Bridging Connections and Insights from Investment Conferences

Bridging Connections and Insights from Investment Conferences

By Punit Dhillon, CEO and President of OncoSec Medical Incorporated

After the conclusion of several conferences this past month, I’ve had time to reflect on key takeaways and principal trends emerging in the healthcare sector. Despite less than stellar market conditions, speakers at conferences (such as J.P. Morgan 2016 and Bio CEO) and ancillary events remained optimistic and highlighted important insights into the future of healthcare. After a busy schedule with non-stop meetings and presentations, I returned home confident in OncoSec’s place in the burgeoning cancer immunotherapy landscape.

Clinical Trials, Data, and Staging

The biotech and medical industries have come a long way. While many marvels have been created – such as vaccines, treatments and prosthetics – some of the research could pose dangers to the public, if it is not used correctly or if the initial findings from early experimentation are wrong. It is for these reasons that the FDA requires proper clinical testing (or clinical trials) to be performed, before they are eligible for public use. We would like to explore what exactly a clinical trial is, the data they collect and how a clinical trial moves on to the next phase:

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.

As relayed in the American Cancer Society’s Cancer Facts & Figures 2012 report, an estimate 1.64 million Americans were diagnosed with cancer, in 2012, along with over 577,000 cancer-related deaths. While cancer treatments have become more and more effective with defeating, minimizing and slowing the growth of cancer – thus increasing life expectancy and lowering the mortality rate of cancer patients – prevention and early detection remain the most important factors. It is this point that National Cancer Control Month seeks to raise awareness for.

Importance of Durable Response Rate for Cancer Treatment Trials

An objective response evaluation is a type of assessment that measures the response to a cancer treatment. This determines whether or not the agent or treatment method demonstrates a viable result that calls for further testing. This can measure clinical, as well as palliative effects, as patient comfort and symptom control can be taken into consideration. The main purpose to measuring objective response is to assure researchers that they are not overestimating response or success rates.

 45 percent of Treated Lesions Demonstrated a Durable Response Of At Least 6 Months

 

SAN DIEGO – March 25, 2013  — OncoSec Medical Inc. (OTCQB: ONCS) – a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors – announced positive, durable response results in an update on interim data from its Phase II metastatic melanoma trial. The data was presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference on March 22, in New York City.

In this analysis, all melanoma lesions that demonstrated at least a partial or complete response (PR or CR) to treatment with ImmunoPulse were followed, to determine durable response. Sixty-eight percent and fourty-five percent of treated lesions demonstrated a durable response at three and six months, respectively.

Punit Dhillon, President and CEO said, “We are encouraged by this updated data from the interim analysis, especially in light of recent announcements related to durability of response for other intralesional therapies. This data not only shows that ImmunoPulse can effectively eliminate the targeted tumors but also that our treatment can have a lasting effect on those tumors.”

Adil Daud, MD – the study’s principal investigator at the University of California San Francisco – said, “This data demonstrates that the lesions we have selected for treatment are responding well to the therapy and that the ImmunoPulse can trigger a lasting immune response, against the treated lesion. It is now important for us to see if this local immune reaction can result in a more widespread response against untreated lesions.”

These interim results reinforce previously announced Phase I data demonstrating that ImmunoPulse therapy is safe and well tolerated, as well as producing robust objective response rates, in patients with metastatic melanoma. OncoSec expects to complete enrollment of approximately 25 patients in total, in Q2 2013, with final analysis anticipated in Q4 2013.

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 can also often 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.

 

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 will be presenting subset data from the Phase II melanoma study at the EADO conference on November 14 – 17 in Barcelona, Spain.

More news to come soon.

The Sun's UV Rays

 

As the leading cause of death from skin cancer, melanoma is often referred to as “the most dangerous type of skin cancer” (Source: ncbi.nlm.nih.gov), despite being less common than Squamous cell and Basal cell skin cancers. Because of its definition as one of the more deadly forms of cancer, public knowledge surrounding melanoma is of great importance. As a visible cancer – and one that is more easily preventable than many other forms – individuals should be actively involved in avoiding risk factors, as well as educating themselves on the causes and symptoms of the condition.

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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