Prestige Biopharma IDC Publishes Preclinical Results for Bispecific Antibody IDC007, Targeting Immunotherapy Side Effects

Simultaneously targets TNF-α and IL-6R; preclinical studies show improved survival
and reduced organ damage Aims to address the limitations of single-target tocilizumab therapy; substance patent application completed, with an IND filing targeted for 2030

Prestige Biopharma IDC, the antibody drug development subsidiary of Prestige Biopharma, has published preclinical results for a bispecific antibody candidate designed to treat cytokine release syndrome (CRS), a major severe adverse event associated with cancer immunotherapy, in an international scientific journal. The company’s strategy is to overcome the limitations of single-target treatments by blocking two key inflammatory cytokines involved in CRS at the same time.

According to industry sources, a preclinical research paper on Prestige Biopharma IDC’s bispecific antibody candidate, IDC007, was recently accepted for publication in the international immunology journal Frontiers in Immunology.

IDC007 is a bispecific antibody engineered to simultaneously neutralize tumor necrosis factor alpha (TNF-α) and the interleukin-6 receptor (IL-6R), both of which contribute to CRS. TNF-α triggers early macrophage activation and vascular endothelial injury, while interleukin-6 (IL-6) amplifies systemic inflammation. IDC007 is designed to suppress both the early inflammatory response and the subsequent systemic spread of inflammation by blocking these two pathways in parallel.

In an in vitro CRS model using stimulated human peripheral blood mononuclear cells (PBMCs), researchers found that IDC007 reduced the release of inflammatory cytokines, including TNF-α and interferon-gamma (IFN-γ), and prevented impairment of barrier function in human vascular endothelial cells. In a humanized CRS mouse model, IDC007 bound to both targets and mitigated worsening physiological indicators such as hypothermia and body-weight loss, while improving survival rates. It also significantly reduced markers of immune hyperactivation, including splenomegaly and lung injury.

The researchers concluded that simultaneous inhibition of the two targets helped preserve vascular endothelial integrity and reduce organ damage in severe CRS, representing preclinical proof of concept for the bispecific-antibody approach.

Tocilizumab, which blocks IL-6R, is used as a standard treatment for CRS. However, it has been criticized for having limited effectiveness in severe cases because it leaves TNF-α, an upstream driver of inflammation, unblocked. IDC007, by contrast, simultaneously suppresses upstream TNF-α and the downstream IL-6 pathway, potentially addressing the limitations of tocilizumab.

Prestige Biopharma IDC is conducting follow-up cell-line development and additional preclinical studies based on IDC007. After accumulating further nonclinical data, the company plans to explore collaborative research and development opportunities with global pharmaceutical and biotechnology companies, as well as research institutions.

A Prestige Biopharma IDC representative said, “The paper containing these research findings is currently awaiting publication, and applications for related substance patents have been completed. In the mid to long term, we aim to refine our development strategy and target an Investigational New Drug (IND) application in 2030.”

Prestige Biopharma IDC is a wholly owned subsidiary of Prestige Biopharma. Based at the Innovative Drug Research Institute in Myeongji International New City, Busan, it develops bispecific antibodies, antibody-drug conjugates (ADCs), and next-generation vaccines. Its parent company, Prestige Biopharma, is pursuing European commercialization of Tuznue, a biosimilar to Herceptin, and has a pipeline that includes PBP1510, an antibody drug candidate for pancreatic cancer.

Source: PRESS9（https://www.press9.kr/news/articleView.html?idxno=79010）