Interview with Ivan Widjaya, Noobpreneur.com

Interview with Ivan Widjaya, Noobpreneur.com

Exclusive Q&A with Punit Dhillon, CEO of OncoSec Medical, on Developing Innovative Cancer Treatments

Being cutting-edge by introducing new tech advances is great, but it’s not the only way to go in entrepreneurship. Just ask the 34-year-old Punit Dhillon.

Punit Dhillon launched OncoSec Medical in 2011, leveraging “dead technology” to develop innovative medical treatments that harness the body’s immune system to detect and fight cancer. The revolutionary breakthrough has given hope to cancer patients and helped the company to grow from $20 to $100 million in less than 4 years. In this Q&A, I talked with Punit about his innovation and entrepreneurship in general.

An Introspective on Immunotherapy

This Tuesday, the OncoSec team will play host to some of the most brilliant minds in immuno-oncology, with our highly anticipated symposium, “An Introspective on Immunotherapy: A Symposium on Intratumoral Therapy.” The event promises to be a notable high point during the week of J.P. Morgan’s annual healthcare conference, a week that has historically attracted the “who’s who” of the healthcare sector.

The causes of cancer can be very broad and complicated. Increased cancer risks stem from genetic history, lifestyle choices, workplace exposures, household exposures, diet, and other factors. Generally, cancer occurs when a cell’s DNA is altered such that the cells go through normal programmed cell death slower than they divide via mitosis. This unregulated cell growth leads to tumors, which can then spread to other nearby parts of the body through proximity. The lymphatic system and bloodstream can transmit cancer from one part of the body to others (referred to as metastasis).

Carcinogens are substances involved in causing cancer. These cancer-causing agents lead to cancer in ways other than DNA modification – such as accelerating cell division – leading to an increase in the opportunities for DNA changes to occur. The risk of developing cancer is an interplay between many factors, such as the nature of the exposure, the intensity and duration of the exposure, and genetic factors. Therefore, exposure to carcinogens does not result in cancer in every situation and the risks are different, from individual to individual.

Alcohol Consumption and Cancer

Increased alcohol consumption can contribute to an increased cancer risk.

Common Carcinogens

The worrisome aspect of carcinogens is their prevalence in every day life. Here are some of the American Cancer Society’s possible cancer-causing substances that are found around the home and the workplace:

– Alcohol

– Antiperspirants

– Arsenic

– Asbestos

– Aspartame

– Benzene

– Cellular Phones + Cellular Phone Towers

– Cosmetics

– Formaldehyde

– Hair dyes

– Radiation

– Smart Meters

– Tobacco

At OncoSec, we focus on late-stage skin cancers, including melanoma, Merkel cell lymphoma, and cutaneous T-cell lymphoma. With many people desiring a tanned appearance, tanning salons and natural tanning have become increasingly popular. With more than 3.5 million cases of non-melanoma skin cancers, and an estimated 76,600 cases of melanoma in the US, each year, the importance of awareness and prevention is high. Melanoma alone claims more than 9,000 of the 12,000+ skin cancer deaths per year. Ways to mitigate your risk are avoiding direct exposure to the sun between 10 am and 4 pm, keeping a non-transparent shirt on, applying broad-spectrum sunscreen (SPF30 or more), putting on a hat, wearing 100% UVA and UVB absorption sunglasses, and avoiding tanning beds and sun lamps. See our previous post on skin cancer myths, for more information.

Household items such as aspartame, antiperspirants, cosmetics, and hair dyes could possibly add to the risk of cancer. However, not all carcinogens are from chemicals and synthetics. Produce can contain high amounts of carcinogenic chemicals from pesticides, with some producing their own natural toxins. Although we have developed an immune system that combats the ill effects of some natural carcinogens, it is still wise to wash your fruits and vegetables: helping to reduce the number of the natural toxins entering your body.

Smoking and Cancer

Smoking is the leading preventable cause of cancer worldwide.

Benzene, commonly found in tobacco smoke, various gas emissions, plastics, pesticides, and detergents, is a carcinogen that is inhaled on a daily basis. Benzidine, commonly found in dyes used for fabrics, paper, and leather goods is also very common throughout. In the workplace, arsenic, asbestos, benzene, formaldehyde, and radiation rank high in commonly exposed carcinogens. Workplace regulations and safety standards must be kept, in order to ensure the preservation of employee.

