Angel wins manufacturing contract from CellCure
manufacturing deal with Danish biotech company CellCure.
While both companies are being guarded and terms of the contract have not been disclosed, a spokesperson for Angel commented that the agreement is significant in terms of their current contracts.
Although specific figures were not forthcoming, it was suggested to In-PharmaTechnologist.com that the deal is on a similar scale to Angel's current contract with Therapeutic Proteins Inc (TPI) which was announced last year and valued at approximately £8m (€12m).
Angel Biotechnology is set to manufacture and provide GMP materials for a Phase II clinical trial using (allogeneic) T-cell based immuno-therapy. Following successful Phase I trials completed in February 2004, Angel will provide CellCure with cells to be further evaluated in the treatment of patients diagnosed with metastatic malignant melanoma.
In June 2005 CellCure completed a $5.4m series B refinancing, partly provided by the company's new CEO, Anders Trojel.
Proceeds from this equity investment are being ploughed into further development of the company's T-cell based approach to cancer therapy.
The main target will be the company's lead product, C-Cure 709, a human T-lymphocyte genetically engineered to recognise and kill melanoma cells. The product was granted Orphan Drug status in May 2004 and is due to enter the Phase II trial in 2008.
According to Angel the scale-up for the 18-month project has already begun, and manufacture will be based at its facilities in Cramlington and Edinburgh in the UK.
"The commencement of this GMP Manufacture collaboration with Angel is an important milestone in CellCure's history," said Trojel.
"Having worked only with laboratory-grown T-cells in the past, the development of a final and fully GMP compliant bio-pharmaceutical preparation is crucial to our future success."
CellCure technology allows the company to produce unlimited amounts of gene-transduced T-cells outside the human body, and the company has filed two families of patent applications, with its C-Cure 709 compound expected to be covered by patent protection until 2021 in major western countries.
With a patient population of 10,000 per year and incidence of metastatic malignant melanoma on the rise, the European orphan drug destination also guarantees C-Cure 709 a market exclusivity of ten years from first year of launch in EU.
