The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. The ISCT 2023 Annual Meeting took place in Paris, France from May 31 to June 3 2023. DDW’s Megan Thomas heard from attendees about key trends in the sector. First, the importance of cell collections. Here, attendees discuss the trend of allo vs auto. In subsequent articles, themes include new generation MSCs, future regulatory changes and redefining manufacturing.
Kathie Schneider, Director Global Commercial, Cell Therapy at Terumo Blood and Cell Technologies, explains that there are two types of stem cell transplants: an autologous transplant uses a person’s own stem cells, whereas an allogeneic transplant uses stem cells from a donor whose human leukocyte antigens (HLA) are acceptable matches to the patient. She said: “In our view, there is no competition between autologous and allogenic therapies. Both approaches offer various benefits to patients and clinicians, and there is absolutely room for both therapies currently, depending on the specific needs of the patient and clinician.”
She said that the advancements in allogenic therapies are demonstrating success across a wide range of patients, but that it’s important to note that certain patients may still require autologous versions of the drug, particularly in cases where the allogenic option may not be as effective. She added: “There are specific indications where the autologous version remains the sole viable treatment option. Terumo Blood and Cell Technologies delivers purpose-built, automated cell manufacturing solutions that reduce manufacturing risks, provide scalability, and support commercialisation of cell therapies to meet the growing number of patients globally.”
Carole Nicco, Chief Scientific Officer of BioSenic, notes that autologous products are safer in terms of immunity, but it is an expensive and private treatment that is difficult to democratise. She said that for biopharmaceutical companies like BioSenic, the ultimate goal is to make cell therapies available to as many patients as possible who can benefit from them. She said: “Autologous cell therapies are proven, and allogeneic cell therapies will be in the near future. BioSenic’s allogenic treatment has been proven to be safe in three clinical trials and the advantage of being cryopreservable for more than 40 months and the production standardised is important. Cryopreserved ALLOB treatment is ready to use and ready to be sent to the centres to treat patients.”
Angela Osborne, CEO of eXmoor Pharma, says that both allo and auto have a place in the long term, with autologous persisting at least for orphan or regionally local diseases but with improved processes so that freeze in and out is possible. She said: “True allogeneic where a single bank of cells can treat a mass market is the direction of travel for more prevalent diseases. eXmoor is helping both auto and allo products become commercially viable – improving the cost of goods by identifying drivers for process development and then carrying out that development to get products to patients as fast as possible.”
Ravi Nalliah, Chief of Product & Strategy of TrakCel, thinks that allogeneic therapies suggest great promise in terms of treating more patients quickly and cost-effectively, but feels that off-the-shelf allo still seems a little way off. He said: “In the meantime, partially matched allogenic processes still represent a supply chain challenge with respect to donor matching alongside COI and COC. Many of the processes that we are seeing now involve the movement of insilico data within the supply chain process as well as the traditional tracking of cell samples. TrakCel is working with partners and customers to investigate how automation and orchestration can help to simplify these processes which are complex even in comparison to some of the more familiar auto therapies.”
Becky Cap, SVP, Business Development, Advanced Therapies at BioBridge Global, said that she has often quoted a quip she heard several years ago: “Auto didn’t go to business school, and allo didn’t go to medical school.” She says she really appreciated the debate at this year’s conference, and it led to a nice conceptual model, both for disease-specific approaches that would favour one over the other, and for using autologous as a proof-of-concept model, and allogeneic as a scaled solution. She said: “We have built our capabilities to support both in our collections, testing, and manufacturing. Our connection to the hospital network puts us in a unique position to support the full range of therapeutic approaches.”
