Seattle-based biotech Orlance announced in July 2024 that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the US NIH to develop and optimise RNA vaccine formulations with its needle-free MACH-1 platform. The technology is intended to enhance the safety, stability, and efficacy of RNA vaccines for infectious diseases and cancer immunotherapy applications. MACH-1 is described as a “potentially significant advancement” in RNA vaccine delivery.
Meet MACH-1
MACH-1 is a needle-free vaccine platform that provides a “rapidly deployable, ambient stable, dose sparing, and easy to use product”. Orlance hopes it will increase immunisation in underserved regions by overcoming logistics or personnel difficulties and needlestick hesitancy. With pressurised gas, MACH-1 accelerates microparticles of DNA vaccines, RNA vaccines, or a combination. Vaccine microparticles penetrate the outer layer of skin to reach the epidermal layer, achieving intracellular delivery and transfection in local antigen presenting cells within the epidermis. This results in “robust” induction of systemic and mucosal antibody and cytotoxic T cell responses.
Compared to traditional lipid nanoparticle (LNP) RNA formulations, the MACH-1 platform uses dry, stable RNA-coated gold microparticles. It is needle-free and painless and ensures better stability at ambient temperatures with “significant supply chain advantages”.
Gene Gun project
The SBIR-funded project, “Gene Gun-delivered RNA vaccines”, is to be led by Orlance Principal Investigators Dr Hannah Frizzell and Dr Kenneth Bagley. They will aim to optimise RNA formulations for MACH-1 gene gun delivery to “maximise loading, maintain functional integrity, and ensure stability and immunogenicity”. The researchers will compare the effectiveness of MACH-1 delivered RNA vaccines against traditional LNP/RNA vaccines.
The 2-year grant provides $300,000 a year to enable Orlance to conduct preclinical studies, expected to “pave the way” for subsequent phases of development. Orlance has already received $13 million in SBIR funding, advancing MACH-1 towards readiness for initial regulatory filings in 2024. The company plans to initiate Phase I clinical trials for its lead infectious disease asset in 2025.
Kristyn Aalto, co-founder and CEO of Orlance, stated that the “breakthrough” of mRNA vaccines in recent years has “established the enormous potential of genetic (RNA and DNA vaccines”. However, there is still “significant work to do to improve utility and overall global health impact”.
“We are very grateful for NIH’s continued support and are rapidly accomplishing MACH-1 platform goals that could truly enhance the clinical research and impact of genetic vaccines.”
With a “well-developed” candidate portfolio and offerings across both DNA and RNA, Aalto hopes to “leverage the attributes of both platforms to provide ideal solutions tuned to the immunogenicity, protection, and durability profiles sought for specific indications”.
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