According to the ACS, tobacco is one of the most publicly attacked carcinogens. It accounts for an estimated 443,000 deaths in the United States every year and approximately 1 in 5 deaths. Cigarette consumption accounts for at least 30% of all cancer deaths, while being one of the most preventable causes of death in our society. Secondhand smoke accounts for an estimated 46,000 deaths from heart disease, in current non-smokers. In the United States alone, the costs of extra medical care, illness, and death due to secondhand smoke amounts to over $10 billion per year. This negative externality poses a significant burden upon society that has led to reform in regulations, as well as a plethora of anti-smoking campaigns.

Alcohol can be frequently overlooked in terms of cancer risk yet heavy alcohol use can cause a myriad of health problems. Known types of cancers affected by alcohol consumption include mouth, throat, voice box, esophagus, liver, breast, and colorectal cancers, while possibly affecting pancreatic cancer as well. The ACS recommends limiting consumption to no more than 2 drinks per day for men, and one 1 drink a day for women. This discrepancy between the sexes is due to differences in body size and metabolism.

For more information, and for a more extensive list of carcinogens, please see the American Cancer Society’s Known and Probable Human Carcinogens article, as well as the National Toxicology Program‘s latest Report on Carcinogens. If you need help with quitting tobacco or alcohol, here is a selection of links for smokers looking to quit, as well as the National Council on Alcoholism and Drug Dependence‘s section on Understanding Alcohol and Alcoholism.

Did we miss any carcinogens that you think are important to discuss? With the high number of possible carcinogens, how do you mitigate the risks of cancer, while maintaining the lifestyle you have chosen? Let us know and come join in on the conversation, on Facebook and Twitter.

 

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 

 

Dear R2CC Supporters:

I wanted to congratulate Team OncoSec and thank all our generous donors for making the 2012 Ride to Conquer Cancer a great success. Our team collectively raised almost $18,000 to support the BC Cancer Agency. Honorable mentions include Jim Heppell and Rebecca Bolthouse who both raised $2,740, and to Lisa Mueller, Jared Kawaoka and Brittney Hawkins who raised $2,500. I am very appreciative of our donors and sponsors helping me raise over $4,600.

We are incredibly grateful to the donors and sponsors who helped make this adventure possible:

$500+ contributions from:

Phil Johnson of Merrill Corporation, Byron Roth of Roth Capital Partners, Amitpal Sandhu of Ampri Group, Greg Trinidad of NorthStar Internet, Punit Dhillon, The Breidinger family, William & Cheryl Struve, Mr. & Mrs. Fred von Bargen, Happy Boy Farms, Lekos Electric, Pal General Engineering, David Sidoo, John Mueller, and Jim Heppell

$250+ contributions from:

Edward Borrelli, Mr. Sukhwinder Singh Rai, Associated Bio Solutions, and Doug & Michele Wurlitzer

$100+ contributions from:

Jessica Mah, Kar Lei Chiu, Dickson Tse, Larissa Kawaoka, Truda Roper, Kathy & Michael Brines, Dr. Adil Daud, Dan Turner, Alex Casden, The von Bargen family, Allan Olson & Charlotte Underwood, Bill & Elaine Vanderspek, Celia Courchene & Ian MacKay, John, Michelle & Brandon, John & Hermine Mueller, Chris & Liisa Wagner, Christina Yip, Clarence Heppell, Dave Bromley, David & Louise Raffa, Jeff Read, Gary Lenett & Karen Ergas, George David Richardson, Peter Moscone, Stephen Leckie & Karen Blair, Val Russo, Tyler & Allison Cerro, Brian McCluskey, Mark Grambart, Ms. Carole Bailey, and Khader Safi

Other contributions from:

