amouravfop alfa (IMM0306) / ImmuneOnco Biopharma - LARVOL DELTA

Anti-CD47/CD20 Bispecific Antibody Enhanced B Cell Depletion and Restored Macrophages Efferocytosis in Patients with Lupus Nephritis (EULAR 2026) - "While B-cell-targeted approaches (e.g., rituximab, obinutuzumab) show limited efficacy—often failing to resolve persistent renal inflammation—defective macrophage efferocytosis also contributes to disease by allowing accumulation of apoptotic cells and autoantigen release...Conclusions IMM0306 achieves more robust depletion of circulating B cells than rituximab and effectively restores macrophage efferocytosis through potent blockade of the CD47–SIRPα checkpoint...K‑M. Levels of inflammatory cytokines (IL-6, TNF-α, IFN-γ) in supernatants from in vitro macrophage cultures under various treatments."

Bispecific • Clinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CD47 • IFNG • IL6 • RAC1 • SIRPA • TNFA

IMC-002 (IMM0306), a bispecific CD20-CD47 fusion protein, demonstrates improvements in active Systemic Lupus Erythematosus (SLE) patients in a phase Ib/II study (EULAR 2026) - P1/2 | "Conclusions IMC-002 demonstrates a well-tolerable safety profile, and a promising efficacy for all dose cohort across multiple organ systems in moderate to severe active SLE patients. Deep B cell depletion and the followed B cell rebound indicate a balance of sustainable efficacy and safety (low infection risk)."

Bispecific • Clinical • P1/2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD20

A Study of IMM0306 in IgG4-Related Disease (clinicaltrials.gov) - P2/3 | N=125 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P2/3 trial • Inflammation

ImmuneOnco Biopharmaceuticals…announced that the first patient has been successfully enrolled and dosed in a Phase II randomized controlled clinical trial evaluating its proprietary drug, amourofavfop alfa (IMM0306), for the treatment of active systemic lupus erythematosus (SLE) (ImmuneOnco Press Release) - "According to the protocol, this Phase II randomized controlled study plans to enroll 90 patients, who will be randomly assigned in a 1:1:1 ratio to three treatment arms receiving either 1.2 mg/kg or 1.6 mg/kg of IMM0306, or a placebo."

Trial status • Systemic Lupus Erythematosus

Preliminary results from a phase I study of IMM0306 in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (AACR 2024) - P1/2 | "IMM0306 was well-tolerated and with a robust preliminary anti-tumor activity especially in pts with R/R FL and MZL. The phase II study is ongoing."

Clinical • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • SIRPA

ImmuneOnco Initiates Phase III Trial of Amouravfop Alfa (IMM0306) in Relapsed/Refractory Follicular Lymphoma (ImmuneOnco Press Release) - "This pivotal trial, evaluating amourofavfop alfa in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma (R/R FL), marks the official entry of the therapy into the pivotal clinical stage."

Trial status • Follicular Lymphoma

IMM0306 in Combination With Lenalidomide VS Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov) - P3 | N=198 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P3 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Phase I/Ⅱ study evaluating the safety and preliminary efficacy of amulirafusp alfa (IMM0306) in combination with lenalidomide in patients with relapsed/refractory CD20-positive follicular lymphoma (ASH 2025) - P1/2 | "Amulirafusp alfa in combination with lenalidomide showed a high rate of response and awell-tolerated safety profile in patients with R/R FL. This phase Ib/Ⅱ study is still ongoing."

Clinical • Combination therapy • Follicular Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • CD20 • SIRPA

ImmuneOnco Biopharmaceuticals…has received the approval of the Phase III clinical study protocol of IMM0306 in combination with lenalidomide for the treatment of relapsed/ refractory follicular lymphoma from the Center for Drug Evaluation (the ’CDE’) of the National Medical Products Administration (the ’NMPA’) (HKEXnews)

New P3 trial • Follicular Lymphoma

Phase Ib/IIa Study of Amulirafusp Alfa (IMM0306) in Combination with Lenalidomide in Patients with Relapsed or Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma (ASH 2024) - P1/2 | "Conclusions : 1.6 mg/kg IMM0306 in combination with 20 mg lenalidomide was well-tolerated and with a promising preliminary anti-tumor activity in patients with R/R FL and MZL. This phase Ib/IIa study is ongoing."

Clinical • Combination therapy • P1/2 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD20 • SIRPA

Updated Results from a Phase I Trial of Amulirafusp Alfa (IMM0306) in Patients with Relapsed or Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma (ASH 2024) - P1/2 | "The RP2D was determined as 2.0 mg/kg based on the integrated evidence from safety, efficacy, PK and PD. Conclusions : IMM0306 demonstrated a manageable safety profile and a favorable anti-tumor activity for patients with r/r CD20-positive B-NHL, especially in patients with r/r FL."

Clinical • P1 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • SIRPA

APPLICATION FOR THE PHASE III CLINICAL TRIAL OF IMM0306 FOR THE TREATMENT OF FOLLICULAR LYMPHOMA (HKEXnews) - "ImmuneOnco Biopharmaceuticals...has submitted the application...to the Center for Drug Evaluation of National Medical Products Administration of the People’s Republic of China (the 'NMPA')."

