Life Science Today 020 – Vaccines, NightWare, Agios, Silverback
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, COVID19 vaccine news, an app to stop nightmares, Agios targets Sickle Cell disease, and Silverback files to go public.
COVID19 Vaccine News
If you read any news last week, you probably heard that the Pfizer/BioNTech partnership released topline preliminary results for their COVID19 vaccine showing 90% effectiveness. What this means is that in the vaccinated group, compared to the placebo control, people were 90% less likely to contract COVID19 in the time so far. This represents an incredibly effective vaccine. If this trend bares out over time, Pfizer/BioNtech will have developed a safe and effective vaccine in record time, setting a new benchmark for what is possible and paving the way for even more truncated development times when facing future diseases.
Markets have continued to exhibit generally positive trends and the news from Pfizer fueled investors’ optimism. However, the markets are still subject to volatility as cases continue to rise and political tensions remain high within the United States.
Just as this podcast was being recorded, Moderna released news that their COVID19 vaccine in 94.5% effective. This number tops that of Pfizer and is shockingly high. Additionally, there were only mild to moderate adverse events, with the most common being mild fatigue in 9.7%. In summary, this is a very safe and very effective vaccine. Not only did a mere 5 people contract COVID19 in the study, but none of these experience severe COVID19 symptoms. While this is not the final word on the clinical trial, it suggests the possibility that even if a vaccinated individual contracts COVID19, they may have reduced severity or duration.
With both Pfizer and Moderna now reporting very positive top-line results, we may be in for a rapid roll-out of vaccinations starting at the end of 2020 through Q1 2021 as production pipelines ramp up.
Special Announcement
Hi folks, Dr. Noah Goodson here. I want to let you know about a special bonus episode coming in a couple of weeks. I’m sitting down with a young COVID survivor who also works in healthcare. Hearing from those who have survived this disease, the dramatic personal consequences, even for the young and healthy, and getting an inside look at the experience of just one of the millions of front-line workers. I think you’re really going to enjoy this, so keep your eyes on your podcast feed for this upcoming Niche Podcast Bonus
NightWare for Nightmares
Your Apple watch is now approved by the FDA to treat nightmares. Yes, this sounds like an absolutely insane statement. But it’s true! NightWare is a digital health monitoring app that uses the heart rate and movement monitor within Apple W atches to track sleep patterns. 80% of individuals with PTSD experience persistent nightmares for months or years after a traumatic event. These nightmares result in broken sleep and frequent nighttime disturbance. NightWare stops these in their tracks. How? It tracks your sleep patterns for a number of nights and utilizes an algorithm to determine when your rest is disturbed outside of the usual bounds indicating a nightmare. When the onset of a nightmare has been detected the Apple Watch will gently buzz, disrupting the sleep state but not waking the user.
Unlike drugs, potential negative risk with NightWare is low and the FDA has cleared them for moving to market. However, the company is moving forward with further clinical testing to validate its platform. NightWare does not provide a therapeutic cure to PTSD related nightmares but improving sleep in those who have suffered trauma can be a critical and advantageous step in the healing process.
Agios Obtains Orphan Drug Designation for Mitapivat
Agios Pharmaceuticals received orphan drug designation for Mitapivat, a potential treatment for Sickle Cell Disease. The FDA designation of Orphan Drug is reserved for therapeutics addressing an unmet need, frequently in a smaller population and provides a rigorous, but less arduous road to approval.
Mitapivat is taken orally and works to activate wild type and mutated pyruvate kinase (PK) enzymes. The drug has primarily been studied for the blood disease pyruvate kinase deficiency in which PK is mutated leaded to a loss of function. PK is critical to the energy cycle within cells and any loss of function can cause major challenges. Mitapivat activates the mutated PK, potentially restoring normal cellular function in pyruvate kinase deficiency. The new distinction as an orphan drug for Sickle Cell Disease is because Mitapivat can also activate normal wild-type PK. By doing this it increases the presence of ATP within cells and may reduce the hemoglobin S polymerization that creates red blood cell sickling.
Agios is partnering with the NIH for clinical trials to determine if Mitapivat can treat Sickle Cell Disease.
Sponsors
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Silverback Piles On The IPO Pile
Silverback Therapeutics pounded its chest on the way to time square this week with a $100 million IPO. The filing is still with the SEC, so don’t expect much of a comment from Silverback until approved. But assuming the process moves forward, this is yet another startup in the targeted medicine and oncology space raising hundreds of millions in private capital and then passing through an IPO. Don’t get me wrong. Silverback’s science is no better or worse from our perspective than the dozen or so other companies we’ve seen do the same this year. But if you’re noticing a pattern you would not be alone. Numerous companies have rushed through multiple rounds of private funding and into an IPO in 2020 and I’d guess there will be a few more before the Christmas slowdown.
Silverback is building a platform to target tumor-associated myeloid cells using multiple antigens. They are currently ramping up their first phase 1 trials looking forward in 2021. The private equity and public funds raised this year should get them through the phase I/II trials for their two primary therapeutics. At that point, it will be up to the data on whether they continue after that.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and applied science industries. You can 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.
Sponsors
https://www.thescopemethod.com
Story References
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy
https://night-ware.com/news
https://investor.agios.com/news-releases/news-release-details/agios-announces-fda-orphan-drug-designation-granted-mitapivat-0
https://sec.report/Document/0001193125-20-290236/
Music by Luke Goodson
https://www.soundcloud.com/lukegoodson