Active Biotech AB and Strathmann Biotec AG conclude agreement regarding manufacturing of TTS cancer product
Active Biotech AB has signed an agreement with Strathmann Biotec AG in Germany. The agreement involves the process development and manufacturing of Active Biotech's cancer product TTS (Tumour Targeted Superantigens) CD3, for the treatment of non-small cell lung cancer (NSCLC).
The agreement with Strathmann Biotec will secure a highly cost efficient long-term development and manufacturing plan, including the possibility for future large volume commercial production. The agreement is based on co-development of the product.
Strathmann Biotec will take an active part in the project and share a part of the financial risk. This will further reduce Active Biotech's initial development costs for the project. In return, Strathmann Biotec is entitled to a limited royalty on Active Biotech's income from future milestones and sales. The potential royalty to be paid is maximised to EUR 10 Millions.
"The TTS CD3 project fits well with the competence and experience of our company. We are confident that our future collaboration will be as efficient and constructive as our negotiations were and we will take an active interest in this promising project", stated Dr. Bert Behnke, CSO of Strathmann Biotec.
"We are very pleased to get Strathmann Biotec as a competent development partner with an excellent reputation. We have now secured cost competitive quality production for clinical and commercial use", said Sven Andréasson, President & CEO Active Biotech.
TTS CD3 is a biotechnology product which is produced using recombinant E. coli based expression system.
The production of the TTS product will be transferred from the present manufacturer (Biovitrum) to Strathmann Biotec. Strathmann Biotec will initiate the further process development and the new process will be established at the production facility in Dengelsberg, Germany, reaching a 1000 litre-scale production.
Strathmann Biotec is a specialised biotechnology company based in Hamburg, Germany, with long-standing experience in the area of microbial protein expression systems and manufacturing in accordance with cGMP guidelines for both clinical testing and commercial use.
A clinical Phase I dose-escalation study of TTS CD3 is currently in progress and involves patients with non-small cell lung cancer at the Fox Chase Cancer Center in Philadelphia, Pennsylvania, US and at the Radiumhospitalet in Oslo, Norway. A first generation of the product, TTS CD2, has recently concluded clinical trials phase IIa in renal and pancreatic cancer with promising results.
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