amulirafusp alfa (IMM0306) / ImmuneOnco Biopharma - LARVOL DELTA

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 • Anemia • Follicular Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • 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

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

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

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

High Level of IL-16 Secreted By Non-GCB DLBCL Facilitates Tumor Growth Though the Tumor-Promoting and Immunosuppressive Tumor Microenvironment (ASH 2023) - "The dynamic change of serum IL-16 levels accurately predicted the treatment response in patients with DLBCL who received R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or anti-CD19 Chimeric Antigen Receptor (CAR) T cells. In conclusion, this study provides insight into the expression and role of IL-16 in DLBCL. IL-16 is proposed to be highly expressed in ABC-DLBCL, and serum IL-16 indicate the tumor burden, treatment response, and clinical prognosis of DLBCL patients. IL-16 may be a key driver of the TME of DLBCL, which can confer growth advantage to the ABC-DLBCL."

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

'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

Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1/2 | N=154 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P1/2 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Combination therapy • New P1/2 trial • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcɣR engagement by simultaneously binding to CD47 and CD20 of B cells. (PubMed, Leukemia) - No abstract available

Journal • Oncology • CD20 • SIRPA

Preliminary Safety and Efficacy Evaluation of IMM0306, a CD47 and CD20 Bispecific Monoclonal Antibody-Trap (mAb-Trap), from an Ongoing Phase I Dose-Escalation Study in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL) (ASH 2022) - "These data indicate that IMM0306 is well-tolerated at the dose levels evaluated. and preliminary anti-tumor efficacy result observed support continuous development of IMM0306 in patients with R/R B-NHL. The phase 1/2 is ongoing."

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

Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=90 | Suspended | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Recruiting ➔ Suspended

Trial suspension • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

The Synergistic Anti-Tumor Activities of CD47-Based Bispecific Molecules in Experimental Solid Tumors Are Dependent on Interaction of Tumor Targets (PEGS 2022) - "Surprisingly, while four bispecific mAb-Traps (IMM0306: CD47/CD20, IMM2902: CD47/Her2, IMM2520: CD47/PD-L1, IMM5601: CD47/CD38) revealed potent synergistic anti-tumor activities, two (IMM0404: CD47/EGFR, IMM3202: CD47/VEGFR2), did not generate such effect. In those two mAb-Trap molecules, linkage of CD47 ligand trap (SIRPa decoy) onto EGFR antibody or VEGFR2 antibody actually reduced therapeutic effects. Thus the synergistic anti-tumor activities of CD47-based bi-specific molecules in experimental solid tumors are dependent on interaction of tumor targets; structural design and target selection deserve careful consideration."

Oncology • Solid Tumor • CD20 • HER-2 • PD-L1 • SIRPA