Melanoma is known by experts to be the deadliest form of skin cancer. Melanoma is curable, but only if it is detected and treated early on. According to the American Cancer Society, nearly 123,000 new cases of melanoma are diagnosed in the U.S. each year, resulting in 10,000 deaths. There are very few treatment options out there for patients with late-stage metastatic cancer that can increase survival rates and time periods. I will discuss two of these options below and compare them to see which offers more promising results.
Amgen (AMGN) recently announced positive results from its phase 3 clinical trial of Talimogene Laherparepvec (TVEC), a cancer drug candidate that targets melanoma. The drug met its primary endpoint in the trial which evaluated the drug's safety and efficacy in fighting later stages of melanoma against subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). TVEC was found to lead to a complete or partial response lasting for six months or more. The drug candidate had a "durable response rate" (DRR) of 16% in patients treated with TVEC, compared to a durable response rate of 2% in patients treated with GM-CSF. A separate interim analysis also favored TVEC over GM-CSF.
TVEC is injected directly into tumors. Once inside the tumor, it goes through selective replication, which causes the cancer cell membrane to burst. The ruptured cancer cells then releases the replicated viruses held inside. These viruses travel to other tumor cells and invade them. The process stops once the weakened virus encounters healthy cells. During the process, TVEC also initiates the production of a white blood cell growth factor within the tumor, which is required for an immune response.
Since the release of the trial data Amgen has traded higher by 6%, as the encouraging news has been well received by Wall Street. The company has one of the highest EPS figures in the industry at $5.52 and has been a strong growth investment for many, since it was a developmental biotech.
OncoSec Medical (OTC:ONCS) is developing its two advanced stage treatments, ImmunoPulse DNA-based immunotherapy and NeoPulse therapy, which are used to treat solid tumors. The company recently announced durable response results from its phase 2 metastatic melanoma trial in its update of interim preliminary data. Treated lesions that demonstrated a partial or complete response were followed to determine durable response rate after being treated with ImmunoPulse. Impressively, 81% of treated lesions showed a partial or complete response at Day 39. And 68% of treated lesions showed a durable response at three months, while 45% of treated lesions showed a durable response at six months. This translated into 69% of patients showing a durable response of their treated lesions at three months, compared to 38% at six months.
OncoSec Medical's ImmunoPulse therapy is superior to Amgen's TVEC candidate. While TVEC had a durable response rate of 16% for six months, ImmunoPulse had a durable response rate of 38% at six months. Just as an added reference, Vical's (VICL) Allovectin had a response rate of 12% in its phase 2 trial. The announcement for the completion of enrollment in the second quarter and a final analysis is expected in the fourth quarter of 2013. Based on its durability, cost and treatment cycle, treatment of skin cancer through OncoSec's ImmunoPulse therapy is a superior option compared to Amgen's TVEC.
In November 2012, OncoSec announced interim analysis of the first thirteen subjects enrolled in a phase 2 study. NeoPulse, OncoSec Medical's other therapy used to treat solid tumors, also appears to have better results compared to surgical resection. A key advantage of this approach appears to be less damage to normal healthy tissues along with improved cosmetics. In addition, should OncoSec remain on track, the technique should require less or no need for reconstructive applications. As it further reduces the cost associated with hospitalization for extensive reconstruction, the approach warrants further exploration as an alternative in select cases of skin cancer.
A total of up to 25 patients with stage 3 or 4 skin cancer/melanoma will be enrolled in this phase 2, single-arm, open-label and multi-center study. The trial is being conducted to analyze local and distant objective response that would follow the treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation, with the most important outcome of this treatment in twenty four 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.
OncoSec had traded higher by as much as 10% following the data presentation at the HemOnc Today conference and saw its volume increase significantly. The company looks to have a cash position strong enough to carry it through the next 18 months and through the completion of the trial.
In summary, OncoSec Medical's Immunotherapy appears to be a superior option for treating metastatic melanoma, with best in class results. The durable response rate for ImmunoPulse is higher for both three months and six months compared to Amgen's TVEC. In addition, the essential features of ImmunoPulse therapy are not restricted to melanoma only. It is also useful in treating patients suffering from T-cell Lymphoma due to its safety and long-term benefits. Electroporation, which is OncoSec Medical's core technology used in its two delivery platforms, is a more beneficial delivery choice due to the increased transfection of agents, and also avoids issues of immunogenicity that is seen in a viral delivery approach. In addition, interleukin-12 (IL-12) cytokine, which is used in the ImmunoPulse therapy, is a naturally occurring protein that activates and boosts levels of macrophages and T-cells. IL-12 has been shown to be a very effective immune-modulator in cancer therapy. IL-12 is thought to activate the immune system by re-educating the immune response in the tumor microenvironment. IL-12, when introduced into the local tumor microenvironment, can significantly alter the immunosuppressive state in the tumor microenvironment to make it inflammatory and destructive to the tumor. While the approach is similar to TVEC, no lingering virus remains floating throughout the body until the healthy cells have controlled it.
Amgen will be to market before OncoSec, with its treatment for the unmet needs of those that suffer from melanoma. However, OncoSec has the ability to supersede the TVEC approach, based on clinical results superiority. Both companies offer investors tremendous growth opportunity.