CAR-T

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients. The reports were received from clinical trials and postmarketing adverse event (AE) data sources. Despite the investigation, the FDA has […]

Hailed as a revolution in the treatment of many diseases, cell and gene therapy is the fastest growing area of therapeutics. This eBook, ‘Cell & Gene Therapy: The advances and innovation’, provides a comprehensive overview of the latest innovations in cell and gene therapies, where the challenges lie and the possible solutions to overcoming these […]

This 24-page eBook sponsored by Sartorius explores the latest innovations in cell and gene therapies, where the challenges lie and the possible solutions to overcoming these obstacles. Download this free resource to learn more about: The ways cell and gene therapies (CGTs) are revolutionising medicine in a range of diseases How to navigate diverging regulatory expectations […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  The breaking news this week was certainly the first regulatory approval for Casgevy, not only the first gene therapy approved for sickle cell […]

News round-up for 13-17 November by DDW Digital Content Editor Diana Spencer. The breaking news this week was certainly the first regulatory approval for Casgevy, not only the first gene therapy approved for sickle cell disease, but also the first therapy to use CRISPR gene editing. However, there were a number of other breakthroughs announced […]

Arcellx has revealed encouraging interim data from its Phase I study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma. The company plans to present new data with a median follow-up of 26.5 months at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition taking place 9-12 December 2023 in San Diego, […]

New trial evidence has shown that Kite’s CAR-T cell therapy Yescarta (axicabtagene ciloleucel: axi-cel) reduces the risk of death by 27.4% in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), corresponding to a 38% improvement in overall survival (OS). It is the only treatment in nearly 30 years to show statistically significant OS, […]

Ahead of protein and antibody engineering conference PEGS Europe 2023 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. On Day 2, Wednesday 15 November 2023, the tracks include: Engineering antibodies, emerging targets and therapeutic approaches, advancing bispecifics and combination therapy to the clinic, innovations […]

The latest acquisitions and strategic partnerships in the drug discovery and development sector reveal the areas where companies predict significant growth in the near future: proteomics, CAR-T, antibody discovery, artificial intelligence (AI) and microbiomics. Thermo Fisher Scientific acquires proteomics experts Olink Thermo Fisher Scientific will acquire proteomics company Olink in a transaction valued at approximately […]

CARsgen has published evidence of over seven years of disease-free survival in advanced hepatocellular carcinoma (HCC) following treatment with its CAR-GPC3 T cell therapy. Hepatocellular carcinoma is one of the most common malignant tumours, with approximately 780,000 annual incidence cases globally. Recurrence and metastasis are common. For HCC patients with concurrent inferior vena cava tumour […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  Immunotherapy has taken centre stage this week, with several announcements relating to regulatory approval, investment and research results for antibody and CAR-T therapies, […]

News round-up for 25-29 September by DDW Digital Content Editor Diana Spencer. Immunotherapy has taken centre stage this week, with several announcements relating to regulatory approval, investment and research results for antibody and CAR-T therapies, perhaps most significantly, encouraging early-stage data for the first in vivo CAR-T therapy. The top stories: €27.3M to advance monoclonal […]

Leucid Bio has been granted clinical trial authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial evaluating autologous NKG2D-targeted CAR-T cell therapy, LEU011, in patients with relapsed or refractory solid tumours. The open-label, single patient cohort ascending dose design aims to rapidly identify the maximum tolerated […]

Umoja Biopharma has revealed data from an ongoing non-human primate (NHP) study demonstrating effective, durable, and well tolerated in vivo chimeric antigen receptor (CAR) T cell generation using the company’s VivoVec platform. The data include results from the first four NHPs treated in an ongoing study and demonstrate rapid and efficient in vivo generation of […]

The first quadruplex-edited, allogeneic CAR-T cell therapy candidate has entered clinical trials in the US. The first patient has been treated with Beam Therapeutics’ BEAM-201 as part of a Phase I/II clinical study for the treatment of relapsed/refractory T-cell acute lymphoblastic leukaemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL). “As the first patient dosed with a Beam therapeutic candidate […]

A new Whitepaper is available from Thermo Fisher Scientific, entitled ‘Lentiviral vector characterization for cell and gene therapy manufacturing using the QuantStudio Absolute Q Digital PCR System’. Recombinant lentiviral vectors are used for ex vivo transgene delivery in several gene-modified cell therapies, such as chimeric antigen receptor (CAR) T cell therapy. Reliable analytical methods such as […]