Phacilitate's Investment for Advanced Therapies in partnership with Biotech and Money will take place May 3 at the CMS offices in London, and brings together investors, pharma and biotech into the same room to discuss the latest industry developments, areas that need investment to develop to their full potential and how this can all be turned into a profitable venture for all involved
Investors, biotech and pharma are all represented in the intense 1-day programme, so everyone can walk away from the event with a clearer idea of the funding landscape with respect to pharma and biotech, and where they can direct their efforts to increase profitability. New speakers are still being added, and in just the last week, we've confirmed the participation of Dr Sara Núñez-García, Principal, Sofinnova Partners.
Biotech and Money: So what is Sofinnova’s current philosophy, strategy and areas of interest?
Sara Nunez-Garcia: Sofinnova’s strategy and philosophy have been rather stable over the years. That is, to find great management teams that are able to identify novel therapies for diseases with no therapies available, or where the therapies are marginally effective - hence diseases with big unmet needs.
I appreciate that the definition of ‘high unmet need’ is somewhat subjective, everyone likely has their own definition. The Sofinnova team prioritizes various indications taking into account the patient needs, HTA feedback and Pharma appetite among others.
Sofinnova is entrepreneur-centric rather than asset-centric. We focus on strong management teams with vast expertise in technology or drug development; we also have backed first time CEOs that have a great capacity to be mentored and grow to become leaders in the space.
B&M: So where are you with the fund at present?
Sara: We closed our 8th fund at the end of 2015; that is a 300 million Euro fund that we started to invest in both biotech and medtech companies. Since then, we have made a number of investments in both Europe and the US.
We typically invest at the seed or Series A stage, and we are very active in company formation as well. With respect of the specific areas of interest, we remain agnostic to the therapeutic area and drug or technology modality. If you look at our portfolio, we may have more or less exposure to certain therapeutic areas or modalities at any specific point of time, but that is coincidental rather than by design. When it comes to backing companies, it typically starts with a dedicated team and an objective to build a solid pipeline in a space where substantial value can be created, and where we could eventually provide an exit for the shareholders and our investors. So that’s in a nutshell what the firm’s philosophy and strategy is.
B&M: I understand you personally have always been a backer and had an interest in the advanced therapies sector. Is there a particular reason for your interest in the cell and gene therapy sectors?
Sara: That’s a good question. Sofinnova has always been focused on great entrepreneurs with an ability to identify great technologies; we have shown a track record of assuming substantial technology risk when the potential therapy could really address a huge unmet need and improve patients’ lives. Over the years, we have done so with small molecules, antibodies, ADCs, and with cell therapy and gene therapy.
Specifically in the ATMP space, looking back in the nineties, there was a lot of activity in the cell therapy and gene therapy space. In 1995 we invested in a rather pioneering French company called Immuno Design Molecules (IDM) which had an autologous ex vivo therapy for oncology indications. The company raised funding from investors and later secured a partnership with Pharma. It was early days back then for such an approach, however Sofinnova decided to back an innovative company with a rather high technology risk because we believed that product could have a profound impact on health.
There has been a lot of activity and progress in the gene and cell therapy space since then. We have seen various companies being created and/or matured in the last few years, and our portfolio company Lysogene is in that pool of the next wave companies. Lysogene is a French company led by Karen Aiach, a strong CEO that has built a pipeline of gene therapy products for rare CNS diseases. We do not have any company in the cell therapy space in the Sofinnova portfolio, but of course, we are monitoring that space for a potential investment as well.
B&M: You’re one of our speakers for our Investment for Advanced Therapies day on May 3rd, organised by Facilitate and Biotech and Money, joining the opening panel entitled ‘The Opportunities of Cell and Gene Therapy and Why Now.’ How do you compare the space compared to other subsectors within life sciences at present?
Sara: Sofinnova is agnostic to the drug modality, whether it is small molecules, cell therapy, gene therapy, etc. However, we appreciate that there are certain chronic indications where cell therapy and gene therapy may have a higher impact than other types of products, and there is already evidence of this in the blood disorders, ophthalmology and oncology spaces.
If you think about haemophilia, sickle cell disease, for example, it was perhaps possible to keep a patient stable on a chronic medication with a biologic of stem cell transplantation. Some of the novel gene therapy products have shown a glimpse of an opportunity to achieve a cure for the patient.
There are certain indications where we think this type of products can serve as a better treatment than a small molecules or antibodies. Of course we do not think that gene therapy or cell therapy can become the standard of care for all indications. But there are certain indications where these technologies can work very well for certain patient populations, they can make a huge difference - more than any other modality. We’re starting to see that as I alluded to before.
B&M: It’s a space growing fast and especially in the last year or two it seems to be growing sense of nearing an inflection point. What do you still see as the remaining barriers and hurdles in full commercialisation of advanced therapy products?
