Gene editing, a technique that adds, deletes or rearranges the DNA in a living organism, is widely lauded as the next cancer-busting miracle cure. Think CRISPR and the like.
But the problem is that current standard gene editing methods are based on unpredictable viruses or can have off-target effects. You may want to edit one particular gene, but could accidentally modify others in the process. This is highly dangerous, and carries with it the added risk of developing unwanted clinical outcomes (ranging from illness to death).
“You can’t completely control what it edits and what it does,” says Svetlana Semykina, Licensing Manager of the Technology Transfer Department at the German Cancer Research Center (DKFZ). The Research Center has developed a new technique that’s similar to gene editing, but without the risk of changing other genes.
“Our technology can, crudely speaking, edit genes, but not in the genome. This is just one advantage amongst others, but you can edit the genes of cells, which is very important for gene and cell therapy, without any risk of integration,” says Svetlana. (Integration is a technical term that refers to the insertion of foreign genetic material into a strand of DNA).
This new technology will face some difficulties as it goes down the path towards commercialisation, however. Svetlana says that the technology now needs to be validated, but unfortunately this phase of a technology’s life is a funding desert.
“The biggest challenge in my opinion right now is the lack of validation funding. Validating a technology is not like making a new discovery, it’s not exciting in terms of new science so there are fewer funding sources available. On the other hand, to persuade investors to invest into a new technology you need to be very well-funded already to reach certain experimental milestones. In order to do that, you need to have access to translational funds, but they are very competitive and there’s very few of them. Of course you can work in collaboration with industry but that also comes with strings attached,” she says.
IP Booster’s evaluation and due diligence service helped her to highlight the importance of funding this research to internal funders based at DKFZ.
“It was really good to see that [our technology] had a value. We had to ask for more funding from our management board, internal funding, and they were not sure whether to give this particular laboratory more money. We mentioned that we had this service done independently and professionally and that there was a €270 million tag on the technology, and they gave us the money. That was the necessary persuasion, the necessary step that they needed to make this decision.”
Their next challenge will be to source additional funding to validate the technology to the required stage, and then to license it to pharmaceutical companies. Convincing the pharma companies will be especially challenging, because they will need to fund the technology through clinical trials, which can cost millions, and this is where having strong IP protection and patents is paramount.
“These companies also want to make sure, not only that you’ve done many experiments up until now, but that your patents are good enough. Why would they invest millions taking this to market if they won’t have the monopoly on it? So they have to be certain of the patent landscape. This links really well to what IP Booster offers,” says Svetlana.
Svetlana’s technology transfer office is currently supporting the commercialisation of many medical technologies, and she confesses that it has been challenging at times.
“Scientists always talk highly about their technology, and as a tech transfer professional, you want to believe them and from the data you see it looks promising, but you’re never quite sure how good they are, how accurate they are, it’s their baby and they are promoting it,” she says.
The independent expert analysis provided though IP Booster that illuminated the real value of the patents and intellectual property that the German Cancer Research Centre had, and strengthened their negotiations with funders and pharmaceutical companies.
If you’re thinking about signing up to IP Booster, but you’re not quite sure what to expect, Svetlana recommends that you prepare your application carefully [read: try not to wait until the last minute to apply!]
“The forms were easy, but definitely think very closely about what you want to get from this service. We could have spent more time designing exactly what our problem was and where this due diligence should lead us. In our case, we were really interested in whether we would be free to operate with our patents and whether we would be infringing anything. Think about what you want to have at the end of your service. If your technology is in the super early stage, you should do the initial IP audit, but apply to the evaluation service if you’re at the stage where you’ve already filed a patent, or if you are planning to apply for funding or to license. Having this value will really make a difference in getting through to the final funding stages and negotiating with your partners.”
Written by Catherine Collins for IP Booster