New P3 trial • Follicular Lymphoma

Phase II safety and preliminary efficacy of amulirafusp alfa (IMM0306) in combination with lenalidomide in patients with relapsed or refractory CD20-positive follicular lymphoma. (ASCO 2025) - P1/2 | "Amulirafusp alfa in combination with lenalidomide showed a preliminary anti-tumor activity and a well-tolerated safety profile in patients with R/R FL. This phase Ib/Ⅱ study is still ongoing."

Clinical • Combination therapy • P2 data • Anemia • Follicular Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Lymphoma • Oncology • CD20 • SIRPA

Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. (PubMed, J Hematol Oncol) - P1/2 | "Amulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943."

Journal • P1/2 data • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • SIRPA

FIRST PATIENT DOSED IN THE PHASE IB CLINICAL TRIAL OF IMM0306 FOR THE TREATMENT OF SLE (HKEXnews) - "The board (the 'Board') of directors ('Directors', and each a 'Director') of the Company is pleased to announce that the first patient has been successfully dosed in the Phase Ib clinical trial of IMM0306 for the treatment of systemic lupus erythematosus (SLE)."

Trial status • Systemic Lupus Erythematosus

Evaluating the Influence of IMC-002, a Novel Anti-CD47 Monoclonal Antibody, on Pretransfusion Compatibility Testing (AABB 2024) - "IMC-002 induced interference during ABO/RhD typing which could be mitigated by using washed RBCs and saline replacement. Plasma spiked with IMC-002 showed concentration-dependent panreactive results in antibody screening tests. However, it is presumed that these interferences are caused by mechanisms other than typical antigen-antibody reactions."

Oncology • CD47

Lymphoma cell-driven IL-16 is expressed in activated B-cell-like diffuse large Bcell lymphomas and regulates the pro-tumor microenvironment. (PubMed, Haematologica) - "This study demonstrates that IL-16 exerts a novel role in coordinating the bidirectional interactions between tumor progression and the TME. IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL."

Biomarker • Journal • Tumor microenvironment • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CASP3 • CD20 • IL10 • IL16 • IL6 • SIRPA

Preliminary results from a phase II study of amulirafusp alfa (IMM0306) in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (ESMO 2024) - P1/2 | "Amulirafusp alfa (IMM0306) was well-tolerated and presented robust preliminary anti-tumor activity in pts with R/R FL. This phase II study is ongoing."

Clinical • P2 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • SIRPA

Preliminary results from a phase Ib study of amulirafusp alfa (IMM0306) in combination with lenalidomide in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (ESMO 2024) - P1/2 | "1.6 mg/kg Amulirafusp alfa + 20 mg Lenalidomide was well-tolerated and with a robust preliminary anti-tumor activity in pts with R/R FL and MZL. This study is ongoing."

Clinical • Combination therapy • P1 data • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • SIRPA

A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients (clinicaltrials.gov) - P1/2 | N=116 | Not yet recruiting | Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

New P1/2 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=218 | Not yet recruiting | Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

New P1/2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Phase I safety and preliminary efficacy of IMM0306 in combination with lenalidomide in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma. (ASCO 2024) - P1/2 | "Background: The combination of rituximab (anti-CD20 mAb) and lenalidomide was approved for use in relapsed or refractory (R/R) indolent non-Hodgkin's lymphoma (iNHL). 1. 6 mg/kg IMM0306 in combination with 20 mg lenalidomide was well-tolerated and with a robust preliminary anti-tumor activity in pts with R/R FL and MZL. The phase I study is ongoing."

Clinical • Combination therapy • P1 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD20 • SIRPA

Preliminary results from a phase I study of IMM0306 in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma. (ASCO 2024) - P1/2 | "IMM0306 was well-tolerated and with promising preliminary anti-tumor activity especially in pts with R/R FL and MZL. The phase Ⅱ study is ongoing."

Clinical • P1 data • Anemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • SIRPA

'New Stock Performance' Immune Onco (01541.HK) opened 14% higher at 21.2 yuan [Google translation] (Yahoo Finance) - "It is expected that the net proceeds raised will be approximately 235 million yuan, of which approximately 40% and 28% will be used for the core product IMM01 respectively., as well as ongoing and planned clinical trials, preparation for registration applications and planned commercial launch of core products IMM0306, IMM2902 and IMM2520; approximately 10% will be used for planned clinical trials of IMM47 (CD24 monoclonal antibody)."

Commercial • Oncology

Preliminary results from a phase I/II study of IMM0306, a CD47 and CD20 bispecific monoclonal antibody-trap, in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma. (ASCO 2023) - "IMM0306 was well-tolerated and with a robust preliminary anti-tumor activity especially in pts with R/R FL and MZL. The phase I/II study is ongoing. Clinical trial information: CTR20192612."

Clinical • P1/2 data • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • CD20 • SIRPA