gamgertamig (OM336) / Keymed Biosciences, Ouro Medicines - LARVOL DELTA

Trial in progress: A phase 1b, open-label, multiple ascending dose study of OM336, a novel BCMAxCD3 T cell engager, in patients with relapsed/refractory autoimmune cytopenias (NCT07083960) (ASH 2025) - P1 | "Patients with relapsed/refractory AICs have unmet medical need requiring additional safeand effective therapy options. This Phase 1b study evaluates a potential treatment for AICs utilizingOM336, a novel T cell engager that targets B cell maturation antigen (BCMA) and CD3. The study is openand actively enrolling patients."

Clinical • IO biomarker • P1 data • Autoimmune Hemolytic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Inflammation • Thrombocytopenia • Thrombocytopenic Purpura

Ouro Medicines Receives U.S. FDA Orphan Drug Designation for Gamgertamig (OM336) for Immune Thrombocytopenia (PRNewswire)

Orphan drug • Immune Thrombocytopenic Purpura

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

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

Anti-CD3/B-Cell Maturation Antigen Bispecific Antibody CM336 in Relapsed/Refractory Multiple Myeloma: An Open-Label, Phase I/II Study (ASH 2024) - P1/2 | "CM336 is expected to improve the prognosis of subjects with RRMM. With longer follow-up, additional efficacy/safety data will be presented."

Clinical • P1/2 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Plasmacytoma • Pneumonia • Respiratory Diseases

Ouro Medicines Announces Expansion of Clinical Development for OM336 in Sjögren's Disease and Idiopathic Inflammatory Myopathy (PRNewswire) - "First Phase 1b study data expected in 2026...OM336 will be administered in the first three weeks by subcutaneous injection in cohorts at ascending dose levels, with follow-up through Week 52. Exploratory endpoints include measures of clinical efficacy, patient-reported outcomes and biomarkers relevant to each indication....The company expects initial results in the Ouro-sponsored AIC trial in 2026."

New P1 trial • P1 data • Autoimmune Hemolytic Anemia • Immunology • Sjogren's Syndrome

OM336 in Autoimmune Cytopenias (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Ouro Medicines | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

Monotherapy • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia (clinicaltrials.gov) - P1/2 | N=158 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P1/2 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Oncology • Plasmacytoma

OM336 in Autoimmune Cytopenias (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Ouro Medicines

New P1 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Ouro Medicines Announces Initiation of OM336 Basket Study in Autoimmune Cytopenias and Granting of U.S. FDA Orphan Drug Designation for OM336 in Autoimmune Hemolytic Anemia (AIHA) (PRNewswire) - "Ouro Medicines...announced the initiation of a multi-national clinical study of OM336, a BCMAxCD3 T cell engager antibody candidate, in autoimmune hemolytic anemia (AIHA) and/or immune thrombocytopenia (ITP), two types of autoimmune cytopenias. In addition, Ouro Medicines announced that OM336 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for development in the treatment of AIHA...This open-label, multi-site, Phase 1b study of OM336, conducted in the U.S. and Australia, will evaluate the safety, tolerability and pharmacokinetics of OM336 in adult participants with active autoimmune cytopenias, specifically relapsed/refractory AIHA, ITP or both (NCT07083960). Exploratory endpoints include clinical efficacy measures and blood biomarkers. OM336 will be administered via subcutaneous injection in ascending dose cohorts, with the primary endpoint evaluated at Week 12."

Orphan drug • Trial status • Autoimmune Hemolytic Anemia

BCMA/CD3 BsAb Therapy for POEMS Syndrome (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Rare Diseases

Radiation Combined With BCMA/CD3 Bispecific Antibody Therapy for Solitary Bone Plasmacytoma With Mild Bone Marrow Infiltration (clinicaltrials.gov) - P2 | N=21 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Oncology • Plasmacytoma

Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P2 trial • Amyloidosis

OM336, A B CELL MATURATION ANTIGEN (BCMA) TARGETING T CELL ENGAGER ANTIBODY, DEMONSTRATES INITIAL SAFETY AND EFFICACY IN THE TREATMENT OF RELAPSED/REFRACTORY MULTIPLE MYELOMA (R/R MM) (EHA 2025) - P1/2 | "Case studies with teclistamab, a BCMA-targeted TCE, show induction of treatment-free remission in several patients with IMDs. OM336 is a highly potent, subcutaneously administered, BCMA-targeting TCE with promising initial efficacy and safety in the treatment of R/R MM warranting further investigation. Clinical development plans are also underway to evaluate OM336 in the treatment of IMDs."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Keymed Biosciences Announces the Latest Clinical Trial Results of CM336 Published in the New England Journal of Medicine (The Manila Times) - P=NA | N=NA | "The study results showed that two patients experienced rapid disease improvement after the administration of CM336, achieving partial remission on days 13 and 19, respectively. Hemoglobin levels returned to normal on days 17 and 21, respectively, while reticulocyte counts, lactate dehydrogenase, and indirect bilirubin levels significantly decreased. Before receiving treatment with CM336, both patients had undergone multiple treatment regimens, including glucocorticoids, splenectomy, anti-CD20 antibodies, BTK inhibitors, and CD19 CAR-T cell therapies, but their disease eventually recurred or progressed to refractory status....As of the date of this announcement, the Phase II clinical study of CM336 for the treatment of primary light-chain amyloidosis has been approved by the Center for Drug Evaluation of the National Medical Products Administration and will commence clinical trials shortly."

Clinical data • New P2 trial • Amyloidosis • Anemia

Keymed Biosciences Announces Annual Results of 2024 (PRNewswire) - :CM336 (BCMAxCD3 bispecific antibody): Continuously proceeded with a multi-center, open-label Phase I/II clinical study to assess CM336 injection in treating patients with relapsed or refractory multiple myeloma. As of the date of this announcement, the product is currently in the dose-expansion phase of Phase I/II clinical study."

Trial status • Multiple Myeloma

A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Shandong First Medical University

New P1/2 trial • Immunology

A single-arm multi-center trial of BCMA/CD3 BiTE for relapsed/refractory AL amyloidosis or newly diagnosed AL amyloidosis with insufficient depth of hematologic response after induction therapy (ChiCTR) - P2 | N=20 | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.; Institute of Hematolog

New P2 trial • Amyloidosis • Hematological Disorders

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

New trial • Amyloidosis • Hematological Disorders

Ouro Medicines Launches to Define the Future of Treatment for People with Immune-Mediated Diseases (PRNewswire) - "Ouro Medicines..today announced its launch with $120 million in funding. The company was founded by Monograph Capital in partnership with GSK plc. The Series A was co-led by TPG Life Sciences Innovations, NEA, and Norwest Venture Partners, with participation from Monograph Capital, GSK, UPMC Enterprises, Boyu/Zoo Capital, LongRiver Investments, and other unnamed investors...Ouro's most advanced product candidate is OM336, a BCMA-directed, bispecific T cell engager recently licensed from Keymed Biosciences (2162.HK)...Keymed Biosciences is currently studying OM336 (CM336) in an ongoing Phase 2 expansion study in multiple myeloma in China. Ouro holds exclusive rights outside of Greater China and intends to start its first Phase 1 study in 2025."

Financing • New P1 trial • Multiple Myeloma

BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New trial • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

Conoya-B (02162): The latest data from the Phase I/II clinical study of CM336 was presented as a poster at the 66th American Society of Hematology (ASH) Annual Meeting [Google translation] (Sina Corp) - P1/2 | N=48 | NCT05299424 | Sponsor: Keymed Biosciences Co.Ltd | "Safety assessments showed that CM336 was safe and well tolerated. The dose was successfully escalated to 160 mg, and the maximum tolerated dose has not yet been reached. The most common adverse events were cytokine release syndrome (CRS), decreased lymphocyte counts, and anemia. Most CRS events were grade 1 events, only 7% (5/68) of subjects experienced grade 2 CRS events, and no immune effector cell-related neurotoxicity syndrome occurred. The median follow-up time in the dose escalation phase was 12.1 months, and 52% (12/23) of the subjects achieved strict complete remission (sCR) or complete remission (CR). The median follow-up time was 3.1 months. The overall objective response rate (ORR) of the 3/20/80 mg and 3/20/80/160 mg dose groups (including dose escalation and expansion phases) was 67% (16/24) and 76% (19/25), respectively."

P1/2 data • Multiple Myeloma

A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology