Pure Biologics announces the first administration of drug candidate PBA-0405 in a Phase 0 (first-in-human) clinical trial.
- PBA-0405, was administered to a patient with a diagnosis of squamous cell carcinoma of the head and neck, who was recruited at Louisiana State University Teaching Hospital in Shreveport (USA). The patient underwent surgical resection of the tumor, which was secured and prepared for immunohistochemical studies.
- Planned immunohistochemical studies are expected to provide information on the pharmacodynamics of PBA-0405, and thus data on the drug candidate’s anticipated anticancer efficacy.
- Results from the first patient are expected within eight weeks. Plans are underway to enroll 12 patients with head and neck cancer, soft tissue sarcoma and triple negative breast cancer. The Company expects to complete the entire Phase 0 trial in the coming months and will continue to monitor the results of the sub-studies. Patient enrollment is ongoing and several patients are currently in the enrollment queue.
Dr John Weinberg, Chief Medical Officer Pure Biologics:
The first administration of PBA-0405 to a patient is a key step in the development of this project. We look forward to confirming the preclinical hypotheses soon and being able to confirm the potential of PB004 to offer a novel approach to cancer treatment.
Dr. Filip Jelen, co-founder, major shareholder and CEO of Pure Biologics:
Several years of research have brought us to a place where we have administered a molecule developed by Pure Biologics scientists to a patient for the first time. Our novel approach to clinical trials, incorporating a Phase 0 trial into the process, will allow us to obtain the first information about the potential efficacy of a drug candidate much sooner than in the classic approach. We look forward to a smooth full trial and complete results as early as 2024.
Project PB004 is a potential biologic drug. It involves the development of a novel therapeutic molecule in the format of an affucosylated 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 (ADCC) 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.