Merkel Cell Carcinoma Recap

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.

FOR IMMEDIATE RELEASE

SAN DIEGO – April 18, 2013 – OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, is one of the first to partner with Smart Patients: a new online community where patients with life-threatening conditions who are looking for or participating in clinical trials can share their feedback and experiences. Google’s former Chief Health Strategist, Roni Zeiger, will be speaking at the TEDMED conference in Washington, D.C. today to unveil the new website.

OncoSec is working with Smart Patients to create a community for Merkel cell carcinoma (MCC) patients. MCC is an extremely rare and aggressive form of skin cancer that currently has no approved therapies. OncoSec is conducting the only active Phase II immunotherapy trial that is focused specifically on the disease. The Smart Patients partnership will provide valuable insight from patients to help improve clinical trial design and enable better collaboration with patients.

“We’re excited to be working with Dr. Zeiger, and to be a part of creating this valuable resource for the Merkel cell community,” said OncoSec’s CEO, Punit Dhillon. “One of the most frightening parts of being diagnosed with a rare disease like MCC is a lack of information about the condition and treatment options. Smart Patients is providing an important resource to help patients connect and learn from each other.”

Roni Zeiger, co-founder and CEO of Smart Patients, noted, “Together with OncoSec, we will be able to gain a better understanding of MCC from a patient perspective, and help design more patient-centered trials that will make scientific breakthroughs for this disease available sooner.”

About Smart Patients

Smart Patients is an online community for cancer patients and caregivers. The community includes a clinical trial search engine that presents trial data from ClinicalTrials.gov in a patient-friendly format. The community platform has been in private beta testing since January 2013 and is now open to all cancer patients and caregivers. To learn more, please visit us at www.smartpatients.com.

 

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.

 

SAN DIEGO, CA, January 15, 2013 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced the company’s upcoming milestones for 2013 at the Biotech Showcase conference held January 7-9 in San Francisco, CA.

“2012 marked a critical year for OncoSec,” said Punit Dhillon, President and CEO. “We launched three Phase II clinical trials, and our interim data from our melanoma and Merkel cell carcinoma studies provided an encouraging signal for our company to move forward with further clinical development. We understand that Merkel cell carcinoma is an aggressive skin cancer with no currently approved therapies. OncoSec is conducting the only exclusive Phase II clinical study for this orphan disease, and if successful, we look forward to launching a pivotal program later this year with the aim of bringing new hope to these patients.”

OncoSec Medical met almost every milestone set in 2012, and plans to continue the positive momentum in 2013. More than seven million dollars was raised in the fourth quarter of 2012 from fundamental institutional investors, positioning the company with a strong balance sheet to fund operations well into Q2 2014.

Key milestones that OncoSec looks forward to accomplishing for 2013 include:

  1. Present interim response data from OncoSec’s Phase II melanoma trial along with long-term progression-free survival (PFS) data from its previous Phase I melanoma program
  2. Present final data from OncoSec’s Phase II melanoma trial and Merkel cell carcinoma trial
  3. Conduct an end-of-Phase II meeting with the FDA for OncoSec’s melanoma and Merkel cell carcinoma program
  4. Present interim data from OncoSec’s Phase II cutaneous T-cell lymphoma program
  5. Plan to launch a pivotal Merkel cell carcinoma program
  6. Plan to launch a Phase IIB metastatic melanoma program

OncoSec also reviewed the significant achievements of the company during the past year.

2012: Initiated Three Phase II trials with Patients Now Enrolling in Eight Centers of Excellence Across North America

The beginning of 2012 marked the launch and development of three Phase II clinical trials in metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. These trials are currently being conducted at eight key centers of excellence across North America, including: the University of California San Francisco, Moffitt Cancer Center, Fred Hutchinson Cancer Center at the University of Washington, and the John Wayne Cancer Institute.

2012: Presented Positive Interim Data

OncoSec’s interim data for the Phase II melanoma study showed positive safety and efficacy results with two of the patients who had met the 180-day time point. One patient showed a confirmed stable disease, while the other showed a confirmed complete response of all treated and untreated lesions. These data are encouraging and so far support findings from the Phase I study that demonstrated treatment with ImmunoPulse not only causes regression of treated lesions, but also can result in regression of untreated distant metastatic lesions as well. Unlike the Phase I study, subjects in the Phase II study are eligible for up to four cycles of ImmunoPulse.

Positive preliminary efficacy and safety results were also reported from OncoSec’s Phase II study of ImmunoPulse in Merkel cell carcinoma (MCC) patients. MCC is a highly aggressive disease that is three times more deadly than melanoma and six times more rare. There are no currently approved therapies for this cancer, and this patient population has limited options confined to surgery, chemotherapy and radiation. The interim data suggest that ImmunoPulse may elicit increased levels of IL-12 in the tumor microenvironment, and has the potential to result in a systemic immune response without adverse safety events. Of the first five patients enrolled, the overall response rate was 20 percent. One patient, after enduring prior therapies with no significant improvement (systemic chemotherapy, radiation and surgery), showed a 70 percent regression of both treated and non-treated tumors for approximately eight months, and no new tumors over six months.

