BMS-986326 / BMS, BMS-Bain Capital Immunology NewCo - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Bristol Myers Squibb and Bain Capital Create New Company Dedicated to Developing Innovative Immunology Therapies that Address the Unmet Medical Needs of Patients (The Globe and Mail) - "Bristol Myers Squibb...and Bain Capital today announced the creation of a new independent biopharmaceutical company ('NewCo') focused on developing new therapies for autoimmune diseases that address significant unmet needs of patients. The newly formed company launches with five immunology assets in-licensed from BMS and a $300 million financing commitment that was led by Bain Capital...The NewCo has a broad pipeline consisting of three clinical-stage and two Phase 1-ready investigational medicines that each target promising mechanisms in autoimmune diseases. The most advanced assets in the NewCo’s portfolio are afimetoran, an oral, potential best-in-class TLR7/8 inhibitor that is currently being studied in a Phase 2 clinical trial for systemic lupus erythematosus (SLE), and BMS-986322, an oral TYK2 inhibitor, which successfully established proof-of-concept in a positive plaque psoriasis Phase 2 trial..."

Commercial • Atopic Dermatitis • Psoriasis • Systemic Lupus Erythematosus

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Nov 2025 ➔ Apr 2026 | Trial primary completion date: Nov 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2025 ➔ Nov 2025 | Trial primary completion date: Aug 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Phase classification: P1b ➔ P1

Phase classification • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

BMS-986326 is a novel IL-2/CD25 fusion protein that induces highly selective and durable expansion of regulatory T cells in vitro and following single doses in healthy volunteers (EADV 2023) - P1 | "In whole blood from patients with immune-mediated disease, BMS-986326 induced comparable maximal IL-2R signaling to that in blood from HVs. In a SAD study in HVs, BMS-986326 was generally well-tolerated with robust, selective, durable, and dose- dependent Treg expansion. Further clinical studies are warranted to investigate how BMS-986326 may restore immune homeostasis by Treg expansion in patients with immune-mediated dermatologic diseases."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilia • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD8 • IL2 • IL2RA • ISG20 • STAT5

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1b | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1b | N=60 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus