What’s Next For Moderna Post-Covid-19: CEO

It’s been a whirlwind year for Stéphane Bancel. Just over a year ago in March 2020, the World Health Organization declared the Covid-19 outbreak a pandemic. That same month Moderna, the biotech company that Bancel has helmed for the past nine years, sent its first batch of a new Covid-19 vaccine to the National Institutes of Health for testing. 

Today, millions of people have been vaccinated with Moderna’s vaccine — the first product that the company ever brought to market — thanks to mRNA technology that enabled vaccines to be prepared, tested and manufactured in just a few months. Until the year 2020, the fastest anyone had ever developed a new vaccine was four years. “I’ve had no life for the past 12 months,” Bancel says with a small laugh. “I dream of a day when I can take a vacation.” 

That frenetic pace has been extremely profitable, both for the company and its CEO. As of year-end 2020, Moderna booked $2.8 billion in unearned revenue for its mRNA vaccine, and reported $18.4 billion in advanced purchase orders for 2021. Bancel, who became a billionaire for the first time in April 2020 according to Forbes, now has a net worth of $4.6 billion. 

Bancel says that Moderna is continuing to charge forward with creating new mRNA vaccines and therapies. “In 2021 and 2022 Moderna is going to scale at a pace that has never happened before in biotech,” Bancel says.  From new vaccines for infectious disease to new cancer treatments and cures for genetic disorders like cystic fibrosis, here’s what Bancel says is on deck: 

First up: New vaccines for new variants

The rise of new variants, some of which are less susceptible to vaccines, means that new variations of Covid-19 vaccines will continue to be produced for years to come. Many experts believe that Covid-19 will never truly go away, but instead become a seasonal illness. “You might end up with a thing like the flu where every year, every two years, you need a boost,” Bancel says.

Moderna has already shipped a new batch of Covid-19 vaccines to the National Institutes of Health for testing that is targeted specifically against the B.1.351 variant that was first discovered in South Africa. In March, it also started clinical trials of a new version of its vaccine that is stable at refrigerator temperatures, unlike the current version that must be stored in ultra-cold freezers. 

A Better Flu Vaccine

Current flu vaccines take about 6 months to make since a version of the virus must be grown in eggs. They’re also only about 30-60% effective at preventing the seasonal illness. Using the same tech it did for Covid, Moderna is working on a new vaccine that Bancel believes will be 90% effective or more against the flu. More importantly, he says, the vaccines can be altered quickly to adapt to yearly changes in the virus. “I think we’re going to create a flu vaccine that the world has been waiting on for a long time,” he says. “It’s going to be in the clinic very soon.” Industry researchers have estimated the global market for influenza vaccines is more than $4 billion, and there’s room to grow here, too—on average, fewer than 50% of U.S. adults bother to get a flu vaccine, and one reason why is the relatively low efficacy. A more effective flu shot could lead to more jabs in arms.

Treating Cancer With A Shot

Moderna currently has five therapeutic cancer vaccines,  injections that train the immune system to attack cancerous cells in the body, in clinical trials. There are two current vaccines on the market that treat existing cancers (as opposed to preventing them, like the HPV vaccine), but both are only used for advanced cancers  and are expensive to produce. mRNA cancer vaccines could have the advantage of being safe, easy to develop and relatively cheap — though there are some hurdles to overcome including limited clinical data and the inherently fragile nature of mRNA. Bancel is enthusiastic about the applications here, “In the future, I think a lot of vaccines and therapeutics will be based on mRNA technology,” he says. One big advantage over existing drugs, he says, is safety. “It’s very very low biology risk. It’s a human protein made in a human cell in your body.”

Preventing Birth Defects

Before flu or cancer, Moderna’s next, non-Covid-19 vaccine to reach the public will likely be its vaccine for cytomegalovirus, or CMV. A harmless virus for most healthy adults, CMV can be passed from parent to baby in the womb. It is the number one cause of birth defects in the U.S., where 1 in 200 babies are born with the virus. In infants, the virus can cause hearing loss, vision loss, learning disabilities and other developmental disabilities. Bancel says that scientists have tried to create a vaccine to prevent CMV for more than 20 years, and Moderna’s current vaccine is a “very complex” shot that involves six different mRNA strands per vial. Despite those challenges Bancel says that so far, “the phase 1 and phase 2 data look very strong.”

