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COVID-19 Proved mRNA Vaccines are the Future – Sanofi Doubles Down with $3.2B Translate Bio Acquisition

Translate Bio is partnering with Sanofi in developing MRT5500, an mRNA vaccine based on Translate’s proprietary MRT™ platform, which it acquired from Shire in 2017.

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Translate Bio CEO Ronald C. Renaud Jr. discusses his company, its mRNA platform, and its partnership with Sanofi in COVID-19 and other diseases as a guest in September 2020 on “GEN Live,” GEN’s monthly live-streaming video discussion series.
Sanofi is acquiring its COVID-19 vaccine collaboration partner Translate Bio for approximately $3.2 billion, the companies said today, in a deal that addresses the buyer’s desire to advance mRNA vaccine technology beyond the candidates it is co-developing for protection from SARS-CoV-2 and seasonal influenza. Headquartered in Lexington, MA, Translate Bio is partnering with Sanofi in developing MRT5500, an mRNA vaccine based on Translate’s proprietary MRT platform, which it acquired from Shire in 2017. The companies began partnering in COVID-19 in March 2020 and earlier this year launched a Phase I/II trial of MRT5500, for which interim results are expected in the third quarter. In June, the companies launched a Phase I trial evaluating two formulations of an mRNA vaccine (MRT5400 and MRT5401) designed to protect against seasonal influenza, with initial results anticipated during the fourth quarter. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA. Furthest along in Translate Bio’s solo pipeline is MRT5005, an mRNA vaccine designed to treat cystic fibrosis that is now in a first-in-human Phase I/II trial (NCT03375047). “Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines,” Sanofi CEO Paul Hudson said in a statement. “Translate Bio adds an mRNA technology platform and strong capabilities to our research, further advancing our ability to explore the promise of this technology to develop both best-in-class vaccines and therapeutics,” Hudson added. “A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space. We will also be able to accelerate our existing partnered programs already under development.” Investors welcomed the prospect of a Sanofi acquisition, touching off a buying spree last night that sent shares of Translate Bio up about 73%, to $50.35 as of 7:59 p.m. ET, from yesterday’s close of $29.15, after Reuters reported that Sanofi had offered to buy the company, citing unnamed sources. Translate’s stock price fell back to $37.60 as of 1:29 p.m.—29% above yesterday’s close. Given the early stage of TBIO’s platform, and the company’s recent pivot into vaccines, the deal terms strike us as favorable for SNY and fair for TBIO,” Geoffrey C. Porges, MBBS, director of Therapeutics Research and a senior research analyst at SVB Leerink, wrote today. “Despite the lofty valuations for mRNA platforms today, and their now-proven value for vaccine development, it is hard for us to see how TBIO could have attracted another buyer, given the companies’ entrenched partnership.”

Collaboration grows to $2.3B

Sanofi and Translate Bio began partnering on mRNA vaccines in 2018, launching an up-to-$805 million-plus collaboration in June 2018. Last year, Sanofi and Translate Bio expanded their collaboration to develop mRNA vaccines for infectious diseases, with the pharma giant nearly tripling to more than $2.3 billion its potential payout to Translate, and the companies increasing from five to seven the maximum number they plan to develop under that partnership. “We generated immunogenicity data, neutralization data for a number of infectious disease targets, both form the viral and the bacterial side. The productivity of that relationship was just a very natural foundation for when we decided to start working together on COVID-19,” Translate Bio CEO Ronald C. Renaud Jr. said September 16 as a guest on “GEN Live”, GEN’s monthly live-streaming video discussion series. “For us and Sanofi to extend this collaboration first into COVID-19 and then beyond that into a much more expanded collaboration was just a very natural transition and natural extension of the work that was already ongoing between our two organizations,” Renaud added. Porges asserted that acquiring Translate was, strategically speaking, a sensible fit for Sanofi given Sanofi’s recent commitment to mRNA and mRNA vaccine development. Sanofi bolstered its mRNA capabilities in April when it acquired Tidal Therapeutics for $160 million upfront plus up to $310 million tied to achieving milestones. Privately-owned Tidal had developed an mRNA-based tech platform for in vivo reprogramming of immune cells inside the body, allowing for an off-the-shelf approach to developing CAR-T therapies. The platform uses proprietary nanoparticles to deliver mRNA selectively, with initial applications targeting specific types of immune cells. The technology’s in vivo approach is designed to provide similar efficacy to current ex vivo approaches where immune cells are genetically modified to enhance their therapeutic properties (such as chimeric antigen receptor CAR-expressing T-cells), with the potential for improved safety, outpatient dosing, and repeat dosing. The platform, Sanofi concluded, offered potential to expand its research capabilities in both immuno-oncology and inflammatory diseases, as well as applicability to other disease areas as well. On June 29, Sanofi announced plans to launch an mRNA Center of Excellence with approximately €400 million ($474 million) a year in funding. That Center is intended to accelerate the development and delivery of next-generation vaccines by joining approximately 400 employees together with end-to-end mRNA vaccine capabilities that include dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, MA and Marcy l’Etoile, Lyon, France.

