Cell therapy weekly: Bispecific T-cell therapy for glioblastoma receives IND clearance
This week: A new facility is set to open in the coming months to help support patient care and cell and gene therapy research, a partnership has formed to advance the automation of cryovial filling and the US Food and Drug Administration (FDA; MD, USA) has cleared an Investigational New Drug (IND) application for a bispecific T-cell therapy for glioblastoma.
The news highlights:
- New facility to support patient care and research in cell and gene therapy
- Collaboration to advance automated cryovial filling in cell and gene therapy
- IND clearance for bispecific T-cell therapy for glioblastoma
New facility to support patient care and research in cell and gene therapy
It is estimated that over the next two years there will be a 25% increase in the demand for cell collection procedures in the UK due to the rise in advanced therapy medicinal products. To help expedite stem cell delivery for patients with blood cancer or blood disorders and support cell and gene therapy research, Anthony Nolan (Hampstead, UK) is set to open a new facility, The Anthony Nolan Cell Collection Centre, in Nottingham, UK, in the coming months.
The new cell collection center will be located at Queens Medical Centre and be run in partnership with the National Institute for Health and Care Research Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust. It will enhance Anthony Nolan’s current Nottingham facilities, including the Cell Therapy Centre at Nottingham Trent University, which includes a cord blood bank and research facility.
“The UK healthcare system is working hard to meet this demand [for apheresis procedures] and Anthony Nolan is proud to play a role in expanding cell collection capacity,” said Nicola Alderson, Chief Operating Officer, Anthony Nolan. “We have nearly one million potential donors on our stem cell register and having our own cell collection centre will ensure they have the best possible experience as well as accelerating patient treatment.”
Additionally, the new center will feature Terumo Blood and Cell Technologies’ (CO, USA) Spectra Optis™ Apheresis system, provided through a partnership agreement, to optimize the quality of donor cell collection.
Collaboration to advance automated cryovial filling in cell and gene therapy
Cellular Origins (Cambridge, UK) has joined forces with 3P innovation (Warwick, UK) to enhance its Constellation™ robotic system by incorporating 3P innovation’s cryoFIL™ cryovial filling platform. This partnership aims to automate cryovial filling within a closed, sterile environment, boosting the efficiency and scalability of cell and gene therapy production. The integration will streamline manufacturing processes, minimize manual intervention and increase production efficiency, advancing Constellation as a fully automated solution for cell therapy manufacturing.
Edwin Stone, CEO of Cellular Origins, stated: “3P innovation shares our belief that embracing automation is the key to addressing the manufacturing bottleneck and improving accessibility to lifesaving therapies. We are pleased to be collaborating with their team to integrate cryoFIL within Constellation, broadening the system’s capabilities and tackling the complex challenges of fully automating and industrializing [cell and gene therapy] manufacturing.”
IND clearance for bispecific T-cell therapy for glioblastoma
The US FDA has cleared an IND application for Adaptin Bio’s (NC, USA) Brain Bispecific T-cell Engager (BRiTE) therapy for glioblastoma, APTN-101.
APTN-101 has been developed to precisely target EGFRvIII proteins associated with brain tumors and eliminate the glioma cells. In preclinical studies, APTN-101 demonstrated potent elimination of malignant glioma tumors across various aggressive orthotopic models. Adaptin plans to evaluate the safety and efficacy in a Phase I clinical trial in patients with Grade IV malignant glioma.
“Our proprietary BRiTE technology harnesses the immune system’s remarkable ability to target and deliver therapeutics to specific tissues, including the brain, potentially revolutionizing treatment for difficult-to-treat cancers,” commented Adaptin Bio’s CEO, Michael J Roberts. “APTN-101 validates the BRiTE platform and its ability to enhance transfer of therapeutics into the brain. We are committed to advancing this novel therapy as a new potential therapy for glioblastoma patients who desperately need new therapies.”
