NAV-240 / IMBiologics, Y-Biologics, Korea Kolmar, Sera Medicines, Huadong Medicine, Navigator Medicines - LARVOL DELTA

Late-Breaking Data on the Role of TNFα and OX40L in Draining Tunnel Lesions (GlobeNewswire) - "Emerging data from skin sections collected from patients living with HS demonstrates that spatially TNFα and OX40L were both found close to tunnel-associated cells suggesting they both play important roles in HS pathology. This research was conducted by Johannes Griss, from the Medical University of Vienna with support from Navigator Medicines, and presented during a late-breaking session. These data suggest that bsAb that can act on both TNFα and OX40L, like Navigator’s NAV-240 and NAV-242 program, could reduce inflammation with specificity at the site of tunnel development. In more advanced HS disease, draining tunnels, also known as sinus tracts or fistulas, can form under the skin connecting lesions and leaking fluid and pus, leading to pain, scarring and a heavier daily disease burden for patients."

Preclinical • Hidradenitis Suppurativa • Immunology

NAV-240 Development in HS Progressing Ahead of Schedule (GlobeNewswire) - "The program is recruiting patients ahead of schedule, reflecting the need for novel therapies in HS. Results are expected in Q3 2027 to inform future development of both NAV-240..."

P2 data • Trial status • Hidradenitis Suppurativa • Immunology

Navigator Medicines Presents New Data at EADV 2026 as Bispecific Antibody Program Advances at Speed in Hidradenitis Suppurativa (GlobeNewswire) - "Early Cohorts in Phase 1 Study of Next-Generation Subcutaneous Bispecific Antibody NAV-242 Indicate Extended Half Life (HLE) on Path to Goal of Delivering Best in Disease Efficacy, and Preferred Patient-Friendly Dosing in HS...New translational data from the Phase 1 SAD and MAD studies of NAV-240 (Poster P1749) to be presented at EADV 2026, assess the safety, tolerability, PK, PD and immunogenicity of NAV-240 after repeat dosing in 64 healthy volunteers at various doses. NAV-240 demonstrated an acceptable safety and tolerability profile with results consistent with the dual-targeting mechanism, low immunogenicity and retention of anti-viral T-cell functionality needed for long-term immune health...Pre-clinical data to be presented for NAV-242 (Poster P1782) show enhanced stability and extended PK in vivo compared with NAV-240, further supporting the potential for extended subcutaneous dosing of NAV-242."

P1 data • Preclinical • Hidradenitis Suppurativa • Immunology

Tunnel-associated keratinocytes in Hidradenitis suppurativa have a distinct pro-inflammatory program spatially associated with TNFα and OX40L positive cells (EADV 2026) - "This not only highlights the central role of TNFα and OX40L in HS but also reveals a surprising spatial specificity where TNFα-induced inflammatory genes are exclusively observed in tunnel-associated keratinocytes. Collectively, these data suggest that mechanistically a bispecific antibody neutralizing both TNFα and OX40L, such as NAV-240 or NAV-242, could specifically attenuate inflammation at a key disease node providing HS patients with an effective treatment option."

IO biomarker • Late-breaking abstract • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis • ANXA3 • CCL27 • CD36 • CTSC • CXCL1 • EGR3 • IL1B • ITGB6 • KLK6 • KRT17 • SCARB1 • SERPINB4 • TNFA • TNFSF4

Preclinical characterization of NAV-242, a half-life extended bispecific antibody against TNFα and OX40L (EADV 2026) - "NAV-240 is a tetravalent bispecific antibody designed to address this unmet need by blocking both TNF-α and OX40L. Conclusions 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 were initiated in early 2026."

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

Safety, PK, immunogenicity and biomarker modulation of NAV-240, an anti‑OX40L/TNFα bispecific antibody, in randomized, double-blind, single and multiple ascending dose Phase 1 studies in healthy volunteers (EADV 2026) - P1, P2 | "NAV-240 demonstrated pronounced, concentration-dependent reductions in inflammatory proteins, suggesting coordinated modulation of T helper 1/T helper 2/T helper 17 cells and metabolic pathways, many of which are associated with HS. Data from both the SAD and MAD studies informed dose selection for the ongoing Phase 2 study in HS patients (NCT07384975)."

Biomarker • Bispecific • Clinical • P1 data • Hidradenitis Suppurativa • Immunology • Inflammation • CCL19 • IL6 • TNFA • TNFSF4

NAV-240, an anti-OX40L/TNFα bispecific antibody, demonstrates biomarker modulation in Phase 1 randomized, double-blind studies of healthy volunteers (SID 2026) - "These data are indicative of target engagement and demonstrate that NAV-240 modulates biomarkers consistently with the dual targeting mechanism, supporting continued development in HS. Proteomic evaluation is ongoing and data from both biomarker approaches will be utilized to inform dose selection for subsequent studies."

Biomarker • Bispecific • Clinical • P1 data • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

Mainsail: A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Navigator Medicines, Inc.

Trial initiation date • Dermatology • Hidradenitis Suppurativa • Immunology

IMBiologics secures $5 mil. milestone as IMB-101 enters global phase 2 (Korea Biomedical Review) - "The payment followed the first patient dosing in the global phase 2 trial of IMB-101 (partner code name NAV-240), which is being conducted by the Korean company’s U.S. partner."

Financing • Trial status • Hidradenitis Suppurativa

Mainsail: A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=115 | Recruiting | Sponsor: Navigator Medicines, Inc.