Repairing Hearts 

The versatility of the mRNA technology means it can be used to treat a variety of diseases, says  Bancel. “mRNA is code,” he says.  In vaccines, mRNA encodes proteins that are intended to provoke an immune response, but there’s nothing stopping the technology from producing proteins that could heal the body in other ways. For example, one of the therapies Bancel is most excited about is a treatment that Moderna is studying in partnership with AstraZeneca that uses injected mRNA to create new blood vessels. This could mean that damage caused to the cardiovascular system by heart failure could be repaired and heart tissue could even be regenerated, helping patients lead healthier lives.  

Fixing Broken Genes

The newest and most radical use for mRNA likely comes in the form of gene therapies — treatments that alter faulty genes that can cause severe disease. Moderna, in partnership with Vertex Pharmaceuticals, is working on gene therapy for cystic fibrosis, a deadly lung disease. “You can use mRNA to do gene editing,” Bancel says, “because what you put in the mRNA is the instruction for the enzyme that will cut the DNA.” 

Many of these treatments under discussion are still a few years  off, but Bancel says their potential paints a picture of what the future could look like when mRNA is a normal tool for drug development. Eventually, Bancel says, “you’re going to have mRNA as another leg on the stool that clinicians will be using” to help patients. When might that happen? According to Bancel, “mRNA is going to be gigantic in the next 10 [to] 20 years.”

https://www.forbes.com/sites/leahrosenbaum/2021/03/24/whats-next-for-moderna-post-covid-19-ceo-stephane-bancel-details-mrna-pipeline/

Red Sox to Partner with Applied UV on Air Quality System in Ball Parks

 Applied UV, Inc. (NasdaqCM:AUVI) ("Applied UV" or the "Company"), an infection control technology company that applies the power of narrow-range ultraviolet light ("UVC") for surface areas and catalytic bioconversion technology for air purification to destroy pathogens safely, thoroughly, and automatically, announced that it has partnered with the Boston Red Sox to install the Airocide® Air Quality-Improvement System (Airocide System) at Fenway Park and JetBlue Park. Airoicide® will also become "The Official Air Purification Provider of the Boston Red Sox."

The Airocide® bioconversion technology is based on patented technology developed by NASA to eliminate harmful, airborne particulates such as bacteria, mold and viruses. The FDA has issued guidance for Air Purifiers and Disinfectants that states that they may reduce the risk of viral exposure to SARS-CoV-2 by keeping aerosol concentration levels low.

The Airocide® Air Purifiers will be installed in all player areas, including weight rooms and both the home and visitors' locker rooms. Additionally, the Airocide® Air Purifiers will be installed in all luxury suites as well as various points of contact in each facility where fans congregate indoors throughout the course of a game or event.

https://finance.yahoo.com/news/boston-red-sox-partner-applied-123000869.html

Kaleido Biosciences says oral drug cuts COVID-19 recovery time, hospitalizations

 Kaleido Biosciences said on Wednesday its experimental oral treatment cut recovery time as well as hospitalizations and emergency room visits in patients with mild to moderate COVID-19, in an early trial.

The treatment, KB109, reduced the total number of hospitalizations, emergency room visits, and urgent care visits by 51% in a study of 350 patients, and by 62% among patients with one or more co-morbidities, the company said.

The median recovery time for COVID-19 patients with one or more co-morbidities or who were aged 45 years and above shrunk by ten days, according to the drug developer.

KB109 belongs to a class of treatments called microbiome metabolic therapy (MMT) that work by changing the composition and metabolic output of microbes in the gut.

An aggressive immune response of the body in some patients is responsible for respiratory failure and pneumonia. Kaleido said gut microbes can produce molecules that are believed to modulate such responses.

The company said it registered the study with the U.S. Food and Drug Administration as a trial of a food compound, and not a therapeutic, adding that it plans to submit an application to begin clinical trials later this year.