 2012: Secured New Patents, Certification and In-licensing

OncoSec secured a new method of use patent for its NeoPulse program in Australia. This patent provides the necessary framework to set OncoSec up to potentially expand market opportunities as an adjunct therapy for the treatment of earlier-stage solid tumors. In addition, a device patent for the company’s OncoSec Medical System electroporation device was issued in China. The issuance of this patent gives the company a strong patent position with both its ImmunoPulse and NeoPulse programs in China, one the largest emerging oncology markets in the world.

In addition, the company also secured an exclusive license for specific patented technology from the University of South Florida Research Foundation. The license 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 (including in several targeted indications). OncoSec’s patent portfolio places the company in a preeminent position within the field of electroporation-based delivery of gene-based treatments for cancer.

OncoSec received Quality Management System (QMS) certification to the International Organization for Standardization (ISO) 13485 Medical Devices standard for the design, development, manufacture and distribution of electroporation devices. The ISO certification affirms OncoSec’s quality management system and supports the potential for future commercialization of the electroporation device in Europe.

Lastly, OncoSec received authorization to CE mark the OncoSec Medical System electroporation device for use in the European Economic Area, marking an essential regulatory milestone for potential future commercialization and partnership in Europe.

2012 marked a transformative year as the company solidified its ImmunoPulse development plan and initiated several trials to advance the technology. With a strong cash position that funds OncoSec’s clinical development plans well into 2014, encouraging data from its Phase II melanoma and Merkel cell programs, a broad intellectual properly estate and a distinguished group of thought-leaders on its clinical advisory board, OncoSec is poised for a strong year ahead.

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.

 

California Sun

 

When researching and actively working towards the treatment of an emerging condition, it is important to pay close attention to the history of the disease and how it might help move forward the field of study and public awareness. Being a lesser-known form of cancer, Merkel cell carcinoma (MCC) has not been paid as close attention as its mortality rate should merit. At OncoSec, we believe that it is of high importance to advance the field of study surrounding MCC and to create a more effective treatment regimen.

Data Presented at 27th Annual Meeting of the Society for Immunotherapy of Cancer

SAN DIEGO – October 23, 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 positive preliminary results from a Phase II multicenter trial investigating the use of ImmunoPulse in Merkel cell carcinoma (MCC) patients at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012). The data suggest that ImmunoPulse, which locally delivers a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12) via electroporation, may elicit increased levels of IL-12 in the tumor microenvironment, which has the potential to result in a systemic immune response in treating aggressive cancers like MCC without serious adverse safety events.

The preliminary results were published in the Journal of Immunotherapy (35(9):721-791, November-December 2012) and will be presented in a poster titled “Intratumoral delivery of Interleukin-12 DNA with in vivo electroporation can lead to regression of injected and non-injected tumors in Merkel cell carcinoma: Results of a phase II study.” Dr. Shailender Bhatia, principal investigator and assistant professor at the University of Washington School of Medicine, is lead author and will be presenting the data.

This open-label study is evaluating the ability of ImmunoPulse to increase levels of IL-12 in the tumor microenvironment, in addition to the efficacy and safety of this treatment for patients with MCC. Preliminary results of this study have demonstrated that 100 percent (3/3) of subjects treated with at least one cycle of ImmunoPulse showed an increased level of IL-12 expression in tumor biopsy done three weeks post-treatment as compared to pre-treatment biopsy. Correlative analysis of limited samples demonstrated that at least one subject had increased CD8+ T-cells (also referred to as killer T-cells) in the tumors. Correlative studies of patient samples are ongoing.

Of the first five subjects enrolled, the overall response rate is 20% (1/5). One patient with baseline progressive MCC, despite multiple prior therapies (systemic chemotherapy, surgery, RT, IT interferon) has had a confirmed partial response (greater than 70 percent regression) that persisted for approximately eight months. The regression of injected as well as non-injected tumors, along with no new tumors over six months, suggest successful induction of systemic immune response from local intratumoral immunotherapy in this patient. This subject remains in the study and will receive a third treatment cycle.

Dr. Bhatia commented, “These preliminary results are encouraging, and we are looking forward to continuing our study of ImmunoPulse. We are pleased to see that a patient with progressive MCC, despite failing multiple other therapies, had a confirmed partial response with regression of even distant non-injected tumors. This creative immunotherapy approach to deliver DNA IL-12 directly into the tumors appears to be tolerated well and so far without any systemic side-effects.”

