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ATMP Seminar and Annual Report Highlight Sweden’s Strengths, but Pediatric Oncology Lags Behind

2025-01-02

Sweden leads in ATMP innovation, but pediatric treatments lag behind. Key insights and challenges from the latest ATMP Sweden report.

The latest annual ATMP report from ATMP Sweden provides both a global and local perspective on the field, showing that Sweden is performing well in clinical trials—particularly in cell and gene therapies. The report highlights the presence of both small startups and larger companies advancing ATMPs in Sweden. However, it also points out a notable gap in the development of treatments for children.

These findings were echoed at a recent two-day seminar in Malmö, where experts discussed the vibrant state of the ATMP field and emphasized the urgent need for pediatric clinical trials, as noted by Kerstin Sollerbrant from the Swedish Childhood Cancer Fund.

Key Insights from the “ATMP Annual Report”

Developed in collaboration with Triathlon, the report gives a comprehensive overview of the sector’s latest advancements.

The report reveals that ATMP treatments are becoming an increasingly common part of Swedish healthcare. Several advanced therapies have already been recommended by the National Therapy Council (NT-rådet), and ongoing research and clinical trials worldwide promise even more breakthroughs in the future.

The Swedish Childhood Cancer Fund, now a member of the newly formed ATMP Sweden association, is represented on the board by Kerstin Sollerbrant, Senior Research Expert. Sollerbrant also contributes to the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), which evaluates and oversees ATMPs within the EU.

“It’s encouraging to see Sweden leading in the research and development of advanced therapies,” says Sollerbrant. “But it’s disappointing that pediatric treatments still lag behind those for adults, despite the clear need.”

Challenges in Pediatric Treatment Development

The slow progress in pediatric ATMP development is largely due to smaller patient populations and a lack of strong incentives. Efforts are underway at the EU level to address these issues, including legislative reviews and targeted initiatives to accelerate innovation for rare diseases.

“I hope the ongoing review of European pharmaceutical regulations introduces incentives that will drive this progress,” says Sollerbrant. “In Sweden, we also need to find new ways to support academic researchers, smaller companies, and patient organizations in developing these often less profitable treatments through to market approval.”

Advances in Pediatric Oncology

Within pediatric oncology, the greatest progress has been made in acute lymphoblastic leukemia (ALL), where CAR-T therapies are already used for patients who do not respond to first-line treatments. Research into CAR-T therapies for solid tumors has also advanced, with clinical trials on the horizon:

“We’re optimistic that CAR-T can be developed to treat brain tumors and challenging neuroblastomas, expanding the treatment options for some of the most severe pediatric diagnoses,” Sollerbrant adds.

Highlights from the Malmö Seminar

On November 25–26, ATMP Sweden hosted its annual conference in Malmö. Sollerbrant attended and left with optimism about the future of ATMPs, which she believes will become even more impactful in treating a range of diseases. However, she noted that significant hurdles remain before ATMPs can be seamlessly integrated into routine healthcare.

Critical areas for improvement include simplifying and scaling up complex production methods, standardizing diagnostic processes, and better planning for long-term monitoring of treatment effectiveness and safety.

“Addressing these challenges will not only improve the cost-efficiency of ATMPs but also make them more accessible,” says Sollerbrant. “I hope these advancements will stimulate even more research and lead to the development of new treatments.”

ATMP Sweden by the Numbers

Key statistics from the report highlight Sweden’s progress:

  • 4 ATMP centers established at university hospitals in Uppsala, Stockholm, Gothenburg, and Lund.
  • Clinical trials for ATMPs doubled between 2021 and 2024, with at least 48 active trials.
  • CAR-T treatments increased by 77% from 2022 to 2024, with 146 infusions provided as standard care.
  • Swedish small and medium-sized enterprises (SMEs) secured over €16 million in EU funding.
  • Sweden leads Europe in ATMP-related publications per capita, with continued growth.
  • 7 ATMPs are recommended in Sweden (4 CAR-T and 3 gene therapies), with 6 more under review.
  • Currently, only one ATMP is approved for pediatric oncology: CAR-T therapy for a specific type of leukemia.

Read the ATMP Annual Report here
Read the original article (Swedish) here