As the surge in cell and gene therapies entering and progressing through the clinic continues, we highlight manufacturing plans from Marker Therapeutics, Freeline, and CDMO RoslinCT.

First up in this cGMP manufacturing investment roundup is clinical-stage immuno-oncology company Marker Therapeutics, which has announced plans to lease a facility in Houston, Texas

The 48,500 square-foot plant, expected to be operational in 2021, will support the firm’s T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications.

Image: iStock/metamorworks

“We are committed to the rapid advancement of Marker’s MultiTAA-specific T cell therapies, which have demonstrated impressive responses in clinical studies across both hematological and solid tumors,” said CEO Peter Hoang.

“With the build-out of our own internal manufacturing capabilities, we will have the flexibility to support our AML trial, and future hematological and solid tumor trials, as well as the potential commercialization of our products.”

Once operational, manufacture of Marker’s MultiTAA-specific T cell therapy will be transferred from the Baylor College of Medicine where it is produced now.

Freeline

London, UK-based Freeline will use proceeds from a $120 million extended Series C financing to develop its AAV gene therapy platform and expand its manufacturing capabilities.

Theresa Heggie, CEO of Freeline, said the financing comes “at an exciting time for Freeline with our lead program in Hemophilia B progressing through clinical development, and with promising programs behind that, including a gene therapy treatment for Fabry Disease in the clinic and for Gaucher Disease and Hemophilia A in late preclinical development.”

The financing augments Syncona’s previously announced Series C investment in Freeline of $40 million with an additional $80 million of new capital. The round was led by Novo Holdings A/S, Eventide Asset Management and Wellington Management Company, with additional participation from Cowen Healthcare Investments, Acorn Bioventures and Ample Plus Fund.

RoslinCT

Staying in the UK, cell and gene therapy contract development and manufacturing organization (CDMO) has begun construction on a 17,000 square-foot expansion at its site near Edinburgh.

The new facility will more than double existing capacity and will include five clean rooms, warehousing, and offices to support demand for advanced therapies. It will also include a dedicated training lab set to be the new home of RoslinCT’s Training Academy.

Janet Downie, CEO of RoslinCT, said the expansion is a significant milestone for the firm.

“Despite the Covid-19 pandemic the cell and gene therapy sector continues to grow and prosper. Beyond this new facility, we have ambitious plans for further expansion providing even greater capacity and increasing our gene therapy service offering. I am very proud of the RoslinCT team and how they have responded to recent challenges, enabling our start the expansion on site and continuing to support for our customers through clinical trials and beyond.”