Originally Published as The Niche Podcast
AstraZeneca and W.H.O., vaccine I-told-you-so’s, Phitonex acquired by ThermoFisher, and Axsome reports success in migraine relief.
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https://www.thescopemethod.com
Story References
https://www.rttnews.com/3157074/astrazeneca-s-covid-19-vaccine-cleared-by-expert-panel-in-india.aspx?refresh=1
https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access
https://www.bbc.com/news/health-55280671
https://thermofisher.mediaroom.com/2020-12-31-Thermo-Fisher-Scientific-Acquires-Programmable-Dye-Platform-Pioneer-Phitonex
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-positive-efficacy-and-safety-0?field_nir_news_date_value[min]=
Music by Luke Goodson
https://www.soundcloud.com/lukegoodson
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, AstraZeneca and W.H.O., vaccine I-told-you-so’s, Phitonex acquired by ThermoFisher, and Axsome reports success in migraine relief.
WHO and AstraZeneca
The World Health Organization has given their stamp of approval to the Pfizer-BioNTech COVID19 vaccine. This is the first vaccine that the W.H.O. has approved as safe and effective. Of course, the vaccine is already accepted in many countries and with vaccine shortages smaller nations who follow W.H.O. guidelines will be waiting awhile for supplies. The U.K. has approved the AstraZeneca COVID19 vaccine and a panel of experts in India has recommended it for approval. Unlike the Moderna and Pfizer mRNA vaccines, AZD1222 uses a more traditional vaccine design by driving production of COVID19 spike proteins through a weakened version of the common cold adenovirus from chimps. The virus won’t make humans sick, but an immune reaction is generated in response to the “infection.” The data suggest this is a safe and effective vaccine. The AZ vaccine has some major advantages that will make it successful. First, it does not require the same extremely low temp cold-chain that the mRNA vaccines need. Second, the use of more traditional vaccination technology will likely make some users more comfortable. While the protective effect of ADZ1222 was slightly lower than the mRNA vaccines the need for billions of doses globally basically makes it so all players are welcome. I’d expect the mRNA vaccines to be more common in the leading countries where cold supply chains exist while more traditional vaccines will spread across the rest of the globe throughout 2021.
Vaccine Role-out Challenges
On December 7th, I predicted that there would be “mixed and confusing messages along with significant hiccups” in the dissemination of COVID19 vaccinations in the United States. Unfortunately, my prediction has proved accurate. I’m seeing daily headlines on the confusion and miscommunication. Last week, I spoke with a physician in NYC who explained the way certain hospital systems have succeeded in a clean role out, while others have experienced long lines, confusion, and chaos. This will be compounded in the coming weeks as those vaccinated also require the second dose at 21 or 28 days.
Adding to the national confusion is messaging about side effects. Unfortunately, vaccines, unlike other medicines have a unique set of challenges to overcome. Chief among them is that by getting vaccinated you will suffer specific pain but gain an uncertain result. The uncertainty is not because they do not work. Rather, it’s because you may never know when and how it protected you. I got my flu shot, I didn’t get the flu. Is it working or was I just not exposed? This is not because the data are lacking in the support of vaccination, but because humans don’t typically assess risk based on data but rather perception. The public perception is that vaccines cause side effects (pain, fever, etc) and that makes people fear they are not safe. Public health officials will have significant challenges in 2021 creating a cohesive message in order to ensure broad public compliance.
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Phitonex Acquired by ThermoFisher
ThermoFisher Scientific has acquired Phitonex, Inc, a small fluorescent probe company. The deal appears to be a complete acquisition for an unspecified (presumably cash) buyout. It is a pretty natural acquisition. Phitonex has a proprietary suit of fluorescent labels and dyes for a variety of application across biology. Significant work is done through conjugating fluorescent molecules to antibodies. Precise control over fluorescent patterns can allow researchers to more accurately distinguish between unique cell populations. It seems like Phitonex platform, tools, and I.P. will be incorporated into the vast suit of tools ThermoFisher already sells in the space. While this may not be a top acquisition story, it does highlight the way small companies are able to build up a hyper-specific niche before being consumed by the larger fish in the life science space. You don’t need a billion-dollar drug to create value and build a business.
Migraine Relief on the way from Axsome
Axsome Therapeutics has announced positive results for their phase III trial for Migraine treatments. Their therapy still developmentally named AXS-07 showed significant improvement. At 1 hour, 40% of people reported significant improvement, at 2 hours 70% had improvement and 40% were pain free. While these numbers might not sound like a dream come true, for anyone suffering from migraines, the idea of an acute therapeutic that could provide relief is very promising. Plus, the current market does not have many fast acting or very effective therapies, so there is definitely space for competition. AXS-07 showed good tolerability, health and safety, and can be taken on an as-needed basis. Only 3% of people reported any adverse events. The drug will be submitted to the FDA this quarter. While it is unlikely to be a mega-block buster, it will likely be popular new therapy when approved.
One trend will be watching in 2021 and beyond is how the FDA and other regulatory agencies respond to the transition to decentralized and remote trials. Many studies had to shift their protocols mid-stream to accommodate the pandemic. The question is, how will long term approvals be impacted by disrupted data? Some drugs, like Axsome’s AXS-07 were likely not significantly impacted, after all participants took the therapy as needed in response to migraines. Will more in-person therapies be able to explain any changes in a reasonable way to approval agencies? Will agencies be more accommodating, risking health and safety concern s, or more stringent causing setbacks in companies’ trajectories? It’s definitely something we will keep our eye on as the year proceeds.
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.