NAV-242 / Sera Medicines, Navigator Medicines, IMBiologics - LARVOL DELTA

Preclinical characterization of NAV-242, a half-life extended bispecific antibody against TNFα and OX40L (EADV 2026) - No abstract available

Bispecific • Preclinical • TNFA • TNFSF4

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in adults with Hidradenitis Suppurativa. (ANZCTR) - P1 | N=6 | Withdrawn | Sponsor: Navigator Medicines | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Dermatology • Hidradenitis Suppurativa • Immunology

Preclinical Characterization of NAV-242, a half-life extended bispecific antibody against TNF-alpha and OX40L (AAD 2026) - "NAV-240 is a tetravalent bispecific antibody designed to address this unmet need by blocking both TNF-α and OX40L. Enhanced stability and in vivo PK were achieved upon generation of NAV-242, a potential best-in-class therapeutic for autoimmune conditions like hidradenitis suppurativa. Clinical studies with NAV-242 are scheduled to initiate in 2026."

Bispecific • Preclinical • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

NAV-242, a Next-Generation, Half-Life Extended Bispecific Antibody (GlobeNewswire) - "Navigator has achieved first participant dosed in the Phase 1 study of its next-generation subcutaneous therapeutic, NAV-242. The Phase 1a/1b portion will assess the safety, tolerability, PK, PD and immunogenicity through SAD and MAD in healthy participants. The phase 1c portion will evaluate the therapy in patients living with HS. Results of phase 1a are expected in Q4 2026. This important progress follows promising pre-clinical data (Poster P74490) that showed enhanced stability and extended PK in vivo compared with NAV-240, suggesting that every other month or quarterly subcutaneous dosing of NAV-242 can be achieved."

P1 data • Preclinical • Trial status • Hidradenitis Suppurativa

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in adults with Hidradenitis Suppurativa. (ANZCTR) - P1 | N=6 | Not yet recruiting | Sponsor: Navigator Medicines

New P1 trial • Dermatology • Hidradenitis Suppurativa • Immunology

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in Healthy Adults. (ANZCTR) - P1 | N=48 | Not yet recruiting | Sponsor: Navigator Medicines

New P1 trial • Immunology

FDA Clears IND Allowing Phase 2a Trial of NAV-240 in Hidradenitis Suppurativa to Begin Dosing in Q1 2026 (The Manila Times) - "HREC Approval Received for Next-Generation Bispecific NAV-242 to Initiate First-in-Human Phase 1 Program with Ph1a Dosing to Begin in Q1 2026...SAD results are expected in 4Q2026....Navigator Medicines is expanding its rights to NAV-240 and NAV-242 outside of Korea to now include China, providing the company with broadened clinical development and commercialization opportunities."

Commercial • First-in-human • New P1 trial • New P2a trial • Crohn's disease • Hidradenitis Suppurativa