Duality Biotherapeutics

Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov

Duality Biotherapeutics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half of 2026.

In April 2024, the company’s BDCA2 ADC patent, which utilizes a glucocorticoid as a payload for the treatment of autoimmune diseases, was published. DB-2304 is a novel BDCA2 ADC that incorporates a hormone analog as its payload with a drug-antibody ratio (DAR) of 4.

BDCA2 is predominantly expressed on plasmacytoid dendritic cells (pDCs). Upon binding, DB-2304 is internalized, releasing the hormone analog into the cells, which enhances the transcription of genes that produce glucocorticoid response elements, thereby inhibiting the secretion of pro-inflammatory cytokines. The antibody binding also suppresses the activation of pDCs and the production of interferons, creating a synergistic effect.

Preclinical studies have confirmed the synergistic effect, demonstrating that DB-2304 can more effectively suppress the release of inflammatory cytokines compared to existing BDCA2 antibodies in clinical use.

Duality Biotherapeutics is actively advancing its pipeline of next-generation ADCs, with candidates such as PD-L1/B7H3 bispecific ADC and BDCA2 autoimmune ADC progressing to clinical stages. In late August 2024, the company submitted an application for listing on the Hong Kong Stock Exchange. According to the publicly disclosed information in the prospectus, since 2023, licensing collaborations with BioNTech have generated revenue of 21.22 billion yuan, and a collaboration with Client A has brought in an additional 2.85 billion yuan.- Flcube.com

Fineline Info & Tech