This article is the fourth in our five part series focussing on mRNA. In our previous articles we took a closer look at mRNA, what it could be used for, the history of mRNA research and the surrounding IP landscape. Here we will take a look at the partnering and M&A activity in the mRNA field, including some recent deals.
As we discussed previously, the synthetic mRNA field is growing rapidly and companies active in the space are enjoying staggering levels of investment. Although the field is still in early days, success of mRNA based vaccines against COVID-19 has generated significant excitement about the potential of mRNA to prevent and cure numerous diseases.
Synthetic mRNA has the potential to be used, not only as a vaccine for infectious diseases, but as a transformative therapy in genetic diseases, cancer immunotherapy and in regenerative medicine. In addition, the predominant delivery system used for mRNA (lipid nanoparticles, or LNPs) also has broader application in other fields, such as gene editing. The broad applicability of mRNA and versatility of LNPs means that there are numerous companies active in the field. It’s perhaps not surprising then that we have seen significant levels of fundraising and M&A, as well as plenty of collaboration and licensing activity, from companies who are working on mRNA technology and those who want to gain a foothold in this rapidly growing field.
Interestingly, analysis of recent deals shows that interest in mRNA is not limited to development of mRNA-based vaccines or therapeutic platforms; there has also been significant activity in related technologies and manufacturing capabilities.
Partnerships and collaborations
As we touched on in our previous article where we discussed the IP landscape surrounding the mRNA field, there is an extensive web of partnerships, collaborations and licences. A lot of the early pioneering work in the field was undertaken at academic institutions, most notably at the University of Pennsylvania, where pioneering work was undertaken on modifying mRNA nucleosides to avoid issues with immune system overreaction in patients. Important work was also undertaken at the University of British Columbia, where key work was done on LNPs – the current delivery system of choice for most mRNA vaccines and therapeutics in development.
As is typical in biotech, once early research had been spun out of academic labs, development was concentrated in a cluster of smaller (at the time) biotech companies such as Moderna, BioNTech, Arcturus, CureVac and Translate Bio. In recent years however, larger pharma companies have been entering the field either through partnering or acquisitions. Perhaps the most well-known partnership is Pfizer’s collaboration with BioNTech, but other notable collaborations include GSK and CureVac’s collaboration on the development of mRNA-based vaccines; Moderna and AstraZeneca’s collaboration on mRNA therapeutics for cardiometabolic diseases and cancer; and Sanofi and Translate Bio’s collaboration on mRNA vaccines for infectious diseases.
Given the importance of the delivery system for mRNA vaccines and therapies, a number of mRNA focussed companies have entered into partnerships with companies specialising in delivery technology, such as Arbutus (whose key LNP patents have been spun out to Genevant) and Acuitas. For example, as highlighted in our previous article, Genevant has granted licences of its LNP technology to BioNTech and Acuitas has partnerships with CureVac and BioNTech.
Incredibly, collaborative research on mRNA-based immunotherapies for cancer has even reached the International Space Station. Last year Kernel Biologics partnered with Boeing and the International Space Station U.S. National Laboratory to launch a study on board the ISS with the goal of using the microgravity environment to improve messenger RNA immunotherapy treatment for leukaemia.
We have set out below a selection of collaboration and licence deals relating to mRNA from this year (2021). Given the excitement surrounding the field of mRNA research and its broad potential applications, we expect to continue to see a healthy pipeline of collaborations and licence partnerships in coming years.
|Collaboration and licensing (2021)|
|AbCellera||mRNA encoded antibody therapeutics across multiple indications||Collaboration and licence to identify therapeutic antibodies. Moderna has rights to develop and commercialise resulting antibodies. AbCellera will receive research payments and is eligible for clinical and commercial milestones and royalties.||September 2021|
|Moderna||Institute for Life Changing Medicines (ILCM)||mRNA therapeutic for Crigler-Najjar syndrome Type 1 (CN-1)||Collaboration to develop a new mRNA therapeutic for CN-1 (an ultra-rare disease). Moderna will license the therapeutic to ILCM with no upfront fees, and without any downstream payments.||September 2021|
|Moderna||Autolus||mRNA therapeutics in oncology indications||Option and licence agreement. Autolus granted exclusive rights to Moderna to develop and commercialise mRNA therapeutics incorporating Autolus’ proprietary binders for up to four immuno-oncology targets. Autolus will receive an upfront payment for each target, development and commercial milestones and royalties.||August 2021|
|Multi-valent candidate vaccines to address emerging variants for pandemic and endemic use||Collaboration to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK will make an upfront payment of €75m and a further milestone payment of €75m, conditional on the achievement of specific milestones.||February 2021
|Gritstone Oncology||Vaccine-based immunotherapy to cure HIV||Collaboration, option and license agreement to research and develop a vaccine-based curative immunotherapy for HIV. Gilead made a $60 million payment at closing. Gritstone is eligible for royalties and up to an additional $725 million if the option is exercised and if milestones are met.||February 2021|
M&A and fundraisings
This year we have also seen a number of M&A deals and fundraisings relating to mRNA. This is perhaps unsurprising given recent excitement generated by the success of mRNA based COVID vaccines. Notable in particular is Sanofi’s recently completed $3.2 billion acquisition of its collaboration partner, Translate Bio. This acquisition supports Sanofi’s recently opened mRNA Centre of Excellence, and the healthy valuation placed by Sanofi on the deal is a clear demonstration of the future potential that big pharma foresees in the mRNA field. We have also seen valuations of listed mRNA companies skyrocket. Moderna in particular has seen its NASDAQ market capitalisation soar from USD 6.9 billion at the end of January 2020 to USD 135 Billion (as of 19 October 2021).
