Novasep, a supplier of services and technologies for the life sciences industry, and McSAF, a French biotech specialized in bioconjugation tools to design bio drugs for health and diagnostics, have announced their successful collaboration for the preclinical production of ADCITMER, a next-generation ADC to treat neuroendocrine cancers. 
 
Novasep performed a proof-of-concept study of McSAF’s bioconjugation technology through the production of the ADC at its bioconjugation unit at its Le Mans site, in France.
 
This site, which now has more than 15 years of experience in supporting ADC drug innovators, leveraged its specific expertise and purpose-built capabilities to support McSAF’s preclinical studies underway in Merkel cell carcinoma, a rare and aggressive skin cancer, a type of neuroendocrine cancer. 
 
Novasep successfully implemented and adjusted the ADC’s laboratory process in its own R&D facilities. The feasibility of process has now been confirmed with a 1st “POC” (Proof of Concept) batch at 600mg scale. This first step of ADCITMER’s development is currently being supported by France’s Centre-Val de Loire region through a collaborative program between the University of Tours and McSAF (ARD-CVL Biomédicaments).
 
“The process transfer of our proprietary bioconjugation technology, McSAF Inside, to Novasep is a huge step in McSAF’s story and is a validation of the manufacturing process for our future product developments. Now, with this pilot batch, we will be able to illustrate further the therapeutic relevance of our ADC for metastatic Merkel cell carcinoma patients currently with unmet medical needs,” said Dr. Marie-Claude Viaud-Massuard, chief scientific officer of McSAF.
 
“As a leading contract development and manufacturing organization (CDMO), Novasep is proud to support innovators such as McSAF, which contribute to the growing pipeline of Antibody Drug Conjugates and participate in strengthening the therapeutic offer for the benefit of patients with rare diseases such as Merkel cell carcinoma,” said Jean Bléhaut, president of Novasep’s Pharma Solutions BU.
 
In this context of dynamic development for this new generation of anti-cancer drugs and the development of its production capacities, Novasep’s Le Mans site, which currently employs approximately 130 collaborators, aims to triple its operational teams between 2018 and 2022.