batoclimab (IMVT-1401) / Harbour BioMed, Roivant, Daewoong Pharma, CSPC Pharma, OmniAb - LARVOL DELTA

THE ROLE OF FCRN ANTAGONISTS IN TRANSFORMING THE MYASTHENIA GRAVIS TREATMENT PARADIGM (WCN 2025) - "Early clinical trials of FcRn antagonists, such as efgartigimod, rozanolixizumab, and nipocalimab, have shown significant potential, including the reduction of symptom severity, rapid clinical improvement, and enhanced quality of life for patients with generalized myasthenia gravis (gMG). Furthermore, a Phase III clinical trial conducted in China for another FcRn antagonist, batoclimab, has also demonstrated positive results, further confirming the effectiveness and safety of this class of medications. The advent of FcRn antagonists marks a significant milestone in the management of MG, opening a new chapter of precision therapy in autoimmune neurology and offering a promising treatment paradigm for other IgG-mediated diseases."

CNS Disorders • Myasthenia Gravis

An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2 | N=108 | Enrolling by invitation | Sponsor: Immunovant Sciences GmbH

New P2 trial • Pain

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Batoclimab Induces Very Rapid and Sustained Post-treatment Euthyroidism in Graves' Disease (ATA 2025) - "Batoclimab resulted in very rapid and sustained normalization of FT3/FT4. Six months after stopping treatment, 52% of patients remained euthyroid either off ATD or on ≤2.5 mg ATD/day."

Endocrine Disorders • Grave’s Disease

Immunovant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease Patients (GlobeNewswire) - "At Week 48, or the end of the six-month follow-up period (patients off-treatment for 24 weeks), ~80% (17/21) patients maintained T3/T4 values ≤ upper limit of normal (ULN), indicating strong durability of response through six months off treatment; Of these 17 patients, ~50% (8/17) were in ATD free-remission and an incremental ~30% (5/17) were on ATD doses of 2.5 mg/day following six months off treatment, even with batoclimab’s suboptimal step-down dosing design during the treatment period."

P2 data • Grave’s Disease • Immunology

The FcRn Inhibitor Batoclimab Rapidly Normalizes Thyroid Function and Improves Clinical Outcomes in Graves' Disease (ENDO 2025) - "Batoclimab treatment rapidly normalized thyroid function and improved both cardiovascular and orbital manifestations of GD."

Clinical • Clinical data • Cardiovascular • Endocrine Disorders • Grave’s Disease • Mood Disorders • Psychiatry • Thyroid Eye Disease

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Major Upcoming Milestones (GlobeNewswire) - "Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of...2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of...2027. Topline results for the Phase 2 trial in CS are expected in the second half of...2026. Roivant and Priovant will be hosting an upcoming investor event on brepocitinib at 1:00 p.m. ET on Tuesday, June 17, 2025; Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025. Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025; Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of...2026"

Clinical data • New trial • Dermatomyositis • Grave’s Disease • Hypertension • Immunology • Sjogren's Syndrome • Thyroid Eye Disease • Uveitis

Comparative efficacy and acceptability of novel biologics in the treatment of myasthenia gravis: systematic review and network meta-analysis of randomized trials. (PubMed, Syst Rev) - "This study provides an updated, relative rank-order efficacy of novel biologics therapies for myasthenia gravis. These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy."

Journal • Retrospective data • Review • CNS Disorders • Immunology • Myasthenia Gravis

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2024 ➔ Jul 2025

Enrollment closed • Trial primary completion date • Endocrine Disorders • Grave’s Disease

Efficacy and Safety of the FcRn Inhibitor, Batoclimab, in Graves' Thyroidal and Extrathyroidal Disease: a Proof-of-concept Study (ESPE-ESE 2025) - "Subcutaneous batoclimab very rapidly normalized FT3 and FT4 in most patients. By Week 12, more than half of patients had both T3 and T4 ≤ULN and were off ATD. Batoclimab also improved extrathyroidal signs."