Delay, success with GSK

Sanofi’s embrace of mRNA came after its other key COVID-19 therapeutic effort suffered a clinical setback before finding success. Sanofi has partnered with GlaxoSmithKline to develop another COVID-19 vaccine, one that incorporates Sanofi’s S-protein COVID-19 antigen, based on recombinant DNA technology; and GSK’s pandemic AS03 adjuvant. The companies were delayed in developing their vaccine in December, after Phase I/II interim results showed that the vaccine generated insufficient neutralizing antibody titers in adults over the age of 50, “likely due to an insufficient concentration of the antigen,” according to a statement. Volunteers were accidentally given lower doses than intended in initial clinical trials due to a miscalculation in the manufacturing process, Thomas Triomphe, Sanofi’s executive vice president for vaccines, told The Wall Street Journal. But on May 27, Sanofi and GSK began enrollment in a 35,000-volunteer Phase III trial after generating positive results in a Phase II study (VAT00002; NCT04762680) showing 95% to 100% seroconversion following a second injection in all age groups (18–95 years old) and across all doses, with acceptable tolerability and with no safety concerns. In announcing the Center of Excellence a month later, Sanofi said it is expected at minimum to generate six clinical candidates by 2025. Those candidates are now expected to incorporate Translate Bio’s MRT platform, through which the company creates mRNA that encodes functional proteins, and encapsulates the mRNA in an LNP. When that mRNA is delivered to the target cell, the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease. Translate’s most advanced MRT-based candidate, MRT5005 in cystic fibrosis, generated positive results in March from a second interim analysis of Phase I/II data suggesting that repeat dosing of MRT5005 was generally safe and well tolerated. MRT5005 is designed to address the underlying cause of CF regardless of genetic mutation by delivering mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to cells in the lung through nebulization. Also in Translate’s solo pipeline are discovery-phase candidates—another cystic fibrosis prospect, and candidates for primary ciliary dyskinesia (PCD), pulmonary arterial hypertension (PAH), and undisclosed liver diseases. The company and Sanofi reason that the MRT platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as oncology.

“Significant Progress”

“The talented and dedicated Translate Bio team has built the foundation of a strong mRNA platform,” Renaud stated in the companies’ announcement. “Our expertise coupled with that of Sanofi has driven significant progress under the collaboration thus far, and we believe that this acquisition will strengthen the team’s ability to achieve the full potential of the mRNA technology.” Renaud and Translate Bio’s largest shareholder—The Baupost Group, a Boston-based investment manager that manages about $28 billion in assets—have signed binding commitments to support the tender offer that Sanofi plans to commence later this month to acquire all outstanding shares of Translate Bio common stock for $38 per share cash—a premium of 56% to Translate Bio’s volume-weighted average price per share over the past 60 days. Following a successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with Translate Bio, while any outstanding Translate Bio shares not already owned by Sanofi or its affiliates that are not tendered in the tender offer will be converted into the right to receive the same $38 per share in cash paid in the tender offer. The binding commitments, combined with the Translate Bio shares already owned by Sanofi or its affiliates, represent a total of approximately 30% of Translate Bio’s total shares outstanding. “We do not expect another bidder to emerge for TBIO given the more or less exclusive collaboration TBIO already has with SNY for infectious disease vaccine development, nor do we expect significant antitrust delays given that pre-existing collaboration to develop joint vaccines,” Porges wrote. Sanofi said it expected to complete the acquisition in the third quarter, subject to the satisfaction or waiver of customary closing conditions. Sanofi plans to fund its acquisition of Translate Bio with available cash. The company recorded a hefty €9.722 billion ($11.5 billion) in cash and cash equivalents as of June 30, according to its balance sheet released with its second-quarter results. “Sanofi and Translate Bio have a shared commitment to innovation in the mRNA space,” Renaud added. “With Sanofi’s long-standing expertise in developing and commercializing vaccines and other innovative medicines on a global scale, Translate Bio’s mRNA technology is now even better positioned to reach more people, faster.” The post Sanofi Doubles Down on mRNA with $3.2B Translate Bio Acquisition appeared first on GEN - Genetic Engineering and Biotechnology News.

