Phase 1 trials increased by 32% in 2021, representing a considerable transition of advanced therapies into first-in-human trials, said the CGT Catapult as it released its 2021 Advanced Therapy Medicinal Product (ATMP) clinical trials database and report.
Moreover, commercially sponsored trials now represent nearly 80% of all UK ATMP clinical trials, demonstrating the attractiveness of the UK’s ecosystem, said the organization.
Matthew Durdy, CEO of CGT Catapult, said that the rising and sustained commercial investment in these trials showcases the incredible strength and dynamism of the UK ATMP industry and "is a testament to the ongoing support of the UK government and the industry.”
Fewer ATMP trials were reported as completed in 2021 compared to 2020, however, and this is likely due to the ongoing COVID-19 pandemic, which has resulted in trial delays, said the organization.
“The MHRA does not need to be notified of interruptions to trials due to COVID-19, therefore the true impact of the pandemic on all stages of clinical trials is not yet completely understood.”
Oncology continues to be key focus
The division of therapeutic indications among the ongoing ATMP trials remains largely unchanged from previous years. Oncology, which includes hematological malignancies and solid tumors, remains the dominant therapeutic area accounting for 37% of ATMP clinical trials, followed by ophthalmology (12%) and hematological (11%).
Again, little difference in the cell types investigated in ATMP clinical trials last year: T cells continue to be the dominant cell type, accounting for 47% of UK ATMP clinical trials. “This is as expected since research into oncology, the largest therapeutic area, is largely T cell focused and is consistent with previous years.”
The majority of the 168 ATMP clinical trials ongoing in the UK in 2021 were gene therapies (72%) followed by somatic-cell therapies (19%). Tissue engineered therapies accounted for approximately 9% of the ongoing clinical trials, noted the publication.
“Of the ongoing gene therapy clinical trials, similar numbers of ex vivo (46%), which includes CAR-T, and in vivo (54%) genetic modifications were investigated.”
For in vivo gene therapy clinical trials, AAV based vectors remain the main vector of choice (72%), followed by oncolytic viruses (17%).
Overall, the majority of the UK ATMP clinical trials ongoing in 2021 are currently recruiting (45%) or in follow- up (29%), indicated the report.
There has been an increase in the overall number of ATMP clinical trials for both autologous and allogeneic therapies since 2016, but the proportion of autologous to allogeneic products has remained fairly consistent, with approximately 70% being autologous and 30% allogeneic, it also noted.