Originally Published as The Niche Podcast
Alphabet buys, uncertain futures, new biotech funds, HIF-2a, PD-1, and a China Biotech emerges.
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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.
Welcome to The Niche Podcast – Your weekly rundown of the biotech, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, Alphabet buys, uncertain futures, new biotech funds, HIF-2a, PD-1, and a China Biotech emerges.
Disclaimer
The views expressed on The Niche Podcast are those of the host and guests. They do not necessarily reflect the opinions of any organizations or companies with which they are affiliated.
Verily Acquires SignalPath
Verily made a big splash early this year by attracting ex-FDA official Amy Abernathy to head up their clinical research efforts. Now, the Alphabet-owned company is starting on the acquisitions path. Last week they scooped up SignalPath, the creators of a clinical trials management system (CTMS). This acquisition seems like more of a kickoff to a series of acquisitions then a one-and-done solution. SignalPath has a lot of big brains and has built out solutions for study Design, Startup, and Oversight along with long-standing relationships with high quality study sites. The details of the deal are not disclosed, but certainly Alphabet isn’t lacking capital. Based on the positioning of Verily to grow their clinical research support services and statements from big tech that they see this as a critical area of research, I anticipate more acquisitions by them in the clinical research space over the next year.
Athira Muddy Waters and Uncertain Future
One of the most powerful forces in science is peer-review. It is not a system free of challenges, for example, papers get through peer-review with glaring errors and down-right lies every year. But the peer-review process does not stop there. Often when lies or errors are published, people eventually get caught. This appears to be the case for the ex-CEO of Athira Pharma, Leen Kawas, who was removed from her position after papers published prior to joining the company displayed apparently altered western blots. Unfortunately for Athira, this isn’t just bad publicity in the distant past. There are allegations that some of these altered images may have been used to obtain $15M in funding from the NIH. The company is also facing legal action for lying to investors about the potential for their pipeline. Fraud in research can cost your career. Lying to investors through an IPO may have far more serious implications. At this time, no clear legal actions have been taken against Dr. Kawas. Unfortunately, the imminent scientist and leader in the industry Dr. Tadataka Yamada was the chairman of Athira’s board and passed away in early August. This doubtless adds a degree of uncertainty as leadership sorts out the future of the company. They are currently advancing their late-stage products with just under $350M in the bank. They burned $12M last quarter so Athira has some runway to sort out issues. New board members have been appointed, but expect a shadow to hang over any future filings whether with the SEC or FDA.
Bain Capital Raises $1.9B Fund
Bain Capital has announced a new $1.9B fund focused on the biotech space. This investment portfolio will be focused on companies that are publicly traded but undervalued, and companies with high potential value who have run into cash snags in their clinical stage. Bain has made a number of forays into the Life Science including a $720M fund in 2017 and a $1.1B fund in 2019. With biotech’s getting startup cash left and right, there is still plenty of space in the market for cany investors to identify undervalued companies that need a little infusion. With current market cash-flows, $1.9B may not be that much, but I think the positioning of this investment gives it a good chance at some long-term value through smart targeting.
Merck FDA HIF-2a Inhibitor
A new HIF-2a inhibitor, welireg, has been approved by the FDA for the treatment of Von Hippel-Lindau (VHL) disease-associated tumors. VHL disease is a rare disease associated with tumor formation affecting nearly 10,000 Americans. welireg represents the first systemic therapy to treat the condition but it’s also the first HIF-2a inhibitor approved as therapy. HIF-2a is normally involved in the physiological response to hypoxia, and contributes to human’s ability to adapt to high altitude. This critical system has been implicated as dysregulated in a variety of cancers including renal cell carcinoma (RCC), a far more common indications with more than 400,000 new cases around the globe every year. Welireg is currently in phase III clinical trials for the treatment of RCC. Obviously Merck sees the rare-disease niche as a starting place in this case.
GSK PD-1 Inhibitors
GSK has earned expanded FDA approval to treat certain endometrial cancers with their PD-1 checkpoint inhibitor Jemperli. The PD-1 receptor related market is massive, with Merck’s Keytruda owning the lions share. But GSK hopes that Jemperli will capture its own portion in the coming years. This expanded approval is the first indication that the antibody may be on the road to more approvals. With numerous PD-1 associated conditions and multiple modes of action, there appears to still be space to expand opportunities for patients. Space GSK is happy to step into.
Abogen Raises $700M Series C
The China-based Abogen Biosciences has raised a $700M series C – a stunning amount for any company, but particularly so in China, where Biotech investment rounds typically do not see numbers more reminiscent of Silicone Valley. Abogen has published evidence of thermally stable lipid nano-particle mRNA vaccines. mRNA is extremely fragile and any exposure to the environment results in it degrading. mRNA vaccines therefore rely on lipid nano-particle packaging to stabilize them till delivery. To keep these tiny delivery vessels stable, very cold supply chains are required. Abogen published a paper in Cell earlier this year showing COVID19 vaccine that could be kept at room temperature for up to a week. This technology has massive implications for getting COVID19 vaccines to rural areas, but it’s also a broadly useful technology for future vaccines and drug delivery. Expect plenty of companies to be developing and selling nano-technology driven solutions in the coming few years as old therapies get repackaged for precise delivery while new ones become possible because of drug stabilizing conditions. All of this means companies like Abogen are getting huge valuations. Will they make billions off COVID? Possibly, but they also may have the backing of China to distribute a new generation of therapies. Plus, it seems like their underlying technology may be critical in its own right.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, pharma clinical research, 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.