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How data integrity issues roiled a biotech seen as ‘Moderna 2.0′

The Somerville headquarters of the biotech firm Laronde.Alex Hogan/STAT

This is an excerpt of a joint investigation between the Boston Globe and STAT, the health and medicine news site that’s a partner to the Globe. For a full version of this story and related coverage, visit STAT.

In February 2022, Diego Miralles, then-CEO of a buzzy new biotech called Laronde, gathered his employees in the company’s shiny new Somerville, Mass., headquarters to relay some unsettling news.

An internal investigation had uncovered a “bad assay” and poor note-taking in some of the core research being conducted at the company, Miralles told Laronde’s roughly 130 staffers. The incident was serious, he said, and the company needed to learn from it.

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Though couched in careful language, his meaning was clear: There was a problem with some of Laronde’s key preclinical data.

It felt, one former staff member recalled, like all of the air had been sucked out of the room.

Miralles said one person was responsible for the issue, and though he didn’t say who, employees quickly connected the dots: Laronde had recently parted ways with one of its veteran scientists, a woman named Catherine Cifuentes-Rojas.

Cifuentes-Rojas had produced data for one of the company’s top drug candidates: an anti-obesity therapy that goes after the same hormone target as the blockbuster new weight loss drugs Wegovy and Mounjaro. It underpinned the enormous $440 million the biotech raised in a 2021 Series B funding round, according to four people with knowledge of its plans, as well as a slide from an internal slide deck, which valued the company at over $1 billion.

“Honestly, it was kind of shocking,” another former staff member said of Miralles’ announcement at the staff meeting. “As an employee, I was really worried. It’s not a good sign for a company.”

Over the following months, concerns over the integrity of the data have led to major tumult at Laronde, according to a STAT and Boston Globe investigation. The biotech shelved its two most advanced programs, including the GLP-1 therapy, and is likely to miss its internal goals of submitting paperwork for a clinical trial by the end of the year, three former employees said. Dozens of employees have left, as well as several top executives at the company.

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For Laronde, which was founded by Flagship Pioneering — the ambitious startup-creating engine that bankrolled Moderna and countless other biotechs — the episode has highlighted how easy it can be to get carried away with the promise of new therapies, despite signs of trouble. Misgivings about the data had been circling for roughly a year before Miralles’ disclosure, according to three people, and many had tried and failed to replicate the stellar results that Cifuentes-Rojas had produced.

The story continues on statnews.com. Globe subscribers get a special discount.