BioNTech is having its Pfizer moment

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Hello, everyone. Damian here with yet another megaround in biotech, a preview of some hotly anticipated data, and the perils of declining revenue.

The need-to-know this morning

• Roche and its partner Chugai said Enspryng, their IL-6-targeted antibody treatment, “did not reach our expectations on the degree of clinical benefit” in a Phase 3 study of the autoimmune disorder myasthenia gravis.
• Shares of Argenx reacted positively to the Enspryng setback. Argenx’s FcRN-targeted antibody drug, Vyvgart, is approved to treat patients with myasthenia gravis. Shares of Immunovant, developing its own FcRN antibody, were also up. Tourmaline Bio, maker of an IL-6 antibody, saw its stock price fall.

After an $11 billion sale, the team behind Prometheus has a new startup

And it just raised $400 million to, like its predecessor, develop new medicines for inflammatory diseases.

As STAT’s Allison DeAngelis reports, the firm is called Mirador Therapeutics, and it’s led by the team that turned Prometheus Therapeutics into a company promising enough for Merck to pay $11 billion for it last year. Mark McKenna, former CEO of Prometheus and current chief executive at Mirador, had unfinished business in immunology, where, despite the recent development of some powerful medicines, there remains a massive unmet need.

Investors would seem to agree. Mirador set out to raise $200 million for its Series A, but an influx of interest led the company to double that figure in its inaugural fundraise, tapping a syndicate that includes Arch Venture Partners, Orbimed, and Fairmount.

Read more.

Can Intra-Cellular succeed where the industry has largely failed?

We’ll find out next month, when Intra-Cellular Therapies is expected to have Phase 3 data on whether its lead drug can benefit people with major depressive disorder, or MDD.

As STAT’s Adam Feuerstein writes, MDD has long bedeviled drug developers, and many studies have been derailed by unexpectedly strong placebo responses that negate a given drug’s positive effects. But Intra-Cellular’s treatment, already approved for schizophrenia and bipolar depression, could have a leg up on past contenders, Adam explains in a detailed preview of the company’s upcoming results.

Speaking of Adam, starting next week he’s launching a newsletter, exclusive to STAT+ subscribers, that will deliver insight and analysis from the intersection of Wall Street and biotech. It’s called Adam’s Biotech Scorecard, and you can sign up for it right here.

The U.K. is trying to figure out n-of-1 medicine

A revolution in genetic medicine has made it possible to craft bespoke therapies for patients with ultra-rare conditions. But the process of turning one-off success stories into a replicable process is more than a little complicated, with research, regulatory, and financial hurdles ahead.

As STAT’s Andrew Joseph reports, researchers and government agencies in the U.K. are trying to figure out a pathway to bring tailor-made treatments to as many patients as possible. That includes standardizing the process for developing such therapies, figuring out how to appropriately test their merits, and ensuring there’s a way to pay for the whole endeavor.

“A lot of the barriers are no longer scientific — we can make these drugs,” said Matthew Wood, a professor of pediatrics at the University of Oxford. “It’s more about, can we make them at a cost that is reasonable enough? And can we get the regulators to reduce the barriers to doing this so that when a patient shows up, you can actually make a drug quickly enough to benefit that patient, rather than it costing huge amounts of money and taking two or three years to do it?”

Read more.

BioNTech is having its Pfizer moment

Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company’s Covid-19 vaccine partner, is now dealing with investor malaise of its own.

Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech’s cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.

Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.

More reads

• Lonza buys Roche site for $1.2 billion to bolster biologics, Bloomberg
• Medicare expected to negotiate obesity drug prices soon, new analysis predicts, STAT