Sara: We have seen a lot of activity and progress in the space in the last 5 years. We have seen a lot of companies reading out clinical efficacy and safety data that look very promising. I think we need more companies showing these types of data to consolidate further the ATMP space. Getting to further consolidation of the ATMP space is in my view a matter of capital, time and investment continuity, waiting for the data to be generated. I think that’s just a matter of time in both the gene and cell therapy spaces.
Importantly, we need long-term efficacy and safety data. And by long-term, that may not be 1 or 2 years, but 5 or 10 years. These are data that will be likely harvested once these therapies are approved in a Phase IV setting. If you look at Strimvelis, the GSK gene product that was approved recently, that product has very long-term clinical data accumulated over the years. You can see that after 5-10 years, some of these SCID boys are still infection-free outside a germ-free environment.
At the moment, we have seen very exciting clinical data for various companies, and this is something that we did not see in the first wave of gene therapy companies in the 90’s. Having long-term data at hand for these products will enable a healthy discussion on pricing and reimbursement among all stakeholders. Personally, I do not think that reaching agreements for these therapies will be as difficult as some predict, however it will take time and willingness to adopt new models. There is an ongoing debate for the price of these therapies which is perhaps too politicized and not totally justified for innovative drugs. I think that the various stakeholders will be able to eventually find common ground with economic models that ensure a good compromise.
On the other hand, and this is common to all gene and certain cell therapy products (eg. CART) , the manufacture at the commercial level and lack of capacity is something that companies are struggling with nowadays. I don’t think there are many companies out there today that can do commercial manufacturing, some are even building their own capacity given the lack of slots. I think though that it is a matter of time and investing in the space and hopefully we will keep meeting milestones. It is important to maintain the traction in the ATMP space that we currently see.
B&M: You mentioned the dollars behind it and investing in the space. Much is made about the difference in financing and environments between the US and Europe, and particularly in the cell and gene therapy field where there have been some high profile VC investments. You mentioned in a past interview with our partners Phacilitate that it was perhaps not the right way to look at this problem. It would be better If companies and investors who back them focused from the outset on a global mind-set. Trying to build the best company and source the best talent, that really the key issue.
Do you see this as a trend, in that mind-set that you were discussing, for European companies doing this? To be working to build companies and talent rather than worrying about this perceived funding gap?
Sara: I think that what we need to worry about is building great companies. If a great entrepreneur has found a great technology that has the potential to change people’s lives, and has a credible development plan, then capital will likely be attracted to that company.
We have seen quite a lot of investments from US investors into European companies; we are also starting to see capital coming in from China as well. Many of our European companies in the portfolio are financed by both European investors and US investors. Again, I think that we need to worry about building great companies and not just companies that are sourcing local human talent, local IP or else because it is the path of least resistance. If we bring a global mindset and aspiration, the path to building value may be more straightforward.
I do not think that the barriers to attracting non-European attention and capital are as high as we think they are, that is my opinion. If you go to any given European conference, you will probably meet US investors looking for the same qualities that we look for in companies; they scout and invest in Europe because they know there is a lot of untapped value and opportunities.
B&M: On that point of sourcing talent, a major geopolitical issue in the last few weeks has been Britain’s formal exit from the European Union. Is this something you see as a potential challenge or issue for British companies in this space, and the biotech sector as a whole, to attract and retain talent?
Or do you see think that globalised nature of the industry means it won’t be as much of a problem as some perceive for British biotech?
Sara: There has been quite a lot said already regarding Brexit, and even the US travel ban. Recently there was a piece written by pharma and biotech executives in Nature to warn about the potential implications of restricting the flow of talent to healthcare companies. And I endorse that personally.
I think it is too early to say about Brexit. We have 2 years of intense negotiations ahead of us. The hope is to be able to implement a policy to allow us and companies to maintain the status quo. That relies on attracting great entrepreneurs and great people. Hopefully we will be able to maintain a free flow of talent to companies.
B&M: And are there exciting milestones that we and our readers should be looking out for from Sofinnova’s portfolio companies in their advanced therapy space, or any particular milestones for portfolio companies as a whole?
Sara: We are intensely monitoring the ATMP space and actively following developments for a potential investment. But one of the exciting companies in the portfolio is Lysogene, a pioneering company in the lysosomal storage disease space. The company will be reading out long term data from their Phase I/II trial in the next few months. That is essential for the reasons we discussed earlier. Lysogene is also running an observational study in anticipation of their registrational Phase II/III trial that will start in the coming months.
That is a very exciting company in our portfolio with great potential to treat this indication where there are limited options.
B&M: Finally, you’re one of our speakers for our Investment for Advanced Therapies day on May 3rd, what are you hoping to get out of the event itself?
Sara: It is always great to be surrounded by investors and companies that are working in this space, to exchange ideas, brainstorm, and of course, it is a great opportunity to talk about our companies, to meet potential new investment opportunities, and also discuss with the experts.
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