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Focus on Skåne – the importance of mapping

2023-09-14

Lund Stem Cell Center ATMP mapping report launched

In 2022, the Lund Stem Cell Center commissioned an exercise to map the ever-expanding development pipeline of ATMPs in the center. The report, released September 2023, aims to provide an outline of the therapies being developed, investigate how far the research has proceeded, and conclude what can be done to further accelerate the development of these therapies. The analysis will be performed yearly to track progress, better understand challenges and evaluate the effectiveness of infrastructures. Find the report on the Lund Stem Cell Center webpage.

The report identified 23 ongoing ATMP development projects, just in the Lund Stem Cell Center. 13 products were classified as GTMP, 7 TEP and 3 sCTMP. 7 products are based on AAV, 4 on lentivirus and 10 on pluripotent stem cells.  Of these studies;

  • 1 is in Phase I – Malin Parmar’s TEP/dopaminergic progenitors for Parkinson’s Disease – first patient treated January 2023
  • 3 TEPs are in preclinical development as well as 5 GTMPs

Elias Uhlin (pictured left), Project Manager of the Lund Stem Cell Center Pre-GMP Facility was responsible for compiling the report by interviewing all PIs at the Center. ”The number of ATMPs under development in our centre was a lot more than anticipated! This means not only are we better aware of the existence and needs of these projects, but now they are better aware that we are here to help them”, says Elias. 

The report showed that many methods used by and support requests from researchers were very similar, helping the Pre GMP facility to plan their infrastructure, focus areas, recruiting and purchasing to suit the anticipated needs in the next year or two and for the next 5-10 years. ”It’s about planning for the efficient use of our resources to maximise the success of translation of ATMPs from our research to broad patient access. This mapping will not only help us correctly target our internal product development capabilities but will also assist in external marketing to connect projects with necessary stakeholders further down in the ATMP pipeline”, says Elias. 

Lund/Skåne was a little ’late to the party’ in regard to establishing GMP manufacture facilities at their university hospital. They were the only Swedish University Hospital that did not bid for funds from the 2007-2017 Vävnadsrådet lead project to establish GMP manufacture capabilities. However, the region has been a strong player in ATMP, with;

  • 2 of their small biotechs establishing their own local GMP manufacture – Amniotics AB and Xintela AB
  • local research spinning out into biotechs including AcouSort AB, Asgard Therapeutics AB, Idogen AB, Amniotics AB, Xintela AB, rAAVen Therapeutics AB and CombiGene AB. Many of these companies and their facilities are located at the science park Medicon Village.
  • acting as a site for the UniQure sponsored clinical trial for hemophilia gene therapy, through clinician Jan Astermark
  • initiating the first Swedish clinical trial in hPSC derived cellular therapy, through local research and development of Malin Parmar’s dopaminergic neuron progenitor product for Parkinson’s disease

Malin Parmar’s Parkinson’s disease hPSC derived cell therapy product was a strong driver for development of ATMP capabilities in the region and at the Lund Stem Cell Center. Due to lack of local manufacturing capabilities, the product was manufactured at the Royal Free Hospital in London. Treatment of patients in Phase I is underway at Skånes Universitetssjukhus Lund. ”Ideally we would have loved to have local GMP manufacture, for ease of technology transfer, but also to build Swedish and local manufacture capabilities. Recent recruitments of Anna Falk, Gisela Helenius, Elias Uhlin and Stefan Jovinge, and necessary dedication from the region and politicians as well as Lund University, have been instrumental for us to now initiate the development of the local infrastructures and competencies needed to ensure that local research adds not only to local healthcare options but also to local economic development”, says Malin.

Anna Falk (pictured right) is a Professor at the Lund Stem Cell Center, Director of the Lund University ATMP Center and project manager of the Vinnova funded National pluripotent cell derived ATMPs project, IndiCell. Anna was recruited to Lund University in 2021 from Karolinska Institutet, Stockholm, Sweden. “The field of ATMPs has been gaining a lot of attention in recent years, and for good reason. These therapies have shown great potential in treating a range of diseases, and as a result, the demand for them continues to grow”, says Anna. ”However, the rapidly expanding ATMP ecosystem brings with it challenges that need to be worked on locally, nationally and internationally to secure the ATMP pipeline, from pre GMP to GMP and beyond. This is what we aim to build in Skåne, learning from the experiences, challenges and successes of other facilities and initiatives, to tailor our ’Lund model’ for accelerating the advancement of high quality, low cost therapies, that can reach more patients with the best possible safety and efficacy profiles”.  

With ATMP development rapidly expanding, it is clear that there is a need for continued investment in research and development to ensure that the potential of these therapies is fully realized. The risks associated with development of novel ATMPs mean that academics need to take their products further into development than for other types of medicinal products, requiring them to venture into lands of product definition, quality, validation, commercialisation, GMP and clinical trial that are not aspects of their academic training. A balance between providing funds for ’research grade’ clinical translation and ’real’ clinican translation that involves quality staff, commercialisation expertise, a whole lot of documentation and repetition, needs to be struck to ensure that translation doesn’t get stuck at peer reviewed publication or even Phase I trial.

Johan Jakobsson (pictured right), is Director of the Lund Stem Cell Center. ”I am excited to see the progress being made in the ATMP field but acknowledge that there is still much to be accomplished in terms of regulatory frameworks and collaboration between stakeholders. The release of the Lund Stem Cell Center ATMP pipeline report is an important milestone for Sweden’s growing ATMP ecosystem. We hope to share our experience with other universities and institutions looking to conduct similar investigations to help paint the full picture of the ATMP landscape in Sweden”, says Johan.

One of the functions of ATMP Sweden is to map and engage national ATMP stakeholders and couple them to not only national but international competencies. Existing resources include the current national initiatives, ATMP companies and ATMP map. These resources are only as good as the information available through stakeholders recognising the importance of visibility and cross-sector collaboration. While we are working with regional ATMP initiatives to improve the depth of the mapping, academics and clinicians have been the hardest to engage in order to publish accurate and approved content, meaning that while our company mapping is very accurate and growing constantly, the visibility of our Swedish research and clinical activities is expected to be less than 20%. None of the 23 Lund Stem Cell Center projects were listed on our map. The biggest problem is not lack of knowledge of these projects/researchers but a need for the researchers to fill in our form, and consent to our publishing of this information, to ensure we are correctly providing information.

Out ATMP map is important not only for stimulating collaboration and dialogue, but also forms the basis for how ATMP Sweden identifies topics, speakers, hosts, chairs and sponsors for our ATMP Sweden and ATMP world tour events. Please fill in the form! and make sure we and potential collaborators can easily find you!

The Lund Stem Cell Center and ATMP Sweden aim to work together to support ATMP mapping initiatives in other institutes and regions to build on the model of proactively working closely with researchers and healthcare providers to map the needs and tailor support towards efficient national and globally competitive development and access to innovative therapies for those in need.

Feel free to get in touch with Elias Uhlin from the Lund Stem Cell Center or Heather Main from ATMP Sweden to discuss how to join the National ATMP mapping activities.