As the project partner, BLA Regulatory congratulates ImmuneOnco on receiving US FDA approval of IMM2902 project IND
Gaithersburg, MD (25 August 2021) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, announced that as the project partner, BLA Regulatory congratulates ImmuneOnco on receiving US FDA approval of IMM2902 project IND and initiating clinical investigation for HER2-expressing advanced solid tumors.
About IMM2902
IMM2902[1] is a new-generation bispecific drug candidate with global proprietary intellectual property rights, developed based on “mAb-Trap” technical platform. IMM2902 targets immune regulatory target CD47 and HER2, to inhibit tumor cell growth by accelerating the endocytosis and degradation of HER2, and to disinhibit and enhance the phagocytosis of macrophages against tumor cells by blocking the “don’t eat me” signal mediated by CD47-SIRPα and activating the “eat me” signal mediated by Ig1Fc-FcγR. By the phagocytosis, processed tumor antigen was presented to T cells thereby exerting a powerful effect of tumor immunotherapy. IMM2902 is expected to be used mainly for HER2-expressing advanced solid tumors such as breast cancer, stomach cancer and lung cancer.
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the US with global reach to other major markets. BLA provides comprehensive regulatory strategy and operation services from pre-IND strategic planning, IND preparation & submission, all the way to submission and approval of BLA/NDA. Our goal is to help moving your product through the development cycle efficiently. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients a broad range of experiences from Big Pharma, CROs, and the FDA. Our services expand across regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission. We have extensive experience across therapeutic areas such as oncology, respiratory, addiction, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
For further information contact:
Jiangang He, BD Dept.
Jiangang.He@bla-regulatory.com
Reference
[1] “ImmuneOnco Received FDA Approval OF IMM2902 as an Investigational New Drug (IND) in the United States.” ImmuneOnco Received FDA Approval of IMM2902 as an Investigational New Drug (IND) in the United States – 宜明昂科生物医药技术（上海）有限公司, www.immuneonco.com/display.php?id=120.