CRISPR selected MaSTherCell for the development and cGMP manufacturing of CTX101
BASEL, Switzerland, CAMBRIDGE, Mass. & Gosselies, Belgium. Jun 6, 2017 – CRISPR Therapeutics AG (NASDAQ:CRSP), a leader in gene-editing based therapeutics, and MaSTherCell SA, a full service contract development and manufacturing organization (CDMO), wholly-owned subsidiary of Orgenesis Inc. (OTCQB:ORGS), today announced the signing of an agreement to develop and manufacture allogeneic CAR-T therapies.
MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies. CTX101 is an allogeneic CAR T-cell therapy currently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies. The program utilizes CRIPSR’s proprietary gene-editing technology to make targeted modifications to the T-cell, thereby enabling an allogeneic, or off-the-shelf, product that is applicable to a broader patient population and addresses the industrialization challenges of the current generation of autologous therapies.
“The signing of this agreement represents an important milestone for CRISPR Therapeutics as it not only demonstrates our progress with CTX101, but also lays the foundation for our broader activities and emerging pipeline in the allogeneic cell therapy field.” said Jon Terrett, Head of Immuno-Oncology Research and Translation at CRISPR Therapeutics.
“We’re really excited to have initiated work with MaSTherCell. Their market-leading capabilities and deeply relevant experience stood out as we looked for a partner to help accelerate our pre-clinical programs towards the clinic in both the US and Europe.” added Samarth Kulkarni, President and Chief Business Officer at CRISPR Therapeutics.
MaSTherCell provides process optimization and manufacturing services to cell therapy organizations. It has quickly built the most extensive experience in the field and is focused on developing solutions to the industrialization challenges facing the cell therapy sector.
“We are looking forward to working with CRISPR Therapeutics. They have made significant progress to date with multiplexed gene editing and this provides a solid platform upon which we can bring to bear MaSTherCell’s significant experience in the manufacturing of allogeneic cell therapies.” said Denis Bedoret, General Manager at MaSTherCell.
Video: Affordable Breakthrough Therapies, Interview with Denis Bedoret
Denis Bedoret, General Manager at MaSTherCell, shares his view on the cell therapy market and what is next for MaSTherCell. Click to watch the video!
Servier appoints MaSTherCell for the development of its CAR-T cell therapy manufacturing platform
Suresnes, France and Brussels, Belgium - 18 January 2017 – Servier, the independent international pharmaceutical company, and MaSTherCell SA, the full-service contract development and manufacturing organization (CDMO) specializing in the delivery of optimized process industrialization capacities to cell therapy organizations, today announced the signing of a master service agreement for the development of a manufacturing platform for allogeneic cell therapies.
Under the master service agreement, MaSTherCell is developing a CAR-T cell therapy manufacturing platform, which will enable industrial and commercial manufacturing of Servier cell therapy products. This is a critical step in development of these products for later stage clinical trials.
Cell therapies have shown promising results in treating cancers. However so far, successful development has been mainly limited to autologous therapies. This approach, where the patient’s cells are collected then used to create a drug for that specific patient, is limited by the lack of possibility of industrialized manufacturing, thus restricting its access to few patients. Allogeneic therapies, or off-the-shelf treatments, potentially offering the technology to a higher number of patients, are developing very rapidly. However the challenges of their manufacturing scale-up still lie ahead.
One of the most advanced cell therapies is based on CAR-T technology, where the T-cells are armed with a Chimeric Antigen Receptor. Servier is developing UCART-19 (see below About UCART-19 for more information), with two clinical trials currently ongoing in Europe, in relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL), in pediatric and adults patients.
Servier selected MaSTherCell because of its leading global cell therapy CDMO position as well as its essential broad expertise in immunotherapy products. MaSTherCell has a track record of designing and delivering cost-effective cell therapy manufacturing platforms.
MaSTherCell anticipates that it will complete the development of the initial CAR-T platform in 2018. This will then be an efficient complement to the bioproduction facilities that Servier is developing at its site at Gidy (France), which will mainly focus on the production of antibodies.
“This partnership will result in developing solutions for one of the biggest challenges to the ongoing development of the cell therapy sector. MaSTherCell has quickly built the most extensive CDMO experience in manufacturing and process industrialization development in the cell therapy industry,” said Denis Bedoret, CBO at MaSTherCell. “This enables MaSTherCell to leverage that experience to deliver solutions to contribute to the Servier cell therapy pipeline. We will thus be able to directly contribute to delivery of life-saving cell therapy treatment to patients”.
“The scale up of manufacturing for late scale clinical trials still remains one of the biggest industry-wide challenges in the cell therapy sector, and especially in a CAR-T field still in its infancy,” said Marielle Anger-Leroy, Director of Biotechnology Industrial Development at Servier. “Being pioneers with these innovative therapies means that we have to find the best partners to maximize the chances of delivering these therapies to patients with few alternative options.”
Cell therapy, a promising sector in Wallonia
The Walloon cell therapy platform represents a strong ecosystem with cell therapy companies, academics, research laboratories, institutions and services companies which transform challenges into opportunities. Sylvie Ponchaut at BioWin, the Health Cluster in Wallonia, presents those opportunities that contribute to develop Wallonia and Belgium.
This article is taken from European Biopharmaceutical Review October 2016, , pages 32-34. © Samedan Ltd
We are pleased to announce that we have been selected by Adaptimmune as a supplier of cell therapy products for use in Adaptimmune’s clinical trials. This deal confirms once again MaSTherCell as a key partner for immuno-based cell therapy.
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