Kyverna Therapeutics, Inc.

German physicians at Ruhr-University Bochum successfully treated two patients with chronic inflammatory demyelinating polyneuropathy (CIDP) using CAR-T cell therapy, achieving over 200% improvement in clinical scores and neurophysiological tests.

The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals.

The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.

• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with potential total value reaching $281.7 billion when including undisclosed deals. • Since 2014, 89 CAR-T companies have secured $7.7 billion in venture capital funding, while 42 companies have raised $6.4 billion through IPOs, demonstrating sustained investor confidence. • Despite a slowdown in M&A activity in 2024, the sector continues to expand with 170+ companies developing 1,944 therapies, including 244 trials targeting solid tumors beyond the current blood cancer focus.

• Donanemab's enhanced titration method significantly reduces ARIA-E frequency and severity while maintaining amyloid reduction in Alzheimer's patients. • Liraglutide demonstrates neuroprotective effects against Alzheimer's disease dementia, highlighting the potential of GLP-1 analogues in AD treatment. • Tolebrutinib shows promise in slowing disability progression in non-relapsing secondary progressive multiple sclerosis patients in the HERCULES trial.

UChicago Medicine launched a Phase 2 clinical trial to explore CAR T-cell therapy for systemic lupus erythematosus, inflammatory myositis, and systemic sclerosis.

The lupus nephritis clinical trial pipeline is robust, featuring over 30 companies developing more than 35 therapies.

KYV-101, an experimental cell therapy, has been granted orphan drug status by the European Medicines Agency for the treatment of myasthenia gravis (MG).

The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies.

• The gene therapy market is experiencing substantial growth, fueled by technological advancements, increased investments, and a deeper understanding of genetic diseases. • Key players are actively engaging in collaborations, mergers, and acquisitions to enhance their research and development capabilities and broaden their product portfolios. • Regulatory bodies like the FDA and EMA are expediting the approval process for gene therapies, acknowledging their potential in addressing unmet medical needs. • Ethical considerations and public perception surrounding gene editing, particularly germline modifications, remain critical factors influencing market dynamics and regulatory policies.