"We believe based on this data that we can go directly to phase three (study)," Chief Executive Officer Daniel Menichella told Reuters.

Kaleido believes there is a market for microbiome-based therapies like KB109, due to their ease of administration.

https://finance.yahoo.com/news/kaleido-biosciences-says-oral-drug-110001229.html

Bausch Health cut to Underperform from Neutral by B of A

 Target $27

https://finviz.com/quote.ashx?t=BHC

Lung cancer resistance: the key is glucose

 Cancers are not only made of tumor cells. In fact, as they grow, they develop an entire cellular ecosystem within and around them. This "tumor microenvironment" is made up of multiple cell types, including cells of the immune system, like T lymphocytes and neutrophils.

The tumor microenvironment has predictably drawn a lot of interest from cancer researchers, who are constantly searching for potential therapeutic targets. When it comes to the immune cells, most research focuses on T lymphocytes, which have become primary targets of cancer immunotherapy - a cancer therapy that turns the patient's own immune system against the tumor.

But there is another type of immune cell in the tumor microenvironment whose importance in cancer development has been overlooked: neutrophils, which form part of the body's immediate or "innate" immune response to microbes. The question, currently debated among scientists, is whether neutrophils help or inhibit the tumor's growth.

Now, a team of researchers led by Etienne Meylan at EPFL's School of Life Sciences has discovered that the metabolism of neutrophils determines their tumor-supportive behavior in lung cancer development. The study is published in Cancer Research, a journal of the American Association for Cancer Research.

What intrigued the scientists was that cell metabolism in cancer becomes deregulated. Being neutrophil specialists, they considered the possibility that when these cells reside within the tumor microenvironment, their metabolism may also change, and that could affect how they contribute to the cancer's growth.

Focusing on glucose metabolism in a genetically-engineered mouse model of lung adenocarcinoma, the scientists isolated tumor-associated neutrophils (TANs) and compared them to neutrophils from healthy lungs.

What they found was surprising: the TANs take-up and metabolize glucose much more efficiently than neutrophils from healthy lungs. The researchers also found that TANs express a higher amount of a protein called Glut1, which sits on the cell's surface and enables increased glucose uptake and use.

To understand the importance of Glut1 in neutrophils during lung tumor development in vivo, we used a sophisticated system to remove Glut1 specifically from neutrophils," says Pierre-Benoit Ancey, the study's first author. "Using this approach, we identified that Glut1 is essential to prolong neutrophil lifespan in tumors; in the absence of Glut1, we found younger TANs in the microenvironment."

Using X-ray microtomography to monitor adenocarcinomas, the researchers found that removing Glut1 from TANs led to lower tumor growth rate but also increased the efficacy of radiotherapy, a common treatment for lung cancer. In other words, the ability of TANs to metabolize glucose efficiently seems to bestow the tumor with the ability to resist treatment - at least in lung cancer.

The scientists think that, because Glut1 loss diminishes the lifespan of TANs, their "age" determines whether they play a pro- or anti-tumor role. "Usually, we don't know how to target neutrophils, because they are so important in innate immunity," says Etienne Meylan. "Our study shows that their altered metabolism in cancer could be a new Achilles heel to consider in future treatment strategies. Undoubtedly, we are only beginning to learn about these fascinating cells in cancer."

https://www.eurekalert.org/pub_releases/2021-03/epfd-lcr031921.php

Prevent and treat high blood pressure with exercise

 The first personalised advice on the most effective exercise to lower blood pressure is published today in the European Journal of Preventive Cardiology, a journal of the European Society of Cardiology (ESC).1 The ESC consensus document recommends specific activities according to an individual's current blood pressure level.

One in four heart attacks are caused by high blood pressure. It is estimated that by 2025, around 60% of the world's population will have hypertension. While it is widely accepted that exercise lowers blood pressure, until now recommendations have focused on the amount of exercise per week, without considering an individual's starting blood pressure level.

This consensus document, for the first time, used an analysis of the highest quality evidence to produce detailed guidance on how to lower blood pressure in people with hypertension, high-normal blood pressure, and normal blood pressure.

