Moderna’s vaccines head steps down as multiple programs undergo phase 1: report

Giuseppe Ciaramella, the leader of Moderna Therapeutics’ infectious diseases business, has jumped to an as yet unnamed “stealth-mode biotech startup,” leaving a long list of clinical programs behind.

As CSO of the vaccines business, Ciaramella was responsible for Moderna’s most advanced programs, including vaccines against CMV, HMPV/PIV3, influenza, Zika and chikungunya, as well as undisclosed targets under a Merck partnership.

Ciaramella joined the mRNA biotech back in 2014. He has about two decades of biopharma industry experience, having previously served at AstraZeneca, Boehringer Ingelheim, Pfizer and Merck, with a focus on antivirals and biotherapeutics.

He was tasked to lead Valera, part of the Moderna family, when the unicorn biotech launched it in early 2015 to focus exclusively on prophylactic and therapeutic vaccines against infectious diseases. But the biotech later ditched the venture-based R&D model in favor of a therapeutic area-oriented approach, bringing all four units, Valera included, under one single corporation.

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Moderna actually used its mRNA-based H10N8 flu vaccine as the first clinical project to lay the groundwork for its entire pipeline. At least according to CMO Tal Zaks, M.D., Ph.D., interim data from a phase 1 study released last April “provide important validation of our core mRNA platform.”

In 2016, the company received an award of up to $125 million from the Biomedical Advanced Research and Development Authority for the development of Zika vaccines. The more advanced Zika candidate it in-licensed, mRNA-1325, is expected to have a phase 1 readout later this year, and the company also has a preclinical backup made of its proprietary formulations.

Other than those programs, Moderna pushed a chikungunya vaccine into the clinic last August with financial backing from the Department of Defense’s Defense Advanced Research Projects Agency. It also advanced a CMV vaccine and a HMPV/PIV3 combination vaccine into human testing in November and December, respectively.

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The news, first broken by STAT, could add to questions around the biotech’s technology. It comes after a trio of top R&D departures from the biotech last year: Matthew Staton, Ph.D., who was head of chemistry; Barry Ticho, M.D., Ph.D., who once headed up cardiovascular and metabolic diseases; and Arian Pano, Ph.D., who led clinical development for rare diseases.

Despite the doubts, Moderna still retains the charm to attract big investments, having just raised $500 million in a series G round to reach a value of $7 billion.

It is unclear why Ciaramella left, and Moderna didn’t immediately respond to a request for confirmation. Ciaramella’s LinkedIn page already shows him as the CSO of a “stealth mode biotech startup” since February. His name also disappeared from Moderna’s website.