Orlance, Inc., headquartered in Seattle, WA, is developing its MACH-1® platform to deliver nucleic acid vaccines and related therapies without cold chain restrictions.  Leveraging $9.6M in NIH SBIR funding, Orlance has developed the MACH-1 platform to intradermally deliver stable, powdered vaccines in a needle-free manner that minimizes dose size, eliminates cold chain requirements, and is poised to increase access and compliance.  The company’s executive team comprises significant immunology, vaccinology, biotech development, bioengineering, regulatory and partnering experience and is well poised to bring its preclinical assets to IND and Phase 1 readiness in 2021.

While the significant potential of nucleic acid vaccines and immunotherapies—including both mRNA and DNA vaccines–has spurred development for two decades, 2020 has provided the watershed breakthrough to widespread clinical and regulatory validation with multiple mRNA vaccines being authorized for Covid-19. Safety and efficacy is now established, along with the significant acceleration of development and production enabled by nucleic acid vaccines vs. other vaccine types. However, 2021 will similarly demonstrate how supply, cold chain and needle aversion limit uptake of this breakthrough field. Nucleic acid vaccines inherently require novel delivery vehicles to maximize cellular update; Orlance’s MACH-1 uniquely accomplishes this by pneumatically driving powdered vaccine into the skin where maximal immune response for mucosal (including respiratory) infections has been demonstrated in multiple diseases and in the elderly. Alternatively, shots typically deliver into the muscle, with lower immune response. With conservative estimates of nucleic acid vaccines securing 10% of the projected $100B vaccine market* and Orlance addressing 20% of the nucleic acid vaccine market, MACH-1 vaccines present a $2B market opportunity. MACH-1 vaccine cost modeling establishes significant profitability in major markets while maintaining sufficient profitability in developing markets.

Orlance has MACH-1 influenza and Covid-19 formulation candidates in preclinical studies and will select its lead program—considering both internal proprietary and partner-developed formulations needing an optimized delivery system–to advance to IND submission and Phase 1 readiness in early 2021. Discussions are ensuing with potential strategic partners. Recent market activity validates multiple exit opportunities within 3-5 years for breakthrough nucleic acid immunology platforms, an acceleration from pre-2020 market timelines.