cancer
The odds on Sellas immunotherapy? Not great
A Phase 3 study from Sellas Life Sciences for its AML immunotherapy galinpepimut-S, or GPS, is nearly a year behind schedule — and that delay may be a warning sign. The outcome is unlikely to be the encouraging signal CEO Angelos Stergiou has portrayed it to be, STAT’s Adam Feuerstein writes.
The event-driven study requires 80 deaths before its final survival analysis, a threshold Sellas once expected to reach by the end of 2025; the company reported the 78th death in May and has said nothing since.
“I’m a student of biotech history,” Adam writes. “That history tells you that event-driven studies that badly miss completion timelines nearly always do so because the company’s underlying assumptions about its own treatment and any treatments being used as a comparator were wrong.”
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Markets
A hedge fund builds its own immunology biotech
Two years ago, Adar1 Capital analyst Mohit Gupta pitched his boss, Dan Schneeberger, on an unusual idea: Instead of investing in another biotech, why not build one themselves? The result is North Immunology, which is going public Thursday through a reverse merger, STAT’s Adam Feuerstein writes.
North’s lead drug, NOR-101, is a long-acting bispecific antibody targeting IL-13 and IL-18 for atopic dermatitis. It plans to launch an early stage trial next year, and post interim data by midyear. The company hopes the combination can approach the efficacy of AbbVie’s Rinvoq with a better safety profile and less frequent dosing, though it faces competition from Talawar Therapeutics and Novartis.
“Creating companies is a lot more painful than I imagined,” Schneeberger said, with a laugh. “Investing is not as time-intensive and you can bet on more, different things. Creating a company takes a lot more time. You need to hire people, which is probably the most difficult thing about it, finding the right talent. It’s a lot more challenging.”
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research
The mice with half-human brains are an ethical test
Stanford scientists have created mice whose brains are roughly half human by volume, growing human cerebral organoids inside animals genetically engineered to lack 98% of their own cortex. The human tissue flourished in the extra space, producing millions of neurons, including rare cell types difficult to obtain in a dish, and forming connections extending as far as the spinal cord.
The “neuro-chimeric” mice performed about as well as normal mice on memory and motor tests, STAT’s Megan Molteni writes, but displayed distinct behaviors researchers don’t yet understand.
"We don't know exactly how to think about those differences yet," said Nita Farahany, a professor of law and philosophy at Duke University who studies the ethical and social implications of emerging technologies. The work raises questions about whether increasingly sophisticated chimeras might warrant greater animal protections. But this chimeric approach could offer a much more realistic way to study psychiatric and neurological diseases than either traditional mouse models or brain organoids grown in dishes.
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