12, as well as to treat tumors with these agents following surgical resection. Thus, this patent will act as a part of the company’s core strategy as we continue to develop and build our commercialization strategy in China, one of the largest emerging oncology markets.”

Numerous research studies have concluded that cancer has now become a leading cause of mortality in China, representing 25 percent of all deaths in urban areas and 21 percent in rural areas. Moreover, cancer mortality in China has been increasing rapidly and continuously during the past three decades, which indicates a significant need for novel therapies.

ImmunoPulse and NeoPulse are investigational therapies being evaluated to reduce the rate of cancer recurrence while minimizing quality-of-life side effects. These therapeutic approaches, as potential adjuncts to surgery, involve injecting the tumor with an anti-cancer agent, followed by electroporation to open up the cell membrane, which helps significantly increase the uptake of the agent. This approach has been shown to selectively kill cancer cells that may exist in the neighboring tissue, which may result in a reduced rate of recurrence and has the potential to complement standard-of-care surgical procedures.

 

Dear Fellow Shareholder,

I wanted to take this opportunity to thank all our valued shareholders and provide an update on OncoSec’s upcoming milestones.

Since January 2012, OncoSec has initiated three Phase II clinical trials in immunotherapy and positioned the company as the leader in the treatment of rare and deadly skin cancers.

Our momentum has been recognized by the scientific and medical community, and we’ve received positive analyst coverage from credible financial institutions including Noble Financial and Roth Capital.

We are excited to share upcoming milestones regarding our NeoPulse program and recently completed interim data analysis from previous Phase 3 Head & Neck trials. In addition, securing a CE Mark for the OMS device is well underway to support our partnering and commercialization activities, along with identifying a strategic partner for the development of NeoPulse.

I encourage you to sign up for our newsletter directly on the home page to stay up to date on company news and updates. Please do not hesitate to contact me or our investor relations team if you have any questions. Please click on the following link to view our latest brochure on company updates and milestones

Best Regards,

Punit Dhillon President & CEO 

 

OncoSec received notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices”. The certification confirms the company’s Quality Management System (QMS) and that the company’s manufacturing processes are controlled, documented and compliant with the stringent requirements set by the European Union.

SAN DIEGO, CA, May 29, 2012 — OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OncoSec Medical System(OMS) ElectroOncology therapies to treat solid tumor cancers, issued the following letter to Shareholders today:

Dear Shareholder:
As we near the mid-point of 2012, OncoSec is successfully executing on its objectives for the year. I want to review the key developments so you can see why all of us at OncoSec are so excited.

Financial Update

  • Strengthened balance sheet: OncoSec recently raised $7.75 million through a public offering underwritten by Rodman & Renshaw, with Roth Capital Partners acting as an advisor. We are now well financed to continue our promising clinical development programs. We currently have over $6.5 million in cash reserves to fund operations, which should be sufficient to complete our current studies.

Clinical Update
We are executing our clinical development plan based on our novel, first-in-class OMS ElectroImmunotherapy platform for the treatment of rare and deadly skin cancers including metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

  • OMS-I100: We initiated and enrolled several patients in OMS-I100, a Phase II study for the treatment of metastatic melanoma led by the University of California at San Francisco, with additional sites at the John Wayne Cancer Institute in Santa Monica and Lakeland Comprehensive Cancer Center in Lakeland, Florida. We expect to report interim clinical data before year end.
  • OMS-I110: We initiated and enrolled several patients in OMS-I110, a Phase II study for the treatment of Merkel cell carcinoma led by the University of Washington and the Fred Hutchinson Cancer Center in Seattle, Washington. We expect to report interim clinical data before year end.
  • OMS-I120: We aim to initiate and begin enrolling patients in OMS-I120, a Phase II study for the treatment of cutaneous T-cell lymphoma (CTCL) by year-end. This study will be led by the University of California at San Francisco and include multiple centers across the US.
  • Expansion of technology platform: We are pursuing clinical and regulatory development of our OMS ElectroChemotherapy in the U.S., Europe and Asia, including the development of new indications for ElectroChemotherapy. The last several months have demonstrated our ability to create incremental value from our advanced-stage OMS ElectroChemotherapy program for the treatment of primary and recurrent localized solid tumors. Since the acquisition of a clinical data set of over 400 patients, we have compiled, reviewed, and analyzed the data and presented preliminary results from a Phase IV European head & neck cancer trial and Phase I/II breast cancer trial. The preliminary data sets from the completed Phase III recurrent head and neck cancer studies carried out in the U.S. are now being analyzed, and we intend to present this data at the 5th International Head and Neck Cancer Conference taking place July 21-25. We are defining a regulatory path with the FDA forclinical development of advanced stage skin cancer and other solid tumor indications. In addition, we are advancing a commercialization strategy focused on creating regional partnerships or establishing a global partner to develop the market potential for OMS ElectroChemotherapy in Europe, Asia and other emerging markets.

Corporate Update

  • Patent portfolio expansion. We are developing new applications of our OMS ElectroOncology for treating solid tumors and metastatic disease, with the goal of expanding our market opportunities and establishing additional patents to maintain our dominance in these areas.
  • Gaining leadership position and creating awareness: We have been able to build physician, partner, and patient awareness of the clinical development of OMS ElectroImmunotherapy for the treatment of metastatic melanoma and Merkel cell carcinoma through the media. These publications include: Xconomy, Medical Device & Diagnostic Industry, Manufacturing Chemist, and the San Diego Business Journal. OMS ElectroImmunotherapy was also featured as a “revolutionary cancer treatment” for Merkel cell carcinoma by a local NBC News affiliate in Seattle, Washington. We continue our proactive outreach to inform relevant audiences of technology and business opportunities.

OncoSec sees the initial market for its OMS ElectroImmunotherapy exceeding $500 million in the U.S. alone. Melanoma andother skin cancers are deadly diseases with very limited treatment options (i.e. limited competition). We have a highly focused effort to develop a new generation of immunotherapy products to provide better care to these patients and we are passionate about the progress of our programs.

I thank you for your ongoing support as we work toward our goal of becoming the preeminent developer of targeted oncology therapies. Ilook forward to updating you on our continued progress in the year ahead.

Best regards,
Punit Dhillon
President and CEO

About OncoSec Medical Inc.

OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapieshave achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook , Twitter, and LinkedIn sites.

* * *

This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause ourresults to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.


Real Time Web Analytics