to-BBB obtains government loan of €1.2 million for clinical trial in brain cancer

04-Apr-2011 - Netherlands

to-BBB is getting ready to point its brain-targeting platform to patients with brain cancer. The Dutch Ministry of Economic Affairs, Agriculture and Innovation (Agentschap NL) supports to-BBB in this challenge by granting an “Innovation Credit”, covering 35% of the costs needed for clinical development of this therapy.

“We highly appreciate the support of the Dutch government for our innovative work in brain-drug delivery,” says Willem van Weperen, CEO of to-BBB. “Our brain cancer lead program will address the high medical need of patients with brain cancer, while also establishing our brain delivery platform in humans.”

Based on its proprietary G-Technology®, to-BBB is developing its lead compound 2B3-101, brain-targeted doxorubicin liposomes. These liposomes are coated with the tripeptide glutathione at the tips of polyethylene glycol (PEG) to safely enhance the delivery of free drug to the brain. 2B3-101 has shown reduction of brain tumor growth in proof-of-concept studies at the Netherlands Cancer Institute. Clinical scale batches of 2B3-101 have been produced by to-BBB’s manufacturing partner TTY Biopharm and pivotal preclinical safety studies were finished in 2010. The Phase I/II clinical trial will start in a few months at 3 academic hospitals in the Netherlands led by neuro-oncology experts of the Antoni van Leeuwenhoek hospital (AVL-NKI). The study will establish a safe therapeutic dosage and collect the preliminary evidence of activity in a specific group of women with brain metastases of breast cancer. The clinical development plan for this product was fine-tuned in scientific advice meetings with European regulatory authorities by to-BBB’s clinical development team.

The “Innovation Credit” of Agentschap NL consists of an initial investment of €1.2 million to support the planned Phase I/II study. The company has the option to apply for an additional credit for a pivotal second clinical study.

https://www.bionity.com/en/news/131704/to-bbb-obtains-government-loan-of-1-2-million-for-clinical-trial-in-brain-cancer.html