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

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

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

Efficacy and Safety of the FcRn Inhibitor, Batoclimab, in Graves' Thyroidal and Extrathyroidal Disease: a Proof-of-concept Study (ESPE-ESE 2025) - No abstract available

Clinical • Endocrine Disorders

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

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

Initiation response, maximized therapeutic efficacy, and post-treatment effects of biological targeted therapies in myasthenia gravis: a systematic review and network meta-analysis. (PubMed, Front Neurol) - "A total of 9 drugs, including Efgartigimod, Rozanolixizumab, Batoclimab, Eculizumab, Belimumab, Zilucoplan, Ravulizumab, Nipocalimab, Rituximab, derived from 12 studies were analyzed. At the post last dose 4-week point, all drugs statistically showed no significant difference from the placebo. Although the MG subtypes were not consistent across trials, within the regimen design of each trial, neonatal Fc receptor inhibitors-represented by Efgartigimod, Rozanolixizumab, and Batoclimab-exhibited the most effective response rates when compared to complement and B-cell inhibitor drugs."

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

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP (clinicaltrials.gov) - P2 | N=277 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Pain

IMMUNOVANT PROVIDES DEVELOPMENT UPDATES AND REPORTS FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2024 (GlobeNewswire) - "IND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025....Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025."

IND • New trial • P3 data: top line • Immunology • Myasthenia Gravis • Rheumatoid Arthritis

Efficacy and Safety of the FcRn Inhibitor, Batoclimab, in Graves' Thyroidal and Extrathyroidal Disease: a Proof-of-concept Study (ATA 2024) - "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 • Late-breaking abstract • Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

FcRn Antagonists (ICNMD 2024) - "Efgartigimod and rozanolixizumab have received US FDA approval for use in seropositive MG, while nipocalimab and batoclimab also hold much promise. Unlike the 'broad-spectrum' conventional immunosuppressants and biological agents that act upstream in MG immunology, FcRn antagonists may only theoretically be below par in terms of mitigating MG immunopathology but have proven clinically efficacious. Further research and direct clinical comparisons among agents will be necessary to unravel these complexities."

CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis • Pain

Efficacy and safety of immunosuppressants and monoclonal antibodies in adults with myasthenia gravis: a systematic review and network meta-analysis. (PubMed, J Transl Med) - "Based on changes in Quantitative MG and MG Composite scores, batoclimab was most likely to exert the best therapeutic effects, with SUCRA values of 99% and 92%, respectively...Eculizumab exhibited the highest potential in reducing the 15-item revised version of the MG Quality of Life score (96%). Regarding safety, belimumab had the highest SUCRA value (85%), demonstrating the lowest likelihood of AEs...Regarding safety, rozanolixzumab exhibited a higher likelihood of AEs than did placebo. The conclusions guide the clinical selection of effective drugs and offer insights for future drug experiments."

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

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Mar 2025

Enrollment closed • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Harbour BioMed Announces Resubmission of Biologics License Application for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis (PRNewswire) - "Harbour BioMed...announces that it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG). Following the clinical trial protocol, the Company completed the extension period for the Phase III clinical trial to collect additional long-term safety data without enrolling new patients."

China filing • Myasthenia Gravis