Clinical • Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

Immunovant Announces Next Phase of Growth with Roivant Including Changes to its Leadership Team and Additional Indications Sjögren’s Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) for IMVT-1402 (GlobeNewswire) - "Immunovant, Inc...announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE...Immunovant has announced these changes in conjunction with a broader strategic transition as development activities begin to conclude for batoclimab and ramp up for IMVT-1402, with increased Roivant alignment and the announcement of two additional indications today....Roivant will host a live conference call and webcast at 8:00 a.m. EDT on Monday, April 21, 2025, to discuss these updates at Immunovant."

Pipeline update • Immunology • Systemic Lupus Erythematosus

Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants. (PubMed, Drug Saf) - "Atorvastatin can mitigate clinically significant increases in low-density lipoprotein cholesterol that may occur with batoclimab treatment."

Journal • P1 data • Dyslipidemia • Immunology

Targeted immunotherapies for Graves' thyroidal & orbital diseases. (PubMed, Front Immunol) - "They include rituximab, an anti-CD20 monoclonal antibody which causes rapid B cell depletion; ATX-GD-59, an antigen specific immunotherapy which restores immune tolerance to thyrotropin receptor; iscalimab, an anti-CD40 monoclonal antibody which blocks the CD40-CD154 co-stimulatory pathway in B-T cell interaction; and K1-70, a thyrotropin receptor blocking monoclonal antibody...Both tocilizumab (anti-interleukin 6 receptor monoclonal antibody) and sirolimus (mammalian target of rapamycin inhibitor) showed promise in glucocorticoid resistant active disease. Teprotumumab, an anti-insulin-like growth factor-1 receptor monoclonal antibody, demonstrated remarkable all-round efficacy across a wide disease spectrum. Linsitinib, a dual small molecule inhibitor of insulin-like growth factor-1 receptor and insulin receptor, displayed significant proptosis reduction in its phase 2b/3 study. Finally, Batoclimab, an anti-neonatal fragment crystallizable receptor monoclonal antibody,..."

Journal • Review • Endocrine Disorders • Grave’s Disease • Immunology • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Thyroid Eye Disease • CD40LG • IL6R • IR

HanAll hits back in Harbour BioMed arbitration, seeks to terminate $81 mil. batoclimab deal (Korea Biomedical Review) - "HanAll Biopharma has stepped up its legal fight with Harbour BioMed, filing a counterclaim with the International Chamber of Commerce (ICC) to formally terminate their licensing deal for the autoimmune drug candidate batoclimab (HL161) and reclaim rights across Greater China...The move, announced Thursday, comes less than two weeks after HanAll disclosed that Harbour had initiated arbitration to contest the deal’s termination. HanAll originally served its termination notice on Jan. 26, citing Harbour’s failure to meet key development milestones for batoclimab...HanAll Biopharma has stepped up its legal fight with Harbour BioMed, filing a counterclaim with the International Chamber of Commerce (ICC) to formally terminate their licensing deal for the autoimmune drug candidate batoclimab (HL161) and reclaim rights across Greater China....Until the ICC delivers a ruling, the original licensing agreement with Harbour remains legally binding."

Commercial • Myasthenia Gravis

Phase 2b CIDP Study Results Highlights (GlobeNewswire) - P2b | N=277 | NCT05581199 | Sponsor: Immunovant Sciences GmbH | "Initial batoclimab data in 73 patients pooled across all cohorts for the run-in Period 1 of the Phase 2b CIDP study demonstrated a 1.8 point improvement in aINCAT (compared to Period 1 baseline) at Week 12. An 84% responder rate (with response defined as an aINCAT improvement ≥ 1) was observed among all patients whose IgG was reduced by ≥ 70%. Other CIDP scales also demonstrated meaningful improvements for pooled batoclimab cohorts, with an improvement in I-RODS of 15.3, an improvement in MRC-SS of 5.6, and an improvement in grip strength of 15.1 all at Week 12. Safety and tolerability were observed to be consistent with prior batoclimab studies."

