Drug intelligence / Profile preview

PDS0301

Development stage
Unknown
Lead developer
PDS Biotech
Modality
Cytokines & Interferons → Recombinant Proteins and Enzymes, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

PDS0301 (formerly M9241, NHS-IL12, or PDS01ADC) is an investigational tumor-targeted immunocytokine developed by PDS Biotech. It consists of a human IgG1 monoclonal antibody (NHS76) fused to two interleukin-12 (IL-12) heterodimers. The NHS76 antibody component specifically targets histone-DNA complexes exposed in regions of cellular necrosis, which is a common feature of solid tumors, thereby delivering IL-12 preferentially to the tumor microenvironment. This localized delivery is designed to enhance the proliferation, potency, and longevity of T cells and natural killer (NK) cells while minimizing the systemic toxicities historically associated with recombinant IL-12 therapy. PDS0301 is being evaluated as a monotherapy and in combination with other cancer therapies, including chemotherapy (such as docetaxel), hepatic arterial infusion pump (HAIP) floxuridine, and other immunotherapies, for the treatment of various solid tumors, including metastatic colorectal cancer, prostate cancer, Kaposi sarcoma, and HPV16-positive cancers.

Other names
NHS-interleukin-12NHS-interleukin12NHS-interleukin 12NHS76-IL12NHS-76-IL12NHS 76-IL12tumor-targeted IL-12 immunocytokinetumor-targeted interleukin-12 immunocytokine
02

Targets

Nucleosome (DNA–histone complex)IL-12R (Interleukin-12 receptor)

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