I-Mab Biopharma (IMAB) Reports First Patient Dosed in China Phase 2 Combination Trial of Lemzoparlimab with Azacitidine

I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the first patient has been dosed in an abbreviated combination clinical study (NCT04202003) of lemzoparlimab (also known as TJC4) with azacitidine (AZA) in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) in China.

Lemzoparlimab is a differentiated anti-CD47 monoclonal antibody designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity. AZA is a chemotherapeutic drug that may synergize with lemzoparlimab to treat hematologic malignancies.

This phase 2 combination cohort expansion study builds on the dose escalation monotherapy trial in China and will evaluate the safety, tolerability and efficacy of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are intolerant to intensive chemotherapy or treatment-naïve patients with intermediate and high-risk myelodysplastic syndrome. Patient enrollment is expected to be completed by Q4 2021.

"Lemzoparlimab has already shown promising and differentiated features as a novel therapy in phase 1 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. A pivotal trial towards registration is anticipated immediately after this," said Dr. Joan Shen, CEO of I-Mab.

The Company is on track with its accelerated clinical development plan for lemzoparlimab with the ambition for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies in China while advancing two ongoing clinical trials of lemzoparlimab in combination with Rituxan® in patients with NHL and Keytruda® in advanced solid tumors in the U.S. The NHL combination study also included clinical sites in China as an international multi-center trial (IMCT) to potentially bridge to a registrational clinical trial in China if approved by the NMPA. Patient enrollment of both the NHL and solid tumor trials will be completed by Q4 2021 with the preliminary topline data expected thereafter.

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