Overview

A US biotechnology company partnered with Novotech to initiate two first-in-human mRNA oncology trials in Australia and expand into North Asia without disrupting enrollment.

The program required coordinated regulatory execution across multiple jurisdictions and the ability to incorporate a new breast cancer cohort during the study.

Novotech structured the program to begin in Australia and expand into North Asia, allowing early clinical activity to start while maintaining continuity as the study progressed.

Challenge

Early-phase oncology studies are complex, particularly across multiple regulatory environments. In this case, the sponsor needed to:

  • Initiate first patient dosing within a short timeframe
  • Navigate regulatory and ethics requirements across three APAC markets
  • Navigate regulatory and ethics requirements across three APAC markets
  • Add a breast cancer cohort without interrupting enrollment
  • Maintain recruitment while expanding into additional countries
  • This required clear sequencing, local regulatory knowledge, and consistent oversight across all regions.

Novotech’s Approach

Novotech implemented a phased regional strategy, starting in Australia and expanding into North Asia.

This approach enabled study start-up in Australia while regulatory approvals in North Asia progressed in parallel, avoiding delays associated with sequential country activation.

  • Activated six sites in Australia to support early enrollment
  • Managed ethics and regulatory submissions through in-country teams across HREC, MFDS, and TFDA
  • Sequenced country expansion to maintain enrollment as approvals progressed
  • Activated an additional site to support the breast cancer cohort without delaying the study
  • Maintained oversight across start-up, enrollment, and data delivery across all regions

The study continued without interruption as requirements evolved.

Outcome

Novotech delivered both studies within the sponsor’s timelines and maintained enrollment across regions.

  • Achieved 88.9% enrollment (24/32 patients) in Australia
  • Added a breast cancer cohort without impacting recruitment
  • Secured South Korea regulatory approval within six months
  • Achieved Taiwan TFDA approval in approximately six weeks (accelerated due to TGA approval streamlining TFDA approval)
  • Initiated patient dosing across multiple countries within planned timelines

The sponsor was able to generate early clinical data while retaining flexibility for next steps in development.

At a Glance

  • Phase: Phase I, First-in-Human (FIH), dose escalation and expansion
  • Therapeutic Area: Oncology (solid tumors, breast cancer, non-frontline HCC)
  • Modality: mRNA immunotherapy
  • Regions: Australia, South Korea, Taiwan
  • Sites: 6+ activated across APAC
  • Enrollment: 88.9% achieved (24/32 patients)
  • Expansion: Breast cancer cohort added mid-study
  • Regulatory Milestone: ~6-week TFDA approval timeline