Welcome to another edition of “3 Things in Biotech You Should Learn Today,” a digest dedicated to helping you keep up with the news emerging from the world of pharmaceuticals and biotechnology.
Let’s get started!
Gilead Has a Proof of Concept in NASH
Gilead Sciences (NASDAQ:GILD) has been struggling as of late to identify products that can rescue the revenue stream it saw at the height of its antiviral boom. One of the strategies that investors hope will help take over for the HCV therapies is treatment development for a condition called non-alcoholic steatohepatitis (NASH). One such agent, GS-0976, is an acetyl-CoA carboxylase inhibitor and is currently being investigated in a few clinical studies for NASH.
GILD announced that it presented findings of one of these early-stage studies at the 2017 International Liver Congress. Patients saw a decrease (29% reduction) in the production of palmitate after 12 weeks of study, as well as a statistically significant decrease (43% relative reduction) in relative fat content from baseline. Moreover, the biochemical profiles of these patients indicated signs that their fibrosis was resolving.
Looking forward: This study represents a crucial proof-of-concept for GILD in the study of NASH. Currently, lifestyle modification to prevent NASH is the standard best path forward, but there aren’t many effective options once NASH develops. These findings support GILD’s further development of GS-0976, which is currently being explored in a phase 2 study along with other agents like selonsertib and GS-9674. So you can expect GILD to keep plugging away at novel therapies for NASH.
BeiGene Rocketing Forward in China for a PD-1 Inhibitor
Titans like Bristol-Myers Squibb (NYSE:BMY) and Merck (NYSE:MRK) have been two of the main innovators of immune checkpoint inhibitors like nivolumab and pembrolizumab in Europe and the US. In China, however, the story has been less clear, with big pharma not getting quite the momentum we’ve seen over the past two years.
BeiGene (NASDAQ:BGNE) has capitalized on the relative slowness to gain approval in China by developing a PD-1 inhibitor of its own and speeding it to pivotal trials, which have now begun for relapsed Hodgkin lymphoma. This could allow BGNE to gain a foothold in China for indications where we already have a good idea that PD-1 inhibitors work, both for nivolumab and pembrolizumab.
Looking forward: Business-savvy move, but it doesn’t seem quite fair, does it? BMY spent a great deal of time and effort on Hodgkin getting that approval, and now another company is able to swoop in and take advantage of China’s heretofore difficult market. Certainly, whoever makes it to market with PD-1 inhibitors in any indication in China will have a huge source of revenue on their hands. And this could mark the entry of an important competitor for Western pharma giants.
Disappointing News for XBiotech in Colorectal Cancer
XBiotech (NASDAQ:XBIT) is a developer of so-called “true” human antibodies for a variety of diseases, with its flagship developmental product being Xilonix, an antibody that scavenges the inflammatory cytokine interluekin-1a as part of an anticancer strategy.
Unfortunately, the company announced that a meeting with the EMA did not go according to their hopes, as the agency gave a strong indication that they would not give a positive opinion of Xilonix for colorectal cancer, which has been their key tumor target being investigated in phase 3 trials. It has not been divulged at this time what, specifically, has led to the EMA’s pessimism, and the company itself seemed quite surprised and disappointed.
Looking forward: This announcement comes as a surprise, given that earlier results of Xilonix appeared to show a promising trend toward improvement in patients with colorectal cancer, and follow-on results suggested that the company had met primary objectives with its agent. It remains to be seen what exactly happened, and the company expects to issue an 8-K in the near future.
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I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.