JNJ-5939 / Kaken Pharma, J&J - LARVOL DELTA

AI-Guided Generation and Preclinical Evaluation of an OX40L-IL31 Bispecific Antibody (AAD 2026) - "It potently inhibits IL31 activity in IL31R-STAT and HaCaT assays, outperforming Nemolizumab and NM26-2198 analogues. Meanwhile, HXN-1022 exhibits robust in vitro activity for OX40L in the OX40-NFκB reporter assay, OX40L-induced PBMC activation, and Th2 differentiation experiments, with potency comparable to Amlitelimab... HXN-1022 is a first-in-class bsAb that simultaneously targets IL-31 and OX40L, two key drivers of inflammation and pruritus in skin disease. These findings support HXN-1022 as a promising therapeutic candidate for AD and other autoimmune skin disorders. HXN-1022 is currently under IND-enabling studies."

Bispecific • Preclinical • Atopic Dermatitis • Dermatitis • Graft versus Host Disease • Immunology • Inflammation • Pruritus • IL1R1 • TNFSF4

AI-Guided Generation and Preclinical Evaluation of an OX40L-IL31 Bispecific Antibody (AAAAI 2026) - "It effectively inhibits IL31 biological activity in the IL31R-STAT reporter assay and HaCaT cell activation, with superior efficacy to the benchmarks, Nemolizumab and NM26-2198 analogs. For the OX40L arm, HXN-1022 significantly blocks OX40L-induced downstream signaling and PBMC activation, with potency comparable to Amlitelimab...The bsAb represents a highly promising therapeutic option for patients with autoimmune skin disorders. HXN-1022 is currently under IND-enabling studies."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • Inflammation • Pruritus • IL1R1 • TNFSF4

DUPLEX-AD: A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P2 | N=256 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2026 ➔ Mar 2026

Enrollment closed • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Johnson & Johnson Statement on the Phase 2b DUPLEX-AD Study (J&J Press Release) - "The results of a planned interim analysis met prespecified criteria for early termination of the study, as they did not meet the high-bar efficacy we established for advancing our clinical development programs for atopic dermatitis. JNJ-5939 was well tolerated in the study."

P2b data • Trial termination • Atopic Dermatitis

Ai-guided Generation and Preclinical Evaluation of an OX40L-IL31 Bispecific Antibody (ACR Convergence 2025) - "This antibody significantly inhibits IL31 biological activity, as demonstrated in the IL31R-STAT reporter assay and HaCaT cell activation assay, outperforming the benchmark antibodies Nemolizumab and NM26-2198 analogs. HXN-1022 is a first-in-class bsAb that simultaneously targets IL31 and OX40L, two major pathogenic factors associated with skin inflammation and itch. The bsAb holds great potential as a more effective therapeutic option for patients with a variety of autoimmune skin disorders."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • Inflammation • Pruritus • CD123 • IL1R1 • IL31RA • TNFSF4

AI-Guided Generation and Preclinical Evaluation of an OX40L-IL31 Bispecific Antibody (EADV 2025) - "The antibody significantly inhibits IL31 biological activity in the IL31R-STAT reporter assay and HaCaT cell activation, with an efficacy that is superior to the benchmark Nemolizumab and NM26-2198 analogs. HXN-1022 is a first-in-class bsAb that simultaneously targets IL31 and OX40L, two major pathogenic factors associated with skin inflammation and itch. The bsAb holds great potential as a more effective therapeutic option for patients with a variety of autoimmune skin disorders."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Inflammation • Pruritus • CD123 • IL1R1 • IL31RA • TNFSF4

Evaluation of NM26-2198 in Healthy Subjects and in Patients with Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=126 | Terminated | Sponsor: Numab Therapeutics AG | Trial completion date: Apr 2025 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Oct 2024; Asset acquisition by Johnson & Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.

Trial completion date • Trial primary completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Johnson & Johnson Strengthens Pipeline to Lead in Atopic Dermatitis With the Completion of the Acquisition of Yellow Jersey Therapeutics, Gaining Ownership of NM26 (Businesswire) - "Johnson & Johnson...announced today that it has successfully completed the acquisition of Yellow Jersey, a demerged subsidiary of Numab Therapeutics to secure the global rights to NM26, a novel, investigational first-in-class bispecific antibody, in an all-cash transaction of approximately $1.25 billion, as announced on May 28, 2024."

M&A • Atopic Dermatitis • Dermatitis • Immunology

Numab Therapeutics Announces Johnson & Johnson to Acquire its Wholly-Owned Subsidiary Yellow Jersey Therapeutics Including Rights to NM26, a Bi-Specific Antibody for the Treatment of Atopic Dermatitis (GlobeNewswire) - "Numab Therapeutics AG...announced today that the Company has entered into a definitive agreement whereby Johnson & Johnson...acquires Yellow Jersey Therapeutics (YJT), a wholly-owned subsidiary of Numab to be spun-off to Numab's shareholders. YJT comprises all assets relating to NM26, an investigational first-in-class bi-specific antibody for the treatment of atopic dermatitis (AD) set to advance into Phase 2 clinical development. Under the terms of the acquisition, J&J will pay a purchase price of $1.25 billion in cash for YJT....The closing of the transaction is expected to occur in the second half of 2024, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions."

M&A • Atopic Dermatitis

Evaluation of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Numab Therapeutics AG | N=102 ➔ 140

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Bispecific, Tetravalent Antibody Targeting Inflammatory and Pruritogenic Pathways in Atopic Dermatitis. (PubMed, JID Innov) - "In reporter cell lines, NM26-2198 concomitantly inhibited IL-4/IL-13 and IL-31 signaling with a potency comparable with that of the combination of an anti-IL-4Rα antibody (dupilumab) and an anti-IL-31 antibody (BMS-981164). In a repeat-dose, good laboratory practice toxicology study in cynomolgus monkeys, no adverse effects of NM26-2198 were observed at a weekly dose of 125 mg/kg. Together, these results justify the clinical investigation of NM26-2198 as a treatment for moderate-to-severe AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • FCER2 • FCGR2A • FCGR2B • IL13 • IL4

Numab Therapeutics Announces First Patient Dosed in Phase 1 Multiple Ascending Dose (MAD) Study of NM26 for Moderate to Severe Atopic Dermatitis (Businesswire) - "Numab Therapeutics AG...announced today that the first patient has been dosed in the multiple ascending dose (MAD) study of the Phase 1a/b clinical trial of NM26, a first-in-class bi-specific antibody for the treatment of moderate-to-severe atopic dermatitis (AD)...The MAD study in AD patients is a planned continuation of the Company’s ongoing single ascending dose (SAD) portion of the Phase 1a/b trial in healthy volunteers....'We look forward to evaluating the potential of NM26 and expect to report preliminary data from the MAD part of the study in mid-2024.'"

P1 data • Trial status • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Numab Therapeutics AG

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

The development and characterization of NM26-2198, an anti-IL-4Ra anti-IL-31 bispecific antibody to reduce inflammatory immune activation and pruritus in patients with moderate to severe atopic dermatitis (EADV 2022) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus