The Cell and Gene Therapy Landscape in the DACH Region

The landscape of cell and gene therapy is changing and maturing, though – after record years of financing flowing into the cell and gene therapy sector, investment is slowing down.

But what is the cell and gene therapy industry outlook in the DACH region?

An overview

Though investment into cell and gene therapy has slowed down, venture capital financing for the sector has remained robust and is the single largest driver of sector investment.

Much of this can be attributed to the anticipation and excitement around the scientific breakthroughs and potential to change the face of treatment across a variety of rare diseases.

One area receiving high levels of attention is CAR-T therapies, such as Swiss multinational pharma company Novartis AG’s Kymriah CAR-T therapy, which was granted accelerated approval by the FDA in May 2022 to treat adult relapsed or refractory follicular lymphoma.

Clinical trials in Europe have been down by 18%, though this follows a global trend of a decrease in active clinical trials, with cell therapies making up the largest categories of ongoing trials, followed by cell-based immune-oncology, gene therapies, and tissue-engineered therapies.

However, DACH countries lead Europe in R&D spending and collectively filed more than four times the number of patents of individual European countries in 2020 and are known for their ability to access diverse patient populations through international collaboration.

But which other factors are contributing to the cell and gene therapy industry outlook in the DACH region?

Leading companies in the cell and gene therapy space

A significant contributing factor to the outlook of DACH’s cell and gene therapy industry is the leading organisations within the region.

This includes the likes of:

• Novartis (Switzerland): Has a major research facility in Basel focused on developing CAR-T cell therapies, with the aim to broaden the impact of cell therapy in oncology by going deeper in B-cell malignancies and researching next-generation CAR-Ts that focus on new targets and utilise new technologies.

• TAmiRNA (Austria): Focused on developing microRNA-based diagnostics and therapeutics, TAmiRNA’s technologies are based on research conducted at the Medical University of Vienna and target a range of diseases, including cancer and cardiovascular disease.

• BioNTech: (Germany): Headquartered in Germany, BioNTech is a biotech company primarily known for its development of the Pfizer-BioNTech Covid-19 vaccine. BioNTech is also developing personalised cancer immunotherapies using mRNA technology as well as other mRNA-based therapies.

There are a multitude of other innovative companies within the DACH region, such as Haplogen - a biotech based in Austria - that is building a pipeline of antiviral programs mainly in viral diseases that have no treatment option available, whilst also developing antiviral therapies based on CRISPR technology. 

Another example of a highly innovative company in the DACH region is the Berlin-based biotech Glycotope which specialises in developing glycoengineering technologies that include cell and gene therapies. 

Glycotope’s lead candidate, Gatipotuzumab, is an investigational monoclonal antibody that enables tumour-specific binding to a novel carbohydrate-induced conformational epitope, TA-MUC1. 

In short, the DACH region isn’t short of companies that are innovating in the industry and keeping excitement and interest high in their upcoming developments.

Strong support networks

Beyond the leading companies in the region that are contributing to the outlook of DACH’s cell and gene therapy outlook, there are also the strong support networks of research institutions, universities, and hospitals.

For example, the Medical University of Vienna, the Vienna BioCenter, and the Austrian Cluster for Tissue Regeneration are all involved in the development of cell and gene therapies for a range of diseases in Austria.

Similarly, Switzerland has a number of renowned institutions, such as the University of Zurich, the Swiss Institute for Experimental Cancer Research (focused on developing new cancer therapies), and the Novartis Institutes for BioMedical Research.

Many of these institutions are focused on areas of cell and gene therapy such as CAR T-cell therapy, gene editing, stem cell biology, and regenerative medicine.

What sets the DACH region apart, however, is the way that these institutions often work in a highly collaborative manner towards shared goals.

The Swiss Biotech Association is a prime example of this, as a non-profit organisation that acts as a platform for networking and collaboration for key stakeholders in the industry.

Germany also isn’t short of notable institutions involved in the research and development of cell and gene therapies, including the German Society for Gene Therapy (DG-GT), a platform for collaboration among industry stakeholders, researchers, and clinicians in the industry.

Regulatory expertise

The approval process for cell and gene therapies can only be described as rigorous and thorough.

In Germany, the Paul-Ehrlich-Institut (PEI) is the regulatory agency responsible for the evaluation and approval of cell and gene therapies, carrying out stages of the regulatory process such as preclinical development, Investigational New Drug (IND) application, clinical trials, and marketing authorisation.

All of these stages are designed to evaluate the safety and efficacy of the cell and gene therapies before they can be used.

In Switzerland in particular, extra steps or regulations are often included to cover the full scope, including regulations relating to technology and/or transportation, with Swissmedic collaborating with other European regulatory agencies to meet international standards for safety.

Overall, the regulatory process for cell and gene therapies in the DACH region is thorough and links heavily with the region’s ability to collaborate effectively and safely.

To summarise

The DACH region is a hub for innovation and collaboration for cell and gene therapy, with world-class research institutions and leading companies spearheading the positive outlook.

With such a strong foothold in what is still, by all accounts, a new and not yet matured industry, it is clear that the future for cell and gene therapy in the DACH region is positive.

Though progress may be slow, particularly as overall investment into cell and gene therapy in Europe decreases, that’s not to say it isn’t significant – the DACH region will undoubtedly play a key role in the future of cell and gene therapy.