Cell therapy weekly: FDA warns manufacturer of unapproved cord blood therapies
This week: First Australian T-cell therapy manufacturing license awarded and a biotech acquisition aims to progress the marketing of potentially curative type 1 diabetes cell therapies.
The news highlights:
FDA warns manufacturers of unapproved cord blood therapies
First Australian T-cell therapy manufacturing license awarded
Biotech acquisition aims to progress marketing of potentially curative type 1 diabetes cell therapies
FDA warns manufacturers of unapproved cord blood therapies
As part of an ongoing warning effort against unapproved and unproven cell-based therapies, the US FDA has issued a warning to Stemell (CA, USA), and its President Peyman Taeidi, concerning its selling unapproved cord blood and cord blood-derived therapies. The manufacturing processes of Stemell’s StemL UCB-Plus and StemL UCT-Plus products failed to comply with current good tissue practices and good manufacturing practices such that recipient patients were being placed at potentially significant safety risks.
Ned Sharpless, Acting FDA Commissioner, commented: “We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true. [Stemell] failed to take appropriate measures to protect patient safety. The FDA will be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”
First Australian T-cell therapy manufacturing license awarded
In an Australian first, the Therapeutic Goods Administration (TGA; Canberra, Australia) has awarded Cell Therapies Pty, a Peter MacCallum Cancer Centre company (both Melbourne, Australia), a T-cell therapy commercial manufacturing license. The warrant will allow for the company’s production of marketable advanced therapies, including CAR-T cell cancer immunotherapies, without the need to send patients’ samples and blood off-shore, as is currently required.
Michael Dickinson, Deputy Director of the Centre of Excellence in Cellular Immunotherapy at Peter Mac, commented: “We are delighted to see the TGA has issued a license which would allow this process to be completed within Australia. For hospitals like Peter Mac, on-shore processing would remove bottlenecks and risk of delay while patients can benefit from less time needed from blood collection to reinfusion. We look forward to the day when our patients are treated with CAR T-Cell products that are made in Australia.”
Biotech acquisition aims to progress marketing of potentially curative type 1 diabetes cell therapies
Vertex Pharmaceuticals (MA, USA) has announced their US$950 million acquisition of Semma Therapeutics (MA, USA), a pioneering biotechnology company looking to employ stem cell-derived human pancreatic islets for the potentially curative treatment of type 1 diabetes mellitus.
Jeffrey Leiden, President and Chief Executive Officer of Vertex, commented: “This acquisition aligns perfectly with our strategy of investing in scientific innovation to create transformative medicines for people with serious diseases in specialty markets. We are excited to work with the talented scientists at Semma to build on their significant progress toward providing effective and potentially curative cell therapy options for people living with type 1 diabetes.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.