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19 Nov 2024
Admin
News Article

Acepodia Secures FDA Approval for ACE1831 in IgG4-Related Disease

Overview

Acepodia has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ACE1831.

IgG4-Related Disease

IgG4-Related Disease (IgG4-RD) is a rare autoimmune condition characterised by inflammation and fibrosis in multiple organs, caused by elevated IgG4 antibodies.
Treatment focuses on controlling inflammation and preventing organ damage.
This marks the company’s entry into autoimmune disease research, targeting IgG4-related disease (IgG4-RD), a multi-organ fibro-inflammatory condition.

IND Clearance: Acepodia

The IND clearance enables Acepodia to evaluate the safety and effectiveness of ACE1831 in patients with IgG4-RD.
The therapy employs bioorthogonal chemistry to attach CD20-targeting antibodies to gamma delta T cells, resulting in a scalable, off-the-shelf treatment that avoids genetic modification.
This approach aims to reduce the risks associated with CAR-T cell therapies, such as T cell malignancies.
ACE1831 is also undergoing a Phase 1 trial for non-Hodgkin's lymphoma (NHL).

Acepodia’s Treatment Strategy

Acepodia’s treatment strategy is based on evidence suggesting that deeper B cell depletion may provide longer remission in autoimmune diseases.
The company has collaborated with global experts in IgG4-RD research to develop this innovative approach.

About the Trial

The upcoming Phase 1b/2a study will be conducted in partnership with Pfizer Ignite, a platform that supports biotech firms with resources and expertise to advance new medicines.
The study will be led by a team at Massachusetts General Hospital, with a focus on assessing the potential of ACE1831 for improved disease control and reduced side effects compared to existing cell-based therapies.

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