Sanofi/Takeda, UniQure & CSL, Fog Pharma, Merck + Imago

Vaccine hesitancy, the most expensive gene therapy in the world, a $178M series D, and a $1.3B buyout

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Story References
Sanofi/Takeda
UniQure & CSL
Fog Pharma
Merck + Imago

About the Show
Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry. 

Transcript

Introduction

Welcome to Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, vaccine hesitancy, the most expensive gene therapy in the world, a $178M series D, and a $1.3B buyout.  

Disclaimer

The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated. 

Vaccine Hesitancy and Approvals

Through the last years of the pandemic, vaccine hesitancy has often been framed in highly siloed political categories – with very real anti-scientific thinking on one side, and robust data on the other. In the west, it continues to impact us all as low influenza vaccine rates and failure to participate in COVID boosters are combining with other forces to create a so-called “tripledemic” of COVID, the Flu, and RSV. In this context, it can be easy to see vaccine hesitancy as monolithic. But it’s not. Not only are their massive variations in the influences and thinking across the west, the diversity becomes more complex when you head further abroad. 

A great example of this is the Dengue Fever vaccine fiasco in the Philippines. Dengue Fever, alternatively called by the comforting moniker “breakbone fever” is a mosquito born tropical illness caused by the dengue virus. It impacts nearly 400M individuals a year globally. It’s also a particularly challenging virus to combat as there are multiple serotypes in the same region making vaccine creation more complex. In Addition, if you are infected with Dengue more than once with a different Serotype, the body may react with “antibody-dependent enhancement” which can severely increase the symptoms and risk of death. The complexities around this virus and the attempts to make vaccines for it, caused a controversy in the Philippines when the Department of Health rolled out Sanofi’s Dengvaxia in a massive program dosing nearly 800,000 school aged children. However, approximately 10% of the children may have never previously been infected with Dengue fever. Because of how the body responded to the vaccine, these children may have now been at risk for antibody-dependent enhancement if they were infected with Dengue fever. All of this lead to lots of outrage across the Philippines, significant finger pointing, and a long litigious process. Part of the fallout from this is that Dengvaxia is no longer available in the Philipines. Though it is FDA approved in the United States for adults who have been previously infected and live in a high-risk region. 

All of this history with Sanofi and the Philippines complicates the recent news from Takeda that their Dengue vaccine has received priority review from the FDA. This has not been a rushed process, with positive phase III data released back in 2019. It’s not clear if they will earn FDA approval, though the EMA looked on it positively back in October. The vaccine is nothing like COVID19 vaccines with 84% of hospitalizations prevented across a 4.5 year followup and 61% of symptomatic cases. It was more effective during the proceeding study period. 

So you have a complex virus, then you end up with complex vaccines that interact with a complex social political environment. The more you dig into the story, the more you see the complexities of vaccine hesitancy, medical education, and how all of these can mix with multi-national for-profit companies and political intrests. In the case of the Philippines there is a real examples of a questionable rollout of a vaccine program that may have placed some children at risk – approximately 19 of the 800,000 children who received the vaccine died with Dengue Fever and it is possible the vaccine contributed. As a result of the event and surrounding frustration from communities there has been a major drop in childhood vaccinations. This has lead to multiple measles outbreaks impacting tens of thousands of children and taking the lives of 100s. To give you an idea of this impact, the measles vaccination rates were at 89%, close to the 95% required for herd immunity in 2009. By 2019 that rate was just 66%. The Philippines also sits at #5 for highest mortality rate from COVID19 with very poor vaccination rates. 

Takeda will need to decide if they hope to fight this uphill battle in key regions like Indonesia (where it was approved in August) and the Philippines or if they will limit their vaccine to places with relatively low needs like the EU and pending this approval, the US. From the broader context, careful conversations about motivation, profit, efficacy, and risk will be required to maintain societal trust and prevent more unnecessary deaths in the future.

Most Expensive Gene Therapy in the World

Among extensive fanfare and some criticism, UniQure along with their partner CSL have announced the FDA approval of the Hemophilia B gene therapy, priced at a stunning $3.5M. Like most gene therapies, the cost of development and delivery of the one-time therapy are high – but like many other therapies, the current market cost of treating the condition also plays into the hefty price tag. The therapy sold as HEMGENIX resulted in 94% of participants in a clinical trial discontinuing all other treatment. Under the terms of their agreement with CSL UniQure will receive a $500M payment based on this FDA approval is eligible for further milestones of $1.5B as well as royalties. For those that can now get this care and find a way to pay for it, there is a meaningful change in quality of life – but the seemingly endless increase in gene therapy costs leave others asking how much is too much?  

Preclinical Biotech Fog Pharma Takes in a $178M Series D

Fog Pharma has raised a $178M Series D to continue to push forward their pipeline targeting “undruggable” candidates targeting oncology. The proceeds from the round, which include a range of new investors will be used to advance their pipeline of a-helical polypeptide therapeutics. First on their lists of targets set for early phase trials in 2023 is FOG-001, a direct TCF-blocking B-catenin inhibitor. Their basic strategy is to use their unique approach to small precision medicine to achieve new advances across a range of known, but currently undruggable targets. While all early stage their pipeline is broad, and their targets mean Fog only really needs one successful shot-on-goal to create a fairly significant splash in the oncology world. But, with these funds there is likely a lot riding on their first-in-human studies launching middle of next year.

Merck 1.3B Imago Biosciences Acquisition 

Merck (MSD outside the US) has expanded their oncology portfolio with the $1.36B acquisition of Imago Biosciences. The full acquisition brings Imago’s LSD1 inhibitor, bomedemstat, currently in late phase trials for myeloproliferative neoplasms (MNPs), into Merck’s broad oncology portfolio.  The bone marrow related cancers in this category have shown promise across early and late phase studies. This is basically a one-therapy pipeline, but with broad potential. The price tag makes it an expensive one, but a clear indication that Merck remains strongly focused on oncology. 

Closing Credits

Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.