Originally Published as The Niche Podcast
Turning CAR T on and off, Fujifilm’s $2 billion investment, Affinivax raises $226 million, and startups to watch
Sponsors
https://www.thescopemethod.com
Story References
10.1126/scitranslmed.abb6295
https://affinivax.com/affinivax-announces-226-million-series-c-financing-to-advance-its-pipeline-of-novel-maps-vaccines-targeting-infectious-diseases/
https://www.fujifilm.com/us/en/news/Fujifilm_to_Invest_2B_for_Cell_Culture_Manufacturing_Site
https://www.businesswire.com/news/home/20210105005224/en/IconOVir-Bio-Raises-77-Million-in-Series-A-Financing-to-Develop-Next-Generation-Oncolytic-Viruses-to-Treat-Solid-Tumors
https://www.lexeotx.com/
Music by Luke Goodson
https://www.soundcloud.com/lukegoodson
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.
Introduction
Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, turning CAR T on and off, Fujifilm’s $2 billion investment, Affinivax raises $226 million, and startups to watch.
Turning CAR T on and off
Researchers at several big-name Boston research institutes published an incredible work this week demonstrating a novel mechanism for activating or deactivating CAR T antigen receptors. To understand how this works, let me back up and review how CAR T cell therapy works because this is one of the larger emergent oncology trends and is worth understanding.
T cells are a form of lymphocyte. These white blood cells play a number of roles in adaptive immunity. In healthy adults with normal immune systems, T cells will use their T cell receptors to identify cancerous cells and degrade them, along with a host of other functions. There are a variety of T cells with diverse roles, but it is this unique ability to recognize aberrant human cells and break them down that makes CAR T cell therapy work. Chimeric Antigen-Receptors (CAR) are modified T cell receptors that combine both an anti-binding and a T-cell activation function into a single cell-surface receptor. A T cell with CARs can recognize a specific target and initiate an immune response to degrade that target.
CAR T cell therapy coopts this natural immune function and adds in elements of both cell and gene therapy. In simple terms, T-cells are removed from your body. In a lab, these cells are genetically edited to express a specific CAR that targets the specific cancer in your body, but not your healthy cells. The cells are then “grown” in lab, so there are more of them. After a lot of quality control, the patients modified cells are returned to their body, where the CAR T cells can target and destroy the cancer.
The paper published last week adds a critical new mechanistic opportunity in the oncology space. The scientists Jan et al., designed novel CARs that utilized a drug, Lenalidomide, to turn ON T cell activity in mice with cancer, or turn CAR T activity way down (OFF), limiting inflammation. These findings are far from a human approved treatment, and there will be significant fine tuning before you see this applied therapeutically. But it does present the possibility of researchers more precisely controlling inflammatory and immune responses in the future. At the most basic level an OFF-CAR T cell therapy could be engineered as a way to decrease inflammation in patients experiencing serious immune side effects. This could meaningfully improve the safety of the therapy. If you’re at all interested in personalized medicine, oncology, or the mechanisms of targeted immunology this paper is worth a read.
Sponsor
The Niche is brought to you today by The Scope Method LLC. The Scope Method helps companies develop clear vision and strategic processes; Whether you need fresh eyes on your data, independent risk assessment, or are pivoting into a new therapeutic space. The Scope Method will help you focus close to re-examine what you know and look ahead to where you want to go. Find out more at thescopemethod.com
Fujifilm Invests $2 Billion in Contract Manufacturing
Fujifilm has announced they are building a $2 billion plant for large-scale cell culture production in the United States. The capacity of eight 20,000L bulk scale bioreactors will provide enormous specialized capabilities on US soil. Bio contract manufacturing is a big focus for the company, and they state that by the time the plant opens in 2025 they expect $2 billion in contract manufacturing revenue annually. This also positions Fujifilm to see Samsung Biologics as a competitor. We reported on August 17th (Episode 7) about Samsung’s massive capital investment in the same space. It seems probable that Fujifilm’s choice to build the plant on US soil is an attempt to intentionally distinguish their offerings from other Asia-based CMDO services. The site has not been chosen, but their other biomanufacturing facilities on US soil are in Texas, North Carolina, and Wisconsin, so expect those to be top contenders in the tax-write off bidding war for this facility.
Affinivax Big Series C
Affinivax announced a $226 million series C this week. This is perhaps the best time for raising biotech startup capital in history, with markets uniquely positioned and investor interest high. Add to that a global pandemic, driven by the need for a vaccine, and being in the novel vaccine space feels almost prescient. However, Affinivax is not one of these raise 3 rounds of funding and go public in 12-months companies. Following a more traditional model they have been in preclinical development since 2014 and have at least one clinical stage vaccine ready to launch. This particular funding round is building on a partnership they squared away in Q1 2017 for a MAPS vaccine platform. Multiple Antigen Presenting System (MAPS) is a patented mechanism for designing vaccines that target both surface polysaccharides as well as proteins. While there are vaccine platforms that target either or, the MAPS combined approach will generate a more robust immune response to hard-to-target illnesses, including certain bacteria infections. First on Affinivax radar is Streptococcus pneumoniae.
Startups to Watch: IconOVir
IconOVir was launched last week with a $77 million series A. The company aims to develop oncolytic viruses. The idea of targeting cancer with viruses has been around for a long time, but most previous attempts have met serious biological barriers. IconOVir says in effect ‘not a problem, we’ve fix all that.’ It’s not clear whether IconOVir will be as clinically successful as they imagine, but they have so many big names backing them and hunger for novel oncology products is so high that I expect them to raise another $200 mil in the next year regardless.
Startups to Watch: Lexeo Therapeutics
Lexeo Therapeutics has emerged from stealth with an $85 million series A and a mind-blowing 18 candidate pipeline. This is absolutely a company to watch. Lexeo will almost certainly be positioned to raise more capital within 12 months to move into heavy clinical development of multiple gene therapy targets. Keep in mind one of their phase 1 targets is the APOE4 gene that contributes to certain kinds of Alzheimer’s. There are definitely major risks in moving from rare-disease targeted gene therapies to super-not-rare whole brain gene therapy. But with a blend of crazy rare, normal rare, and not rare targets they have a lot to focus on at once. Some startups are too myopic, Lexeo’s risk seems to be choice overload.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.