Melanoma Spotlight

Melanoma Spotlight
Melanoma is the deadliest form of skin cancer, accounting for the majority of skin cancer deaths worldwide. 

While melanoma rates have been rising over the last 30 years, advancements in treatment and early detection are providing new hope for patients everywhere. In this edition of Guided By Science, we explore melanoma prevention, early detection, and new treatments that are changing the way we treat this deadly disease.

Final Trial Data Expected in 6-12 Months

SAN DIEGO – June 18, 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 the completion of patient enrollment in a Phase II clinical trial of ImmunoPulse for metastatic melanoma patients.

The Phase II trial is evaluating efficacy of ImmunoPulse in subjects with Stage IIIb to IVa in-transit cutaneous metastatic melanoma with a primary endpoint of overall objective response (OOR) at 6 months as measured by modified RECIST. Secondary endpoints for this study will evaluate safety and tolerability, as well as local response of treated lesions at Day 90.

“We are pleased that our development milestones continue to meet our expectations. We have shown great adoption of ImmunoPulse with the clinical centers enrolling in this Phase II clinical trial for advanced-stage melanoma patients,” said Punit Dhillon, President and CEO of OncoSec Medical. “We are now interested in directing the focus to data analysis and the design of our next studies for the melanoma program, including expanding the adoption across other key centers of excellence.”

The ImmunoPulse trial is a single-arm, open-label and multicenter study. The trial is designed to assess local and distant 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. This multicenter trial is being conducted in the United States at the University of California San Francisco, the University of Washington and the John Wayne Cancer Institute.

Previously, OncoSec provided an interim safety analysis of 13 patients of its Phase II metastatic melanoma program. The results showed that 95 percent of evaluable treated lesions demonstrated a response at Day 39 and Day 90. In addition, two subjects who were evaluable for the primary endpoint of overall objective response at Day 180 both demonstrated a clinically relevant objective response as measured by RECIST. In March 2013, an update of interim data was announced demonstrating durability of response of treated lesions. These data showed that all melanoma lesions that demonstrated at least a partial or complete response to treatment with ImmunoPulse had a 68 percent and 45 percent durable response at three and six months, respectively.

Merkel Cell Carcinoma Recap

While skin cancer is well-known and well-documented, in most communities, few people differentiate between the various types. Melanoma, basal cell carcinoma and squamous cell carcinoma are, unfortunately, quite prevalent (and on the rise). It is important to understand the risk factors and preventative measures for these cancer types. However, there is one rare type of skin cancer called Merkel cell carcinoma: a deadly type of skin cancer with a low survival rate that still has no approved, specialized treatment method.

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.

OncoSec is continuing to execute on its corporate milestones, which were laid out for our investors at the beginning of 2012. The fourth quarter of 2012 will mark an important achievement for OncoSec – the  announcement of preliminary data from our Phase II ImmunoPulse clinical trials, the first of which will be presented at this years annual meeting for the Society of Immunotherapy of Cancer (SITC) later this week. Here, we will be presenting data from 5 patients treated in our Merkel cell carcinoma (MCC) program. Merkel cell carcinoma is an aggressive cancer that starts in the skin and Merkel cells. If you’d like to know more about this cancer, you can read our previous blog post titled, “What is Merkel Cell Carcinoma“.

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.     

 

 

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.

 

SAN DIEGO, CA — July 30, 2012 OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, announced it has 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.

“The ISO certification is a significant accomplishment and an important milestone for OncoSec. Certification affirms that our QMS meets the highest standards and strengthens OncoSec’s commitment to product quality and development,” said Punit Dhillon, President and CEO. “With this certification in place, OncoSec is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe.”

Companies receiving the ISO 13485 certification must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of OncoSec devices, as well as, the company’s commitment to continuous improvement. OncoSec’s review was performed by SGS, a world leader among notified bodies in inspection, verification, testing, and certification.

OncoSec’s electroporation device, the OncoSec Medical System (OMS), is currently being used in three on-going clinical trials for the treatment of metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. In addition, the OMS has been used in Europe in Phase IV clinical trials for the treatment of head and neck cancer and cutaneous and subcutaneous skin cancers.


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