New P2 trial • 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

A Phase 1b Randomized, Double-Blind Multiple-Ascending Dose Study of NAV-240, an anti-OX40L/TNF-alpha Bispecific Antibody, in Healthy Volunteers (AAD 2026) - "Treatment with NAV-240 in healthy volunteers to date demonstrates an acceptable safety/tolerability profile with pharmacokinetic exposure that supports once-monthly dosing in patients. Collectively, these data support the continued development of NAV-240 in complex autoimmune conditions like hidradenitis suppurativa."

Bispecific • Clinical • P1 data • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

Phase 1b Multiple Ascending Dose Study of NAV-240 (Poster P74215) (GlobeNewswire) - "New positive data presented at American Academy of Dermatology (AAD) Annual Meeting 2026....The clinical progress of NAV-240 builds on results from the multiple ascending dose (MAD) study which assessed the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and immunogenicity of NAV-240 after repeat dosing in 24 healthy volunteers at various doses. NAV-240 demonstrated a favorable safety and tolerability profile, predictable PK and low rates of immunogenicity, consistent with the earlier single ascending dose study (SAD). Dose-dependent reductions in biomarkers were also observed."

P1 data • Hidradenitis Suppurativa

Navigator Medicines…announced it has initiated patient dosing in its Phase 2a MAINSAIL clinical trial evaluating NAV-240, for the treatment of HS (GlobeNewswire) - "MAINSAIL, the Company’s first Phase 2a trial, is a multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of NAV-240 in adults living with moderate to severe HS. Efficacy including a reduction in abscesses, nodules, draining tunnels, as well as improvement in quality of life outcomes will be assessed. Recruitment for the program is ahead of expectations, reflecting enthusiasm for novel therapies in HS. Results are expected in H2 2027..."

P2a data • Trial status • Hidradenitis Suppurativa

NAV-240-201: A study to assess NAV-240 in adult participants with Hidradenitis Suppurativa (clinicaltrialsregister.eu) - P1/2 | N=40 | Not yet recruiting | Sponsor: Navigator Medicines Inc.

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

IMBiologics is pursuing the same dual-target approach. Its lead asset, IMB-101, is an OX40L and TNF bispecific antibody.... (Korea Biomedical Review) - "Ha said IMB-101 has received approvals to run trials in the United States and Canada and the company plans to expand into Europe in the first half of this year. He said IMBiologics expects topline results from a patient-based human proof-of-concept study around September next year...Ha also pointed to dosing and tolerability. He said a US phase 1 study recorded one drug-related adverse event among 30 subjects, and it was Grade 1. The company is targeting dosing every eight to 12 weeks....Ha said the company aims to pursue another major global transaction by 2028 and is targeting a global launch of IMB-101 in 2032."

Launch • P1 data • Trial status • Immunology

Mainsail: A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Navigator Medicines, Inc.

New P2 trial • Dermatology • Hidradenitis Suppurativa • 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

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of Intravenous NAV-240 in Adults. (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Southern Star Research | Recruiting ➔ Completed | Trial primary completion date: Aug 2025 ➔ Nov 2025

Trial completion • Trial primary completion date

A First-in-Human Phase 1a Randomized, Double-Blind, Single-Ascending Dose Study of NAV-240, an anti-OX40L/TNF-α Bispecific Antibody, in Healthy Volunteers (ISDS 2025) - "Treatment with NAV-240 in healthy volunteers was safe and well tolerated. The exposure profile of NAV-240 supports once-monthly dosing in patients. Collectively, these data support the continued development of NAV-240 in complex autoimmune conditions like hidradenitis suppurativa."

Clinical • First-in-human • P1 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

Navigator Medicines Completes Last Participant Last Visit (LPLV) in Phase 1b Trial of NAV-240, an OX40L and Anti-TNFα Bispecific Antibody for Autoimmune Diseases (The Manila Times) - "We are advancing NAV-240 at pace and are on track to share the Phase 1b results in Q1 2026 and proceed with NAV-240 Phase 2 evaluation in HS."

New P2 trial • P1 data • Trial status • Hidradenitis Suppurativa • Immunology

A First-in-Human Phase 1a Randomized, Double-Blind Single-Ascending Dose Study of NAV-240, an anti-OX40L/TNF-a Bispecific Antibody, in Healthy Volunteers (EADV 2025) - "Treatment with NAV-240 in healthy volunteers was safe and well tolerated. The exposure profile of NAV-240 supports once-monthly dosing in patients. Collectively, these data support the continued development of NAV-240 in complex autoimmune conditions like hidradenitis suppurativa."

Clinical • First-in-human • P1 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

Huadong Medicine introduces two autoimmune products... [Google translation] (bydrug.pharmcube.com) - "Zhongmei Huadong obtained exclusive rights to develop, register, manufacture, and commercialize IMB-101 and IMB-102, two of IMB's globally innovative autoimmune products, in 37 Asian countries, including China (excluding Japan, South Korea, and North Korea). Zhongmei Huadong will pay IMB a US$6 million upfront payment, a US$2 million technology transfer milestone payment, up to US$307.5 million in development, registration, and sales milestone payments, and tiered double-digit royalties on net sales."

Licensing / partnership • Immunology

Study of NAV-240 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Navigator Medicines, Inc. | Not yet recruiting ➔ Completed | N=72 ➔ 40 | Trial completion date: Dec 2025 ➔ Sep 2024 | Trial primary completion date: Dec 2025 ➔ Sep 2024

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

A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of Intravenous NAV-240 in Adults. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Southern Star Research | Not yet recruiting ➔ Recruiting

Enrollment open