Originally Published as The Niche Podcast
Biogen gets punted but it’s good, lupus breakthroughs, Senseonics raises capital, and Novavax and Johnson & Johnson… and Janssen.
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Story References
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Music by Luke Goodson
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Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.
Introduction
Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, Biogen gets punted but it’s good, lupus breakthroughs, Senseonics raises capital, and Novavax and Johnson & Johnson… and Janssen.
The Aducanumab Circus of Delays
The Aducanumab circus continues. The FDA has announced a 3-month delay in their decision surrounding Biogen’s Alzheimer’s therapy aducanumab. The potential superstar remains questionable after an independent review panel had significant misgivings. In many cases, the FDA determination committee follows the recommendations of the independent review panel. However, in this case there may be added challenges. As we have discussed on the show, Biogen argues that aducanumab may not be great for everyone but may help a subset of those with Alzheimer’s and there is really nothing else on the market to aid. Additionally, there is some calculation that any approved drug could continue to spur biopharma investments, rather than driving more swaths of capital to emergent hot-commodities like gene and cell therapies. The FDA has requested additional information from Biogen. Biogen says… well nothing about what that information is. But Investors seem to think a 3-month delay is good news. At recording Biogen shares are up around 8.5%. Will new data Biogen submits to the FDA push aducanumab over the edge? Seems possible, but don’t look at the response of stocks to make that kind of guess. Look at the FDA and the data that might cause them to say aducanumab is good enough to approve.
Lupkynis for Lupus
A bit of late-news, but significant enough to merit note. On February 23rd, the FDA approved Aurinia Pharmaceutical’s Lupkynis for the treatment of lupus nephritis (LN). LN is a serious progression of the autoimmune disease systemic lupus erythematosus. LN can occur in up to 60% of lupus patients. The hallmarks of the disease are autoimmune targeting of the kidneys, leading to inflammation, and permanent damage. Uncontrolled, LN leads to full kidney failure. Lupkynis is the first FDA approved oral therapy for LN. It works through competitive binding of Calcineurin, stopping the activation of T cells. Lupkynis significantly beat standard of care across a 52-week clinical trial, earning Aurinia approval and a 25% stock bump.
Senseonics
Senseonics Holdings closed a $115 million bought deal of common stock on January 28th. While not clear from their statements, this money will likely be used to fuel further development and sales of their existing implantable wireless blood glucose monitor for diabetes patients. A sensor is placed under the skin by a physician and can broadcast continual reading to a smart phone. It only needs to be changed quarterly, a significant improvement on finger pokes multiple times daily. We’ll have to see if Senseonics is aiming for independent growth, or just trying to become a juicy acquisition.
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Novavax and Johnson & Johnson… and Janssen
Novavax has released phase III clinical trial results, demonstrating an 89.3% efficacy of their vaccine against COVID19. This represents yet another step forward and a helpful diversification of targeting methodologies. NVX-CoV2373 is a protein-based vaccine. Unlike the Pfizer/BioNtech and Moderna mRNA vaccines, Novavax works through a fully expressed spike protein from the COVID19 virus. The modified 180 kDa protein measures just 27.2 nm. It is produced for vaccination in lab and then nano-packaged in with a proprietary adjuvant, Matrix M. The role of the adjuvant is to stimulate a more robust immune response. Indeed, preclinical prediction have been born out in the most recent clinical trial results.
The UK based study revealed nearly 90% prevention of infection, with zero severe cases in the study group. Data also emerged from trials in South Africa. A key outcome has been the clinical demonstration that the Novavax COVID19 vaccine protects against both the UK and the South African emergent variants. This vaccine also requires two doses, but only needs to be refrigerated, making the cold-supply chain easier to manager for distribution.
Johnson and Johnson also released results demonstrating their COVID19 vaccine developed by Janssen is safe and effective. Their vaccine was 72% effective in the US and 66% effective overall. However, it should be highlighted that it was 85% effective at preventing severe disease and there were 0 hospitalizations or deaths in the study group. J&J’s vaccine holds a couple of other advantages. First, it is based on more “traditional” vaccine technology which may assuage fears from some citizens who worry about the technology in newer vaccine designs. Second, it is a single dose, making distribution and full compliance significantly easier to manage. Finally, the vaccine is stable for months in a refrigerator, significantly improving global and remote access.
There were some discrepancies in the effect of the vaccine on novel variants, but generally it appears to protect against the variant emerging from South Africa. Again, I want to emphasize, this vaccine is relatively easy to distribute and administer and has prevented 100% of COVID19 related hospitalizations and deaths across three continents and more than 26,000 clinical trial participants.
Weekend Addendum
A quick weekend addendum – After recording, stock markets reacted poorly to the news from Johnson and Johnson. But keep in mind, at the same time stocks of Gamestop rose 67%. My point? Just because the stock market doesn’t love the news doesn’t mean it’s not generally good from a scientific perspective. While Novavax is not as effective against the South African variant it was still effective. Same for J&J. Yes, 66% prevention overall for J&J is not what one would hope for. But considering it prevented 100% of hospitalizations and deaths, I consider it a success. Additionally, there are clearly other major economic trends in place, including questions about future stimulus packages and the very real numbers coming out about the US and other economies contracting. I am of the opinion that J&J will have their vaccine readily approved on this data and see significant global distribution. I maintain that both Novavax and J&J delivered good news.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.