On July 26, 2021 Anocca reported that fundraising is the first major venture capital round to go to a European TCR therapy developer this year; another sign that the technology is gaining momentum (Press release, Anocca, JUL 26, 2021, View Source [SID1234591030]).
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Last year was a busy one for companies developing cell therapies for cancer based on engineering T-cell receptors (TCRs), known as TCR or TCR-T cell therapies. One example from the European biotech sector was the German firm Immatics, which entered the Nasdaq stock market in July 2020. Meanwhile, hefty Series A rounds were closed by T-knife in Germany and Neogene in the Netherlands.
Over the first half of 2021, however, Europe has seen few venture rounds going to TCR-T developers — a pattern also reflected in the Asia-Pacific region. But it is in big contrast to the US, which has already had at least three venture capital rounds raised by TCR-T companies. There have also been multiple initial public offerings in the US from TCR-T developers — the latest of which was closed at around €85M ($100M) by TScan Therapeutics earlier this month.
According to Brent Pfeiffenberger, Chief Operating Officer of Neogene, part of the issue is how new cell therapy technology is. One of the most established forms of cell therapy for cancer, CAR-T cell therapies, was first approved by the FDA in 2017 to treat a rare form of blood cancer.
"The industry is now experiencing more rapid growth and investment globally," said Pfeiffenberger. "However, as there are still a very limited number of CAR-T therapies approved in the EU, there is also a more limited experience base in developing and commercializing cell therapies in Europe."
"In addition, there are multiple modalities beyond CAR-T being pursued within cell therapy, and some require further specialization, experience, and capabilities to be successful."
The €40M raised by Swedish firm Anocca in a Series B round is a sign that the field is starting to gain traction in Europe. The company will use the proceeds to take its TCR therapy candidates to phase I/IIa trials for a range of types of solid tumor.
While few in number, Anocca’s financing and the Series A rounds from Neogene and T-knife attracted a lot of cash for European biotech venture rounds.
Part of the enticement is that TCR therapies aren’t limited to scanning for signs of cancerous proteins on the cell surface like CAR-T cell therapies are; TCR therapies can detect signs hidden inside cells. This gives them an advantage at taking the fight to solid tumors.
"This is the promise of TCR-T," said Anocca CEO Reagan Jarvis. "We can leverage the largely untapped and immensely numerous targets that reside within cancer cells."
European countries such as Germany, the UK, and the Netherlands host some of the biggest fleets of TCR-T developers globally after the US and China. Leading TCR-T companies in these countries include Immatics, the Dutch firm Gadeta, GSK, and the UK biotech Adaptimmune.
"I think there has been significant support for TCR-focused biotechs in Europe for the last couple of years," noted Jarvis. "The rounds are always smaller and fewer than in the US, whatever the field."
There are signs that interest in TCR therapies is growing in Europe. Last week, for instance, the Covid-19 vaccine veteran BioNTech acquired a TCR-T cell therapy research program from the Gilead-owned Kite, in addition to a manufacturing space in the US for cell therapies.
"As these specialized, next-generation approaches advance, we would expect to see further interest and investment in TCR development more broadly," said Pfeiffenberger.
This trend is also reflected in European biotech startup activity. In May, Oslo-based Zelluna Immunotherapy licensed technology from the MD Anderson Cancer Center in the US to develop a TCR therapy based on natural killer cells, which could be manufactured ‘off-the-shelf’ from donor cells rather than the patient’s cells. And in February, Pan Cancer T spun out from the Dutch Erasmus Medical Center with a seed round to develop TCR therapies for solid tumors.
"Adoptive T-cell therapy is one of the most promising approaches that has already proven its feasibility and clinical benefit in tumors in several clinical trials," said Katrien Reynders-Frederix, CEO of Pan Cancer T, in a public statement. "We are looking forward to further expanding our investor base and raising a Series A financing round to accelerate our programs."
As TCR-T technology gains momentum, its use could also extend to indications other than cancer. For instance, the US firm TeraImmune is equipping a type of immune cell called T regulatory cells with specific TCRs to prevent the immune system from attacking protein replacement therapies in hemophilia A patients. And Anocca’s technology could be used to make preventative vaccines for infectious diseases.
"There are certainly some niche clinical indications where infectious disease may be suitably controlled with targeted T-cell therapy and Anocca is exploring this space," said Jarvis.
However, in order for TCR-T to realize its full potential, major innovation is needed in the manufacture of cell therapies, which is one of the biggest obstacles to the technology becoming mainstream. European companies such as Ori Biotech and Treefrog Therapeutics are working to make cell therapy manufacturing cheaper, and demand is increasing thanks to the growing market presence of CAR-T therapies.
"We will see a move towards greater standardization of autologous therapy manufacturing and emergence of ‘off-the-shelf’ allogeneic cell therapies," Jarvis told me.