All five subjects treated at the time of this preliminary analysis had distant metastatic disease, and were eligible to receive up to two treatment cycles. Two subjects have withdrawn from the study with progressive disease, and only received one cycle of treatment. Three subjects completed the study and received both treatment cycles. To date, the treatment has been safe and well-tolerated, with treatment-related adverse events including transient grade 1 pain (n=5) and grade 1 injection site reaction (n=1) without any systemic or residual toxicity.

Punit Dhillon, President and CEO of OncoSec Medical, added, “These subset data are positive and validate the results seen in our previous clinical trial. Thus far studies have shown that the administration of IL-12 using electroporation safely results in efficient transfection of the agent and a marked increase in production of the IL-12 protein inside the tumor. These results represent the first human data for a gene therapy using in vivo electroporation in MCC patients, and is a positive step towards advancement of this program.”

About Merkel Cell Carcinoma

Merkel cell carcinoma is a rare and highly aggressive cancer, with approximately 1,500 new cases each year in the United States, 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.

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“.

OncoSec announced positive preliminary results from a Phase II multicenter trial investigating the use of ImmunoPulse in Merkel cell carcinoma (MCC) patients at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012). The data suggest that ImmunoPulse, which locally delivers a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12) via electroporation, may elicit increased levels of IL-12 in the tumor microenvironment, which has the potential to result in a systemic immune response in treating aggressive cancers like MCC without serious adverse safety events.

The preliminary results were published in the Journal of Immunotherapy (35(9):721-791, November-December 2012) and will be presented in a poster titled “Intratumoral delivery of Interleukin-12 DNA with in vivo electroporation can lead to regression of injected and non-injected tumors in Merkel cell carcinoma: Results of a phase II study.” Dr. Shailender Bhatia, principal investigator and assistant professor at the University of Washington School of Medicine, is lead author and will be presenting the data.

This open-label study is evaluating the ability of ImmunoPulse to increase levels of IL-12 in the tumor microenvironment, in addition to the efficacy and safety of this treatment for patients with MCC. Preliminary results of this study have demonstrated that 100 percent (3/3) of subjects treated with at least one cycle of ImmunoPulse showed an increased level of IL-12 expression in tumor biopsy done three weeks post-treatment as compared to pre-treatment biopsy. Correlative analysis of limited samples demonstrated that at least one subject had increased CD8+ T-cells (also referred to as killer T-cells) in the tumors. Correlative studies of patient samples are ongoing.

Of the first five subjects enrolled, the overall response rate is 20% (1/5). One patient with baseline progressive MCC, despite multiple prior therapies (systemic chemotherapy, surgery, RT, IT interferon) has had a confirmed partial response (greater than 70 percent regression) that persisted for approximately eight months. The regression of injected as well as non-injected tumors, along with no new tumors over six months, suggest successful induction of systemic immune response from local intratumoral immunotherapy in this patient. This subject remains in the study and will receive a third treatment cycle.

Dr. Bhatia commented, “These preliminary results are encouraging, and we are looking forward to continuing our study of ImmunoPulse. We are pleased to see that a patient with progressive MCC, despite failing multiple other therapies, had a confirmed partial response with regression of even distant non-injected tumors. This creative immunotherapy approach to deliver DNA IL-12 directly into the tumors appears to be tolerated well and so far without any systemic side-effects.”

All five subjects treated at the time of this preliminary analysis had distant metastatic disease, and were eligible to receive up to two treatment cycles. Two subjects have withdrawn from the study with progressive disease, and only received one cycle of treatment. Three subjects completed the study and received both treatment cycles. To date, the treatment has been safe and well-tolerated, with treatment-related adverse events including transient grade 1 pain (n=5) and grade 1 injection site reaction (n=1) without any systemic or residual toxicity.

Punit Dhillon, President and CEO of OncoSec Medical, added, “These subset data are positive and validate the results seen in our previous clinical trial. Thus far studies have shown that the administration of IL-12 using electroporation safely results in efficient transfection of the agent and a marked increase in production of the IL-12 protein inside the tumor. These results represent the first human data for a gene therapy using in vivo electroporation in MCC patients, and is a positive step towards advancement of this program.”

CE Certification Enables Commercialization of OncoSec Medical System (OMS) Electroporation Device in European Economic Area 

SAN DIEGO – October 17, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse drug-based chemotherapy to treat solid tumor cancers, announced it has received authorization to CE mark its proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA). SGS Group, an industry-leading inspection, verification, testing and certification company, supervised the assessment and certification process.

A CE mark verifies the OMS electroporation device has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The granting of this CE mark involved a comprehensive audit of the company’s quality system as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed.  The CE mark affirms OncoSec’s commitment to product quality and development, and augments the notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices,” which the company received in July.

Punit Dhillon, President and CEO of OncoSec, commented,

“The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.”

 


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