WINDSOR, ON / ACCESSWIRE / December 14, 2015 / The Wealthy Biotech Trader (or“WBT”), an investment newsletter focused on showing everyday investors new opportunities in rapidly growing, little-known biotech, pharma, medical device and general healthcare stocks making news and subsequent market moves, would like to mention a few highlights from 2014/ 2015 in the crazy world of biotech investing.
In 2014 51 new medicines were approved by the FDA, the most in almost 20 years. A whopping 8 of those approvals were new drugs for cancer treatment–since 1990, cancer death rates have declined nearly 22%–and approximately 83% of the survival gains are attributable to new treatments.
And although 2015 is shaping up to be another banner year for scientific and drug breakthroughs for cancer, there are a few areas in oncology (cancer treatment) that most pharma companies are having a very difficult time seeing any meaningful progress.
Pancreatic cancer is by most measures the deadliest of the 200+ cancers as evidenced by its 7% 5-year survival rate–meaning only 7% of people diagnosed with this horrific killer will live longer than 5 years. 75% of patients die in the first year, and only a few out of 100 will live longer that 10 years. In nearly 40 years there has been virtually no improvement in the overall survival rates in those diagnosed with pancreatic cancer. Until now?
One tiny Australian biotech company is working on a novel compound / drug that they have recently stated could have a major impact on this deadly disease. The company is pre-clinical, but has just released very compelling news of shrinking pancreatic cancer tumors in mice by 84% in only 26 days (click the next paragraph to read the news).
Investors will be watching PPCH like a hawk over the next 1-3 months as they wrap up their“animal studies” and prepare their “Initial New Drug” application with the FDA. The company has stated in news releases they have the cash in the bank to get to that point, which could be a huge inflection point for shareholder value creation if approved by the FDA.
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338,000 new cases of pancreatic cancer are diagnosed each year, which is why SeeThruEquity, a research firm, has pegged a global market for treating this cancer at roughly $9 billion. If PPCHshows any results in results on humans in clinical testing they will no doubt be an attractive target acquisition by a larger pharma company which could be at a much higher price per share than the current market prices ($0.04).
Another company working on a treatment for pancreatic cancer is Immunomedics Inc. (IMMU). Immunomedics’ most advanced candidate is 90Y-clivatuzumab tetraxetan. The radiolabeled antibody is in a Phase 3 registration trial in patients with advanced pancreatic cancer. Immunomedics expects patient enrollment to be completed in calendar year 2016. This product candidate utilizes radioimmunotherapy, or RAIT, which combines the targeting power of monoclonal antibodies with the cell-damaging ability of localized radiation. WBT feels that there are better ways to deliver and apply certain existing forms of treatment, and IMMU appears to have a novel approach using a more efficient, localized form of radiation combined with the very hot newer form of treatment, immunotherapy, or harnessing the bodies ability to fight cancer.
Aduro Biotech Inc.’s (ADRO) new GVAX drug appears to be promising for the potential treatment of late-stage pancreatic cancer but could still be some distance from actual approval. Like Immunomedics, ADRO is an immunotherapy company–harnessing the body’s own ability to fight cancer–but Aduro’s LADD technology platform is based on proprietary attenuated (genetically modified to be harmless to the patient) strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. In other words, ADRO’s drug candidate is a harmless form of listeria introduced into the body in order to provoke a “immuno-response” from the patient which in turn helps fight tumor cells. ADRO is in phase 2 in trials of GVAX and any news could send the stock soaring or cratering–Investors just need to place their bets!
Another biotech playing in the pancreatic cancer space is an example of what can go wrong if you do not do your homework on your investments, or maybe just a plain and simple example of how bad luck can strike. Threshold Pharmaceuticals Inc. (THLD) had a sweetheart deal with the German drug giant Merck & Co. (NYSE:MRK) which had the pharma giant pay roughly $50 million in various fees and costs associated with THLD’s development of their lead product Evofosfamine only to see it be rejected in phase 3 by the FDA this week. The stock plummeted 80%+.
Its been 10 years since THLD’s chart peaked at about $100/ share (it hit a low of $0.60 this week) which corresponded with their positive phase 1 results of the same drug, Evofosfamine. The sheer time to get this product through trials combined with the constant decline in share price over the same time-frame should have been a clue to Investors that this may not be as ground-breaking as once thought. Once lesson for biotech investors would be to take profits on the initial hype which surrounds a company/ stock at the beginning of a human clinical trial.
One thing is sadly for certain: the $100 billion+ market for cancer treatments is set to grow at an astounding rate for the foreseeable future. The average Investor undoubtedly does not know of the recent strides small and large pharma companies have been making, but we at the WBT see much of the capital flows from energy and materials flowing into healthcare, and more specifically into biotech. For a primer on the wonderful things being developed in the world of oncology readers may want to also research some of the following new blockbuster drugs:
– Cyramza, a stomach cancer treatment from Eli Lilly (NYSE:LLY)
– Opdivo, approved for advanced melanoma from Bristol-Myers Squibb (NYSE:BMY)
– Keytruda, a first-in-class melanoma drug from Merck (NYSE:MRK)
– Blincyto, a treatment for a rare form of acute lymphoblastic leukemia from Amgen (NASDAQ:AMGN)
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