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

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

Navigator Medicines Announces First Participants Dosed in a Phase 1b Trial of NAV-240, a Potential Best-in-Class Anti-OX40L and Anti-TNFα Bispecific Antibody Therapeutic for Autoimmune Diseases (Businesswire) - "First subject dosed with NAV-240 in multiple-ascending dose study in healthy volunteers; Primary objective of Phase 1b study is safety, tolerability, PK and PD of NAV-240 after repeated administration; Trial expected to enroll approximately 24 subjects across three dosing cohorts with interim data available before year-end 2025."

Trial status • Immunology

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

New P1 trial

Huadong Medicine: HDM3019 clinical trial application approved [Google translation] (Eastmoney.com) - "People's Finance reported on March 26 that Huadong Medicine (000963) announced on the evening of March 26 that its wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as 'Sino-US Huadong') received the 'Notice of Approval for Drug Clinical Trials' approved and issued by the National Medical Products Administration (NMPA). The clinical trial application for HDM3019 submitted by Sino-US Huadong was approved for rheumatoid arthritis."

New trial • Rheumatoid Arthritis

A First-in-Human Phase 1a Randomized, Double-Blind Single-Ascending Dose Study of NAV-240, an anti-OX40L/TNF-alpha Bispecific Antibody, in Healthy Volunteers (AAD 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 • P1 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • TNFA • TNFSF4

Navigator Medicines to Present Data at the American Academy of Dermatology (AAD) Annual Meeting (Businesswire) - "Navigator Medicines, Inc...today announced that it will present early clinical data from its lead program, NAV-240, at the American Academy of Dermatology (AAD) Annual Meeting, taking place in Orlando, Florida, from March 7-11, 2025."

P1 data • Rheumatoid Arthritis

Navigator Medicines Appoints Tausif ‘Tosh’ Butt as Chief Executive Officer and Khurem Farooq as Chairman of the Board of Directors (Businesswire) - "Navigator Medicines, Inc...today announced the appointments of Tausif (‘Tosh’) Butt as Chief Executive Officer and Khurem Farooq as Chairman of the Board of Directors. The additions of Mr. Butt and Mr. Farooq augment Navigator’s leadership team as the Company continues to advance NAV-240, a clinical-stage bispecific antibody targeting TNFα and OX40L, alongside a pipeline of OX40L-based biologics for complex autoimmune diseases...'We’re fortunate to have one of the most mature bispecific antibody programs in immunology and inflammation, with NAV-240 recently completing a Phase 1a study and advancing into multi-dose studies later this year.'"

Commercial • New trial • Immunology

Y-Biologics, IMBiologics partner again to develop antibody drugs for autoimmune diseases (Korea Biomedical Review) - "Y-Biologics and IMBiologics announced Wednesday that they have signed a collaboration agreement to jointly research and develop new antibody drug candidates for autoimmune diseases....The two companies have co-developed IMB-101 (OXTIMA, a bispecific antibody targeting OX40L/TNF-α) and IMB-102 (a monoclonal antibody targeting OX40L) for autoimmune diseases with HK inno.N and transferred the technology to Navigator Medicine in the U.S. for $944.7 million (1.37 trillion won) in June 2024 and to China’s Huadong Medicine for $315.5 million in August."

Licensing / partnership • Immunology

Y-Biologics, IMBiologics, and HK inno.N license out dual-antibody drug to US biotech (Korea Biomedical Review) - "Y-Biologics, IMBiologics and HK inno. N, said on Monday they have agreed to license out their jointly developed IMB-101, a dual-antibody candidate targeting OX40L and TNF-α (Tumor Necrosis Factor-α), to Navigator Medicines, a U.S. biotech...The deal includes an upfront payment of $20 million and potentially up to $940 million for three companies depending on the development process. The contract covers all regions globally, excluding Asia, but includes Japan....Y-Biologics spearheaded the discovery of the OX40L-targeting antibody and the development of the dual-antibody."

Licensing / partnership • Immunology

A Study of IMB-101 in Healthy Volunteers and Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: IMBiologics Corp.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Dual Inhibition of TNF-α and OX40L on Synovial Inflammation and Osteoclastogenesis in Rheumatoid Arthritis (ACR Convergence 2023) - "These results indicated that dual inhibition of TNF-a and OX40L axis simultaneously are associated with reduction of invasiveness in synovial fibroblast and joint destruction in RA."

IO biomarker • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CCL2 • CD14 • CSF1 • CX3CL1 • HIF1A • ICAM1 • IL6 • MMP1 • MMP3 • TNFA • TNFSF4 • TRAP

IMBio, 'bispecific antibody' “approved for phase 1 in the US, entering the second half of the year” [Google translation] (Biospectator) - "IMBiologics announced on the 1st that it has received approval from the U.S. Food and Drug Administration (FDA) for the phase 1 clinical trial protocol (IND) for OX40LxTNF bispecific antibody ‘IMB-101’, which is being developed as a treatment for autoimmune diseases....The approved phase 1 clinical trial is a placebo-controlled trial that evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics of IMB-101 in single and repeated doses in healthy subjects and patients with rheumatoid arthritis (RA)."

IND • Immunology • Rheumatoid Arthritis • Rheumatology

IM Biologics, attracts 20 billion won Series B investment [Google translation] (HIT News) - "IMBiologics...announced on the 24th that it had attracted 20 billion won in Series B investment....IMBiologics will use the investment secured this time to carry out phase 1 clinical trials of 'OX40L/TNF' bispecific antibody IMB-101..."

Financing • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

IM Bio, 'OX40LxTNF' bispecific antibody “US phase 1 IND application” [Google translation] (Biospectator) - "IMBiologics announced on the 29th that it had submitted an IND for phase 1 clinical trial of OX40LxTNF bispecific antibody ‘IMB-101’ to be developed as an autoimmune disease treatment to the U.S. Food and Drug Administration (FDA)....This phase 1 clinical trial is conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeated administration of IMB-101 to healthy adults and patients with rheumatoid arthritis (RA)."

IND • New P1 trial • Immunology

THE ROLES OF OX40L AND TNF BISPECIFIC ANTIBODY IN OSTEOCLASTOGENESIS (EULAR 2023) - "IMB-101 further reduced PU.1, RANK and NFATc1 expression during early stage of osteoclast differentiation (day 3) compared to TNF inhibitor or TNF inhibitor and OX40L inhibitor (n=3). Conclusion Our data suggested that IMB-101 might have a beneficial effect on imbalance of the bone resorption in RA especially by suppressing osteoclast differentiation."

IO biomarker • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD14 • CSF1 • NFATC1