gamgertamig (OM336) / Keymed Biosciences, Lakefront Biotherapeutics, Gilead - LARVOL DELTA

Low-Dose BCMAxCD3 Bispecific Antibody CM336 Induces Rapid and Universal Deep Hematologic Responses in Newly Diagnosed Systemic AL Amyloidosis: Primary Analysis of the Prospective Phase 2 AL-003 Trial (IMS 2026) - P2 | "In this first prospective frontline trial of a BCMA / CD 3 bispecific antibody in newly diagnosed AL amyloidosis, low-dose CM 336 produced unprecedented depth and speed of response: 100% of evaluable patients achieved ≥ VGPR and median time to hematologic response was only 9.5 days. Cardiac and renal organ responses occurred within the first 5 to 6 weeks of treatment in the majority of evaluable patients. The safety profile was manageable . ."

Bispecific • Clinical • P2 data • Amyloidosis • Heart Failure • Hematological Disorders • Infectious Disease • Leukopenia

CAREMM-010: CM336 Plus Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

CAREMM-011: CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

Lakefront plans to start registrational trials for gamgertamig in ITP and AIHA in 2027, with additional autoimmune basket studies expected early that year (Yahoo Finance) - "Lakefront expects to end the year with approximately €2 billion in cash, supported by Gilead funding, legacy royalties and tax-credit receipts. The company has also largely completed its costly cell-therapy restructuring and announced a €50 million share buyback."

Commercial • New trial • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura

OM336 in Sensitized Transplant Candidates (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Medical University of Vienna

New P2 trial • Transplantation • CD20

CAREMM-013: CM336-SOC for Dynamically High-Risk Multiple Myeloma Study (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Jun 2026 ➔ Oct 2026

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

U.S. FDA Grants Orphan Drug Designation to Gamgertamig for the Treatment of Pemphigus (GlobeNewswire) - "...Expansion of the clinical trials program is anticipated in 2027. Phase 1b study with gamgertamig in patients with autoimmune cytopenias (including ITP and AIHA) (NCT07083960), active in Australia and the United States. Phase 1b study with gamgertamig in seropositive autoimmune diseases (including idiopathic inflammatory myositis, Sjögren’s disease, pemphigus vulgaris (PV), and pemphigus foliaceus (PF)) (NCT07229144) active in Australia, New Zealand, Czech Republic, and Japan."

New trial • Orphan drug • Trial status • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura • Myositis • Pemphigus Vulgaris • Sjogren's Syndrome

Design and preclinical characterization of an affinity-tuned BCMA×CD3 bispecific T-cell engager for broad B-cell depletion. (PubMed, MAbs) - "In vivo, gamgertamig produced dose-dependent tumor inhibition in human PBMC-reconstituted xenograft models and sustained depletion of circulating B cells and bone marrow plasma cells in rhesus monkeys, with a serum half-life exceeding five days. Together, these data demonstrate that gamgertamig mediates potent, target-dependent cytotoxicity and broad depletion of disease-relevant B-cell populations, supporting its development as a BCMA×CD3 T-cell engager for autoimmune diseases and B-cell malignancies."

IO biomarker • Journal • Preclinical • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology

BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2028 ➔ Aug 2029 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Enrollment open • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

AL-005: Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Biomarker • IO biomarker • New P1/2 trial • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology

Use of gamgertamig (OM336), a B cell maturation antigen (BCMA) x CD3 T cell engager antibody, in a patient with active antiphospholipid syndrome and concurrent autoimmune thrombocytopenia (ISTH 2026) - P1 | "A 62-year-old male with APS and concurrent ITP, receiving prednisone 7.5mg daily but no regular anticoagulation given his thrombocytopenia, was enrolled. The rapid clinical response, favorable short-term safety and PK support additional clinical investigation. DOI*10.1016/j.rpth.2026.104419"

Clinical • Autoimmune Hemolytic Anemia • Cardiovascular • Genetic Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

CM336-RI: CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Renal Impairment (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=20 ➔ 26

Enrollment change • Hematological Malignancies • Multiple Myeloma • Nephrology • Oncology • Renal Disease

GAMGERTAMIG (OM336), A NOVEL B CELL MATURATION ANTIGEN (BCMA) X CD3 T CELL ENGAGER ANTIBODY, AMELIORATES DISEASE IN PATIENTS WITH WARM OR COLD AUTOIMMUNE HEMOLYTIC ANEMIA (AIHA) (EHA 2026) - P1 | "Baseline Demographics Patient # Diagnosis Age, years Sex Sex Prior medications for AIHA Medications for AIHA at enrolment Baseline Hb (g/dL) Gamgertamig regimen 1 CAD (PMHx of RA & CLL) 76 F Zanubrutinib (CLL), Rituximab, Darbepoietin, Adalimumab (RA), Methotrexate (RA) Zanubrutinib (CLL) 8.6 High dose 2 wAIHA 44 F Prednisolone, Rituximab, Mycophenolate, Povetacicept Prednisolone, Folic Acid 6.8 Mid dose 3 wAIHA 71 M Prednisolone, Rituximab, Mycophenolate Prednisolone, Mycophenolate 9.9 High dose Results Administration of gamgertamig has been completed in two patients. Preliminary efficacy data suggest improvements in anemia and biomarkers of hemolysis following a short course of gamgertamig; short-term safety and PK were favorable. These data warrant additional clinical investigation, with longer-term follow-up to assess the durability of response."

Clinical • IO biomarker • Anemia • Autoimmune Hemolytic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Immunology • Infectious Disease • Inflammation • HP

OM336 in Seropositive Autoimmune Diseases (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Ouro Medicines | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Myositis • Sjogren's Syndrome

CAREMM-013: CM336-SOC for Dynamically High-Risk Multiple Myeloma Study (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

CAREMM-011: CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

CM336 for Active Sjogren's Syndrome Study (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P1 trial • Immunology • Sjogren's Syndrome

Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines to Further Expand Inflammation Pipeline (Businesswire) - "The acquisition adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio and will be the foundation of Lakefront’s clinical development pipeline....Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027....Under the terms of the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1,675 million and up to $500 million in contingent milestone payments."

M&A • New trial • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura • Inflammation

CM336-RI: CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Multiple Myeloma • Nephrology • Oncology • Renal Disease

A Clinical Trial of OM336 to Help Immunized Patients Become Eligible for Kidney Transplantation (clinicaltrialsregister.eu) - P1/2 | N=6 | Sponsor: Medical University Of Vienna

New P1/2 trial • Chronic Kidney Disease • Renal Disease • Transplantation

BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=20 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Amyloidosis • Hematological Disorders

OM336-SAI-1002: An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants with Active Sjogrens Disease or Idiopathic Inflammatory Myopathy (clinicaltrialsregister.eu) - P1 | N=8 | Not yet recruiting | Sponsor: Ouro Medicines Limited

New P1 trial • Immunology • Myositis • Sjogren's Syndrome

A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Shandong First Medical University | Phase classification: P1/2 ➔ P2 | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Phase classification • Trial completion date • Trial primary completion date • Immunology

Gilead Sciences to Acquire Ouro Medicines to Advance First in Class T Cell Engager Program for Autoimmune Diseases (Businesswire) - "The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio.....OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig...is expected to enter registrational studies in 2027."

M&A • New trial • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura

CM336-001: BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology