Scancell And OncoSec looking good with melanoma immunotherapies

It often happens that paradigm-shifting breakthroughs in science are stumbled upon by different independent sources arriving at their breakthroughs nearly simultaneously. It happens often enough that there’s even a term for it: multiple discovery. One famous example is the race between Newton and Leibniz, who were both independently developing the mathematical methods behind calculus in the 17th century, Newton in Great Britain, Leibniz in Germany. Another is Darwin and Wallace, who both independently came upon the theory of natural selection and the evolution of species in the mid 19th century. There’s also Mendeleev and Meyer, who independently discovered the structure and layout of the periodic table in 1869.

People have their beliefs and theories as to why these coincidences happen – fate, cosmic forces, collective maturation of the human spirit or what have you. Nothing can ever be proven in that sphere, but we can assert that when a breakthrough is coming from multiple independent sources simultaneously, chances are there’s something to it, and a paradigm shift may be occurring.

Melanoma trials – nibs and mabs

Do an active clinical trials search for melanoma, narrow it down to industry-sponsored phase II and above, and you’ll find about 150 active melanoma trials in progress right now. Organize it by company and you’ll find some familiar names. The leader in terms of number of trials sponsored is GlaxoSmithKline (GSK) with 20 ongoing, 6 in phase III. Bristol Myers Squibb (BMY) is right behind with 18, also 6 in phase III. Novartis (NVS) is third, with 17 and 3 in phase III and IV. Roche (RHHBY) has an honorable mention with 10, 5 in phase III and IV.

The importance of these 4 large clusters of clinical trials, accounting for 65 of the 150 or 43%, is not to show a new revolutionary bent, but to show the aftereffects of a revolution that has already occurred. Focus in a little more on each of these companies’ trial groups and you’ll find that most of them are testing out the same medications in different combinations that end with either mab or nib. Both are targeted cancer specific drugs. Mabs are monocloncal antibodies, engineered to bind to cancer cell receptors called antigens to either directly destroy or else carry some sort of cancer toxin on their tails to release once they lock on. Nibs are tyrosine-kinase inhibitors or TKI’s, which act to shut down cancer growth signals thereby inducing cancer cell suicide.

Of Bristol Myers’ 18 trials, nearly all of them involve the drug ipilimumab, branded Yervoy, combined with other TKI drugs. Approved for late-stage melanoma in 2011, Yervoy had sales of $360M in 2011 and inclusion criteria for ImmunoPulse patients is a less than 6-month life expectancy. These patients are at the end of their rope, and it is very doubtful that any data monitoring committee would deny them due to “safety concerns”. But you never know with bureaucrats. Perhaps this is the very reason OncoSec decided to treat only late stage cancer patients with ImmunoPulse.

Conclusion

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Bottom line, if phase II results show a complete response rate similar to the phase I, OncoSec will clearly be in the running for leader of the plasmid DNA immunotherapy paradigm shift. These patients have similar stage disease to Scancell’s pool of patients and a much clearer picture than Mannkind.

While in the end I believe plasmid DNA immunotherapy will succeed as a treatment class given its safety profile notwithstanding the Allovectin failure, OncoSec’s ImmunoPulse has the most upside. To what extent, that all depends on ImmunoPulse’s and SCIB1’s success rates with other less accessible cancers. TKI’s began with Gleevec’s incredible success in all but curing CML and then fizzled out in terms of complete response rates with other cancers. Whether DNA plasmids are the oncology revolution we’ve all been waiting for…we’ll all have to wait a little bit longer for that. For now, let’s see how we do with melanoma.