Receive our newsletter – data, insights and analysis delivered to you
  1. News
December 20, 2017

Aduro Biotech doses first patient in Phase I/II myeloma trial

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.

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.

“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.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU