ImmuneOnco Received NMPA Authorization to Proceed with 3 Phase Ib/IIa Clinical Trials of IMM01 Combined with Azacytitin, Rituximab and Inetetamab

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.

About IMM01

MM01 for injection is a new generation of immune checkpoint inhibitor with independent intellectual property rights, which is developed based on the "MAB-TRAP" technical  platform of  ImmuneOnco. Aiming at the immune regulatory CD47, it can activate the phagocytosis of macrophages on tumor cells and present tumor antigens to T cells. Thus, it takes powerful effects of tumor immunology. The IMM01 project faces the challenge of CD47 target drug research and development, and has been granted invention patents in China, Japan and the United States.

About ImmuneOnco

Founded in June 2015 in the Zhangjiang Hi-Tech Park of the China (Shanghai) Pilot Free Trade Zone, ImmuneOnco focuses on the development and research of anti-tumor immunotherapy products, including bi-specific antibodies, novel recombinant proteins, and TankTM cellular therapy. The common feature of these products is to activate the patient's own immune system to exert the anti-tumor effects, and ultimately inhibit the endless growth of tumor cells and reverse the malignant symptoms, so that the patients gradually return to healthy. So far, several new anti-tumor drugs are in clinical research stage. ImmuneOnco is recognized by authorities as one of the ‘Top 50 Start-up Enterprises with the Most Investment Potential in Shanghai’ in 2016, the "Excellent Enterprise" in the 2017 China Innovation and Entrepreneurship Competition, and the "Enterprise Excellence Award" of Shanghai Science and Technology Entrepreneurship in 2017.

About Sunshine Guojian

Founded in 2002, Sunshine Guojian is one of the first batch of innovative biomedical enterprises focusing on antibody drugs in China. Sunshine Guojian has developed into a pioneer of antibody drugs in China with capabilities of independent research and development, industrialization and commercialization. With innovative therapeutic antibody drugs as the main direction of research and development, the company provides high-quality, safe and effective clinical solutions for the treatment of autoimmune diseases, tumors and other major diseases. At present, the company has 18 at the different development stage, tumor, autoimmune and eye disease in research in the field of antibody drugs (including 8 post-clinical and clinical stage of drugs, 10 in the preclinical phase of drugs), most of these drugs in development are in the category of biological products type-1, some of the drugs in development are carried out in both China and USA.