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The Bloc’s Secrets of Success: 5 Ways The Health Creative Agency Won 200 Awards

As a global pandemic has reshaped society, The Bloc has been at the forefront of changing not just what stories get told about healthcare, but how they are told. In doing so, the health creative agency has won more than 200 film and advertising awards…

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The Bloc’s Secrets of Success: 5 Ways The Health Creative Agency Won 200 Awards

The Bloc achieved unprecedented levels of acclaim and recognition by embracing creativity, racial justice, technology, new practices, and people

New York, NY, September 22 – Over the past two years, The Bloc has redefined health creative to become one of America’s most talked about agencies. As a global pandemic has reshaped society, The Bloc has been at the forefront of changing not just what stories get told about healthcare, but how they’re told. In doing so, they’ve won over 200 film and advertising awards in 2020 and 2021. Recently, The Bloc became the first ever health agency listed on the “Of The Year” ranking for the entire Cannes Lions International Festival of Creativity. In addition, The Bloc is a founding member of The BlocPartners, the acclaimed global network of independent health creative agencies. The BlocPartners recently placed second in the “Health Network of the Festival” category at the Cannes Lions Health Festival.

The Bloc CEO Jennifer Matthews (PRNewsfoto/The Bloc)

“The work we’ve been so awarded for lately has been a natural extension of our motto ‘Be Great to Do Good,’” said Jennifer Matthews, CEO at The Bloc. “Health is life. It deserves the very best in creative excellence.”

  1. Invest in Hollywood Level Filmmaking 

A man walks through a futuristic train station, suffering from a cough, and decides to seek help from an automated doctor. That’s the premise of The Bloc’s award-winning short film Instant Doctor. Made so as to give thanks to doctors and released on National Doctor’s Day (March 30, 2020), the film highlighted the importance of the human element in healthcare by showing a world where medicine is done via machines.  

Instant Doctor won the Grand Jury Award for Best Short at the New York International Film Awards and was declared the Best Sci-fi Short Film at the 2020 Rhode Island International Film Festival.

“Instant Doctor has shown the industry that healthcare advertising can have not just the production quality but also the storytelling excellence of Hollywood movies,” said Bernardo Romero, Chief Creative Officer at The Bloc. “Healthcare has never been more important, which means health creative should be of the same quality as what you would see in a movie theatre or stream on Netflix.”

  1. Tackle the Biggest Issues – Including Racism and Racial Bias in Healthcare

Some of The Bloc’s most acclaimed recent work has centered around racial justice, both in healthcare and in the broader world. 

In early 2020, The Bloc, in partnership with acclaimed ballet dancer Ingrid Silva’s EmpowHer New York, released “The Call,” a short film where an actress went undercover on nursing advice hotlines to expose racial disparities in healthcare treatment. 

The Bloc went on to work with Ingrid on two more films. First came Skindeep, an animated story about racial trauma told through watercolor frames by Black women illustrators. Skindeep was followed by Making Space, a documentary about Ingrid’s life journey which premiered at Cannes Lions. 

In partnership with the National Black Child Development Institute, The Bloc created ABC’s of Survival, a tear-apart book for black children and their parents. The book aims to support mental health and change laws by including postcards that can be sent to congress. The ebook can be found at abcsofsurvival.com.

  1. Hire and Promote the Best People

The Bloc continues to grow rapidly and has recently hired Stuart Goldstein as COO and promoted Antoinette Bobbitt to EVP, strategy director. Stuart will be The Bloc’s first COO, and he’ll oversee the management for over 4,500 projects a year, with the goal of increasing efficiency and profitability. Meanwhile, Antoinette will ensure that The Bloc’s competitive differentiation is present in all client work.

The Bloc’s commitment to its employees was underscored this summer when Fortune magazine listed it as one of the best workplaces in New York for 2021. The Bloc is one of three advertising agencies on the list, and the only health creative agency focused exclusively on health.

