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What: Shares of NewLink Genetics (NASDAQ:NLNK), a clinical-stage biopharmaceutical company focused on developing immunotherapeutic products for the treatment of cancer, spiked higher by as much as 14% after announcing positive phase 2 data utilizing dorgenmeltucel-L and pegylated interferon-alpha 2b in patients with advanced metastatic melanoma.
So what: According to NewLink's press release, its once-weekly injectable drug (for 12 weeks) plus pegylated interferion (from weeks 5 through 12) produced 21 evaluable patients out of 25 enrollees. Of the 16 stage 4 disease patients enrolled, two has a complete RECIST response, one had stable disease, and four had no evidence of disease. Of the remaining nine patients that were stage 2/3, three had no evidence of disease, while one stage 2C patients had slow progressive disease. As noted, 60% of patients survived longer than a year with the median overall survival of the study being 29 months. Dorgenmeltucel-L was also shown to be safe and tolerable in its study. In addition to its positive phase 2 study, NewLink launched an additional melanoma trial utilizing dorgenmeltucel-L and ipilimumab which will test dorgenmeltucel-L in a higher dose concentration to determine if it will help metastatic melanoma patients live longer.
Now what: Cancer immunotherapies remain a hot topic discussion among biotech investors, even if these stocks have given up most, or in NewLink's case all of their 2014 gains. NewLink is developing quite an extensive pipeline of therapies meant to stimulate a patient's immune system in the hope that it will attack targeted cancer cells. The early indications from all of its studies are that its methods are working. Of course, keep in mind there's still plenty of risk here as we're dealing with a wholly clinical-stage company that's burning through large amounts of cash to conduct these extensive trials which often take years. Perhaps the best way to put it is I'm cautiously optimistic of NewLink Genetics going forward, but I would suggest only risk-willing and biotech-savvy investors with a taste for volatility consider digging deeper into this company.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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