Scientists from Acepodia recently described progress on an off-the-shelf cancer therapy. Sonny Hsiao, PhD, CEO and co-founder, made time to talk with GEN about this work and what lies ahead.

GEN: How would you describe your therapeutic and its status?

Sonny Hsiao, PhD: The technology is based on our antibody-cell conjugation, or ACC. With our ACE1702 therapeutic candidate, for example, complementary single-stranded DNAs link a natural killer cell to a monoclonal antibody, trastuzumab, that targets HER2-expressing cancer cells. So, only micrograms of antibody are needed. Our ACC platform could conjugate any antibody to any live cells, so it can be used for autoimmune diseases and infectious diseases, such as a virus, but we are focusing on oncology. Our ACE1702—an off-the-shelf cell therapy—is in a Phase I clinical trial of HER2-expressing solid tumors.

GEN: How would you describe your approach to bioprocessing?

Hsiao: We are using our proprietary immune effector cells, which make this a truly allogeneic, off-the-shelf product. What we mean is that we manufacture them in large-scale, and we have a successful cryopreservation process that can retain the antitumor potency of our product. Currently, we have a shelf life over two years, with the product stored at liquid nitrogen’s temperature. Plus, it’s not like CAR-T where you have to do a lot of work that could take weeks to get a treatment ready. For us, once it’s prescribed, somebody could get it.

GEN: In developing your approach to bioprocessing, what was the biggest challenge?

Hsiao: It’s actually a bit hard to imagine, but the biggest challenge was essentially the supply chain, due to COVID-19. It was previously trivial, but now it can take seven to 12 months to get some plastic bags. So, you need to plan ahead 12 or 18 months.

GEN: Is there anything else that makes your bioprocessing unique?

Hsiao: Because our process doesn’t involve any genetic manipulation, we actually can run in a regular GMP factory. We don’t change the genome of the cells, so there’s no risk of genotoxicity. The result is that we won’t need to run so many QC assays after giving a treatment to a patient to make sure the cells are unaffected, that they have not become tumorigenic. This all fits with our mission statement, which is to make these powerful cell therapy drugs of the future accessible to all patients.