Tours and Lyon, France, November 18th 2021 – Novasep, a leading supplier of services and technologies for the life sciences industry, and McSAF, a French biotech based in Tours, specialized in bioconjugation tools to design innovative and efficient bio drugs for health and diagnostics, are pleased to announce 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 state-of-the-art 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 Pr 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 Mr Jean Bléhaut, president of Novasep’s Pharma Solutions BU.
In this context of important and dynamic development for this new generation of anti-cancer drugs and the development of our production capacities, Novasep’s Le Mans site, which currently employs approximately 130 collaborators, ambitions to triple its operational teams between 2018 and 2022. For more information, visit Novasep’s Job Center.
Since 2015, McSAF, biotech based in Tours, France, has been specialized in bioconjugation tools to design innovative and efficient biodrugs for health and diagnostics. Its core capabilities and know-how span the modification of payloads and proteins to develop next-generation antibody-drug conjugates (ADCs) for oncology and beyond. McSAF proposes licences of its proprietary technologies for the generation of homogeneous, stable, and improved antibody-drug conjugates, harnessing the power of human antibodies combined with the potency of payloads.
Our affiliate, McSAF Inside® Oncology, founded in feb. 2021, is dedicated to the development of next-generation ADC for patients in oncology. Our first lead product candidate, ADCITMER®, is a first-in-class proprietary ADC integrating McSAF technological tools, to treat neuroendocrine cancers.
Novasep offers flexible contract development & manufacturing (CDMO) solutions for small molecule APIs & biopharmaceuticals to innovators. We propose a wide range of flexible cGMP manufacturing assets on multiple sites with an outstanding regulatory track record. We are a world leader in a number of specialized technologies including HPAPIs, ADCs, hazardous & cryogenic chemistries & industrial chromatography (batch and continuous). Through a series of investments in both payload and bioconjugation manufacturing (the latest expansion involving the creation of an additional 40 full time jobs), Novasep has evolved to become a leading CDMO provider in the ADC arena, working closely with our innovator partners, to supply their preclinical, clinical and commercial needs. The bioconjugation facility was successfully inspected by the ANSM (French regulatory drug authorities) in 2021.