  1. Get High Tech

More and more agencies are realizing that their creative skills can be used to power tech innovations, and The Bloc has focused on the development of tech to address pressing health needs. At the beginning of the pandemic, The Bloc pioneered SafeCode, a device concept which combined a bar-code scanner with UV light to help stop the spread of disease on delivery packages. 

The Bloc has also created a tool to aid mental health. At the end of 2020, they worked with Rockwell Ventures to create Scrollaby, an app which takes the habit of “doomscrolling” and turns it into a sleep aid, with over 1,000 pieces of custom content that support rest and relaxation.

  1. Rethink Agency Practices

To expand upon the capabilities it has developed, The Bloc has established new practice areas that distinguish it in the healthcare agency space.

One new practice area is The Bloc Science Foundry, which applies behavioral science and scientific expertise to medical communications. The other is The Bloc Storytellers

And this year, The Bloc announced its Storytellers department, which is dedicated to bringing unsurpassed production and narrative quality to healthcare creative. Storytellers seeks to replicate the success The Bloc has had with The Call, Skindeep, and Instant Doctor. The Bloc is currently searching for the best creative minds from the film, theater, and TV industries to join their team. Resumes can be sent to storytellers@thebloc.com.

 

About The Bloc

The Bloc is a leading independent health creative agency in the United States. Celebrating 21 years in 2021, The Bloc delivers comprehensive omnichannel communications for audiences across the health spectrum and partners with innovative clients who are doing some of the most meaningful and exciting work in health today. A founding member of The BlocPartners, the leading global network of independent health creative agencies, The Bloc’s work has been globally recognized for creativity and innovation. For more information, visit www.thebloc.com.

 

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Spread & Containment

Long COVID: double vaccination halves risk of developing long-lasting symptoms

Want to avoid long COVID? Get vaccinated.

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Studio Romantic/Shutterstock

In unvaccinated people, around one in 20 who get symptomatic COVID-19 experience symptoms for at least eight weeks. Around one in 50 have symptoms that drag out for three months or more.

We wanted to know whether COVID-19 vaccines might protect against developing long-lasting symptoms. To find out, we looked at data provided by more than a million regular contributors to the COVID Symptom Study, a project in which members of the public log their symptoms via an app to help with research.

Our latest analysis of the study’s data, covering around 2 million vaccine doses, shows that vaccines significantly reduce the risk of catching COVID-19, with only 0.2% of those fully vaccinated later testing positive for the virus.

Even if you’re unlucky enough to catch the virus after being vaccinated, your chances of falling seriously ill or dying are slashed. Double-vaccinated people are 31% less likely to experience acute COVID-19 symptoms and 73% less likely to be hospitalised – a result that’s borne out in the relatively low hospitalisation and death rates we’re seeing now even as tens of thousands of people are still testing positive every day in the UK.

Reassuringly, for those who did fall ill with COVID-19 after being vaccinated, only around 5% went on to have symptoms that lasted for more than four weeks, meaning their chances of developing long COVID were cut by half. One of the best ways to reduce your risk of getting long COVID is to get fully vaccinated as soon as possible.

However, we did notice that frail older people and those living in more socially deprived areas were more likely to be infected and fall ill with COVID-19 after being vaccinated, especially if they had only had one vaccine dose. This suggests that we should prioritise further vaccination efforts and public health measures such as masking and social distancing among these groups, especially where infection rates are high and people are mixing and moving around.

Vaccines and long COVID

As the UK vaccination programme rolled out, we also started to notice anecdotal reports from people living with long COVID that their symptoms seemed to improve after being vaccinated.

The patient-led LongCovidSOS group chose to investigate this by surveying over 800 long COVID patients early in 2021. More than half of those surveyed noticed an overall improvement in their symptoms after vaccination, which then appeared to be sustained in about half of this group. Around a quarter of the overall respondents reported no difference and one-fifth said their symptoms had got worse. These findings have been released as a preprint, so haven’t yet been reviewed by other scientists, but they’ve been backed up by data from the COVID Symptom Study, which we’ll be publishing soon.

However, while there does seem to be some kind of link between receiving a COVID-19 vaccine and improvements in long COVID, it’s not clear exactly how the two are connected. It could be that the immune response triggered by the vaccine has a direct impact on symptoms.

Alternatively, it could just be that time has continued to pass since these people were originally infected and they’re experiencing a natural recovery from the virus. Or it could be a bit of both. Either way, more research is needed to tease out what’s going on.