Efrain Solis & Maribel Montiel, Jaswinder Singh, Susan Foreman, Shannon & Andy Chen, Theresa Halliday, Jessica Mah, Aaron Hawkins, Abnology, Anna Orlando, Alexa Giesen, Damian Gomez, Heather Kline, Jim Broshears, Nicole Mehara, Patrick & Lainey Crown, Phyllis Knibbs, Shellie Camarillo, Allen Myers, Allen & Karin Spiegelman, Dave Radick, Lisa Pasin, Metal & Wood Products, Peter Lyon, Ted Wheeler, Grantie Lewin, The Bostic Family, Dennis & Kim Peek, Dionna Kawaoka, Dorothy Chat, Jessica Hickey, Art & Candy Silva, Nancy Campos, Abigail Garibay, Annette & Reginald Dahlen, Anthony, Kendall & Lacey Sand, James Bolthouse, Jen Clem, Mark Wescott, Mary Draper, Jon-Mark Bolthouse, Teresa Goshorn, The Thush Family, Tony Bolthouse, Tyler Garibay, Warren Hogarth, William Garibay, Cindy Adams, Dawn Ternig, Gilberto Espinoza, Michael A Stiegel, Mrs. Kathy Moore, The Czech Family, Tina Jasso, and all others who donated anonymously, as well as those friends and family who contributed with their love, wisdom, kind words and support

Support and Gear (SAG) Vehicle: David Tamble

Cycling Kits: Hincapie Sportswear

Exhaustion, fierce headwinds, and torrential downpour did not affect the high spirits and passionate dedication of the team.

I hope you left this weekend with a feeling pride and joy, knowing that you were a part of something powerful that has great impact in helping make this world cancer free. Through your devotion to helping the B.C. Cancer Foundation, lives will be changed, families will have hope, and we will continue our battle to conquer cancer.

My Sincerest Thanks,

 

 

 

Punit Dhillon
President and CEO

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 for clinical 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 and other 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. I look forward to updating you on our continued progress in the year ahead.

Best regards,

Punit Dhillon
President & CEO

2011 has been a resounding success for OncoSec, and 2012 is shaping up to be a pivotal year. Over this last year OncoSec has established a robust clinical development plan based on its novel, first-in-class OMS ElectroImmunotherapy treatment platform for the treatment of rare and deadly skin cancers, including (1) metastatic melanoma; (2) Merkel cell carcinoma; and (3) cutaneous T-cell lymphoma. In conjunction, the company has continued to create value from its advanced-stage OMS ElectroChemotherapy program for the treatment of primary and recurrent localized solid tumors, by analyzing a database of over 400 patients and presenting preliminary results of its Phase I/II breast cancer and preliminary Phase IV skin and head and neck cancer studies.

This year our management has laid out a focused corporate strategy, which was communicated with our shareholders in a recent press release. Complete detail of the Company’s key goals for 2012 can be found using this link.

One of the Company’s goals for 2011 was to increase OncoSec’s visibility in the scientific and investment community. Since our inception in March 2011, we feel that we have achieved this goal, however, it is an effort that we continue to make a priority to ensure that our the urgency of our message of revolutionizing targeted cancer therapy to treat rare and deadly skin cancers is continually voiced for the benefit of those who continue to suffer for these diseases, while still have little treatment options available to them. As a result of our public relations efforts has established a robust social media strategy through Facebook, Twitter and Linkedin, where we hope to reach a broad audience. In addition, OncoSec has been featured in a number of news and journal articles with the most recent being in Drug Discovery News where our President and CEO, Punit Dhillon, contributed an article outlining cutting-edge strategies for the treatment of solid tumors. As 2012 progresses, you can look forward to finding more articles about OncoSec and our revolutionary OMS ElectroOncology therapies.

If you have any questions about OncoSec or our current activities, please contact us at investors@oncosec.com. Thank you for your support

Best,

Punit Dhillon
President & CEO

Right now, University of Washington researchers are engaged in a potentially life-saving quest: the world’s first clinical trial using electroporation in immunotherapy that’s specifically targeting Merkel cell carcinoma. This is a rare and highly aggressive form of skin cancer with a 40% mortality rate and about 1,500 new cases each year. Last week, OncoSec was featured in a news segment by a local NBC affiliate in Seattle, WA, KIRO News 7, that told the story of the great work being done by researchers at the University of Washington to better understand and treat Merkel cell carcinoma.

