Kyverna Therapeutics, Inc.

Adicet Bio's ADI-100, a CAR-engineered gamma delta T-cell therapy, received FDA clearance to recruit patients with idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) into its phase 1 clinical trial for lupus nephritis (LN). The trial now includes arms for LN and systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic autoantibody associated vasculitis (AAV), and IIM and SPS, with treatment for the latter expected to start in Q1 2025.

Amgen's Phase 3 results for rocatinlimab in atopic dermatitis and Uplizna in myasthenia gravis were met with skepticism by analysts, who noted rocatinlimab's underwhelming efficacy and safety concerns, while Uplizna's potential as a second-line treatment was seen as sizable but not a threat to market leaders.

Three drug startups raised over $700 million in IPOs, marking a significant event in 2024's biotech market. Bicara Therapeutics secured $315 million, Zenas BioPharma $225 million, and MBX Biosciences $163 million. Despite challenges, these companies have drugs in later stages of testing, reflecting a trend of later-stage IPOs amidst market uncertainties.

Latigo Biotherapeutics appoints Tim Lugo as CFO and adds Beth Seidenberg and Jim Tananbaum to its board, aiming to advance non-opioid pain medicine development.

Biotech IPOs surged to $3.72bn in Q1 2024, the highest in over a year, but a global stock market crash threatens future listings. High interest rates and market volatility may delay IPOs, despite a positive shift with six IPOs raising nearly $5bn in H1 2024.

Kyverna Therapeutics' KYV-101, a new CAR-T cell therapy for stiff person syndrome, received FDA's RMAT designation, promising accelerated development and approval. The therapy aims to reset patients' immune systems, offering hope for durable remission. Clinical trials show positive results, with ongoing studies for multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus.

The Systemic Sclerosis Treatment Market is projected to grow significantly by 2034, driven by increasing prevalence, awareness, and FDA approvals like CABA-201's Orphan Drug and Fast Track Designations. Key players include Kyowa Hakko Kirin, AstraZeneca, and others, with therapies such as LUMICEF and SAPHNELO leading the pipeline. The market's expansion is also fueled by ongoing clinical trials and the development of new treatments targeting systemic sclerosis and related conditions.

Recent research, particularly by Georg Schett's team, shows cellular medicines can induce remission in lupus and other autoimmune diseases, sparking industry interest and clinical trials. CAR-T therapies, derived from patients' cells, show promise in rewiring immune systems, with some patients maintaining remission for years. Despite challenges like cost and side effects, the approach represents a significant advancement in autoimmune disease treatment.