Evelo Bio raises $47.5M for I/O work; Vertex gets started on a fast pivotal effort for triple CF combo
→ Seven months after Google-backed Evelo Biosciences brought its total venture raise to $100 million, the microbial experts are at it again. Evelo has raised another $47.5 million, according to a new filing with the SEC. Flagship Pioneering seeded Evelo and has helped to keep a marquee group of investors behind the company, which merged two fledgling operations into one. The big idea here is that Evelo believes it has the tech needed to advance a new immuno-oncology drug at a time the lead PD-1/L1 therapies are becoming semi-commoditized as a new wave of checkpoint therapies hits the market.
→ Vertex’s triple combo for cystic fibrosis — which includes VX-659 — is off and running in a pivotal Phase III trial that will be closely followed at every step. Of note, analysts are applauding the FDA’s willingness to go with a 4-week snapshot of FEV1 for the primary, accelerating the timeline to seeing whether the triple can greatly expand the percentage of patients who could be effectively treated with one of its drugs. Baird’s Brian Skorney notes: “The pace here is quicker than expected, and we think this trial design should bridge some of the gap between the Street’s eagerness to get data and FDA’s need for longer-term safety data.” The quick-snap trial, though, has been accompanied by considerable controversy. Vertex dropped trial sites in France, citing the government’s unwillingness to reach a compromise on the price of the biotech’s marketed drugs. The company says it believes keeping the sites would falsely raise patients’ hopes, though some could see it as a hard ball maneuver aimed at spurring patients in France to demand regulators resolve the standoff in Vertex’s favor.