ProBio Supports Commercial Manufacturing of the World's First DNA Immunotherapy Targeting HSIL

May 10, 2023

On May 10, ProBio and Beijing Apollo Venus Biomedical Technology Limited ("ApolloBio") entered into strategic collaboration on ABC-3100, the world's first DNA immunotherapy targeting high-grade squamous in-traepithelial lesion (HSIL). ProBio will provide technology transfer, clinical sample and commercial manufacturing services for ApolloBio's program. The collaboration is expected to bring the immunotherapy targeting HSIL caused by high-risk HPV infections to patients and change the paradigm in treating related diseases and preventing cervical cancer.

Plasmids are used as drug substance for DNA drugs, subject to different regulatory requirements on the roles and quality management of plasmids in different development stages. ProBio is capable of providing one-stop plasmid manufacturing services from preclinical research to commercialization based on different plasmid applications and different development stages. By constantly optimizing, adjusting and validating manufacturing processes, ProBio has in place a well-established GMP plasmid manufacturing system featuring stable processes that ensures delivery of high-quality plasmids.

ABC-3100 is an immunotherapy targeting HSIL caused by high-risk HPV infections and the first DNA immunotherapy to enter Phase III clinical trial in the world. Long-term results from the existing clinical trials showed that for patients whose abnormal tissue has been removed after treatment, no further surgery is needed. Clinical outcomes are comparable in patients treated with ABC-3100 versus those treated with traditional surgery, and patients treated with ABC-3100 are much more likely to clear their viral infection.

Apart from local manufacturing of ABC-3100, the parties also intend to jointly develop a number of innovative DNA immunotherapies.