The rate of incidence of MDS grows with age, specifically among people aged 70 years and more. Credit: Steve Buissinne from Pixabay.

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.

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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.