List Biotherapeutics, Inc, is a newly formed subsidiary of Genome and Co, the South Korean business focused on microbiome anticancer drug development. The Asian company has been expanding into the US over the past 18 months, with it making a majority strategic investment in List Labs and Scioto Biosciences, firms located in California and Indiana, respectively.
List Labs was the first contract development and manufacturing organization (CDMO) to produce a live biotherapeutic product (LBP) for clinical trials.
List Bio announced today that it is ready to use recently raised funds - US$48.4m – from a Series A investment round to go towards the build of a large-scale manufacturing facility in in the Fishers Life Science and Innovation Park, in Indiana.
The subsidiary raised a US$31m tranche of Series A financing last December followed by a second tranche of US$17.4m just last month. The financing round saw participation from investors such as Paratus Investment and SV Investment, along with Korea Investment Partners and DSC Investment.
Its plan to build of a 110,000 sq. ft [10219.34 sq. m] microbiome therapeutics focused contract manufacturing facility will see 201 jobs created by the end of 2023. The build will involve substantial capital investment, two to three years of construction time, and the establishment of a workforce to maintain and run the facility, said List Bio's president, Jonathan Yongwan Jo.
He told us the company is looking to start GMP production in the second half of 2024. "We will have some test runs beforehand, as we complete the facility construction."
In terms of the facility's reach, he said: "Microbiome R&D companies in the US will be a natural target for List Bio, but there are many other international potential customers who want to go through FDA clinical trials in the US. List Labs currently has customers from all over the world."
There is significant demand for third-party manufacturing of live biotherapeutic products, he confirmed. The industry trend is moving toward outsourcing manufacturing to specialized contract manufacturing organizations: "Manufacturing an LBP compared to researching and developing it requires different capabilities and skill sets."
The microbiome therapeutics market, according to data from research firm, MarketsandMarkets, is expected to grow at a CAGR of 21.5%, from US$788.8m in 2025 to US$1.416bn in 2028.
The decision to build in Fishers, said List Bio, was driven by its status as a destination for technology and life science industry growth.
The Fishers Life Science & Innovation Park was established in August 2021 and has seen more than US$200m in investment from two life science firms already: Stevanato Group and INCOG BioPharma Services.