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Landmark Bio secures USD 18.3m ARPA-H funding for extracellular vesicle manufacturing

Landmark Bio, a contract development and manufacturing organization (CDMO) based in Watertown, Massachusetts, has secured up to USD 18.3 million in non-dilutive federal funding through the Advanced Research Projects Agency for Health (ARPA-H) TRANSFORM-EV program. The award will support development of a continuous manufacturing platform for extracellular vesicles (EVs) over a three-year period.

The funding was secured with support from EverGlade, a Houston-based advisory firm that assisted Landmark Bio through negotiations with ARPA-H, including multiple redesigns of the statement of work, milestones, and financial documentation. No private investors participated in this award. The TRANSFORM-EV program — formally titled Enabling Access to Transformative Therapies Through Continuous Manufacturing of Extracellular Vesicles — is directed at overcoming the low-yield, high-cost batch production methods that currently constrain clinical and commercial access to EV-based therapeutics.

Landmark Bio is an Artis BioSolutions company, having been acquired by Artis BioSolutions in April 2025. Prior to that acquisition, the company was established in 2021 through a founding consortium that included Harvard University, MIT, Cytiva, FUJIFILM Diosynth Biotechnologies, and Alexandria Real Estate Equities, alongside clinical partners such as Beth Israel Deaconess Medical Center, Boston Children's Hospital, Mass General Brigham, and Dana-Farber Cancer Institute. The ARPA-H award represents the largest single disclosed funding event in the company's history. Earlier non-dilutive support included a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), awarded in partnership with ChromaTan Inc. to develop intensified AAV production processes.

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Landmark Bio operates as a services-focused CDMO rather than a drug developer with its own therapeutic pipeline. Its work centers on process development, advanced analytics, and GMP manufacturing for biotechnology and pharmaceutical partners advancing cell therapies, viral vectors, and related modalities. The ARPA-H award extends that remit into EV manufacturing infrastructure, where current batch-based production presents a recognized bottleneck. EVs — naturally secreted lipid bilayer vesicles capable of carrying proteins and RNA cargo — have attracted interest as both drug delivery vehicles and therapeutics in their own right, but scalable production has remained a constraint on clinical translation. The three-year TRANSFORM-EV project will integrate upstream, downstream, and analytical manufacturing technologies with the aim of improving yield, consistency, and cost efficiency at scale.

Gregg Nyberg, Chief Technology Officer at Landmark Bio, said EverGlade supported the company through several rounds of document revision during the negotiation process and that the company intends to continue working with the advisory firm during the post-award execution phase. No details on the company's management structure beyond Nyberg's role were provided in the source materials.


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