Originally Published as The Niche Podcast
100 million vaccines, EvoQ’s NanoDisk, Merck gets FDA priority, and startups in wearables, startups in diagnostics.
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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, 100 million vaccines, EvoQ’s NanoDisk, Merck gets FDA priority, and startups in wearables, startups in diagnostics.
100m Vaccines
The incoming administration has significant short- and long-term plans for healthcare in the United States. While this is not a political podcast, any changes in regulation may have massive implications for our industries. With control of both houses, expect a concerted effort over the next two years to change the way the current insurance system functions. But before any of that, there is a global pandemic. The President-elect has double-down on the goal of 100 million vaccinations in his first 100 days in office. Last week, just under a million doses a day were given out across the US. However, with both Pfizer and Moderna having 2-dose vaccines, the rates will need to double quite quickly in order to see the numbers the incoming administration is hoping to achieve. A third proposed stimulus package includes billions to support this effort through centralized guidance, as well as assistance in everything from popup vaccination clinics to mobile units in rural areas. I suspect it will be a real challenge to integrate plans by the new administration into the complex state-by-state process that is currently happening. But we’ll definitely get to 100 million… eventually.
A startup lead by professors at the University of Michigan struck a massive deal with Amgen last week. EvoQ Therapeutics was not just in stealth mode, they were in almost-no-one-has-heard-of-them-ever mode. The $240 million upfront cash payment + royalties is a massive infusion for the small company.
EvoQ gets $240m Deal with Amgen
EvoQ has created a platform called NanoDisk. Their technology uses a disk of high-density lipoprotein (HDL) in a lipid bilayer that has some form of surface marking antigens. The power of this NanoDisk is that you can attach all kinds of antigens to the surface. In fact, EvoQ has published on the platforms uses in a couple of oncology models. But that’s not what Amgen wants. Amgen is targeting autoimmune diseases. NanoDisk has demonstrated specific capabilities in lymph node absorption. In theory, through targeted delivery, antigens can be used to reset specific overactive immune functions.
While $240 million cash is a hefty upfront payment, that can disappear rapidly in clinical trials, plus Michigan will likely want a big slice of the pie. Hopefully EvoQ has enough capital and payments in undisclosed milestones to get NanoDisk all the way to market. With a pretty small staff they appear to have been quite productive to date. Based on my reading NanoDisk could be used as a delivery system for numerous therapies and probably multiple disease targets. I’d expect to hear more from them later in 2021.
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Merck gets FDA Priority
Merck has been granted priority review for a 15-valent pneumococcal conjugate vaccine. The vaccine, still called developmentally V114, targets 15 high-risk strains of pneumococcal bacteria. In September of last year, Merck announced positive topline results when compared to Pfizer’s Prevnar 13, as well as better performance against certain serotypes. While Prevnar 13 is usually targeted for children, it is used in some adults with specific conditions. Merck’s study was conducted in adults 50+ which broadens their potential target group. Taken together this puts Merck in a strong position for approval. In Q3 of 2020 Merck had $375 million in Pneumovax sales. While these are not oncology block-buster numbers, they were on the rise in response to COVID, suggesting a significant untapped market still exists in the elderly population around the globe.
Noctrix Series B for Restless-Leg-Syndrome
A small wearables startup, Noctrix Health, has raised a $17m series B to support the development of a device to treat Restless-Leg-Syndrome. While the company’s public presence is almost non-existent, they have received a breakthrough device designation from the FDA. This does not mean their device will work or is scientifically validated. Rather, it is an expedited pathway for devices with novel approaches that generally have a lower risk, though not necessarily. Historically, silicone valley startups like this do not have a very high success rate in navigating the complexities of medical device development. Noctrix has expanded their board, including a board member from the $16 billion OrbiMed fund. This suggests they are at least getting a team in place to help guide them through the next phase of development.
Delfi Diagnostics' Cancer Detection
Speaking of OrbiMed, they lead a $100 million Series A for Delfi Diagnostics. Founded in 2019 with a $5.5 million seed round, Delfi has been focused on developing liquid biopsies for cancer. They are attempting to integrate more sophisticated machine learning analysis of genome-wide DNA fragments. Built on the back of a 2019 Nature paper showing high specificity and sensitivity to multiple cancers, they have been refining their platform for about 2 years. If functional, Delfi will be able to detect multiple cancers with high precision, earlier, and at a low cost. Since early affordable detection is literally life-changing in the oncology space, this could represent a major advancement, provided they can put that $100 million to work to gain regulatory clearance.
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.