Kyverna’s CAR-T Relapse in Lupus Dents Autoimmune Hopes Amid Biotech Gold Rush

1. Relapse in Lupus Patient: A patient with lupus nephritis in a phase 1/2 clinical trial of Kyverna Therapeutics' CAR-T therapeutic, KYV-101, has relapsed after five months despite initially responding.
2. Impact on Stock: Kyverna's stock fell about 34% following the news, from $14.44 to $9.53 in premarket trading.
3. CAR-T Therapy: Chimeric antigen receptor T-cell (CAR-T) therapy has shown promise in treating autoimmune diseases like lupus, but the relapse raises concerns about its long-term effectiveness.
4. Industry Reaction: Wall Street analysts were generally impressed by the results, but the relapse has tempered expectations. Some analysts believe that redosable CAR-T therapies might be needed to address the issue of relapse.
5. Safety Concerns: The treatment has shown mild side effects, including immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome, but these were not severe.
6. Long-term Benefits: Despite the relapse, some patients have shown long-term reductions in autoreactive antibodies or other disease-associated biomarkers, and a few have been able to stop taking immune-modulating drugs.
7. Industry Competition: Other companies like Cabaletta, Novartis, iCell Gene Therapeutics, and JW Therapeutics are also working on CAR-T therapies for autoimmune diseases, creating a competitive landscape.