This week, our CEO, Punit Dhillon, presented at the 15th Annual Rodman & Renshaw Global Investment Conference. The annual event hosted over 150 established and emerging biotech and pharmaceutical companies. During the presentation, Mr. Dhillon reviewed previous data points and provided an update on upcoming milestones. Here is an overview of the presentation:
Now more than ever, skin cancer has become a great concern. With 1 in 5 Americans expected to contract some form of skin cancer in their lifetime (with approximately 2 million new cases occurring annually), effective means of risk assessment, prevention and treatment are of the utmost importance. Melanoma itself – often referred to as the deadliest form of skin cancer – is seeing an increasing rate of diagnosis faster than any other solid tumors. This is especially noticeable in those aged 18 to 39, where we have seen a 600% increase, from 1970 to 2009.
One of the major issues with the current state of skin cancer treatment is the need for more effective, possibly cost-oriented therapies that are less damaging to patients. Current established drug options often have high levels of toxicity associated with them, a low response rate and the potential for patients to become resistant to treatment. The overall cost of treatment for skin cancer can be in excess of $100,000 – not including the cost of managing side effects (up to $75,000).
OncoSec is hoping to address some of these issues, in our potential treatment option currently in clinical trials. Named ImmunoPulse, this highly targeted and minimally invasive immunotherapy method consists of injecting DNA-IL-12 (a gene-based immune trigger) into tumors, followed by the use of electroporation, in order to open microscopic pores in the cell membrane that allow entry of the agent. The objective is to trigger an immune response, in order to target and destroy cancer cells, while leaving healthy cells intact.
Metastatic Melanoma Clinical Trials
The current evidence discovered in the interim analysis of our Phase II clinical trials for metastatic melanoma has been encouraging. The Phase II trials have shown no adverse events higher than grade 2. Of the 13 patients analyzed in the preliminary interim data update, the durable response rate at 3 months was 69%, and 38% at 6 months. With an objective response of 53% and a complete response of 15% for treated lesions, it can be argued that OncoSec’s data is relatively significant in the melanoma landscape.
Merkel Cell Carcinoma Clinical Trials
A rare orphan indication, Merkel cell carcinoma is a highly undertreated type of skin cancer with no approved specialized treatment. A mortality rate of 33% also makes MCC noticeably more deadly than melanoma. The orphan drug market accounted for $50 billion in sales, in 2011; with the lifetime of some orphan drugs estimated at over $70 billion. In the interim safety and efficacy analysis of our Phase II clinical trial for Merkel cell carcinoma, there were no systemic-related AEs reported. The overall response rate was 20%, with one subject confirmed to have a partial response and a regression of both injected and distant lesions greater than 70%.
There are many important key milestones set for OncoSec, throughout the rest of 2013. Continuing our Phase II clinical trials, we will be releasing interim data on the Phase II melanoma study and response data from the Phase II Merkel cell carcinoma study this year, along with data from our combination study of Anti-CTLA4, Anti-PD1 and Anti-PD-L1 therapies for metastatic melanoma in mice, in Q3/Q4. Enrollment for our metastatic melanoma trial has been completed, with enrollment for our MCC trial currently over 50%. Final data for our Phase II trials for metastatic melanoma and MCC are expected in 2014.
FDA meetings for the end of our Phase II trials are planned for Q1/Q2 of 2014. We plan to move forward with Phase IIB trials for our metastatic melanoma and Merkel cell carcinoma programs, in 2014. We look forward to sharing more data, as it becomes available.
The full slide deck and voice recording of our presentation at the Rodman & Renshaw 15th Annual Healthcare Conference is available here.