HDT Bio Receives ARPA-H GIVE Award to Lead Development of Automated, Point-of-Care Manufacturing for Personalized RNA Medicines

Award of up to $39.5 million funds a closed, end-to-end RNA manufacturing and quality-control platform; program includes a personalized cancer immunotherapy demonstration with Houston Methodist Research Institute and marks HDT Bio's expansion into personalized cancer medicine

SEATTLE, Sept. 15, 2026 /PRNewswire/ -- HDT Bio, a clinical-stage biotechnology company based in Seattle, Washington, today announced that it has been awarded an Other Transaction Agreement (OTA) by the Advanced Research Projects Agency for Health (ARPA-H) under the Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. The award provides $5.2 million in Phase 1 funding, with a total potential value of up to $39.5 million, for HDT Bio to lead "An Integrated Platform for Distributed Manufacturing and Quality Control of Personalized RNA Medicines", a closed, fully automated system designed to manufacture personalized RNA medicines, including individualized cancer immunotherapies, at or near the point of care.

A Closed, End-to-End Platform for Personalized RNA Medicines

RNA-based genetic medicines are today produced in large, centralized facilities through multi-site processes that add cost, time, and logistical risk; a poor fit for medicines designed for a single patient. Under the GIVE program, the HDT Bio-led Distributed RNA Synthesis (DRS) consortium will develop a compact, automated platform that executes the entire manufacturing process, from DNA template synthesis and RNA drug substance production to formulation, and fill-finish, all including integrated quality control with automated batch records and release certificates.

In Phase 1, the consortium will complete engineering design and feasibility demonstrations. In Phase 2, the integrated system will be built and deployed at Houston Methodist Research Institute (HMRI) in Houston, Texas, where it will manufacture three demonstration products: a personalized self-amplifying RNA (repRNA) neoantigen immunotherapy formulated with HDT Bio's proprietary LION™ delivery system; a CD19/BCMA CAR-T mRNA for ex vivo cell therapy; and a circular RNA (circRNA) gene therapy.

The DRS consortium brings together HDT Bio (team lead), Elegen Corp. (ENFINIA™ automated DNA synthesis), RiboPro B.V. (RiboFlux™ automated RNA manufacturing), Triple Ring Technologies (system software), The University of Queensland's BASE facility (analytical quality control), and Houston Methodist Research Institute (system integration and clinical translation).

"We are pleased that our RNA/LION platform has been selected for this program, which aims to optimize manufacturing efficiency of RNA medicines, technology which holds great promise for cancer treatment" said Steve Reed, PhD, Chief Executive Officer of HDT Bio.

 "LION is a modular and scalable formulation technology that can be adapted across RNA payloads. The ARPA-H GIVE award allows us to leverage the flexibility of our platform to enable rapid manufacturing for personalized RNA medicines" said Amit Khandhar, PhD, Director of Formulations at HDT Bio and Co-Investigator of the program.

Expansion into Personalized Cancer Immunotherapy with Houston Methodist

The announcement comes soon after the first positive Phase 3 readout for an individualized neoantigen therapy, Merck and Moderna's intismeran autogene in resected melanoma, establishing personalized cancer immunotherapy as a clinically validated modality and highlighting the need for manufacturing that can deliver patient-specific medicines at scale.

HDT Bio's GIVE program's lead demonstration product, a personalized repRNA neoantigen immunotherapy formulated with LION™, marks HDT Bio's expansion into individualized cancer immunotherapy, in collaboration with HMRI's Center for RNA Therapeutics. HDT Bio will contribute its self-amplifying RNA construct design and LION™ formulation expertise; HMRI will contribute its neoantigen selection and clinical capabilities and will host the integrated manufacturing system.

"The field's first positive Phase 3 readout for an individualized neoantigen therapy was a landmark for everyone working in this space" said Jesse Erasmus, PhD, Director of Virology at HDT Bio and Principal Investigator of the program, referring to Moderna and Merck's recent announcement. "The next frontier is extending that proof of concept beyond melanoma, a highly immunogenic tumor type, into cancers that are far harder to treat. That will require RNA modalities engineered for more potent and durable antigen expression, such as self-amplifying and circular RNAs, delivered with formulations like our LION platform and manufactured on demand, at or near the point of care."

"Houston Methodist was the first hospital system to leverage its infrastructure and expertise to develop and deliver a personalized mRNA cancer vaccine", said Dr. John Cooke, Director of the Center for RNA Therapeutics, and leader of the Houston Methodist team in the GIVE program. "Accordingly, we are excited to work with our colleagues in this ARPA-H consortium to build an automated cell-free device to generate clinical grade drugs for personalized RNA therapies".

"This multidisciplinary group intends to make feasible the distributed manufacturing of high-quality RNA-based genetic medicines wherever they are needed, making personalized therapies more accessible and affordable", said Jimmy Gollihar, head of the Houston Methodist Antibody Discovery & Accelerated Protein Therapeutics Laboratory and Chief Translational Science Officer. "This development underscores Houston Methodist's commitment to innovation, collaboration, and personalized medicine".  

About HDT Bio

HDT Bio is a clinical-stage biotechnology company based in Seattle, Washington, with a mission to develop innovative immunotherapies and preventive technologies for cancer, infectious diseases, and global health security. The company's proprietary LION™ delivery platform enables the development of scalable, deployable vaccines and immunotherapies suited for both public health and biodefense applications. For more information, visit www.hdt.bio 

About Elegen

Elegen has redefined synthetic DNA manufacturing with proprietary cell-free technologies that deliver longer, higher-quality DNA at unprecedented speed, scale and now affordability. With its commercial GEN II DNA Production Platform and ENFINIA DNA product suite, Elegen accelerates scientific discovery and therapeutic innovation for customers around the world. Headquartered in Menlo Park, Calif., Elegen remains privately held and focused on expanding access to next-generation genetic tools. For more information and updated ENFINIA DNA pricing, visit elegenbio.com and ecommerce.elegen.com. Connect with us on LinkedIn and X.

About RiboPro

RiboPro is a Netherlands-based leading service and technology provider specializing in mRNA and lipid nanoparticles (LNPs). Its technology portfolio includes RIBOFLUX™, a proprietary, fully automated and scalable RNA manufacturing platform. RiboPro also provides sequence optimization, development, manufacturing, quality control and optimization services for mRNA- and LNP-based products. For more information, please visit www.ribopro.eu.

About BASE

BASE is a non-profit mRNA-LNP research infrastructure facility, funded through the National Collaborative Research Infrastructure Strategy, based at the Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, Brisbane, Australia. Its mission is to help researchers develop new mRNA medicines. With end-to-end capabilities in software design, mRNA manufacture and LNP formulation, BASE scientists have experience in the pre-clinical development of mRNA medicines. For more information, visit basefacility.org.au

About Houston Methodist Research Institute

For more information about Houston Methodist, visit our newsroom or our social media pages on X, Facebook, LinkedIn, Instagram and TikTok or our On Health and Leading Medicine blogs. 

About Triple Ring Technologies

Triple Ring is a co-development company headquartered in Silicon Valley, with offices in Boston, Toronto, and Copenhagen. Working at the intersection of engineering, biology, and medicine, Triple Ring partners with clients and government agencies to create new technologies, launch innovative products, and start new ventures across smart medical devices, TechBio, life sciences, advanced imaging, and physics-based AI. Triple Ring's capabilities span early R&D, technology translation, product development, manufacturing, regulatory approval, market access, strategic investment, and incubation. For more information, visit www.tripleringtech.com.

Contact: [email protected]

SOURCE HDT Bio Corp.