P2b data • Immunology • Inflammation

Phase 3 MG Study Results Highlights (GlobeNewswire) - P3 | N=240 | NCT05403541 | Sponsor: Immunovant Sciences GmbH | "In the Phase 3 MG study, batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants. Participants entering the study and randomized to 680mg of batoclimab given weekly by subcutaneous injection achieved a 5.6 point improvement in MG-ADL at Week 12, while those randomized to 340mg of batoclimab given weekly by subcutaneous injection achieved a 4.7 point improvement in MG-ADL at Week 12 and those randomized to placebo experienced a 3.6 point improvement in MG-ADL at Week 12. Large differences between the dosing arms were observed, especially for deeper response thresholds....Safety and tolerability were observed to be consistent with prior batoclimab studies."

P3 data: top line • Myasthenia Gravis

OmniAb Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights (Businesswire) - "Fourth quarter 2024 and recent partner highlights include the following:...Batoclimab: (i) Immunovant also plans to announce additional data from the batoclimab proof-of-concept study in GD, including six-month, treatment-free remission data in the summer 2025; (ii) Additionally, Immunovant reported that top-line results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, are expected in the second half of 2025."

P2 data • P3 data: top line • Grave’s Disease • Thyroid Eye Disease

Immunovant to Host Investor Webcast at 8:00 AM ET on Wednesday, March 19 to Review Results from Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Programs (GlobeNewswire) - "Immunovant, Inc...today announced that it will host an investor webcast on Wednesday, March 19th at 8:00 a.m. ET to review results from its Phase 3 study of batoclimab in MG and initial results from its Phase 2b study in CIDP."

P2b data • P3 data • Immunology • Inflammation • Myasthenia Gravis

HanAll Biopharma's batoclimab earns orphan drug designation in Japan for TED (Korea Biomedical Review) - "HanAll Biopharma announced on Tuesday that its autoimmune disease treatment, batoclimab (HL161BKN), has been designated as an orphan drug for thyroid eye disease (TED) by the Ministry of Health, Labour and Welfare of Japan....According to HanAll Biopharma, batoclimab is a novel antibody designed to eliminate pathogenic autoantibodies that cause autoimmune diseases. Developed as a subcutaneous injection formulation, it is expected to allow for self-administration by patients, enhancing treatment convenience and improving their quality of life....The company is currently conducting a phase 3 trial in Japan for TED and anticipates announcing top-line results later this year."

Orphan drug • P3 data: top line • Thyroid Eye Disease

HanAll Biopharma, ‘Batoclimab’ Phase 3 Clinical Trial Results Announced Imminently… What is its Competitiveness? [Google translation] (Money Today Network (MTN)) - "The clinical results of HanAll Biopharma's core pipeline (new drug candidate) Batoclimab (IMVT-1401) are expected to be released one after another next month....According to the industry on the 26th, the US partner company 'Immunovant' will announce the results of the phase 3 clinical trial for Batoclimab's indication for myasthenia gravis (MG) and the phase 2b clinical trial for its indication for chronic inflammatory demyelinating polyneuropathy (CIDP) next month."

P2b data • P3 data • Myasthenia Gravis

Immunovant Reports Financial Results for the Quarter Ended December 31, 2024 (GlobeNewswire) - "Additional results from batoclimab proof-of-concept study in GD, including 6-month treatment free remission data expected in summer 2025; Top line results of the batoclimab trial in myasthenia gravis (MG) and initial results from period 1 of batoclimab trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025...As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026...Top-line results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025..."

New trial • P2 data • P2b data • P3 data: top line • Grave’s Disease • Immunology • Myasthenia Gravis • Thyroid Eye Disease

FcRn inhibitors in the context of myasthenia gravis. (PubMed, Expert Opin Emerg Drugs) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Jun 2025 ➔ Aug 2026 | Trial primary completion date: May 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Jan 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease