The company has been granted an Advanced Therapy Medicinal Product (ATMP) certificate following a review of manufacturing quality and non-clinical data for its lead pipeline program vididencel by the European Medicines Agency (EMA).

Although this certification is not a requirement for a future application for marketing authorization, it affirms that manufacturing quality and non-clinical development has been performed in accordance with regulatory guidelines, taking into consideration the stage of product development.

“A clear validation”

“The ATMP certification by the EMA is a clear validation of our investments into manufacturing and process development and increases the value of our lead pipeline product vididencel significantly,” says Leopold Bertea, Chief Technology Officer of Mendus. “The ATMP certificate now granted will build an excellent basis for the next steps we have planned and puts vididencel on a solid path towards late-stage development and commercialization preparedness.”

Read more: Mendus enters alliance with NorthX and announces a directed share issue

Vididencel

Vididencel is currently being evaluated in AML and ovarian cancer as a potential maintenance therapy to reduce tumor recurrence. Vididencel is an intradermal vaccine derived from the Company’s proprietary DCOne leukemic cell line. In December 2022, the Company announced positive results from the ADVANCE II study in AML. The analysis demonstrated the potential of vididencel to control measurable residual disease (MRD) and extend durable relapse-free survival in the majority of patients. Mendus expects to present a next survival read-out of the ADVANCE II trial in the fourth quarter of 2023.

A really positive environment for innovation and entrepreneurship

Ola Björkman asked Erik Manting, CEO, Mendus, at BIO International Convention to comment on the Swedish life science industry in general – which are the strong points and what can be improved?

“Sweden has a long history and a wide range of companies active in the life sciences sector. This is a really positive environment for innovation and entrepreneurship. What is more challenging is that a lot of companies go public at a very early stage, which results in early hope of quick success, whereas in reality biotech entails hard work and is very capital intensive. This requires support from professional investors with deep pockets or it could come from partnering with big pharma companies, which however are highly selective and cannot be counted on as a solution. Therefore, also based on my experience from Investment Banking, I believe the life sciences sector in Sweden could become even stronger if companies would first secure an institutional investor basis and a more solid operational basis before going public,” he said.

Photo of Mendus’ management team