I-Mab has dosed the first subject in a Phase II abbreviated combination clinical study of lemzoparlimab (TJC4) in combination with azacitidine (AZA) in recently diagnosed acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) patients in China.
An anti-CD47 monoclonal antibody, lemzoparlimab can potentially reduce inherent binding to normal red blood cells and maintain its anti-tumour activity.
Azacitidine is a chemotherapeutic that could be combined with lemzoparlimab for treating hematologic cancers.
This Phase II combination cohort expansion trial will assess the safety, tolerability and efficacy of lemzoparlimab plus azacitidine in AML subjects who are intensive chemotherapy intolerant.
It will also include previously untreated subjects with intermediate and high-risk myelodysplastic syndrome. I-Mab plans to conclude subject enrolment by the fourth quarter of this year.
The latest trial follows a dose-escalation monotherapy trial in China and the company intends to commence a pivotal trial, on concluding the combination trial, to register the treatment.
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I-Mab CEO Dr Joan Shen said: “Lemzoparlimab has already shown promising and differentiated features as a novel therapy in Phase I studies.
“We look forward to advancing lemzoparlimab as a combination treatment in patients with AML and MDS to further validate its safety and clinical efficacy.”
The company has expedited the clinical development of lemzoparlimab to obtain new drug application approval for hematologic malignancies treatment in China.
Furthermore, I-Mab is carrying out two US trials of lemzoparlimab plus Rituxan for non-Hodgkin lymphoma treatment and with Keytruda for advanced solid tumours treatment.
Subject enrolment in these two trials is slated to conclude in the fourth quarter with preliminary top-line results expected by year-end or early next year.
In various preclinical studies, the drug showed hematologic safety benefits and significant anti-tumour activities.
I-Mab and AbbVie signed a global strategic partnership to develop and market lemzoparlimab across the globe including in China, in September last year.
In August last year, I-Mab commenced dosing patients in a Phase Ib clinical trial of plonmarlimab (TJM2) for the treatment of rheumatoid arthritis (RA) in China.