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Angelica Loskog’s area of research is cancer, specifically, chimeric antigen receptor (CAR) T-cells, which she began to study as a postdoc at the world’s largest cell and gene therapy center, the Baylor College of Medicine in Houston, Texas. Today she is CEO of Uppsala-based Lokon Pharma, which is attempting to combat tumors with the help of oncolytic adenoviruses. Their first gene therapy candidate, known as LOAd703, is already being clinically tested and evaluated for several different cancers; pancreatic, ovarian, colorectal, biliary tract and melanoma.

Now Lokon Pharma has managed to scale up its manufacturing process and demonstrated that it works reliably. They are more than happy with the results gained after just nine weeks at Testa Center.

– We have achieved fantastic results in a very short time. We spoke directly with all the expertise at Testa Center, utilizing their broad know-how as a filter in direct discussions with people familiar with our own company’s specific project needs. This paved the way for success. We have, for example, being able to run tests relevant to just our particular product.

Angelica Loskog, CEO at Lokon Pharma.

Together with Testa Center staff, Lokon Pharma has ‘set the stage’ and obtained a good overview of the manufacturing process, thereby becoming experts in their product. It’s cool, comments Angelica, emphasizing that the time spent at Testa Center was particularly valuable in securing a robust CMC (Chemistry, Manufacturing and Controls) road map for their process.

– We can now state with certainty what the CMC should look like and that’s a fundamental basis for market approval. In all the excitement of collecting clinical data, it can be easy to forget that you still need effective and reproducible products!

Angelica also emphasizes the contribution of Lokon Pharma’s own CMC expert, Sara Häggblad. Her knowledge and experience have also been crucial for the success of the project. Before Lokon Pharma, Sara was an adenovirus expert within CMC at Cytiva. She now believes that their newfound success at Testa Center can provide a better understanding of this type of adenovirus product – specifically, that it can be produced reliably at a large scale.

Previously, process development of this type has been driven by big international players – the industry’s dragons – but this ‘homegrown’ success story shows that neither large nor specialist facilities are essential. Angelica also believes that it will be easier for Lokon Pharma to engage with manufacturers now that they know their process inside out. In other words, it will be easier to guide production partners correctly and that, in turn, will have a great impact on the result.

– When you understand exactly what to do. Uncertainty disappears. Having our process verified at Testa Center is pure risk minimization. It’s also a seal of quality. Testa Center is an incredibly important bridge that leads from academia straight into industry. Its value cannot be overstated. Cell and gene therapy has always been strongly grounded in academia, but now I firmly believe in a future shift towards large-scale manufacture, broader application in cancer treatment, and greater patient benefits, concludes Angelica Loskog.