"The goal of the recommendations for all three groups is primarily to lower blood pressure," said first author Professor Henner Hanssen of the University of Basel, Switzerland. "Ultimately, through blood pressure reduction, we can reduce the risk of heart attack, stroke and death from cardiovascular disease - thereby spending more years of life in good health."

For each of the three groups, the paper outlines the first exercise priority for lowering blood pressure, followed by alternatives that still achieve reduction but to a lesser extent.

For people with hypertension (blood pressure of at least 140/90 mmHg), aerobic exercise is the most effective method. This includes activities such as walking, running, cycling or swimming. "In people with hypertension, the blood pressure reduction that can be achieved with aerobic exercise is the same, or even slightly more, than taking a single antihypertensive medication," said Professor Hanssen.

In those with high-normal blood pressure (130-139/85-89 mmHg), dynamic resistance training is the first priority. This refers to strength training typically involving at least six large muscle groups where muscle contraction results in movement - for example, lifting weights, squats, and push-ups.

People with normal blood pressure (less than 130/84 mmHg) benefit most from isometric resistance training. This involves static contraction of the muscles - for example, the handgrip exercise. "People with normal blood pressure, but who are at raised risk of developing hypertension, may be particularly motivated to keep their levels down," said Professor Hanssen.

He continued: "Obese individuals are very likely to develop high blood pressure if obesity persists over the years. Healthy individuals with a hypertensive parent are also at risk of developing high blood pressure, as are women who had high blood pressure during pregnancy (gestational hypertension). People in these groups can postpone or even prevent hypertension by exercising."

Professor Hanssen noted that physical activity should be done regularly to sustain the benefits. He said: "For most exercises, the blood pressure lowering effect lasts for about 24 hours, similar to medication, so it's best to be active every day if possible."

https://www.eurekalert.org/pub_releases/2021-03/esoc-htp032221.php

Competition in telehealth, primary care spaces heats up as Amazon Care expands: analysts

 This week, Amazon announced a move that many had been expecting since the tech giant launched a virtual health pilot 18 months ago.

Amazon plans to expand its virtual health service benefit, called Amazon Care, to all its U.S. employees this summer while also making it available to other companies as an employee benefit. Amazon Care’s in-person service will expand to Washington, D.C., Baltimore and other cities in the coming months, the company said.

It marks Amazon's first foray into direct patient care on a national scale as it makes strategic moves to gain a foothold in the $3 trillion healthcare market.

"Amazon believes healthcare is a space they can improve and likely be profitable in, and that didn’t require deep-pocketed partners to do so," said Nathan Ray, a director in the healthcare and life sciences practice at business and technology consulting firm West Monroe.

"For the telehealth and virtual care market, this will set a bar for experience and convenience. For others in the healthcare ecosystem, this may complement or challenge their own strategies," Ray said, pointing to payer vertical integration and internal tool development.

Amazon is increasingly focused on the home as a site of care. Amazon Care joined with Intermountain Healthcare and Ascension along with other health systems and home care companies to form the Moving Health Home coalition, which aims to lobby Congress to make permanent changes to home health care reimbursement policies.

The company also aims to address employee healthcare costs through primary care models. Amazon teamed up with trendy tech-enabled primary care group Crossover Health to launch health centers in five major regions.

Amazon's telehealth move will heat up market competition for virtual care Teladoc and tech-enabled primary care company One Medical, according to Canaccord Genuity healthcare IT analyst Richard Close.

"Game on! We knew this day would come in some form or fashion—Amazon in earnest targeting healthcare services as another leg of growth," Close wrote in a note to investors.

Shares of Teladoc and One Medical parent company 1Life Healthcare dipped Wednesday after news of Amazon's telehealth expansion. Teladoc's stock slumped 2.3% in afternoon trading Thursday after shedding 4.4% on Wednesday, while 1Life shares slid 4.1% after losing 0.8% the day before, MarketWatch reported.