Dr. Paul Nghiem
What is Merkel cell carcinoma and how is OncoSec working with the University of Washington and the Fred Hutchinson Cancer Center to try and find a treatment that for this rare and deadly skin cancer.
View Here.

Merkel cells are found in the skin (see diagram below) where their key function is as touch receptors.

What is a Merkel cell?

Merkel cells are found in the skin (see diagram below) where their key function is as touch receptors.

Figure Copyright by Paul Nghiem, MD, PhD & Quade Medical Group.

Normal Merkel cells in the skin: In this illustration of a cross-section of skin, normal Merkel cells are shown in red and connect to nerves shown in yellow. The structures drawn include the epidermis (upper third), dermis (middle), and deeper adipose layer containing the fatty tissue. Arteries are depicted as red and veins are blue.

What is Merkel cell carcinoma?

Merkel cell carcinoma (MCC), sometimes referred to as a neuroendocrine carcinoma of the skin, arises from the uncontrolled growth of Merkel cells in the skin. It is a rare skin cancer with roughly 1,500 cases per year in the United States, making it about 40 times less common than melanoma and three times more lethal, thus prompt aggressive treatment is warranted.

Understanding OncoSec’s Merkel Cell Cancer Program (OMS-I110)

The University of Washington, in conjunction with the Fred Hutchinson Cancer Center is the leading site for OncoSec’s Phase II study for the treatment Merkel cell carcinoma, in which, the Company’s OMS ElectroImmunotherapy technology is being used to stimulate the immune system to recognize and attack cancer cells. A total of up to 15 patients with local and distant Merkel cell carcinoma will be enrolled in this Phase II, single-arm, open-label, multi-center study. The trial is designed to assess the clinical and biologic effects of increased local expression of IL-12 protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy. It is anticipated that marked local expression of IL-12 in the tumor will induce an immunologic response in the tumor microenvironment, which may result in clinical benefit for the patient. Several patients have been enrolled with the first patient successfully completing treatment on January 6, 2012.

If you have any questions about OncoSec or our current activities, please contact us at investors@oncosec.com. Thank you for your support.

Best,

Punit Dhillon
President & CEO

NUMBERS ARE ONLY PART OF THE STORY
Numbers are important. They can be compared against others and tell us how far we have come and how far we have to go. Numbers help us measure our goals and aspirations, and show the world how we intend to reach them. They estimate odds and probabilities and they calculate results. They are necessarily impartial, rational and dispassionate.

But numbers only tell half the story.

They will never be able to put a value on the loss of a loved one, or convey the appreciation for every battle that is won against cancer. However, the largest number would still be too small to measure an empty space in a family photograph.

FROM BENCH TO BEDSIDE
At OncoSec, our dedication to research and development is underpinned by the belief that behind every statistic is a life, and behind every estimate, hope. These principles have guided our work – from a product based clinical development plan and enhancing our capacity to strengthening the scope and depth of our team.

We are committed to improving the quality of life for patients living with deadly skin cancers by providing them with safer and more effective approaches to treating these terrible diseases. The patient is our focus and our path has never been clearer as we move closer than ever to making our commitment a reality.

In less than one year, OncoSec not only initiated and completed the formation of the Company, but also committed to three Phase II clinical studies in rare and deadly skin cancers with significant unmet medical needs. This important milestone was the pinnacle of a number of accomplishments made throughout 2011 that advanced OncoSec from a start-up to a clinical-stage company.

2011 IN REVIEW
The formation of OncoSec in 2011 occurred through the acquisition of certain non-DNA vaccine technologies and intellectual property assets relating to the Company’s OMS ElectroOncology therapies for treating solid tumor cancers. With seed capital secured, the Company quickly moved to attract and acquire an experienced and respected management team and scientific and clinical advisory board.

The Company then established a robust clinical development plan based on its novel, first-in-class OMS ElectroImmunotherapy platform for the treatment of rare and deadly skin cancers, including (1) metastatic melanoma; (2) Merkel cell carcinoma; and (3) cutaneous T-cell lymphoma. OMS ElectroImmunotherapy uses electroporation to deliver, directly into the patient’s own cells, a gene, which expresses interleukin-12, a potent, naturally occurring protein that is central to the regulation of the body’s anti-cancer immune function. Preclinical and Phase I studies have shown that the therapy is safe, without toxic side effects, and has resulted in immune responses that produced both a local and systemic response against cancerous lesions. Positive clinical data of DNA-based IL-12, the first-ever to demonstrate electroporation-mediated delivery of a DNA plasmid designed to express a therapeutic protein in humans, was presented at the 2011 Annual Meeting of the American Society of Clinical Oncology. In the Phase I human study, 15% of patients demonstrated 100% clearance of distant, untreated metastatic melanoma (stage III/IV) tumors; in retrospect only 0.25% would be expected to spontaneous resolve on their own if left untreated. If OncoSec’s Phase II trials further validate this evidence, the DNA-based IL-12 ElectroImmunotherapy platform would represent an important advancement in the treatment of both local and metastatic cancers. All three Phase II studies will be physician-sponsored clinical trials.

This past year also demonstrated the Company’s ability to continue to create value from its 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, OncoSec has compiled, reviewed, and analyzed the data and presented preliminary results from previous Phase IV European head & neck cancer trials and a 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. and a comprehensive review of the Phase IV European trials in recurrent and primary skin cancers and head & neck cancer are now being analyzed. The Company expects to share this information with potential partners for the continued development of this program.

ON THE FUTURE, PATIENTS – AND NUMBERS
While the near-term outlook for OncoSec is exciting, the long-term outlook may be even brighter. Our platform technology is novel and unique, and data from our OMS ElectroOncology therapies are first-in-class. Over the next 12 months we expect to have interim clinical data from all three of our Phase II trials. We have successfully made the transition to a clinical development company and are well positioned to capitalize on the opportunities for growth ahead of us.

HOW?
The Company will continue to build product value through next generation devices and drugs and generate additional intellectual property organically or through other in-licensing opportunities. In 2011, OncoSec established in-house capabilities to build, maintain and develop its own devices. In 2012, the Company expects to boost its capabilities by meeting additional stringent quality assurance standards and increasing manufacturing capabilities for its ongoing and future clinical trials through additional efficiencies and ability to scale up production as needed to support potential partners.

At OncoSec, we believe 2012 will continue the momentum gained in 2011: by maintaining a lean enterprise through outsourcing and cash flow management, while remaining flexible enough to respond to emerging opportunities; by collaborating with partners such as the University of California San Francisco, the University of Washington and the Fred Hutchinson Cancer Center in order to strengthen our treatment platforms; by creating value from our late-stage OMS ElectroChemotherapy program through potential partnering deals with regional or global partners; and by focusing on the health of the patient.

With our clinical studies off the ground, we look forward to treating the first patient with DNA-based IL-12 and moving ever closer to being able to improve lives with a potentially revolutionary treatment that could offer greater efficacy and safety than existing therapies. That we have advanced so far towards our goal underscores the hard work of the entire OncoSec team, scientific advisors, the Board of Directors, and the tremendous support of our investors. We are dedicated to bringing the entirety of our resources and expertise to try and meet the expectations of our shareholders and patients around the world.

February 3, 2012

Punit Dhillon
President & CEO

This letter contains certain forward-looking statements relating to our plans to develop our OMS ElectroOncology therapies. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that Phase I clinical results referenced in this letter may not be indicative of results achievable from testing in Phase II clinical trials) and the other factors set forth in detail in our Annual Report on Form 10-K for the year ended July 31, 2011 and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products. We encourage our shareholders to carefully review the section entitled “Risk Factors” in the Annual Report with which this letter is provided.

OncoSec – Positive Phase IV ElectroChemotherapy Clinical Data

OncoSec has continued to demonstrate a commitment to achieving our corporate milestones and confirming the company’s urgency for developing revolutionary targeted therapies using its proprietary electroporation delivery system, the OncoSec Medical System, or OMS. With our recent $7.75 million financing we are now poised to focus our resources on exceeding expectations and continuing to drive value from our novel OMS treatment platforms.

