I-Mab has dosed the first patient in China in a Phase lll registrational trial of lemzoparlimab plus azacitidine (AZA) to treat patients with higher-risk myelodysplastic syndrome (MDS).
Lemzoparlimab is a new CD47 antibody that is capable of targeting tumour cells with the least untoward effect on red blood cells.
The Phase lll trial is a randomised, controlled, open-label, multi-centre study that has been designed to assess the efficacy and safety of lemzoparlimab combined with AZA against AZA monotherapy as first-line therapy in the targeted patients.
It represents the first approved Phase lll study for anti-CD47 therapies in mainland China.
MDS is a form of haematologic malignancy that primarily affects aged adults, thereby triggering dysplastic haematopoiesis, cytopenia(s) and risk of acute myeloid leukaemia transformation.
The rate of incidence of the disease grows with age, specifically among people aged 70 years and more.
I-Mab president and acting CEO Dr Andrew Zhu said: “We are excited to have dosed the first patient in the Phase III study for lemzoparlimab in higher-risk MDS, a disease with very limited treatment options.
“This milestone represents a significant step towards addressing the unmet medical needs of MDS patients and underscores our commitment to developing innovative therapies that could make a meaningful difference in their lives.
“We are hopeful that lemzoparlimab could become the first-to-market CD47-targeting therapy in China, providing a potentially new, safer, and effective treatment option for patients in need.”
In September last year, I-Mab reported positive top-line results from a Phase II trial of lemzoparlimab (TJC4) combined with azacitidine (AZA) in recently diagnosed patients with higher risk MDS.