lomedeucitinib (BMS-986322) / BMS, Beeline Medicines - LARVOL DELTA

Beeline Medicines…announced the closing of a $126.3 million Series A extension, bringing its total Series A financing round to $426.3 million. (GlobeNewswire) - "The proceeds from the upsized Series A will support the initiation of several clinical studies across the Company’s broad immunology portfolio, including planned pivotal development of its lead program, afimetoran, in lupus...The Company has commenced pivotal development preparations in lupus ahead of the expected Phase 2 readout of afimetoran in systemic lupus erythematosus in the second half of 2026...Over the next 12 months, the Company expects to initiate additional clinical trials across its pipeline, including for lomedeucitinib...and BLN-481 (formerly BMS-986481)."

Financing • P2 data • Pipeline update • Atopic Dermatitis • Immunology • Inflammation • Systemic Lupus Erythematosus

Beeline Medicines formally launched Wednesday with $300 million in series A financing and a ready-made pipeline of immunology assets in-licensed from Bristol Myers Squibb that it hopes will help reshape how autoimmune and inflammatory diseases are treated. (Firstwordpharma Press Release) - "Beeline's lead programme, afimetoran (BMS-986256), is a once-daily oral small molecule designed to inhibit toll-like receptors 7 and 8 (TLR7/8), components of the innate immune system linked to the aberrant activation seen in systemic lupus erythematosus...'we expect several additional clinical trials to start across our pipeline over the next 12 months.'...Beyond afimetoran, the pipeline also includes an IL-2-CD25 fusion protein dubbed BMS-986326...The company is also working on a once-daily oral TYK2 inhibitor called lomedeucitinib (BMS-986322)....Additionally, the pipeline includes two IND-stage biologics, BMS-986481 and BMS-986498..."

Financing • New trial • Atopic Dermatitis • Immunology • Psoriasis • Systemic Lupus Erythematosus

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

Bristol Myers backs out of Dupixent fight, axing allergy asset despite phase 3 win (FierceBiotech) - "Bristol Myers Squibb has continued its ruthless cost-cutting push, dropping plans to commercialize a rival to Dupixent despite meeting its phase 3 goals and pumping the brakes on a would-be Sotyktu successor...Cendakimab fell short of the bar...Last year, BMS reported a phase 3 trial in eosinophilic esophagitis met both co-primary endpoints, positioning the drugmaker to challenge Dupixent and Takeda’s Eohilia for the market...Yet, BMS quietly removed cendakimab from the pipeline in its fourth-quarter update...'Given the data that we have seen, we've made the decision not to commercialize cendakimab'....Similar thinking underpinned BMS’ decision on investing in TYK2."

Commercial • Discontinued • Eosinophilic Esophagitis • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=109 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed

Trial completion

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2 trial • Dermatology • Immunology • Psoriasis

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | N=44 ➔ 76 | Trial completion date: Jan 2023 ➔ Nov 2023 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed | N=30 ➔ 42

Enrollment change • Trial completion

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

A Study Investigating Interactions Between BMS-986322 and Rosuvastatin or Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants (clinicaltrials.gov) - P1 | N=171 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=432 ➔ 171 | Trial completion date: Oct 2020 ➔ Jul 2021 | Trial primary completion date: Oct 2020 ➔ Jul 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Bristol-Myers Squibb’s novel, oral, selective TYK2 inhibitor delivered significant skin clearance in patients with moderate to severe plaque psoriasis in phase 2 trial (Bristol-Myers Squibb Press Release) - P2, N=270; IM011-011 (NCT02931838); Sponsor: Bristol-Myers Squibb; "Bristol-Myers Squibb Company...today announced results from a Phase 2 study of BMS-986165...in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment....with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported....In addition, data from the Phase 2 study describing biomarker changes and the selectivity of BMS-986165 for TYK2 in relation to clinical responses will be presented at EADV on Sept. 15, during a late-breaker session. 'Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,' said Dr. Kim Papp, M.D., Ph.D..."

P2 data • Immunology • Psoriasis