OncoSec Issues Annual Letter to Shareholders

First Patient Enrolled in Combination Study with UCSF and Merck

On behalf of the OncoSec team, we’re thrilled to announce the first patient enrolled in the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the safety and efficacy of the combination of our investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma.

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.

SAN DIEGO – January 7, 2014 — OncoSec Medical Inc. (OTCQB: ONCS), a biotechnology company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced that Punit Dhillon, President and CEO, will provide a corporate update at Biotech Showcase 2014; one of the world’s largest life sciences conferences held annually in San Francisco.

The presentation is scheduled to take place on Tuesday, January 14 at 2:30 p.m. PST at the Parc 55 Wyndham San Francisco–Union Square, located at 55 Cyril Magnin Street. A live webcast will be available by visiting the following link: http://www.media-server.com/m/p/byw47js4.

About Biotech Showcase 2014

Biotech Showcase™ is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week, which is widely viewed as setting the tone for the coming year.

Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,700 attendees. The program includes lunch plenary sessions featuring top industry leaders and innovators speaking on industry and time-relevant topics, as well as presentations from both private and public companies.

 

SAN DIEGO – April 17, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that Punit Dhillon, President and CEO, will present a company overview at the 2013 BIO International Convention. Mr. Dhillon’s presentation will take place on Wednesday, April 24, 2013 at 9:00 a.m. CT at the McCormick Place convention center in Chicago, IL.

About Bio International Convention 2013

Bio International Convention is the global event for the biotechnology industry attracting over 16,000 decision makers from 65 countries. The three-day event attracts thousands of companies from around the world and helps build strategic partnerships. BIO covers the wide spectrum of life science innovations and application areas. Drug discovery, biomanufacturing, genomics, biofuels, nanotechnology, and cell therapy are just a few of the industries represented at the BIO International Convention.

 

95 Percent of All Treated Tumors Demonstrated Response to ImmunoPulse Therapy

SAN DIEGO – November 15, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announces positive preliminary results from a Phase II trial investigating the use of ImmunoPulse in metastatic melanoma patients at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th EADO Congress. This preliminary interim analysis of 13 out of 25 patients supports key findings from a Phase I trial suggesting that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment.

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 was designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with ImmunoPulse. As per the protocol, a preliminary interim analysis was scheduled upon completion of 50 percent enrollment in the study.

The purpose of the analysis was to confirm safety and efficacy observed in the Phase I study. At the time of this preliminary interim analysis, 13 patients were enrolled and treated. Thirteen subjects were evaluable at Day 39, nine at Day 90, and two at Day 180. Ninety-five percent of treated lesions demonstrated response at Day 39 (5 percent progressive disease, 14 percent stable disease (SD), 42 percent partial response (PR), 39 percent complete response (CR)). All treated lesions at Day 90 (5 percent SD, 50 percent PR, 45 percent CR), and at Day 180 (33 percent PR, 67 percent CR) demonstrated a response. At Day 180, two subjects were evaluable for the primary endpoint of objective overall response (ORR). One patient has a confirmed stable disease, and the second patient has a confirmed complete response of all treated and untreated lesions. Analysis of the safety data for the subjects analyzed confirms that intratumoral administration of DNA IL-12 with electroporation is safe and well-tolerated. No related adverse events reported were greater than grade 2, and were generally limited to transient pain related to electroporation treatment.

The preliminary results are being presented in a poster titled “Preliminary Analysis of a Phase II Trial of Intratumoral Delivery of Plasmid Interleukin-12  (pIL-12) with In Vivo Electroporation in Patients with Metastatic Melanoma.” Dr. Adil Daud, principal investigator and co-director of melanoma research at the University of California San Francisco School of Medicine, is co-author.

These data are also being orally presented at a parallel scientific symposium, hosted by OncoSec, titled “Electrogenetherapy: Intralesional Immunotherapy Approach for Skin Cancers Using Electroporation.” Drs. Adil Daud and Axel Hauschild will chair the event, which will be held on Thursday, November 15 from 6:00-7:00pm Barcelona time. The agenda is as follows:

– Application and Versatility of Electrogenetherapy – Dr. Richard Heller

– Clinical Experience: Case presentation and discussion of intralesional injection of

plasmid interleukin-12 with electroporation – Dr. Adil Daud

– Immune correlates and biomarkers: Immune related responses following intralesional injection of plasmid interleukin-12 with electroporation – Dr. David Weiner and Dr. Edward Cha

– Outlook on intralesional immunotherapies for the treatment of metastatic melanoma – Dr. Adil Daud

Punit Dhillon, President and CEO of OncoSec Medical, commented, “We are encouraged to have observed at least one complete response based on the evaluable patients that have met the primary endpoint timeline, and we will continue to follow this patient and the others to assess the durability of response. These data validate the results from the Phase I study and effort we have put into this program, while providing further evidence of the potential role of ImmunoPulse as a safe and effective option for treating this aggressive disease.”

Dr. Daud commented, “Preliminary results from this Phase II study appear to offer solid support to the earlier study indicating the efficacy of ImmunoPulse in treating metastatic melanoma. Enrollment in the study is ongoing and expected to be completed by the end of 2012. Long-term follow-up will assess durability of response.”

About the Phase II ImmunoPulse Study

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.

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 that 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 remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.

Merkel Cell Carcinoma

 

Cancer can be a very difficult subject for people. Whether it is a fear of the results or the technical nature of the medical field, cancer can elicit a very strong response from patients, professionals, and the public alike. For those at risk for cancer – as well as the general public – it is important to know how certain cancers work, where they come from, and how they can be treated. One lesser talked about cancer that has been experiencing a rapid increase in diagnoses is Merkel cell carcinoma (MCC).