OMS ElectroChemotherapy: Targeted Ablation of Solid Tumor Cancers

Today, we announced positive data from our late-stage Phase IV pre-marketing study conducted in Europe at leading clinical centers of excellence using OncoSec’s OMS ElectroChemotherapy treatment platform for primary and recurrent squamous cell carcinoma of the head and neck (HNSCC). Click here for a full copy of the press release.

Interim analysis of this study indicated that the primary endpoint of 8-month local tumor control rate for primary and recurrent HNSCC was excellent with 46/49 (94%) and 12/21(57%) respectively. In addition, the secondary endpoint of preservation of organ function and appearance using established quality of life instruments demonstrated a positive outcome. The functional outcome measurement to evaluate quality of life, specifically any deterioration of swallowing function, normalcy of diet and eating in public was assessed by the subjective Performance Status Scale for Head and Neck cancer (PSSHN) and general QOL by the European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQ). HNSCC patients showed a mean overall score of 264 at baseline vs. 249 at 8 months (p=0.3412) indicating no significant difference in quality of life at 8 months following treatment with OMS ElectroChemotherapy, therefore providing an advantage in maintaining quality of life. Furthermore, evaluation of safety using the OMS ElectroChemotherapy for this patient population demonstrated that the treatment was safe and well-tolerated with no grade three or higher adverse events related to treatment during this study.

Secondary endpoints evaluated for this trial included Pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) and performance of the OncoSec Medical System and applicator. This data is being summarized in combination with the above results for final publication.

The impressive quality of life outcomes in conjunction with strong local tumor control responses are significant: the majority of patients treated in this study had advanced complicated tumors and the only alternative therapy would have been extensive surgery, with potential post-operative radiotherapy. Surgery may have precipitated collateral damage to surrounding tissues and vital structures. While post-treatment care could repair some of this damage, it may also result in further quality of life, physical and emotional burden on the patient and significant additional treatment costs.

In addition to these clinical results, we are preparing to present data from our Phase III head and neck cancer study carried out in the United States. This study was a randomized trial comparing preservation of function status after either OMS ElectroChemotherapy or surgery in patients with locally recurrent or second primary squamous cell carcinoma of the head and neck. These results will be presented at:

The 8th International Head and Neck Cancer Conference
Toronto Convention Center
Toronto, Canada
July 21-25, 2012

Poster Session
“Interim analysis of two randomized Phase 3 trials comparing electrochemotherapy to surgery in recurrent head and neck cancer”

OMS ElectroImmunotherapy: On-going Clinical Trials for Rare and Deadly Skin Cancers

Two Phase II clinical trials for metastatic melanoma and Merkel cell carcinoma are now underway, and several patients in both trials have already been dosed. We expect our third Phase II trial for cutaneous T-cell lymphoma to be initiated in the coming weeks. We expect enrollment for these trials to continue through 2012, however, preliminary results will be shared before the end of the year.

The media has picked up the enthusiasm for our clinical trials and technology with several news outlets covering stories about the company. Below is a sample of OncoSec’s recent news coverage:

San Diego Business Journal– The article, titled “OncoSec Inches Ahead on Skin Cancer Zapping Technology” discusses OncoSec’s development plan, highlighting the company’s OMS ElectroImmunotherapy program for the treatment of Merkel cell carcinoma, metastatic melanoma and cutaneous T-cell lymphoma. This article is only available online to subscribers of the San Diego Business Journal

The Journal- The article, titled “Fighting skin cancer with electroimmunotherapy,” outlines the rationale for the Phase II Merkel cell carcinoma study and describes the urgent need for a new therapy for this patient population.

Today’s Medical Developments– The article, titled “A Novel Delivery System,” details the components and processes governing use of the novel OncoSec Medical System (OMS) technology platform, which leverages electroporation technology to target tumors and deliver powerful cancer therapeutic agents without affecting surrounding healthy tissue.

Medical Device and Diagnostic Industry– The article titled “OncoSec Could Revolutionize Oncology Therapy,” details the company’s promising OMS ElectroOncology treatment platform, as well as the on-going Phase II clinical studies in metastatic melanoma and Merkel cell carcinoma.

If you have any questions about OncoSec or our current activities, please contact us at investors@oncosec.com. Thank you for your support.

Best,

Punit Dhillon
President & CEO


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