Pure Biologics to test molecule PBA-0405 in project PB004 in a Phase 0 clinical trial in patients with solid tumors – The Antibody Society

The Antibody Society shared on their LinkedIn page:

“In an unusual (to us anyway) move, Pure Biologics has applied to the U.S. Food and Drug Administration for approval to test molecule PBA-0405 (exploratory Investigational New Drug; eIND), the lead candidate in project PB004 in a Phase 0 clinical trial in patients with solid tumors.

Project PB004 involves the development of a novel therapeutic molecule in the format of an afucosylated IgG1 class antibody to stimulate the immune response of NK cells against tumor cells bearing the tumor antigen ROR-1, leading to their direct killing by an antibody-dependent cellular cytotoxicity mechanism.

The PB004 molecule is being developed for the treatment of solid tumors, including triple-negative breast cancer, as well as for the treatment of selected hematological malignancies, including chronic lymphocytic leukemia, among others.
The inclusion of a Phase 0 in an antibody development program is not common.

We look forward to hearing about study results.”

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Source: The Antibody Society/LinkedIn