Cell & Gene Therapies

© GettyImages/Pheelings Media

FDA rebuff for Keytruda in breast cancer indication

By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

© GettyImages/Lars Neumann

KIYATEC flags checkpoint inhibitor response prediction milestone

By Jane Byrne

US company, KIYATEC, says a new study has shown that its immune-modified ex vivo platform can measure treatment response through direct interaction between a patient's cancer and infiltrating immune cells, and immuno-oncology agents.

© GettyImages/alphaspirit

UK deal sees consolidation of two players in the iPSC space

By Jane Byrne

Axol Biosciences, a UK provider of human induced pluripotent stem cells (iPSC) derived cells, media, and characterization services, has merged with Scotland based, Censo Biotechnologies, a cell biology CRO with expertise in iPSC-related technologies.

Pic:getty/dolgachov

Janssen acquires rights to novel AMD gene therapy

By Rachel Arthur

Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).

© GettyImages/ipopba

Study: Early test and treat is vital in people infected with COVID-19

By Jane Byrne

A new mathematical modeling study by Ashish Goyal and colleagues, informed by data collected from 25 patients hospitalized with COVID-19 in four different countries, offers some important new insights into the optimal timing of four different antiviral...

© GettyImages/AndreyPopov

Disruptor in cell and gene therapy space secures US$30m in funding

By Jane Byrne

Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.

© GettyImages/iLexx

BARDA and Locus in tie-up to tackle UTIs with phages

By Jane Byrne

Locus Biosciences has signed a contract with BARDA to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).

© GettyImages/metamorworks

Fujifilm expands its gene therapy drug CDMO business

By Jane Byrne

Fujifilm is boosting its gene therapy offering, taking the first steps to expand its viral vector contract development and manufacturing organization (CDMO) services to Europe, at the site of Fujifilm Diosynth Biotechnologies (FDB) in the North East of...

Pic:getty/dilenua

Sartorius acquires BIA Separations for $423m

By Rachel Arthur

German life science company Sartorius will merge Slovenian purification specialist BIA Separations with Sartorius Stedim Biotech, in a deal worth €360m ($423m).

A broad shift in the gene therapy space impacts demand for viral vectors. Pic: getty/yourphoto

Why viral vector manufacturing capacity is constrained

By Nick Taylor

Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.

AGTC's clinical pipeline is focused on rare genetic eye diseases, but is expanding. Pic:getty/drpas

Using HSV helper viruses to increase AAV production

By Nick Taylor

Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.