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Molecular Minute: February 2022

Welcome to Molecular Ideas, and thank you for sharing your time with us! Our Molecular Minute series covers some of the other notable events in the life science innovation that we didn't get to discuss in the moment this month. While some topics may be covered in greater depth in future posts, we hope to provide an exciting overview of what's next.

Just when you thought we could settle into a new year's routine, the life sciences continue to subvert expectations. In February, we saw major companies take hits and get wins, interesting advances of clinical science, and were given pause by Russia's unprovoked invasion of Ukraine. In our Molecular Minute series, we aim to briefly recap and share our takes on some of these notable events.

Image Source: Media from Wix

When at First You Don't Succeed...

Arguably the most notable splash in the biotech world in the last month was the release of preliminary clinical trial data by Sanofi & GlaxoSmithKline (GSK) for their new COVID-19 vaccine. While the full trial results are expected to be published later this year, the two-dose regimen claims to have an astonishingly high 100% efficacy rate against severe COVID-19 infections. There are some caveats here. While this is not a 100% guarantee that a patient will avoid developing symptoms and likely favors the current Omicron variant, this will go a long way in reducing the burden of disease in healthcare systems around the world. Being able to introduce a powerful immune response, as measured by neutralizing antibodies, means that we may have another viable candidate to fight COVID-19 around the world.

Sanofi and GSK were among the first of the major vaccine companies to partner at the outset of the COVID-19 pandemic on a vaccine, and were promptly defeated by poor clinical trial results in a Phase I/II trial. Instead of giving up in the face of Pfizer, Moderna, and AstraZeneca gaining headlines and market share, they went back and reformulated their vaccine while leveraging insights from their first attempt. What's also interesting here is the mechanism for this vaccine - unlike the cutting-edge mRNA vaccines of Pfizer and Moderna, the Sanofi-GSK vaccine leverages a conventional protein-based approach. This means that the vaccine is stimulating immune responses by exposing us to a wide range of COVID-19 spike protein antigens rather than instructing our cells to produce a single antigen type with mRNA. How this modality will affect long-term patient immunity, as well as pricing, production costs, and market penetration, are yet to be seen.

When You Miss Your Revenue Target, But Still Come Out Ahead...

Ah, Q1. After a warm, safe holiday season with our friends and family, nothing continues the optimism around a new year like a cold, hard look at annual reports and 10-k filings. That is, until you remember that we're still in a global pandemic and nothing quite makes sense like it used to (yet). Pfizer took a major hit on its stock price in early February following news that the company missed its 2021 revenue projections of $24.16 billion. It only brought in $23.84 billion.

The most ironic part of all of this isn't that the company actually improved its net income and earnings per share considerably by the end of 2021 - it's that the largest contributing reason it missed its target was because they didn't sell enough of their COVID-19 vaccine, Comirnaty®.

At the risk of stating the obvious, this feels very much like overhyped analyst expectations rather than, say, a lack of demand for the COVID-19 vaccine. While COVID-19 vaccine pricing varies from country to country, Pfizer's pricing tends to be on-par with Moderna across the US and EU, and charging slightly higher per-dose pricing in developing countries when compared with AstraZeneca. According to the New York Times' COVID-19 vaccine tracker, nearly 5 billion people have received a dose. It's fair to say that there is still plenty of work to be done, and Pfizer is going to continue to do it.

And if you are curious about what Pfizer is planning to do with all this cash, you're in luck. CEO Albert Bourla mentioned that "Acquisitions are very much in the cards." His BD team is going to be very busy this year.

When There Might Be Traction on Curing HIV...

HIV, the retrovirus known to cause Acquired Immunodeficiency Syndrome (AIDS), has long been a public health scourge with a tragic history. For the past few decades, the name of the game has been to create significantly better treatments for patients to slow the spread of the virus and limit its devastating effects on the body. What has defined 'better' in this context has been more tolerable adverse event profiles, treatment regimens that are easier to follow thanks to the combination of multiple drugs in a single pill, and improved active ingredients. Certain antiretroviral agents, like Gilead's Truvada®, have been approved for prophylactic use in a regimen known as PReP.

Ever so slowly though, the game has been changing. Last month, a third person was cured of HIV following a successful bone marrow transplant containing hematopoietic stem cells with a rare mutation. This mutation prevents HIV from infecting a patient's CD4+ T-cells (a.k.a., 'Killer-T' cells), which are responsible for battling infection. The source

Further, this third patient showed few, if any signs of graft-vs-host-disease (GVHD) - a potentially deadly condition where transplant recipients reject new tissues, causing the body's immune system to attack the body.

Does this mean that we will see HIV cured, or even eradicated in our lifetime? Maybe. The rise of CAR-T and cellular therapies gives me hope that we can scale this treatment and limit patient risk. As it stands, the director of the stem cell transplant program at Weill Cornell Medicine, Dr. Koen van Besien was stated that approximately 50 U.S. patients per year could benefit from this procedure. While this is a small drop in the bucket compared to the 37.7 million people worldwide with HIV, forward motion is always preferable to standing still.

Startup Spotlight: Curevo

In this section, we shine a light on a pre-commercial biotechnology or medtech company with interesting and innovative technology. This month, we are pleased to highlight Cureveo, a vaccine company going up against the Goliath of GlaxoSmithKline (GSK).

Remember getting vaccinated for the chickenpox? Probably not, as you were likely a little kid, but imagine if you could get a painful, blistering rash as an older adult. That's shingles, and it's what Curevo is trying to prevent with its vaccine, dubbed CRV-101.

What makes this company interesting is not the $60 million they just raised in Series A funding - it's the fact that they're going up against GlaxoSmithKline (GSK), one of the world's biggest vaccine producers, to do it. GSK is known for producing some of the world's most well-known vaccines, especially for children and adolescents. These range from Infanrix® and Pediarix® (diphtheria, tetanus, & pertussis), to Priorix® (measles, mumps & rubella), to Cervarix® (cervical cancer). (Yes, despite the FDA's guidance on brand naming, they almost all end in -rix. That's intentional). Among this portfolio is Shingrix®, indicated guessed it, shingles! It blows competition out of the water, having shown a 97% effectiveness rate in preventing disease in adults ages 50-69, compared to Merck's discontinued Zostavax® with a mere 51% efficacy rate. It's also young - the FDA approved it in 2017 and it is unclear as to when it will come off patent.

Curevo has their work cut out for them, but current Phase I trial results showed remarkable results. Participants quadrupled their antibody response against the most abundant shingles virus protein. The question to Curevo is if they can have similar results with a better safety profile compared to Shingrix® during upcoming clinical trials. The question to GSK is now 'Do you fear the underdog?' If you don't, you may not survive.

That’s all for today! Thanks for spending your time with us. Please share this article, and sign up to leave your thoughts, ideas, and opinions in the comments. Your feedback is always welcome and helps Molecular Ideas grow!


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