Kali, Sanofi's tri-specific T-cell engager cleared for US study in rheumatoid arthritis

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  "detected_at": "2026-09-03T16:11:11+00:00",
  "company": {
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    "url": "https://allsci.com/news/regulatory/kt501-fda-clearance-kali-therapeutics-receives/",
    "title": "Kali, Sanofi's tri-specific T-cell engager cleared for US study in rheumatoid arthritis - AllSci",
    "excerpt": "California-based Kali Therapeutics announced US FDA clearance of an investigational new drug (IND) application for KT501, a trispecific B-cell–depleting antibody licensed globally to Sanofi in a deal worth up to approximately USD 1.23 billion. The clearance allows Kali to expand development of the autoimmune candidate into the US after beginning first-in-human testing in rheumatoid arthritis in Australia. KT501 is an IgG-like trispecific antibody that engages CD19, BCMA, and CD3, with the aim of depleting both mature B cells and plasma cells while recruiting T cells to drive cytotoxic activity. A masking design on the CD3-binding arm is intended to reduce cytokine release, although whether that translates into a wider therapeutic window in humans remains to be established. The Phase Ia first-in-human trial ( NCT07234773 ) in Australia is an open-label, dose-escalation study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous dose. Estimated completion is August 2027. The US clearance will allow expansion of clinical activity to American sites, with RA as the entry indication for a broader program targeting B cell–mediated autoimmune diseases. The broader competitive context for multi-targeted B-cell depletion in autoimmune disease is evolving rapidly, driven in part by early signals from CD19-directed CAR-T therapies in conditions...",
    "product": "KT501",
    "summary": "Sanofi has licensed Kali Therapeutics' KT501, a trispecific antibody, in a global deal potentially worth up to $1.23 billion.",
    "planning": false,
    "image_url": "https://allsci.com/og/article/news/regulatory/kt501-fda-clearance-kali-therapeutics-receives.png",
    "confidence": 0.9,
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    "published_at": "2026-09-03T16:11:11Z",
    "article_sentence": "California-based Kali Therapeutics announced US FDA clearance of an investigational new drug (IND) application for KT501, a trispecific B-cell–depleting antibody licensed globally to Sanofi in a deal worth up to approximately USD 1.23 billion.",
    "amount_normalized": 1230000000,
    "related_company_name": "Kali Therapeutics",
    "related_company_domain": "kalitherapeutics.com"
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