SHANGHAI and GAITHERSBURG, Md. – I-Mab (the “Company”) (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.
About CD47 and Lemzoparlimab
CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a “don’t eat me” signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.
Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumors in the U.S. and with Rituxan® for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.
In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China.
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company’s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab’s globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company’s unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.
Jielun Zhu, Chief Financial Officer
E-mail: [email protected]
Office line: +86 21 6057 8000
Gigi Feng, Chief Communications Officer
E-mail: [email protected]
Office line: +86 21 6057 5785
The Piacente Group, Inc.
E-mail: [email protected]
Office line: +86 21 6039 8363