Therapy Areas: Oncology
Acepodia's ACE1831 Investigational New Drug application receives FDA approval to commence phase one first-in-human, multi-centre clinical study
21 June 2022 -

Acepodia, a US-based clinical-stage biotechnology company, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a phase one, first-in-human, multi-centre clinical study of its ACE1831 in patients with non-Hodgkin's lymphoma.

ACE1831 is a potential antibody armed allogeneic gamma delta T cell therapy developed using the company's antibody-cell conjugation (ACC) technology as an optimised T cell engager platform intended to treat patients with non-Hodgkin's lymphoma.

Sonny Hsiao, PhD, chief executive officer of Acepodia, said, 'The FDA clearance of our IND application for ACE1831 is a significant milestone for Acepodia as we move into the clinic with a first antibody armed allogeneic gamma delta T cell product candidate through our unique ACC platform. Based on ACE1831's encouraging preclinical data, we believe that our antibody armed gamma delta T cell therapy has the potential to provide additional treatment options for patients with NHL. The ACC approach allows us to circumvent the limitations of current T cell engager therapies. Meanwhile, we can also significantly reduce manufacturing costs and has the potential to generate a cost-effective cancer treatment for patients. We look forward to advancing ACE1831 into its first clinical trial.'