General – VJRegenMed

CYP-001 in adults with steroid-resistant GvHD

Simon Ng — Tue, 03 May 2022 16:17:07 +0000

Mesenchymal stem cells (MSCs) derived from induced pluripotent stem cells (iPSCs) have shown promising efficacy as a cell therapy. Ross Macdonald, PhD, Cynata Therapeutics, Melbourne, Australia, discusses results from a Phase I trial (NCT02923375) assessing CYP-001, a MSC-based cell therapy in patients with steroid resistant graft-versus-host disease (GvHD). For patients who progress from corticosteroids, treatment options remain poor and mortality remains high. CYP-001 resulted in a complete response in over half of the cohort and after a two year follow-up, a survival rate of over 50% was reported. This interview was conducted during Meeting on the Mediterranean 2022.

Streamlining cell therapy manufacturing with CliniMACS Prodigy

Simon Ng — Thu, 28 Apr 2022 08:38:41 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, gives an overview of CliniMACS Prodigy, a novel next-generation automated cell processing platform that aims to separate and process cell cultures for the manufacturing of cell therapies. The closed, scalable system enables the production of good manufacturing practice (GMP) compliant products of consistent quality in a safe and clean environment. CliniMACS Prodigy additionally is flexible in a centralized or decentralized setting and can be used for various cell types including induced pluripotent stem (iPS) cells, chimeric antigen receptor (CAR) T-cells and natural killer (NK) cells. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Implementing automation technology in the CGT space

Simon Ng — Thu, 28 Apr 2022 08:38:40 +0000

The advent of automation has brought improvements in the manufacturing of advanced therapies in terms of reducing the number of staff needed, cost, and safety. Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, discusses potential barriers developers might face in automating their manufacturing processes. Companies will need to make sure the product can be translated from a research to clinical setting, as well as if the reagents can be scaled-up if necessary. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Utilizing flow cytometry in CAR T-cell research

Simon Ng — Thu, 28 Apr 2022 08:38:38 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, comments on the importance of flow cytometry in the characterization of chimeric antigen receptor (CAR) T-cells. Standardization of flow cytometry techniques is necessary to optimize CAR T-cell therapies, and Dr Rösch discusses automated workflow solutions offered by Miltenyi, as well as CAR detectors that can quantify CAR T-cells in a given sample. She additionally highlights a consortium that will create a gold standard for the analysis of engineered CAR T-cells. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Addressing challenges in using MSCs in cell therapies

Simon Ng — Thu, 21 Apr 2022 15:04:28 +0000

Mesenchymal stem cells (MSCs) have demonstrated potential in cell therapies, as they have unique immunomodulatory properties. Ross Macdonald, PhD, Cynata Therapeutics, Melbourne, Australia, comments on the hurdles in commercializing MSC-based cell therapies. Unlike autologous chimeric antigen receptor (CAR) T-cell therapies, MSCs are derived from allogeneic sources, which in itself presents logistical issues in terms of obtaining enough donors. Cell expansion for commercial usage additionally is an issue, as MSCs become less potent as they expand, and Dr Macdonald presents solutions offered by Cynata Therapeutics that attempt to overcome the aforementioned barriers. This interview was conducted during Meeting on the Mediterranean 2022.

Generating iSPC-derived MSCs with the Cymerus™ Platform

Simon Ng — Thu, 21 Apr 2022 15:04:27 +0000

Ross Macdonald, PhD, Cynata Therapeutics, Melbourne, Australia, discusses the process of manufacturing mesenchymal stem cells (MSCs) derived from induced pluripotent stem cells (iPSCs) with the Cymerus Platform. MSCs have shown encouraging efficacy as cell therapies and using iPSCs enables the MSCs to remain potent, as they do not require expansion. The iSPCs also do not require multiple donors as they can replicate indefinitely, resulting in MSCs of a consistent quality. This interview was conducted during Meeting on the Mediterranean 2022.

Meeting the growing demand for gene therapy manufacturing

Simon Ng — Wed, 20 Apr 2022 16:45:45 +0000

John Maslowski, CCO, Forge Biologics, Columbus, OH, gives an overview of Forge Biologics’ plans to meet the increasing demand for gene therapies. The recent $80 million expansion of the manufacturing facilities at Forge Biologics with automated components and clean rooms will enable global expansion. Additional recruitment of personal and inhouse analytical services will also enhance current adeno-associated virus (AAV) vector production capabilities. This interview took place at Advanced Therapies Week 2022.

Direct detection and isolation of CAR cells from patient samples

Simon Ng — Thu, 14 Apr 2022 15:56:42 +0000

Saskia Rösch, PhD, Miltenyi Biotec, Bergisch Gladbach, Germany, discusses strategies to isolate and identify chimeric antigen receptor (CAR) from patient samples for the purposes of quality control. Dr Rösch outlines a CAR detection agent that finds active CARs by detecting CD19, CD22, CD33, and B-cell maturation antigen (BCMA) in the product, as well as measure their transduction rate. Monitoring the efficacy of CAR T-cell therapies can additionally be carried out by assessing metabolome of CAR T-cells. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Addressing immunogenic barriers facing CRISPR-Cas9-based therapies

admin_vjr_user — Tue, 05 Apr 2022 15:59:59 +0000

Lena Peter, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany, provides an overview of strategies to overcome immunogenic barriers in vivo CRISPR-Cas9-based treatments face. As humans have existing immunity to Cas9 of various bacterial strains, safety and efficacy may be affected when they are treated with gene therapies using modified Cas9 proteins. She also highlights the suppressive nature of Cas9-specific regulatory T cells (Tregs), which can inhibit production of effector T cells targeting Cas 9. However, the ratio of effector T cells and Tregs should be monitored in patients to assess safety. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.

Enhancing CAR T-cells with an AvidCAR platform

Simon Ng — Tue, 05 Apr 2022 10:25:12 +0000

Michael Traxlmayr, PhD, University of Natural Resources and Life Sciences, Vienna, Austria, provides an overview of the development of an avidity-controlled CAR (AvidCAR) platform and its potential applications in regulating the specificity of chimeric antigen receptors (CAR) T-cell therapy. AvidCARs have a lower antigen binding affinity compared to typical CAR T-cells and the reduced affinity results in increased tumor specificity as AvidCARs are dependent on bivalent antigen integration for activation. This interview took place at the International Conference on Lymphocyte Engineering (ICLE) 2022.