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Good morning. I’m nonetheless recovering from yesterday, when Chicago was reportedly colder than Antarctica. I hope you’re all staying heat wherever you might be. Let’s get into the information at this time.
The necessity-to-know this morning
- Johnson & Johnson kicked off the fourth-quarter and 2024 year-end earnings season. The well being care large reported adjusted fourth-quarter earnings of $2.04 per share on whole income of $22.52 billion.
Bispecific antibodies are the most cancers area’s newest ‘gold rush’
The primary era of immune checkpoint inhibitors, medicine that may assist make the immune system acknowledge and destroy most cancers extra aggressively, have lengthy been pillars of most cancers remedy. Researchers and drug corporations at the moment are turning their consideration towards a brand new era of immunotherapies: bispecific antibodies that focus on a mix of the proteins VEGF and both PD-1 or PD-L1.
There’s been a surge of curiosity in these kind of compounds in the previous few months, spurred by promising medical knowledge from Summit Therapeutics and BioNTech. “We’re undoubtedly seeing a gold rush right here,” one biotech chief stated.
What’s so particular about these molecules? Evidently combining the targets right into a single bispecific antibody is important, main the strategy to be probably more practical and fewer poisonous than giving two totally different antibodies on the identical time.
Learn extra from STAT’s Angus Chen.
Chinese language biotech says it is going to begin first in vivo beta-thalassemia trial
From my colleague Jason Mast: Main U.S. gene-editing biotechs are racing to develop the primary remedy that may remedy sickle cell illness with a easy IV infusion. Such an in vivo strategy might be far safer and extra scalable than Casgevy, Vertex’s CRISPR-based remedy, which requires sufferers’ blood cells to be eliminated, edited in a lab, after which re-infused. Poisonous chemotherapy is required to filter outdated cells.
On Monday, Chinese language biotech YolTech Therapeutics introduced it could begin what seems to be the primary trial testing such a remedy. It would focus first on beta-thalassemia, a associated blood dysfunction, however each situations will be handled with the identical strategy. Beta-thalassemia is extra widespread in China than sickle cell illness.
YolTech’s announcement comes amid rising anxieties amongst U.S. drug builders over competitors from China, the place cheaper expertise and supplies and a special regulatory regime can speed up growth. U.S. corporations — together with Editas Drugs, Tessera Therapeutics, and Beam Therapeutics — have been obscure about once they count on to begin in vivo sickle cell trials.
Most, together with YolTech, are successfully utilizing iterations of the identical strategy, attempting to focus on lipid nanoparticles, loaded with CRISPR enzymes, to blood stem cells within the bone marrow. The problem has been reaching and correcting a sub-group of notably long-lived cells that may maintain pumping out new wholesome cells for years to return.
But when they will resolve it, there’s an enormous market: Solely two U.S. sufferers are identified to have obtained Vertex’s remedy in its first 12 months after approval, partly due to the conditioning required, and the remedy isn’t obtainable in any a part of Africa or India, the place a lot of the world’s sickle cell sufferers reside.
Opinion: Medicare negotiations want a ground value
To make sure that Medicare’s drug value negotiations shield innovation, the method ought to contain setting a ground value that displays the worth of a drug to sufferers, argues Darius Lakdawalla, chief scientific officer on the USC Schaeffer Middle for Well being Coverage & Economics, in a brand new opinion piece.
At present, Medicare has a method for negotiating costs down from a “ceiling value.” A ground value method, although, “would function a test in opposition to arbitrarily giant value cuts,” Lakdawalla writes, and the 2 pricing formulation mixed would set excessive and low boundaries and supply guideposts for drugmakers and their traders.
“The shortage of predictability undermines the aim of encouraging higher innovation, as a result of if at this time’s traders can’t anticipate how drug costs will likely be set 10 years from now, they’re more likely to discover different locations to place their cash,” he writes.
Biotech founders have extra diluted possession than in different sectors
Usually in enterprise capital, new traders take part every new spherical of funding, main the possession stake of the founding workforce to say no. A new report concluded that founding groups in biotech are inclined to expertise larger dilution in possession than startups that promote digital merchandise like these within the well being tech, fin tech, and software program sectors.
In biotech, founding groups maintain a median 50% possession stake after the seed spherical, a determine that drops right down to 11% after the Sequence B, in line with the information, analyzed by Carta, an organization that gives software program providers to startups and traders.
Compared, in well being tech, the median possession stake for founding groups after the seed spherical is 54%, and it drops down to twenty% after the Sequence B.
Sectors that make bodily merchandise are extra reliant on preliminary capital and intensive analysis and growth earlier than manufacturing can start, and the tradeoff for elevating that capital can in some circumstances be greater dilution, the report stated.
The report additionally discovered that biotech startups on common have bigger founding groups than corporations in all the opposite sectors that have been analyzed. Among the many biotech startups that Carta checked out, 13% had one founder, whereas 20% had 5 founders.
Extra reads
- Overwhelmed down underneath Biden, large pharma hopes for brand spanking new chapter underneath Trump, Wall Road Journal
- Sanofi is warned by the FDA over ‘vital’ issues at a key manufacturing plant, STAT
- Eleos raises $60 million for AI scribe for behavioral well being suppliers, STAT
