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Good morning, everyone. Damian here with data on biotech’s belt-tightening, the advance of xenotransplantation, and the escalating Ozempic panic.
The need-to-know this morning
Biotech VC is nearing a six-year slump
Venture capital dealmaking in the life sciences is on pace for its slowest year since 2017, according to new data, both in number of deals and amount of money raised.
As STAT’s Allison DeAngelis reports, there have been roughly 1,300 life sciences VC deals this year, according to an analysis from Pitchbook and the National Venture Capital Association. That means the sector is on pace for a roughly 20% decline in deals compared to 2022.
Actual funding levels are trending at a six-year low, and the number of exit opportunities — the acquisitions, mergers, or IPOs that help VCs recoup their investment — are at their lowest point in more than a decade. There have been just 56 VC exits so far this year, compared to 89 last year and 195 in 2021.
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CRISPR’d pig organs move closer human transplant
The long-struggling science of xenotransplantation took a step forward yesterday when the startup eGenesis reported a genome-edited breed of miniature pig produced kidneys that were successfully transplanted into monkeys.
As STAT’s Megan Molteni reports, the organs, derived from pigs containing up to 69 genetic changes, functioned well in their simian recipients for an average of 176 days and in one animal for more than two years. The results, published in Nature, are part of a historically large experiment meant to develop CRISPR-edited pig organs that can be safely transplanted into humans.
That goal remains years away. In the U.S., eGenesis plans to conduct another long-term survival study in non-human primates, a multi-year process, before asking the FDA for permission to begin a human clinical trial.
Cell and gene therapies could be a safer bet than other drugs
One of the drug industry’s most widely cited stats is that 90% of drugs that enter clinical trials fail to win approval. But a new analysis suggests that cutting-edge cell and gene therapies are more likely than more traditional treatments to succeed in cancer and rare disease trials.
Researchers pulled past data from IQVIA, the Biotechnology Innovation Organization, and ClinicalTrials.gov and found that CAR-T and T cell receptor therapies for blood cancers that reached clinical trials were twice as likely to be approved as the average drug in this space (17.2% vs 7.5%). They also found that gene therapies for rare disease were twice as likely to win approval compared to drugs developed to treat rare hematologic, autoimmune, metabolic, eye, and neurological disorders (28% vs. 13%).
The results, reported in a research brief by NewDigs, a drug development think tank at Tufts Medical Center, come with caveats. The number of approved cell and gene therapies is relatively small. And the study was inspired and partially funded by the Alliance for Regenerative Medicine, a group that advocates for cell and gene therapy. But Mark Trusheim, one of the study’s leaders, believes the analysis is an encouraging sign that scientific discoveries in this space can be translated into actual drugs: “They seem to be a reasonable be a reasonable bet,” he said of cell and gene therapies. “Hopefully, it’s encouraging for future investors to take a look.”
Wall Street is reaching peak Ozempic panic
Earlier this week, it was NASH. Companies developing medicines for the prevalent fatty liver disease saw their share prices tumble in part because the market believes medicines like Ozempic, with their dramatic effects on body weight, will decimate demand for NASH drugs.
And now it’s dialysis. Davita and Fresenius, makers of dialysis machines, lost about 20% of their value yesterday on the news that Novo Nordisk’s drug had succeeded in a study testing whether it could slow the progression of kidney disease for patients with Type 2 diabetes.
Both reactions seem more than a little hasty. Neither Ozempic nor any other GLP-1 treatment is approved for NASH, and manufacturers are struggling to keep up with current demand, much less the kind of market saturation that would be required to displace dialysis.
The Ozempic panic is hardly limited to health care. Executives from Walmart, Pepsi, and McDonald’s have all faced recent investor questions on whether the rise of GLP-1 medicines poses a threat to their businesses. And while the impacts remain both hypothetical and questionable, that doesn’t keep stock prices from moving on the specter of GLP-1.
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This content was originally published here.
