Life Science Today 012 – Probiotics, Lipid Nanoparticles, Transparency, and Immuno-therapy
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly 5-minute rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, Finch does probiotics the expensive way, lipid nanoparticles, a followup on transparency, and LAVA gains immuno-therapy support.
Probiotics Through the FDA
Antibiotics are great at killing bacteria. That works out well when you have a deadly infection. Unfortunately, they also are a lot like using atomic bombs for an assassination. Yes, you killed off what you wanted to, but there were a lot of innocent bystanders that got swept up in the blast. A common secondary infection to antibiotic use is C. difficille. This inflection of the colon may result in mild but unpleasant fever and diarrhea, all the way to severe immune mediate colon damage that can be fatal.
The infection is caused by opportunity. In a healthy gut, some of your trillions of bacteria occupy the niche were C. difficille attacks. However, after a round of antibiotics, these niches may be left unoccupied and that is when the infection can take over. The normal treatment is further antibiotics, but as you might imagine this does not solve the underlying challenges.
Finch Therapeutics has raised another $90 million series D this week to deliver a probiotics therapy. Unlike most probiotics, which are untested dietary supplements, Finch has opted to pass through the FDA gauntlet. Their specific therapy involves extracting bacteria from healthy human feces, drying it, repackaging it, and delivering it in an oral capsule. The therapy includes proprietary mechanisms for getting the bacteria through the entire digestive tract to the large intestine. They are on the verge of submitting to the FDA for the treatment of C. difficille. The rational is simple. Rather than blasting a weak gut with more antibiotics, repopulate with a healthy bacteria and stop the infection before it can take over.
In addition to the treatment of C. difficille, Finch has products in the pipeline for the treatment of Colitis, Crohns, and even autism related digestive issues. Probiotics have long been touted to treat various diseases. The difference with Finch is that they have raised the capital and performed the studies to demonstrate their approach is safe and effective for the treatment of diseases. If approved, this will be the first FDA approved probiotic therapy.
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Lipid Nanoparticle Delivery Systems
Moderna struck a strategic partnership with Vertex Pharmaceuticals last week. The deal sees Vertex pay Moderna $75 million up front with up to $380 million in milestone payments for the development of a lipid nano particle delivery system for cystic fibrosis gene therapy. This deal is the first real move that Moderna has made in creating a stable outcome to their recently acquired fame and capital. The company skyrocketed in the market this year for their COVID19 mRNA vaccine. However, they have yet to deliver a single product to market. Their pipeline is structured around mechanisms of packaging and delivering mRNA via lipid nanoparticles.
What are lipid nanoparticles? Think of them like specialized miniature boxes for cells. They can be used as a means of encasing and delivering therapeutics that would otherwise be broken down too early or incorrectly targeted. A careful look across the pharmaceuticals industry will reveal that nearly every major player has more than one investment in nano-particle pipelines. In the case of a Vertex, it is likely they want to aerosolize their therapy to be inhaled into the lungs. mRNA gene therapies are generally very fragile to external stimuli. To function properly, they need to be protected via some form of encasement and delivered directly to their target sights. This deal with Moderna will see them develop the packaging and delivery system. Moderna will need to see a lot more deals like this if they are going to live up to their current $26 billion market cap.
Transparency in COVID19 Vaccine Trials
We reported last week on the calls for transparency after Astra-Zeneca’s COVID19 vaccine trial went on hold for a week. Moderna and the Pfizer/BioNTech partnership both released their COVID19 trial protocols. The news is basically a win-win for them in terms of transparency. These massive documents are what is used to administer clinical trials and must be approved by appropriate review boards prior to a trial being conducted. Technically they are “secret” documents, in that specific procedures are not generally publicly released, but there is nothing inherently secret about the design and execution of clinical trials. In fact, every risk factor and potential outcome must, legally and ethically, be communicated to the administering physicians who are responsible for the information in the document as well as participants.
Last week we talked about the risk of shark statistics – that is people misinterpreting the data to over-estimate risk. What these pharma companies are doing is the equivalent of saying, “ah yes, I heard you might be concerned about shark attacks, do you know how the Ampullae of Lorenzini work? Their what allows sharks to detect electricity. Oh you don’t know? let me review all the known scientific literature in detail.” The technical back-end of running a trial is normally not released to the public. That’s because most people don’t need to know every reason why someone is included or excluded from a trial or what each qualifying criterion may be. Releasing this information, like talking about shark biology to someone afraid of shark attack, tells very little about risks but gives an appearance of transparency. However, if you happen to work at a clinical research organization and are curious about a phase III vaccine trials, there are now some great PDFs for you to review!
Immuno-Oncology and Gamma-Delta T Cells
The immuno-oncology market will be worth an estimated $135 billion dollars by 2024. With money like that on the line, it is not a surprise to see more capital flowing into companies advancing these therapies. Lava Therapeutics raised an $83 million dollar series C last week to advance their immuno-oncology platform. Unlike the most common platforms in this space, Lava targets gamma-delta T cells. These so called “surveillance cells” work as intermediaries between innate and adaptive immunity by patrolling for and identifying tumors. Lava’s product is designed to target tumors. Their preclinicals are promising according to investors and they are currently heading into early stage clinical trials on the back of this funding round. To date, no gamma-delta t-cell therapies have gone to market.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly 5-minute 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.
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Story References
https://finchtherapeutics.com/blog/finch-therapeutics-announces-90-million-financing
https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
Music by Luke Goodson