I-Mab receives China NMPA clearance to begin phase 1 trial of lemzoparlimab in relapsed/refractory advanced lymphoma

I-Mab, a clinical stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the US Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China is currently underway with clinical results expected in early 2021.

Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

The preliminary results of the recent phase 1 clinical trial in the US have shown differentiation of lemzoparlimab in terms of safety and pharmacokinetics profiles in cancer patients. Lemzoparlimab was well tolerated as a single agent at a dose up to 30 mg/kg/week without introducing any priming dose strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year. At the same time, combination therapy of lemzoparlimab with pembrolizumab in patients with solid tumors and classical Hodgkin’s lymphoma are also ongoing in the US.

“We strongly believe that lemzoparlimab has the potential to make a significant difference in the treatment of multiple cancers, particularly hematologic malignancies in China,” said Dr. Joan Shen, CEO of I-Mab. “We look forward to accelerating this program through close collaboration between the US and China teams and delivering a potentially life-changing medicine to patients in need.”

Earlier this month, I-Mab entered into a global strategic partnership with AbbVie to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents.

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 tumor and with Rituxan for lymphoma in the US, in addition to an on-going clinical trial in patients with AML in China.

I-Mab, a clinical stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products

Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1

clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the US

Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China is currently underway with

clinical results expected in early 2021.

Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab. It is designed to minimize

inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab

from other antibodies of the same class currently in development.

The preliminary results of the recent phase 1 clinical trial in the US have shown differentiation of lemzoparlimab in terms of safety and

pharmacokinetics profiles in cancer patients. Lemzoparlimab was well tolerated as a single agent at a dose up to 30 mg/kg/week without introducing

any priming dose strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will

be presented at an appropriate scientific conference later this year. At the same time, combination therapy of lemzoparlimab with pembrolizumab in

patients with solid tumors and classical Hodgkin’s lymphoma are also ongoing in the US.

“We strongly believe that lemzoparlimab has the potential to make a significant difference in the treatment of multiple cancers, particularly

hematologic malignancies in China,” said Dr. Joan Shen, CEO of I-Mab. “We look forward to accelerating this program through close collaboration

between the US and China teams and delivering a potentially life-changing medicine to patients in need.”

Earlier this month, I-Mab entered into a global strategic partnership with AbbVie to develop and commercialize lemzoparlimab. Both companies will

collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and

commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-

related therapeutic agents.

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 tumor and with Rituxan for lymphoma in the US, in addition to an on-going

clinical trial in patients with AML in China.