As the regulatory consultant, Dr. Frank Li, congratulates BiOneCure Therapeutics on receiving US FDA IND may proceed letter for BIO-106
Gaithersburg, MD (21 April 2022) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, congratulates BiOneCure Therapeutics on receiving US FDA IND may proceed letter for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors.
About BIO-106
BIO-106 [1] is an anti-Trop-2 ADC to target cancer cells expressing Trop-2, a protein overexpressed in a broad range of tumors including TNBC, HR+/HER2 mBC, NSCLC, and others. BIOneCure has developed BIO-106 using its proprietary TAMTM payload technology to enable homogenous high drug load. In the pre-clinical study, BIO-106 has demonstrated broad anti-tumor activities with excellent safety profile and wide therapeutic window.
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
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