Novasep and McSAF have confirmed their successful collaboration for the preclinical production of ADCITMER®, a next-generation Antibody-drug Conjugate (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 the company’s facility in Le Mans, 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 neuroendocrine (skin) cancer.
Each year an estimated 12,000 people will be diagnosed with a neuroendocrine tumor, sometimes called a carcinoid tumor. In contrast to cancers that are identified by where they are located in the body (i.e. breast cancer or colorectal cancer), neuroendocrine tumors (NETs) grow from neuroendocrine cells, which are found throughout the body. As a result, NETs can form anywhere where endocrine cells are present. Endocrine cells help regulate various body functions, including growth, reproduction, and metabolism. These cells are distributed throughout the body, however, NETs commonly develop in the lungs, small intestines, and pancreas.
Merkel cell carcinoma, also is called neuroendocrine cancer of the skin, is a neuroendocrine tumor that arises in Merkel cells, which are located in the top layer of the skin near nerve endings that receive touch sensations, and often expresses CD56. This form of cancer occurs most often in areas of skin exposed to sun.
While immune checkpoint inhibitors constitute a major advance for treating patients with Merkel cell carcinoma with advanced disease, this disease represents a major unmet medical need, and new therapeutic options are still urgently needed.
ADCITMER® is a new CD56-targeting auristatin E-conjugated ADC that may offer a potential therapeutic approach for the treatment of Merkel cell carcinoma. 
As part of the collaboration, Novasep successfully implemented and adjusted the ADC’s laboratory process in its own R&D facilities. The feasibility of the process has now been confirmed with the first Proof of Concept (POC) batch at 600 mg 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 for McSAF’s 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”, noted Jean Bléhaut, president of Novasep’s Pharma Solutions BU.
Based on the dynamic development for this new generation of anti-cancer drugs and the development of production capacities at Novasep’s Le Mans site, the company plans to triple its operational teams between 2018 and 2022.
 Esnault C, Leblond V, Martin C, Desgranges A, Baltus CB, Aubrey N, Lakhrif Z, Lajoie L, Lantier L, et all. Adcitmer® , a new CD56-targeting monomethyl auristatin E-conjugated antibody, is a potential therapeutic approach in Merkel cell carcinoma. Br J Dermatol. 2021 Sep 28. doi: 10.1111/bjd.20770. Epub ahead of print. PMID: 34582565.
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