Regenerative Medicine

Kite says rolling application to FDA finishes soon

Country
United States

Kite Pharma Inc has published further positive data for its lead chimeric antigen receptor (CAR) T cell therapy for cancer, while confirming that its rolling application to the FDA to receive marketing approval should be complete by the end of the first quarter.

UCART19 cleared for trial in US

Country
United States

The US Food and Drug Administration has given regulatory clearance for a Phase 1 trial of Cellectis SA’s allogeneic, gene-edited cell therapy for the treatment of refractory acute lymphoblastic leukaemia (ALL). The product is being developed by Servier and Pfizer Inc.

Case study of gene therapy

Country
United States

A case study of a young patient with sickle cell disease who was successfully treated with an experimental gene therapy has been published in the 2 March 2017 edition of The New England Journal of Medicine. It is believed to be the first treatment to deliver substantial relief from a disease that can sometimes lead to an early death.

TxCell embraces the CAR

Country
France

TxCell SA expects to start a clinical trial in late 2018 of a regulatory T cell product that has been engineered to contain a chimeric antigen receptor (CAR). The French company’s therapeutic focus is severe inflammatory and autoimmune diseases as well as organ transplant rejection.

Chimeric organs described

Country
United States

Scientists at the Salk Institute in California, US have described a series of experiments in which they were able to integrate stem cells from one species into the early-stage development of another. The research was published in the 26 January 2017 edition of Cell, and raises hopes for transplantation.

Letter from the Editor: Innovation in the New Year

Country
Belgium

(The following editorial appears in the January 2017 edition of MedNous) Yes, there are plenty of geopolitical risks going into 2017, but the biopharma industry is entering the New Year with plenty of cash and good prospects for innovation. In this issue we look at some recent developments.

Remission reported for aggressive brain tumours

Country
United States

A 50-year old patient with recurrent cancer involving tumours in both the brain and spinal cord has been treated with a chimeric antigen receptor (CAR) T cell therapy targeting an antigen that is overexpressed in a majority of glioblastomas.

TiGenix raises $35.65 million in US IPO

Country
Belgium

The cell-therapy company TiGenix NV has raised gross proceeds of $35.65 million in an initial public offering of its shares on the Nasdaq exchange in the US in order to support the clinical development of its allogeneic product portfolio.

Patient with mutant KRAS successfully treated

Country
United States

A patient with KRAS mutant metastatic colorectal cancer has been successfully treated with an autologous T cell receptor therapy, suggesting there may be a path forward for tackling difficult solid tumours, according to Kite Pharma Inc.

FDA approves tissue-engineered product

Country
United States

The Food and Drug Administration (FDA) has approved Maci, an autologous tissue-engineered product for the repair of cartilage defects in the knee, the first product of its kind to be authorised for the US. Maci is manufactured by Vericel Corp, formerly Aastrom Biosciences Inc.