| | | |   | Good morning, all. Damian here with a preview of some massive news in Alzheimer's disease, what happens when Pfizer's CEO calls, and some dimming expectations in synthetic biology. | | | What to know before the next big Alzheimer’s readout With the Aduhelm disaster now firmly in the rear-view mirror, partners Biogen and Eisai have the rare opportunity for a do-over. By the end of next month, the world will learn whether lecanemab, their next treatment for Alzheimer’s disease, can succeed where its predecessor failed.
The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — but probably not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.
The lecanemab study, called CLARITY-AD, could reach statistical significance by showing a small benefit relative to placebo, an outcome that would spark debate over just what qualifies as clinically meaningful for patients with Alzheimer’s. And, like similar studies past, the trial could fail in one of many nuanced ways that would have implications for competing therapies from Roche and Eli Lilly.
Read more. | When the CEO of Pfizer calls you It can mean billions of dollars are about to change hands.
That was the case for Ted Love, CEO of Global Blood Therapeutics, who told STAT’s Adam Feuerstein about his phone call with Pfizer’s Albert Bourla pitching what would become the $5.4 billion merger disclosed Monday. “He told me Pfizer was excited to deploy its resources and global footprint to address all the patients” with sickle cell disease, Love said.
Global Blood has made some commercial inroads on its own since winning U.S. approval for its sickle cell drug in 2019, but Pfizer’s infrastructure makes it possible to reach more of the estimated 20 million people in the world affected by the disease. “Some of those patients are in parts of the world where you’re unlikely to make profits,” Love said, “but Pfizer sees eye to eye with us that these are human lives and we have the capacity to help them, so we will.”
Read more. | Over a decade later, what’s next for the future of immunotherapy? Since 2011, the FDA has approved over three dozen novel immunotherapy treatments for patients with various forms of cancer. While these therapies have improved outcomes for some patients, there are others whose tumors don’t respond well enough to these medicines. Learn how the next generation and personalization of immunotherapies will help deliver more options for people with cancer. | Another synthetic biology company runs into trouble Berkeley Lights, a synthetic biology firm worth nearly $7 billion in late 2020, slashed its prior revenue projections yesterday and outlined a plan to cut spending and streamline its business.
The company, which sells machines for drug discovery, has been on a downward spiral since 2021, when the short seller Scorpion Capital raised questions about its business model and the actual utility of its technology. In January, the company replaced its CEO and disappointed Wall Street by missing sales projections and forecasting 2022 revenue growth of just 30%. Yesterday, Berkeley Lights abandoned those numbers, saying full-year sales are more likely to mirror those of 2021 and outlining a plan to stop losing money by 2025.
Berkeley Lights now trades at $5 a share, roughly one-fifth of its IPO price and a smaller fraction of the $103 all-time high it reached in 2020. The company’s gradual decline coincides with a downturn among its peers in synthetic biology, a field focused on using cellular engineering to produce a host of products. Zymergen, which went public at $31 a share in 2021, went through a pivot of its own and last month sold itself to rival Ginkgo Bioworks at a valuation of about $2.50 a share. Ginkgo, now the largest player in the space, has lost nearly 70% of its value since going public in a SPAC merger last year. | Merck makes a bet on Alzheimer’s research Four years after concluding a series of expensive failures in Alzheimer’s disease, Merck has invested in an early-stage approach to combating neurodegeneration.
Cerevance, a private company that spun out of Takeda in 2016, said yesterday that it had signed a deal with Merck to find novel biological targets for the treatment of Alzheimer’s. Merck is spending $25 million up front, with the promise of another $1 billion or so if the research turns into actual medicines.
The deal, however small, is Merck’s first public commitment to Alzheimer’s research since 2018’s high-profile failure of verubecestat, an oral treatment meant to halt the production of amyloid plaques in the brain. | More reads - U.S. moves to stretch out supplies of monkeypox vaccine. STAT
- FDA says possible carcinogen found in some Merck diabetes drugs. Reuters
- Implant recipients shouldn’t be left in the dark when a device maker cuts off support. STAT
- A vaccine for Lyme disease is in its final clinical trial. NPR
| Thanks for reading! Until tomorrow,  | | | |
No comments