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ImmuneOnco Received NMPA Authorization to Proceed with 3 Phase Ib/IIa Clinical Trials of IMM01 Combined with Azacytitin, Rituximab and Inetetamab
2021-08-24
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August 25, 2021, Shanghai, China ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. ( hereinafter referred to as "ImmuneOnco") announced that 3 phase Ib/IIa trials of company’s lead drug candidate, IMM01, Fc fusion protein targeting CD47,the first in China, combined with Azacytitin for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS),  with Rituximab for relapsed/refractory B-cell lymphoma and with Inetetamab (CipterbinTM) in her2-positive solid tumors have been approved by the National Drug Products Administration (NMPA). All clinical trials will be Initiated in the near future. The clinical trial of IMM01 combined with Inetetamab (CipterbinTM) will be cooperated with Sunshine Guojian (stock code , SHA: 688336) and mainly conducted by it. So far, total five clinical trial applications for IMM01 have been approved, which further establishes ImmuneOnco leading position in the research and development of CD47 target drugs.


The ongoing Phase I study of IMM01 monotherapy for the treatment of patients with relapsed/refractory lymphoma (NHL & HL) has completed all scheduled doses of participants. No dose-limiting toxicity (DLT) is observed and no subjects developed anti-drug antibodies (ADA) except for minor infusion response in some patients. There were no drug-related serious adverse events (SAE). At the same time, some patients had an exciting indication efficacy response, especially for patients with recurrent/refractory classic Hodgkin's lymphoma: 1 case of PR and 3 cases of SD in 5 patients with cHL, and the disease control rate reached 80%. Among them, the patient with PR was drug-resistant to PD-1 therapy. Currently, PR has lasted for 40 weeks and is still receiving treatment. In 1.5mg/kg dose group (the highest escalation dose group), four of the five patients enrolled had SD, two of them were SD with tumor shrinkage (17% and 33%, respectively). CR for 26 weeks was also observed in one patient.


"We are very pleased to see that the National Food and Drug Administration (NMPA) has approved clinical studies of IMM01 combined with Azacytitin, Rituximab and Inetetamab. The drug candidate IMM01, which is being tested in phase I clinical trials, has achieved long-lasting efficacy in some patients with advanced lymphoma at a low dose range with a good safety profile. Those clinical benefits are supported by the proprietary molecular design of IMM01. IMM01 does not bind to human red blood cells at all so as to avoid "Antigenic sink". Due to that in vivo infusion of the molecule doesn’t produce ADA and a smaller molecule (half molecular weight of regular IgG), it has higher tissue permeability and bioavailability. IMM01 has been tested in preclinical experiments in vitro in combination with various targeting and immunotherapeutic agents, efficacy appeared to be robust in tumor suppressive activity and potential to be applied to solid tumors. "We believe that IMM01 in combination with other drugs will provide significant advantages in clinical development." Dr. Tian Wenzhi, the founder of ImmuneOnco, is very confident of the IMM01 clinical trials. "We plan to expand IMM01 to apply in new indications and combination studies in the future to benefit more patients," he said.


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