One of the key programs that inspired Sanofi’s $2.5 billion buyout of Synthorx in late 2019 is now the subject of a $1.6 billion writedown.
Sanofi disclosed in its Q3 earnings that it’s closing down Phase II platform trials for SAR444245, an IL-2 candidate that it had hoped would serve as a next-gen foundation of the oncology franchise. An early look at the data, it said, suggests efficacy that’s “lower than projected.”
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September marked the 12th anniversary of Moderna’s founding, when we set out to study whether it is possible to instruct a patient’s own cells to produce proteins that may have the potential to treat a wide range of conditions with mRNA.
Since then, we have built a diverse clinical portfolio of mRNA vaccines and therapeutics across seven modalities. We have pioneered the development of our mRNA platform and have expanded our mRNA pipeline to 47 programs in development including 31 in clinical studies.
Almost half of adults with type 1 diabetes say they felt like quitting sports as a kid because of their health condition – and one in five ended up doing so. Now Dexcom wants to encourage the next generation to stick with sports, so it’s lined up a first-ever name, image, likeness (NIL) college athlete program to showcase 14 players living with type 1 diabetes.
The mostly Division I men and women athletes who crisscross a range of sports — from baseball, basketball and football to cheerleading, lacrosse and swimming — all use Dexcom’s continuous glucose monitoring devices. Called Dexcom U, the program aims to bring on a new class of athletes every year who will co-create content on social media and serve as role model advocates for others living with diabetes. They’ll post about their day-to-day lives, how they train and prep for game day and how they use the Dexcom CGM to understand their diabetes state.
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In the historic campaign to vaccinate the world against Covid-19, Corbevax was far from the first vaccine to reach the market. While the first mRNA shot became available 326 days after the SARS-CoV-2 virus was sequenced, the journey of Corbevax — which has so far gone into the arms of 75 million kids in India and recently won approval for adults — spanned about 600 days.
But Peter Hotez, one of its co-inventors, believes it could’ve played out differently if his team had received more funding and there was a smoother regulatory path.
“That could have been probably cut in half had we had the support to move faster,” said Hotez, the co-director of the Texas Children’s Hospital Center for Vaccine Development.
There was good reason to go faster. The mad scramble for life-saving shots exposed the stark disparities between the vaccine haves and have-nots. Corbevax, a patent-free vaccine based on older but proven technology, can be affordably produced and distributed to lower-income countries.
The Corbevax story is relevant to a bigger question as the world attempts to strengthen vaccine research and development infrastructure to go even faster and more equitably distribute vaccines. Vexing scientific, regulatory and manufacturing challenges must be solved ahead of the next pandemic, public health experts and advocacy group representatives said in interviews.
The Coalition for Epidemic Preparedness Innovations, or CEPI, which launched in 2017 in the wake of the Ebola outbreak in West Africa, has proposed what it calls a moonshot goal of spurring a vaccine against a new pandemic-causing pathogen in 100 days. The initiative is known as the 100 Days Mission.
Melanie Saville, CEPI’s executive director of vaccine R&D, reckons the group would’ve been “laughed out of the room” if they had told people before the Covid-19 pandemic that a vaccine would arrive within 326 days – but already there’s a path to going faster.
“If you actually put everybody’s innovation together from Covid-19, we already probably could shave off two months by looking meticulously at every step of the process,” she said, citing a CEPI analysis based on interviews with companies, international organizations, regulatory agencies, academia and the media.
To get to 100 days, though, much more needs to be done. The key is to do as much of it upfront as possible, she added, during so-called peacetime, much like decades-long RNA research ushered in the first Covid-19 vaccines.
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Australian pharma giant CSL is making a late bid for mRNA glory, and they’ve lined up one of the also-ran US Covid-19 biotechs touting their own particular tech twist to partner with.
CSL Seqirus, the big vaccines arm of the global player, is shelling out $200 million in cash and putting up another $4.3 billion in milestones — including a hefty $1.3 billion for development goals — to ally itself with Arcturus Therapeutics. Joe Payne’s San Diego-based biotech — where Payne had to mount a counter-coup to wrest back control of the company from some rebellious board members in 2018 — is just coming off a $63 million BARDA contract, where they’re putting their mRNA tech to work on the flu.
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GSK appears to have beaten Pfizer in getting a BLA for its RSV vaccine in front of the FDA, securing priority review for the use of its jab among older adults.
CEO Emma Walmsley spotlighted the RSV vaccine candidate in a media call Wednesday, saying that GSK is “incredibly confident” about its efficacy and the “tremendous commercial opportunity” it represents.
With the spinout of the consumer healthcare business into Haleon, and Tony Wood filling the CSO position previously filled by Hal Barron, Walmsley remains upbeat. She argued that GSK is in a “far better position” than it was when it laid out its R&D strategy four years ago, with a heavy focus on immunology and oncology as well as technology and data.
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So much for Rubius II.
A little more than a year after the one-time Flagship star $RUBY looked to restructure around a second try at making red blood cells a drug tech of the future, the biotech put out word after the market closed Wednesday that it’s axing the bulk of the remaining staff and looking for a sale or merger.
With shares trading slightly north of 30 cents apiece, it won’t take much to take over the crumbling structure that once commanded a market valuation in the billions.
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Months after GSK changed its name from GlaxoSmithKline and spun off its consumer health division into the standalone Haleon, the Big Pharma is reporting better-than-expected sales — with both opportunities and challenges ahead.
CEO Emma Walmsley touted record sales of shingles vaccine Shingrix on the earnings call Wednesday, noting that the vaccine recorded £760 million in sales for the quarter — over $800 million.
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We all know the scene. Jamie Lee Curtis’ character in “Freaky Friday” pens a book titled “Through the Looking Glass: Senescence in Retrograde,” and she goes on a talk show to promote the work, but it’s not her doing the talking — her daughter, played by Lindsay Lohan, has swapped bodies with her and the two must figure out how to reverse the odd turn of events.
There are a few big days to recall in the six-year history of Endpoints News. (Actually, six years, four months and 12 days, but who’s counting.)
One was a sit-down I had with Arsalan Arif in New York a few weeks before the launch, when we agreed to some basic values for what we were going to do. That conversation is a regular touchstone for us. We committed to being honest with each other and the staff. We’d give it everything we had, and we would conduct ourselves independently and with integrity.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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