US-based biopharmaceutical firm Aduro Biotech has started dosing patients in a Phase I/II clinical trial of BION-1301 to treat relapsed or refractory multiple myeloma in adults.
BION-1301 is a humanised anti-a proliferation-inducing ligand (APRIL) antibody that has demonstrated the ability to destroy malignant cells and minimise therapy resistance in disease models.
The multi-centre, open-label Phase I/II trial is designed to assess the safety and activity of BION-1301 in subjects who progressed following a minimum of three previous systemic therapies with immunomodulatory drugs (IMiDs), proteasome inhibitors, chemotherapies or monoclonal antibodies.
Aduro Biotech chief medical officer Natalie Sacks said: “Neutralising APRIL is a differentiated approach in the treatment of multiple myeloma, and it has been shown to inhibit tumour growth and overcome drug-resistance in preclinical studies.
“BION-1301 is our wholly owned novel antibody that has been shown in non-clinical studies to fully block the APRIL-induced signalling cascade at a critical juncture, and we are eager to further characterise its potential activity in the clinic.”
The trial’s Phase I portion is designed to investigate the safety, pharmacokinetics, and pharmacodynamics of increasing doses of BION-1301 given once every two weeks in a 28-day cycle.
Determination of the recommended Phase II dose in the first part will be followed by the initiation of the Phase II portion to evaluate the safety and preliminary activity of the selected dose.
The primary activity endpoint of the second part is objective response rate.