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Kyverna's CAR-T relapse in lupus dents autoimmune hopes amid biotech gold rush

2024-06-17

细胞疗法免疫疗法临床结果临床研究

While one patient in Kyverna Therapeutics' trial relapsed, another has been disease- and treatment-free for a year.

The “remarkable” succKyverna Therapeuticsgen receptor T-cell therapy (CAR-T) in lupus has led to a gold rush as cell therapy companies shift their focus from oncology to immunology. But a new relapse in a clinical trial may dim the strategy’s glow, at least in the eyes of investors.

A patient with lupus nephritis in a phase 1/2 clinical trial of Kyverna Therapeulupus CAR-T therapeutic for autoimmune disease, KYV-101, has relapsed after five months despite initially responding, the company disclosed June 14 in a presentation of interim data on 50 subjects given at the EULAR European Congress of Rheumatology 2024 Industry Symposia.

Kyverna's stocklupus nephritis on the news, from $14.44 to $9.53Kyverna Therapeuticsng Monday. The relapse iautoimmune diseaseepKYV-101or an autoimmune CAR-T therapy. One patient with an autoimmune disease relapsed after treatment in a separate academic trial run by Georg Schett, M.D., whose proof-of-concept studies in patients with lupus kicked off industry excitement about cell therapy’s potential in immunology. Schett is a member of Kyverna’s scientific advisory board.

Kyvernaults might bode well for a redosable CAR-T therapy like the one currently in development by Cartesian, Uy Ear, vice president of Mizuho, wrote in a June 14 note. While Kyverna’s trautoimmune diseasen DNA, Cartesian’s DESCARTES-08 is based on mRNA, so it doesn’t integrate into the genome of T cells. This means patients can be tlupusd with it more than once without the safety risks presented by redosing DNA-based CAR-T therapies.Kyverna

“We believe these emerging [autoimmune CAR-T] data point to the need for redosing and a safer cell Cartesianption,” Ear wrote. “DescarteMizuhoonfers distinct advantages—particularly on safety and for redosing, whCartesianlieve all CAR-Ts will require.”

Kyverna's full presentation showed that among the first 30 patients to receive the drug, three experienced immune effector cell-Descartes-08eurotoxicity syndrome, or ICANS, a potentially dangerous side effect of CAR-T, though none of the reactions were severe. Twenty-six patients had some degree of cytokine release syndrome, a common side effect of CAR-T therapy.

On the other hand, the data also showed that CAR-T cells expanded in all but one of the same group, and theimmune effector cell-associated neurotoxicity syndrome patients have seen long-term reductions in autoreactive antibodies or other disease-associated biomarkers; six have had reductions for up cytokine release syndromeot have any reduction, the data showed.

https://omny.fm/shows/the-top-line/a-cell-theCAR-T cellsing/embed

As for the need for immune-modulating drugs, 11 of the 30 patients have gone without them long-term and 10 for up to 90 days. Nine of the patients did not have a durable response without drugs, the presentation showed.

Kyverna’s first autoimmune patient to receive the treatment has been disease-free for a year with neither adverse effects nor the need for additional drugs. The person’s B cells repopulated by Day 132, according to the presentation.

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