NEWS RELEASE

 Study Marks First Time Immunotherapy Delivered with Electroporation Will Be Evaluated for This Condition  

SAN DIEGO, CA — July 9, 2012OncoSec Medical Inc. (OTCBB: ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announces it has received Investigational Review Board (IRB) approval at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center for a Phase II clinical trial evaluating OncoSec’s OMS ElectroImmunotherapy for the treatment of cutaneous T-cell lymphoma. UCSF investigators are actively recruiting for this clinical trial.

A total of up to 27 patients with cutaneous T-cell lymphoma will be enrolled in this Phase II, single-arm, open-label multi-center study. The trial’s primary endpoint is to assess local and distant response rate following treatment of cutaneous T-cell lymphoma lesions (mycosis fungoides or Sezary patients) with a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12) and electroporation. One treatment cycle will consist of three treatments applied to up to four lesions on days one, five and eight with a maximum dose of 3.0 mg DNA IL-12 per treatment cycle.  Patients with stable disease or better at three months will be eligible to receive a second treatment cycle. Additional treatment cycles at six, nine and 12 months can be applied if there is no evidence of disease progression or intolerability of the treatment, with a maximum of four cycles. Treatment response at untreated sites will be evaluated according to the standard modified SWAT definition. 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. The first patient has been enrolled and successfully completed their first treatment cycle.

“The initiation of this study will mark the first time patients suffering from cutaneous T-cell lymphoma will be treated with an immunotherapy delivered using electroporation,” said Punit Dhillon, President and CEO of OncoSec. “We are excited to be working with Dr. Weiyun Ai and a leading academic institution, UCSF, in this study.”

OMS ElectroImmunotherapy utilizes OncoSec’s proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (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, which significantly increases DNA IL-12 uptake into these cells. Phase I data using OMS ElectroImmunotherapy to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53 percent of patients with distant metastatic lesions demonstrated an objective response, with 16 percent of these patients having a complete response to the treatment.

Dr. Ai said, “There exists a substantial need for novel treatments for cutaneous T-cell lymphoma. The role of electroporation in enhancing the efficiency and/or the tolerability of various agents, such as DNA IL-12, can be delivered to patients is well worth studying.”

 

About Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) is a heterogeneous class of non-Hodgkin’s lymphoma, which is a type of cancer of the immune system, with the most common forms being mycosis fungoides (MF) and Sezary syndrome (SS). The malignant T cells in the body initially migrate to the skin, causing various lesions to appear. These lesions change the depth of skin penetration as the disease progresses, typically beginning as what appears to be a rash, which can be very itchy and eventually forming plaque tumors as well as spreading to other parts of the body other than skin. The incidence of CTCL in the United States is approximately 1,500 new cases per year.

 

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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.

 

University of California Disclaimer: The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.

 

 

 

 

 

 


UCSF Joins University of Washington To Become Second Site in Trial
 

SAN DIEGO, CA — July 9, 2012 — OncoSec Medical Inc. (OTCBB:ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announces it has established the University of California San Francisco (UCSF) as the second enrolling site for its Phase II Merkel cell carcinoma clinical trial (OMS-I110). UCSF investigators are actively recruiting patients for this clinical trial. OMS-I110 was initiated at the University of Washington in January 2012, and the first patient was dosed there on January 6, 2012.

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’s primary endpoint is to assess the clinical and biologic effects of increased local expression of interleukin-12 (IL-12) protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy from baseline to two to four weeks after the first injection. 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. Investigators at the University of Washington have received Investigational Review Board (IRB) approval and will continue recruitment for this clinical trial as the lead enrollment center.

“We are pleased to have established a clinical site at UCSF for our Merkel cell carcinoma trial that joins our previously established site at the University of Washington,” said Punit Dhillon, President and CEO of OncoSec. “We are excited to be working with Dr. Siegrid Yu and UCSF in this Merkel cell carcinoma study. This is the third clinical trial conducted at this academic institution, which includes our ongoing trials for patients with metastatic melanoma and cutaneous T-cell lymphoma.”

Dr. Siegrid Yu, principal investigator and dermatologic surgeon at the UCSF Dermatologic Surgery and Laser Center, said, “There is a potential for electroporation to enhance the efficiency with which agents such as IL-12 can be delivered to Merkel cell carcinoma patients. We are glad to be joining the University of Washington in a trial to gauge the efficacy of this technique.”

OMS ElectroImmunotherapy utilizes OncoSec’s proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (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, which significantly increases DNA IL-12 uptake into these cells. Phase I data using OMS ElectroImmunotherapy to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53 percent of patients with distant metastatic lesions demonstrated an objective response, with 16 percent of these patients having a complete response to the treatment.

About Merkel Cell Carcinoma

Merkel cell carcinoma is a rare and highly aggressive cancer, with approximately 1,500 new cases each year, in which malignant cancer cells develop on or just beneath the skin and in hair follicles. The majority of Merkel cell carcinomas appear to be caused in part by a virus, Merkel cell polyomavirus. If this cancer metastasizes to the lymph nodes, the five-year survival rate is about 50 percent. A patient with a small tumor (less than 2 cm) that has not metastasized to the lymph nodes may have a five-year survival rate of more than 80 percent. Current treatment options for these patients is surgery, radiation and chemotherapy; however, up to half of patients suffer a recurrence. Rapid advances in the biology of this disease provide a strong rationale for immunotherapy of this virus-associated cancer.

 

 

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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.

 

University of California Disclaimer: The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.

 

 


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