Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Before we begin, I'd like to spotlight an interesting analysis I saw by Dr. Tran BioSci as it relates to Gilead's (GILD) entry into the Chinese market with its hepatitis C virus drug Sovaldi. This offered some crucial insight that fell outside of my personal radar, which could prove important to the overall GILD thesis. As you know, I am easily swayed by movements in oncology, in particular, and I notched an acquisition of a company like KITE as an important piece of the solution for its continued growth. However, we would all do well to remember the untapped potential of Chinese markets. So give that article a read!
Without further ado...
Bayer's prostate cancer combo hits a huge roadblock
Therapy: Abiraterone and radium-223 dichloride
Disease: Metastatic, castration-resistant prostate cancer (CRPC)
News: BAYZF announced that the phase III trial combining the new-gen anti-androgen abiraterone acetate and the bone-targeted therapy radium-223 dichloride was unblinded early after an independent monitoring board observed an increase in the number of deaths in the treatment arm. At this time, the study will continue with monitoring, and no new safety concerns have yet been identified.
Looking forward: This is perplexing and unexpected, given the general favorable tolerability and efficacy of these two agents. I would have expected that BAYZF would capitalize on this combo in CRPC. For now, we have to wait to see what has potentially derailed this trial. Maybe nothing? But this is definitely a very unusual and unfortunate finding.
On the other hand, Bristol-Myers stops early for a good reason
Company: Bristol-Myers Squibb (BMY)
Therapy: Nivolumab, a PD-1 inhibitor
Disease: Non-small cell lung cancer (NSCLC)
News: BMY announced the early termination of CheckMate-078 due to efficacy. This study was designed to assess the benefit of nivolumab (branded Opdivo) compared with docetaxel in patients with previously treated NSCLC. It was a multinational confirmatory trial that focused mainly on the enrollment of Chinese patients. BMY also submitted an application for approval in China, which was accepted by the authorities there.
Looking forward: Much like the article I headlined this particular entry with, BMY is making a perhaps underestimated splash here, since China represents a profoundly huge potential market, especially in the arena of lung cancer due to the high prevalence of smoking in that country. This marks a major step for BMY's ambitions there, and it will be competing with new competitors, like BeiGene (BGNE), in the PD-1 space.
Provectus inches toward a better understanding of its psoriasis drug
Company: Provectus Biopharmaceuticals (OTC:PVCT)
News: PVCT announced the presentation of a "mechanism of action" study for its drug PH-10 at the 8th International Congress of Psoriasis. Therein, the company detailed modulation of genes like IL-17A, IL-22, IL-26, IL-36, and keratin 16 in patients who had undergone topical treatment with PH-10. The company expects these findings to provide a foundation to move more fervently into inflammatory skin disorders.
Looking forward: Microcap biotech PVCT is probably not on a lot of radars, as it has been around for years and has only declined in stock price as the failures to identify a bona fide, marketable drug have mounted. It's difficult to prognosticate further based on these findings, but this kind of news should put PVCT into your sights, as the rest of its pipeline has been focused in oncology, which has not led to a major breakthrough for the company.
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