Servier appoints Yposkesi for lentiviral vector GMP-manufacturing in CAR-T cell development technology
Service agreement gives Servier access to Yposkesi’s robust production capacity
Suresnes and Corbeil-Essonnes, France, June 5, 2019 – Servier, an international independent pharmaceutical company, and Yposkesi, a leading CDMO for gene therapy viral vector manufacturing, today announce that they have signed a manufacturing service agreement.
Servier selected Yposkesi to develop and GMP manufacture lentiviral vectors to support allogenic CAR-T cell technology development.
Cell-based gene therapies have shown promising results in treating hematological malignancies. So far, successful therapeutic results have mainly been obtained with autologous CAR-engineered products. This approach, where the patient’s cells are collected then used to manufacture a drug for themselves, is limited by the need for recurrent apheresis in the patient and time to manufacture a GMP compliant product. On the other hand, allogeneic therapies offer the opportunity to manufacture large batches of the drug product, thus making off-the-shelf treatments available for a large number of patients. However, the challenges of manufacturing the scale-up of allogenic CAR-T still lie ahead.
“We are pleased to collaborate with Yposkesi, whose ability to produce the highest quality of lentiviral vectors in the most robust and sustainable way is in line with the stringent requirements for the industrial production of allogenic CAR-T cell therapy,” said Pierre Venesque, Executive Vice President Industry at Servier. “Allogenic CAR-T cell therapy is a promising new technology with an amazing potential to treat cancer patients.”
Under the terms of the agreement, Servier will have access to Yposkesi’s world-leading know-how and technology for manufacturing lentiviral vectors, as well as its analytical development and quality assessment resources and capacity. Yposkesi has proven expertise in lentivirus manufacturing with several dozens of batches used in clinical trials both in Europe and the US. Servier will draw benefit from this track record in its strategic program.
This partnership has the potential for a longer-term lentiviral vector provision agreement, as Servier progresses towards commercialization.
“Yposkesi is delighted to partner with Servier and bring a meaningful contribution to making its therapeutic innovations a reality for patients,” said Dr. Frederic Revah, chairman of Yposkesi. “Manufacturing is a critical element in the development of gene therapies, where expertise and available capacity are key factors in allowing patient access to these treatments. We aim to deliver true industrial expertise, innovation and support services to accelerate development of these innovative treatments.”
Today, 700 Servier employees in 50 countries are working to develop innovative solutions for people with cancer. In the next two years, oncology will account for 50 percent of the company’s R&D budget. Currently, five treatments are available on the market and the Servier group is developing 12 new therapeutic options. Servier has forged 21 partnerships with academic institutions as well as with industrial partners and/or biotechnology companies. With this broad range of worldwide partners dedicated to innovation in the treatment of cancer, Servier’s research in oncology is focused on therapies aimed at restoring programmed cell death (apoptosis) in cancer cells and on mobilizing the immune system against cancer cells (immuno-oncology).
Yposkesi is a leading Contract Development & Manufacturing Organization (CDMO) for gene therapy vector manufacturing. Created in November 2016 in Corbeil-Essonnes (France) as a spin-off from the world-class gene therapy pioneer Genethon, Yposkesi provides integrated services; covering bioprocess development (USP & DSP), from small/pilot to large-scale production, analytical development, GMP manufacturing of lentiviral and AAV vectors and regulatory support. Its current facility consists of a 50,000 ft2 (approx. 5,000 m2) building, operating multiple manufacturing suites for bulk drug substance and fill & finish. By 2021 it will increase its global footprint to 100,000 ft2 (approx. 10,000m2) with a second large-scale facility designed for EMA and FDA compliance. Capitalizing on the more than 25 years’ expertise of Genethon, Yposkesi invests significantly in innovation in bioprocessing to deliver on high-quality projects, cost-effectively.
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