This week we look to make sense of COVID-19 variants. We also examine what appears to be heightened scrutiny on accelerated approvals for some treatments, gaps in the understanding of racial and ethnic representation in vaccine trials, tiny cancer-fighting robots and a new contract development and manufacturing organization facility coming to Texas.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
Understanding where COVID-19 variants come from and how they impact our response
Just as vaccines are starting to become more broadly available in the United States and restrictions are easing in some places, talk of coronavirus variants seems to be threatening that progress. This article in the Washington Post examines scientists’ understanding of how this virus mutates and why we are seeing more new variants than once expected. The piece also examines why—although the virus and variants aren’t going away—the pandemic’s days are still numbered.
The Food and Drug Administration appears to be placing new scrutiny on accelerated approvals
When patients have significant unmet needs, the FDA can issue an accelerated approval for treatments based on clinical trial results that show a benefit for a surrogate endpoint, but have yet to show a benefit on a primary endpoint. After accelerated approval, confirmatory clinical trials are required to determine whether the treatment meets the primary endpoint. The FDA has been reviewing the results of some phase 4 confirmatory trials for the past several months, and as this article points out, several drugs have been voluntarily withdrawn as a result.
Data gaps prevent a better understanding of race and ethnicity in vaccine trials
A recent analysis shows that over the past decade, over 40% of clinical trials for vaccines didn’t report data on patients’ race and 65% didn’t report on ethnicity, as this STAT article explains. Those figures represent 220,000 participants in various studies, resulting in a significant gap in our understanding of diversity in clinical trials.
Bionaut Labs designs tiny cancer fighting robot
Last week, Bionaut Labs announced a $20 million funding raise to support the development of its remote-controlled robot designed to deliver cancer-fighting drugs inside the body. The company is targeting to treat a rare type of cancer known as brain stem glioma, often diagnosed in young children. Due to the location of the cancer, the illness is very difficult to treat with traditional therapy. Bionaut’s device would allow doctors the ability to deliver drugs precisely with minimal damage to the surrounding healthy tissue.
The company plans to begin human clinical trials in 2023, and also plans to expand the technology to address other forms of cancer. Visit its website to see the size of the device relative to a penny.
A CDMO looks to Texas to build its new facility
A theme we have been paying close attention to from both an industry and policy perspective is the pressure in the United States to onshore the production of critical medicines and devices. Although we don’t expect this to change overnight, we are seeing increasing investment in drug development and manufacturing facilities in the U.S.
One example is CDMO Matica Biotechnology’s plans for a new plant on U.S. soil. While San Francisco, Boston or New Jersey might have been more obvious choices for such onshoring efforts, Matica—a subsidiary of South Korea-based CHA Biotech—is embarking on building a new plant in Texas instead, as this Fierce Pharma article explains.
