Merck enlists 4D Pharma's microbiome platform in a bid to build a new class of vaccines
Merck has signed a research deal with 4D Pharma to use its MicroRX platform to turn living bacteria into vaccines.
The collaboration comes in the nascent field of “live biotherapeutics” – a term the FDA uses to describe living organisms, generally bacteria, used as medicine. 4D Pharma, a small biotech based in Leeds, UK, builds its LBP by extracting bacteria from a healthy donor and putting it in a capsule patients swallow.
The deal allows 4D Pharma to cause New Jersey-based Merck to purchase $5 million of ordinary 4D Pharma shares during the first year. There’s an undisclosed cash payment to 4D, along with $347.5 million in options hinging on development and regulatory milestones, and royalties.
But there’s no word yet on what those indications are. Or what precisely these vaccines are.
Although 4D Pharma talks about developing “live biotherapeutic vaccines” with Merck, the FDA’s 2016 guidance on LBP clinical trials specifically defines LBPs as something that contains living organisms, is used to prevent or cure human ailments, and “is not a vaccine.”
It appears, though, that this is a new development and not an attempt by either company to rebrand the more established preventative LBP targets. To its long list of pipeline targets, the company very recently – the Wayback Machine only lets us check as recently as July 15, when it was not yet there – added “MRx Vaccines.” It appears with the shortest line, and links to the message: “We have entered a research collaboration and option agreement with MSD, utilising the MicroRx platform to discover and develop LBPs as novel vaccines.”
LBPs are currently being investigated as a preventative treatment for bacterial vaginosis, necrotizing enterocolitis, and allergic rhinitis. 4D is currently involved in four clinical trials, studying Blautix in IBS, MRx0518 in combination with Merck’s Keytruda on solid tumors and MRx0518 in a neoadjuvant setting for solid tumors, and MRx-4DP0004 for asthma.
Daria Hazuda, Merck’s VP of infectious diseases and vaccines discovery research added, “we hope to gain meaningful insights into the role for the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.”