A woman with long COVID lying on a bed, covering her face
There isn’t a definitive answer yet on whether vaccines can relieve people’s long COVID symptoms. True Touch Lifestyle/Shutterstock

What we can say is that COVID-19 vaccines certainly aren’t harmful for people with long COVID. What’s more, because we know that it’s possible to be reinfected with the virus, there’s a risk that catching it a second time could exacerbate symptoms for people living with long COVID and set them back even further. It’s therefore vital that we encourage anyone with long COVID who has not been vaccinated to do so as soon as possible, to help protect themselves and those around them.

A serious threat

Although the chances of developing long COVID after being vaccinated are small, this is a numbers game and a small percentage of a big number can still be substantial. As long as we are seeing tens of thousands of cases every day, we can still expect to see a substantial number of people living with lingering symptoms over the coming months.

This is particularly important for younger people, who may be less worried about hospitalisation or death, yet who can still be susceptible to the debilitating long-term effects of the virus. A lot can happen in a few months when you’re young, and long COVID can mean that people miss out on life-changing opportunities, like sitting an exam or taking up a new job, as well as the social activities that bring joy and wellbeing to life.

It’s likely that we’ll all be living with COVID-19 for some time to come. But with a combination of vaccination and public health measures where necessary, we can help to make sure that as few people as possible have to directly live with its life-limiting long-term effects.

Claire Steves consults for ZOE Ltd which is the company which developed the COVID Symptom Study together with King's College London. She receives funding from the Medical Research Council, the National Institute for Health Research, the Wellcome Trust and Chronic Disease Research Foundation.

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Incyte nabs approval of topical ruxolitinib in atopic dermatitis, but gets slapped with JAK warning

Incyte has made a pretty penny with its JAK inhibitor ruxolitinib over the years, but on Tuesday the drug crossed a new threshold.
Julie Block
The FDA approved a topical formulation of the drug for mild-to-moderate atopic dermatitis, Incyte announced…

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Incyte has made a pretty penny with its JAK inhibitor ruxolitinib over the years, but on Tuesday the drug crossed a new threshold.

Julie Block

The FDA approved a topical formulation of the drug for mild-to-moderate atopic dermatitis, Incyte announced Tuesday afternoon, giving the Wilmington, DE-based company a new arrow in its ruxolitinib quiver. The drug, which will be marketed as Opzelura, is the first topical JAK inhibitor approved in the US and is indicated for AD patients aged 12 and up who struggle to control their disease on other prescription creams.

“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, CEO of the National Eczema Association, in a statement. “The chronic itch is difficult to cope with and related sleep issues can be exhausting.”

It wasn’t immediately clear how Incyte planned to price the drug. Endpoints News has reached out for comment and will update accordingly.

Tuesday’s approval also came with the black box warning seen across the JAK class of drugs, highlighting risks of serious infections, heart attack, stroke or cardiac death.

Ruxolitinib has morphed into a blockbuster for Incyte since it garnered its first approval as an oral treatment for myelofibrosis back in 2011. The drug continued to rack up FDA endorsements ever since, getting nods for polycythemia vera in 2014 and acute graft-versus-host disease in 2019.

In these indications, the drug is marketed as Jakafi in the US and as Jakavi by Novartis elsewhere. Jakafi netted $995 million in revenue through the first half of 2021, maintaining some growth but also taking sales hits due to the Covid-19 pandemic, Incyte said.

But Incyte has been pushing to move ruxolitinib into a topical formulation for a while as well. By treating mild and moderate AD with a cream, patients can more easily treat their affected areas than with an oral drug. The topical formulation is also in development for vitiligo, another skin condition that can result in the loss of pigmentation.

The approval will also give Regeneron and Sanofi’s Dupixent some competition in the eczema field. Incyte is hoping it can advance Opzelura on ease of use, given that Dupixent is administered by injection. The company will have a tough task ahead, however, as Dupixent pulled in nearly $1.5 billion in sales in 2021’s second quarter alone.

At the very least, Incyte has hoped topical ruxolitinib can prove a more appealing alternative to corticosteroids, the standard of care in mild-to-moderate AD. Tuesday’s approval came on the basis of two Phase III studies that compared the cream to a placebo, with patients seeing at least a two-point improvement on an investigator assessment and a reduction in itch from baseline after eight weeks.

Peak sales estimates for the topical drug have ranged from $300 million to $1.1 billion by 2025.

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