Monday, December 23, 2024

Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy

Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, announced that it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human, multi-center clinical study of its ACE1831 in patients with non-Hodgkin’s lymphoma.

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“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,” said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. “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,” said the chief executive officer.

Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of allogeneic cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as gamma delta T cells to create novel antibody cell effector (ACE) therapies, which have increased binding strength against tumors that express low levels of tumor antigens.

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