"Clearly, competition has increased, and we do not discount Amazon's potential for success," Close wrote. "We have been covering healthcare tech and services since 2004 and historically the entrance of bigger competitors has not been a wildly successful endeavor. Healthcare is hard. It will take time for Amazon to earn the trust of consumers, providers, payers and employers. With that said, Amazon has proven itself as a formidable competitor in all other areas it has entered."

But analysts are still bullish on Teladoc's potential growth. Compared to Amazon's telehealth offering, Teladoc also offers chronic condition management solutions through remote patient monitoring thanks to its blockbuster acquisition of Livongo last year.

Teladoc officials have said the company has plenty of "running room" with 65 million potential telehealth users at its current clients, weighted toward additional populations with payers.

"Amazon Care only mentioned targeting the employer market, so it is yet to be seen if the payer market is in the ultimate plans," Close wrote. "Teladoc has spent multiple years developing a global network of clinicians totaling more than 50,000 that would take Amazon some time to attempt to replicate."

One Medical, which says it serves 8,000 employers, will feel the heat from Amazon's move into direct patient care. But its partnership model with a local health system in each market may help insulate the company from the competition going forward, Close wrote in the investor note.

Further, One Medical has announced new markets that should provide robust growth over the coming two to three years, he wrote.

Amazon's push into telehealth services could spur more M&A activity among virtual care companies as they look to increase their scale and size, according to Michael Abrams, a managing partner at consulting firm Numerof & Associates. 

There is the potential for more vertical integrations, such as Cigna's planned acquisition of MDLive, he said.

"That's probably the safer bet rather than simply merging with another telehealth or adjacent company. They're going to need a certain market presence to have a shot to survive in this business if Amazon is going to stay in it," he said.

Amazon will likely target large employers with concentrated workforces for its Amazon Care service, Abrams said.

"There isn’t one of them that doesn’t want to find a way to save money on their healthcare benefits. At the end of the day, there is potential for Amazon to have a very compelling product," he said.

Amazon has been rapidly expanding its reach in the healthcare space, most notably in 2018 with its acquisition of online pharmacy PillPack. Last fall, the tech giant announced Amazon Pharmacy, a new store on Amazon, that will allow customers to complete an entire pharmacy transaction on their desktop or mobile device through the Amazon app. 

Amazon also made a major move into the health wearables market with the launch of the Amazon Halo fitness tracker last year.

There is the potential for the tech giant to create synergies with its different healthcare plays, Abrams said.

"Amazon can offer things that other players can’t, and that is what makes it such a powerful company in the space. It can offer virtual healthcare visits, prescription medication delivery and also can deliver all the over-the-counter products and even durable medical equipment. In addition, they can offer on-demand, in-person visits with a provider," he said.

With the advances in at-home testing kits, Amazon could integrate diagnostic labs and other ancillary services to home kits, Ray said.

The company also could leverage its HIPAA-compliant Alexa skills and its Halo wearable for remote monitoring.

"The Halo device can monitor the vitals of someone with a chronic disease, Alexa can then remind them that it's time to make an appointment they can do a virtual visit and also get a test kit in the mail for lab testing. It's all very synergistic," Abrams said.

That raises the stakes for hospitals and medical practices as consumers could opt to get more healthcare services delivered remotely without leaving home.

But the healthcare market is huge and is ripe for disruption, with plenty of room for many companies to be successful and continue to show respectable robust growth, Close wrote in his investor note.

"This is not a 'zero-sum game' and that there can be multiple winners in various sub-segments of the healthcare ecosystem," he wrote.

Amazon's success with Amazon Care is not guaranteed. Its highly publicized partnership with JPMorgan and Berkshire Hathaway to run a healthcare venture called Haven shut down in January 2021 after having been formed in 2018.

But even as Haven floundered, Amazon never missed a beat in terms of its own strategies to move into healthcare, Abrams noted.

Amazon's e-commerce strategy is its biggest strength. "If it can bring that same sophistication to the undertaking of providing virtual and in-person on-demand medical care, it could be a very compelling value story. Amazon has proven itself to be very adaptable and innovative and if anybody out there can master it, they probably can," Abrams said.

https://www.fiercehealthcare.com/tech/game-competition-healthcare-space-heats-up-as-amazon-care-expands-analysts-say