Why is it surprising when drug executives stay true to their word?

And can neoantigen cancer vaccines work? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

Oruka Therapeutics CEO Lawrence Klein joins us to discuss how his company raised its first round of financing before competing with major players in the inflammation space. We also discuss the latest news in the life sciences, including the end of the Amylyx ALS saga, another use case for GLP-1s, and a hurdle in Verve's gene editing plans.

Listen here.

Autoimmune disease

Caribou developing cell therapy for lupus

Caribou Biosciences has added an off-the-shelf cell therapy for patients with the autoimmune disease lupus to its research pipeline. A clinical trial will begin before the end of the year, the company said.

Autoimmune disease has become the new focus for almost all of the cell therapy companies set up originally to target blood cancers. Lupus, like certain types of blood cancers, is caused by faulty B cells, so in theory, engineering T cells to identify and remove faulty B cells could potentially provide patients with a functional cure.

The autoimmune shift is supported by data presented last December by a group of German scientists who used personalized T cells — CAR-T therapy — to induce complete remissions in 14 patients with severe autoimmune disease, including eight patients with lupus.

Caribou's experimental treatment, called CB-010, is an off-the-shelf, CD-19-directed CAR-T. In the soon-to-start lupus study, Caribou intends to use HLA partial matching between patients and the donor T cells that could improve outcomes, the company said. CB-010 is also being investigated as a treatment for B-cell lymphoma.

Cabaletta Bio is another biotech shifting the development of CAR-T therapies to autoimmune diseases. Initial data on its lead treatment, called CABA-201, will be reported from studies in patients with myositis and lupus later this year.

legal affairs

Sanofi resolves most Zantac litigation

Sanofi will settle about 4,000 personal injury claims from people who used the heartburn drug Zantac — resolving all of its litigation across the country, except in Delaware, FierceBiotech writes.

Zantac was developed by GSK and approved in 1983. In 2020, there was concern that ranitidine, the drug's main ingredient, could potentially transform into a carcinogen over time, or when exposed to high temperatures. Many of these Zantac cases were dropped against companies like Pfizer in 2022 when a Florida judge rejected the claims that Zantac causes cancer.

"Sanofi is settling these cases, not because we believe the claims have any merit, but rather to avoid the expense and ongoing distraction of the litigation," a Sanofi spokesperson said. "No concessions of liability have been made."

biotech scorecard

Have you read Adam's newsletter yet?

A once-struggling company developing a marijuana-esque weight loss drug has suddenly become one of the best-performing biotech stocks this year. Skye Bioscience's antibody drug, nimacimab, targets the body's endocannabinoid stem. Investors took interest, of course, when evidence emerged that it could pair with GLP-1 drugs. Later this year, Skye will kick off a Phase 2 study testing nimacimab alone, and in combination with a GLP-1 drug.

Also, last week a federal judgment dismissed defamation lawsuits filed by Cassava Sciences against three people who criticized the company's experimental Alzheimer's treatment. The defendants also had been shorting Cassava's stock. Adam, who repeatedly voiced the same critique, pointed out that the judge acknowledged that "the short positions on their do not support a showing of actual malice," but rather a rational choice given that Cassava's stock was overvalued.

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