We have outlined a selection of mRNA M&A deals and fundraisings that took place this year (2021) below. Interestingly, recent M&A activity has not been confined to development of mRNA-based vaccines or therapeutic platforms. There has also been significant M&A and fundraising activity in related technologies and manufacturing capabilities. For example, Merck KGaA’s acquisition of AmpTec (a leading mRNA CDMO) combines Merck’s expertise in lipid technology with AmpTec’s specialised PCR based technology for mRNA manufacturing. The SPAC acquisition of Greenlight Biosciences is yet another example; according to Greenlight, its mRNA biomanufacturing platform promises fast, scalable and cost efficient mRNA manufacturing. On the fundraising side, London based Touchlight successfully raised $125 million in a Series B fundraising in September 2021. Touchlight has a synthetic DNA vector (which it refers to as “doggybone” or dbDNA) which can act as a template for mRNA production via in vitro transcription.
This interest in manufacturing capabilities may be symptomatic of the industry wide squeeze on biologics manufacturing we have seen over the past 18 months as a result of the COVID-19 pandemic. This squeeze has led to bottlenecks in manufacturing and left some biotech companies scrambling to ensure sufficient manufacturing capacity. With demands on CDMO capacity increasing, interest in manufacturing capabilities and capacity has surged.
|Sanofi||Translate Bio||$3.2 Billion||Clinical stage mRNA therapeutics platform||August 2021|
|Environmental Impact Acquisition Corp (SPAC)||GreenLight Biosciences Inc||$1.5 Billion||mRNA biomanufacturing platform||August 2021|
|Sanofi||Tidal Therapeutics||$470 million ($160 million upfront and up to $310 million milestone-based)||Pre-clinical therapeutics platform||April 2021|
|Merck KGaA||AmpTec||Confidential||mRNA contract development and manufacturing organisation (CDMO)||January 2021|
|Strand Therapeutics||$52 million Series A||mRNA therapeutics for cancer immunotherapy||June 2021|
|Stemirna Therapeutics||$200 million Series B||mRNA Covid Vaccine||June 2021|
|Abogen||$700M Series C||mRNA Covid Vaccine||August 2021|
|Replicate Bioscience||$40 million Series A||Self-amplifying RNA (saRNA) constructs for preventing drug resistance in various cancers and for taming autoimmune disorders||September 2021|
|Touchlight||$125 million Series B||Enzymatic DNA production (including for use in mRNA vaccines)||September 2021|
The recent success of mRNA vaccines, which has demonstrated both the safety and efficacy of the technology in the fight against COVID-19, has triggered a wave of interest in mRNA. This trend is illustrated by the significant number of mRNA related partnerships, acquisitions and fundraisings we have seen over the past year, including in manufacturing and related technologies. Research and development on mRNA, which had previously been concentrated in a cluster of smaller biotech companies, is increasingly becoming a key element of the pipeline of a number of large pharma companies and mRNA focussed biotech companies. As such, companies such as Moderna and BioNTech have seen their valuations soar.
Whenever there is significant activity in any sector of the market, there are always rumours of a market bubble. With that in mind, it is important to remember that, despite the swirling excitement, mRNA is still a nascent field. The fight against COVID-19 has been an important proving ground for the technology, but if mRNA is to live up to its much vaunted potential, we will need to see positive results coming out of clinical trials for other indications. While the early pace of development in the mRNA field was slow (see our article on the history of mRNA research here), given the current level of investment and momentum in the field, we expect we will find out sooner rather than later if mRNA really is ushering in a new era of genetic medicine.
The authors would like to thank trainee Vivien Zhu for her assistance with this article.