In this special series, we explore the state of select public companies operating in a particularly intriguing area of life sciences. This week, we look at metastatic cancer, an area of significant unmet need. These companies, including OncoSec Medical, are having success with their innovative approaches to treating metastatic cancer, and are seeing results in their performance int he public markets.
Despite a number of treatments in clinical development – and a few approved approaches – metastatic melanoma still remains a therapeutic puzzle. According to the World Health Organization, nearly 50,000 deaths a year can be attributed to melanoma-like cancers alone, and the market as a whole is starved for effective treatment solutions due to the harsh, complex, and costly treatments currently used.
Much like the rest of the bioscience sector, companies that historically specialize in cancers of this type deal with few proven treatment options and investor perception that the space historically carries significant risk. The biotech community calls this a stigma, which in reality is the result of a variety of diverse, isolated events – such as a loss of a patent challenge or failed endpoints in clinical trials.
Cancer treatment in this decade, however, is evolving into a steadier market than during the last biotech boom in the mid-late 1990s, in which massive failures across the whole market were as common as promising developments. The technology is finally catching up, and investors are beginning to notice: the biotech sector which has grown over 100% since 2011.
In the area of metastatic therapies, OncoSec Medical Inc (OTC BB: ONCS) is developing an intriguing novel drug delivery method and therapy. The company in June reported positive data from its Phase II metastatic melanoma study, an ongoing trial testing safety and efficacy of up-regulating plasmid interleukin-12 with electroporation (an immunotherapeutic process known as ImmunoPulse). The company also initiated a Phase II in July trial involving the treatment of cutaneous T-cell lymphoma with ImmunoPulse.
OncoSec uses electrooncology – enhanced immunotherapy (which the company has named ImmunoPulse) and chemotherapy (named NeoPulse) with electroporation – for a minimally invasive, efficacious and more targeted attack of the tumor. Electroporation is a particularly interesting technology, which increases the electrical conductivity of the cell plasma membrane to increase porosity. Greater porosity means the pre-injected anti-cancer agent can penetrate the tumor cells without affecting the surrounding healthy tissue. When the current is removed, the tumor cells reseal rapidly and trap most of the anti-cancer agent.
Studies have also shown that high voltages of electroporation can irreversibly destroy target cells within a narrow range while leaving neighboring cells unaffected. OncoSec uses its OncoSec Medical System electroporation device for up-regulation of IL-12, and ablation of tumors combined with bleomycin (an approved chemotherapy agent).
After the presentation of positive data from a Phase III trial for NeoPulse (which had been licensed in Phase III from Inovio Pharmaceuticals in March 2011) for head and neck cancer, Phase II trials are underway (announced in July) at the University of California-San Francisco (UCSF) for Merkel cell carcinoma and cutaneous T-cell lymphoma. It should be interesting to see how updates later this year are received by regulators, potential strategic partners and the public market. It is a very fair assessment that OnsoSec will be trading significantly to the upside if the results are as promising as they say. The undertaking of over $11 million in financing since 2011 has provided the company with enough capital to sustain the clinical trial phase and tell their story to the world.
Based on Q2 earnings filed in June, the company has over $6MM in cash, with 87MM shares outstanding. On September 5, the company received a new Method of Use patent in China for the company’s electroporation device platform.
If we also look at the metastatic treatment market as a whole, pioneers such as OnsoSec may pave the road for the success other therapies that are more complex.
Anothersuch therapy used to treat metastatic cancers is an antibody-based therapy developed by Immunomedics Inc. (Nasdaq: IMMU). IMMU stock is up 4% YTD, mainly due to the patent filing in May of its antibody-based metastatic therapy. The therapy is targeted for non-Hodgkin’s lymphoma as well as for certain types of Lupus.
Investment value of IMMU comes from the potentially diverse application of therapies and from the company’s financial situation. It seems the company’s plans remain on course despite not being in the realm of the stock’s all-time high of $8.95 in September 2003. IMMU recorded profit of .20 cents/share in Q3 of 2011, followed by a .10 cent/share loss in both Q4 2011 and Q1 of this year. Fiscal discipline has been noted as but one attribute of companies looking to sustain in this space, but it is nonetheless a significant factor. It will be interesting to see where IMMU’s Q4 2012 gross profit falls, as this total has dropped in a YOY comparison in previous quarters.
When investors look to unlock value of a company they will also look at the patents and pipeline diversity, with a goal of multi-use therapy development. Both OncoSec and Immunomedics maintain a pipeline exploring several different indications. OncoSec is particularly well-positioned for licensing opportunities, as the company develops its electroporation technology as a drug delivery mechanism.
If OncoSec’s electro-oncology trials are successful the company could see collaborative partnership opportunities and/or the funding of subsequent trials with different chemotherapeutic agents.
EndoCyte Inc. (Nasdaq: ECYT) is another company in this space making news. EndoCyte’s therapy focuses on small molecule drug conjugates (SMDCs). Merck acquired the development and marketing rights to EndoCyte’s vintafolide, an anti-mitotic chemotherapy derivative, in April 2012. Endocyte had planned to file for marketing approval in the third quarter of 2012. The drug received orphan drug status from the EU in March 2012.
Merck is underway with a Phase III trial evaluating Endocyte’s drug used in combination with DOXIL for the treatment of recurring late-stage ovarian cancer. The primary endpoint of the trial is progression-free survival as measured by the RECIST (Response Evaluation Criteria in Solid Tumor) standard, with the eventual endpoint of the patient making a full recovery.
EndoCyte is up 144% YTD, with a healthy financial picture and a promising position going into Phase III testing with patents for their therapies issued late last year.
Looking at the various applications of the therapy, licensing ventures, patent rights and a strong pipeline into an underserved market shows, EndoCyte is as uniquely positioned as OncoSec and Immunomedics.
The state of metastatic therapies looks to be very promising, given the lack of viable therapies and the potential for multi-use. Further, these therapies are on the cutting-edge, which presents a myriad of partnerships and patent opportunities.
How can you write about metastatic cancer drugs without mentioning anti-PD-1 drugs from Bristol-Meyers and others? They are the bear in the room. BMS is the leader at present having acquired residual rights with the purchase of Medarex and a deal with ONO,but Merck and others are at their heals. The oncology community sees anti-PD-1 as a potential breakthrough not only with respect to melanoma but also for NSCLC and renal cancers based on results from BMS’s Phase 1B study. My only question is why is BMS allowing other companies to eliminate their lead? They are sitting back on an advanced melanoma trial and pursuing the other indications.The only reason I can see for their doing so is that they do not want to reduce the market for Vervoy which already is approved. They need a new blockbuster having lost patent protection for Plavix and withdrawn their Hepatitis C drug from testing.However, Vervoy has drawn negative recommendations from most cost-effectiveness agencies and increaing competition from BRAF inhibitors and other targeted therapies. It is a good drug but bot the blockbuster that anti-PD-1 can be. The question is whose blockbuster?