KT501 / Kali Therapeutics, Sanofi - LARVOL DELTA

Kali Therapeutics Receives U.S. FDA Clearance for KT501 Investigational New Drug Application (PRNewswire) - "IND clearance enables U.S. clinical development of KT501, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager for B cell–mediated autoimmune diseases, building on safety data generated in the ongoing Australian first-in-human study in rheumatoid arthritis."

IND • Rheumatoid Arthritis

Kali Therapeutics signs deal with Sanofi to develop autoimmune treatment (The Economic Times) - "Under the deal, Sanofi will obtain global rights to KT501, a tri-specific antibody utilizing Kali Therapeutics' proprietary discovery research platform...Kali therapeutics recieved $180 million in up-front and near-term payments and is eligible for up to $1.05 billion in development and commercial milestone payments."

Licensing / partnership • Rheumatoid Arthritis

Kali Therapeutics Announces First Patient Dosed in Phase 1a Clinical Trial of KT501 for Rheumatoid Arthritis (PRNewswire) - "The First-in-Human (FIH) Phase 1a study (NCT07234773) is an open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KT501 administered as a single subcutaneous injection in adult participants with RA."

First-in-human • Trial status • Rheumatoid Arthritis

A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA). (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Kali Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | N=14 ➔ 24

Enrollment change • Enrollment open • First-in-human • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology