I-Mab, a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, announced the advancement of clinical development of the highly differentiated anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) in the US and China, achieving milestones as planned. The Company is progressing its US combination trial (NCT03934814), studying lemzoparlimab in combination with Rituxan and Keytruda in dose expansion cohorts in non-Hodgkin lymphoma (NHL) and advanced solid tumours, respectively. The combination study with Rituxan will enroll NHL patients from both the US and China. Topline results from this study are expected next year.

"The results from early investigational studies support the notion that lemzoparlimab is a differentiated CD47 antibody therapy for cancers that remains among the most common causes of death around the world," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial in the US. "As preclinical studies have suggested potential therapeutic effect when combined with other immuno-oncology drugs, we believe this warrants further study of the compound as a combination therapy."

I-Mab is also poised to advance lemzoparlimab into late-stage clinical development in China. It will soon complete its ongoing phase 1/2a dose escalation trial (NCT04202003) to assess lemzoparlimab as monotherapy for patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in China. The clinical results from this monotherapy dose escalation study will be presented at an appropriate scientific conference early next year.

Further, last week, China CDE accepted I-Mab's IND application to advance to a combination trial with azacitidine (AZA) in untreated AML or MDS. The open-label, multi-center combination trial will evaluate the safety, efficacy and tolerability of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are ineligible for intensive chemotherapy, or in patients with higher-risk MDS. The planned study builds upon the ongoing phase 1/2a monotherapy dose escalation trial and will potentially lead to a registrational study in China.

"It has been reported and demonstrated that AZA can lead to significant increase of the 'eat me' signals on cancer cells. The combination of lemzoparlimab, which blocks the CD47 'don't eat me' signals on tumour cells, with AZA can greatly enhance macrophage activity to offer a strong therapeutic effect in patients," said Prof. Jianxiang Wang, principal investigator in China and Director at the Institute of Hematology, China Academy of Medical Services. "There are limited treatments available currently for those patients suffering from AML and MDS."

I-Mab's global collaboration with AbbVie will facilitate global development of lemzoparlimab. In September, I-Mab and AbbVie entered into the partnership, subject to certain pre-closing conditions, to develop and commercialize lemzoparlimab, including design and conduct further clinical trials to evaluate lemzoparlimab globally including China. Both companies have jointly developed plans for the treatment of multiple cancers.

"Based on the strength of our data to-date, we have been able to rapidly advance the clinical development of lemzoparlimab. The progress we have made for our China and US trials, as well as our global partnership with AbbVie, has well positioned I-Mab to accelerate the clinical development towards a registrational trial and to be one step closer in benefiting cancer patients globally,"said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab.