Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Hello, all. Damian here with an update on the plight of the other Covid-19 vaccine company, Wall Street’s latest GLP-1 trade, and the quest for a universal antivenom.
The need-to-know this morning
- Ocular Therapeutics announced a shakeup of its senior management team and a $325 million private placement.
- Amylyx Therapeutics said results from a closely followed Phase 3 study of its treatment for ALS could come before the start of the second quarter — earlier than previously expected.
- Moderna earnings are here.
Novavax’s money is going in the wrong direction
The good news for Novavax is that it’s no longer facing a $700 million dispute with a global charity organization. The bad news is that settling that dispute will force the struggling company to pay out $400 million over the next five years.
As STAT’s Ed Silverman reports, the dispute centers on undelivered doses of Novavax’s Covid-19 vaccine contracted by Gavi, a public-private partnership that worked with the World Health Organization to bring vaccines to low-income nations. In light of Novavax’s financial problems, Gavi agreed to a repayment schedule in which the company will hand over $20 million every quarter for five years. If Gavi wants any Novavax vaccines during that period, the value of the doses will count against the total debt, meaning the company might not have to pay the whole $400 million.
The news marks one more monetary issue for Novavax, which has reduced its revenue expectations and is in the process of cutting its workforce by about 30% to conserve cash. The next big milestone comes next week, when Novavax will disclose how much revenue it made on Covid booster doses in the fourth quarter. If results fall short of expectations, there could be further cuts to come.
Some mice are worth $100 million
Shares of Ventyx Biosciences roughly doubled yesterday on news that the company’s pipeline treatment for Parkinson’s disease might have a future in obesity. The details of that news — the data came from another company, and the observed effect was in mice — seemed to have little bearing on the reaction.
The data come from a privately held company called NodThera, and they describe how two treatments aimed at a protein called NLRP3 led to significant weight loss for mice with obesity, roughly matching the effects of Wegovy and a calorie-restricted diet. Mice, famously, are not people, but NodThera believes the results bode well for its ongoing Phase 2 study enrolling human beings with obesity.
Ventyx, whose value was decimated after a clinical failure last year, happens to have some NLRP3 inhibitors of its own in clinical development. The company has no data in obesity and hasn’t disclosed plans to generate any. But NodThera expects to have Phase 2 results in May, and if those data are positive, Ventyx “could attract pharma attention,” Jefferies analyst Michael Yee wrote in a note to clients.
Never mind the war. Ukraine is open for biotech business
Ukraine had long been a hub for clinical research, hosting hundreds of trials for sponsors around the world. Russia’s 2022 invasion all but halted demand, but local researchers and executives want the global drug industry to know they’re back up and running.
As STAT’s Andrew Joseph reports, Ukraine emerged as an in-demand locale for clinical trials because it has a digitized health system but is comparatively cheap compared to Western Europe. Studies gave Ukrainians a chance to try treatments not otherwise available in the country, easing the process of recruitment, and the country has a wealth of contract research organizations that specialize in running trials.
That all came unraveled at the outset of the war, but researchers have spent the ensuing years building workarounds that have allowed ongoing studies to continue, and now they’re ready to reclaim their role in global drug development. “Before the war, we couldn’t have imagined how it was possible to continue our usual working tasks,” said Yuriy Lebed, the CEO of the CRO Pharmaxi. “Now we are adjusted, we are adapted to this.”
The dream of ‘universal antivenom’ is alive
Despite a century of scientific progress, the standard method for making an antivenom is a grim procedure involving horses, snakes, and a lot of bloodwork. But new, early-stage research points toward what could be a path for a universal antivenom, one that could be more easily produced and widely distributed than the old-fashioned ones.
As STAT’s Jason Mast reports, current antivenoms are regional products, made by dosing horses with sub-lethal amounts of venom from local snakes and then isolating the resulting antibodies. But those products have shortcomings when it comes to potency, and they can lead to painful immunological side effects, including the occasional anaphylactic shock.
A team of researchers in India and the U.S. set out to find a single, horse-free antibody treatment that could counteract whatever poisons the reptile world cooks up. They began by analyzing the genetic profiles of the world’s venoms in search of common proteins and then crafted an antibody treatment that appeared to neutralize as many of them as possible. An early study, conducted in mice, suggests they’re on the right track.
More reads
- Small study adds to growing hope CAR-T cell therapy could revolutionize autoimmune disease treatment, STAT
- A startup’s mission to bring back the woolly mammoth is being made into a docuseries, Wired
- Does ketamine therapy help treat depression or is the drug dangerous? Bloomberg