Helix structure

BRIDGE (Bringing RNA Innovations through the Developmental Gap Effectively)

The challenge

The BRIDGE program stands at the forefront of addressing a pivotal challenge in the field of RNA-based treatments. This challenge revolves around the pronounced knowledge and skill gap that often hinders academic researchers from successfully transitioning promising RNA treatments from the late clinical stage to clinical trials. While academia has been a driving force behind ground-breaking discoveries in RNA-based technologies, the intricate processes and regulatory complexities involved in clinical development have historically posed significant barriers. The BRIDGE initiative recognizes the critical need to bridge this gap by establishing a dedicated infrastructure that empowers academic researchers to advance their RNA therapeutics towards clinical trials. By providing the necessary support, resources, and expertise, BRIDGE aims to unlock the full potential of RNA-based innovations, accelerating their translation into real-world clinical applications, and ultimately, improving the lives of patients in need of novel treatments.

The project

The consortium, called BRIDGE (Bringing RNA Innovations through the Developmental Gap Effectively), is an academic industry partnership, bringing together the Kirby Institute, Medicines Development for Global Health, Scientia Clinical Trial Research, the Garvan Institute for Medical Research, UNSW RNA Institute, along with community representatives on the Clinical Development Advisory Committee.

The BRIDGE Program is led by Kirby Institute Director Scientia Professor Anthony Kelleher. This Program is supported by Medical Research Future Fund (MRFF – MRFCTI000007).

We are a not-for-profit organisation that supports endeavours for improving healthcare in low- to middle-income countries.

The method

The Consortium coordinates and builds upon existing infrastructure and developmental expertise to streamline a developmental pathway for RNA candidates. These candidates will be taken through 4 steps:

  1. Identification of lead candidate
  2. cGMP/cGMP-like manufacture
  3. Clinical trial-enabling studies
  4. Early phase clinical trials

Key components of this process include compliance with regulatory agency requirements for pharmaceutical development; enhancement of intellectual property; enhancement of existing capabilities, and active fund raising. The primary objective is to allow inventors and host institutions to undertake rigorous, efficient product development in an academic setting.

The impact

The proposed clinical trials-enabling infrastructure will fill a gap in the rapidly evolving scientific and medical ecosystems facilitating development of RNA vaccines and therapeutics in NSW. In addition to providing scientific expertise to help academic researchers overcome the developmental challenges for their inventions, we will incorporate the principle of ‘fail fast’ to guide decision-making during the development process. Reflective of the focus of this call, preference will be given to initial products that are focussed on COVID-19; however, the long-term intention is to support the progress of RNA-based treatments in general. The consortium will encourage inventors/owners to consider a not-for-profit approach in the developing world.

Project collaborators

NSW Office for Health and Medical Research ABN 92 697 899 630 of 1 Reserve Road, St Leonards NSW 2065

The Office of the NSW Chief Scientist and Engineer ABN 51 766 912 245 of Level 6, 52 Martin Place, Sydney NSW 2000

Garvan Institute of Medical Research ABN 62 330 391 937 of 384 Victoria Street, Darlinghurst, NSW 2010

Medicines Development for Global Health Limited ABN 79 116 977 523 of Level 1, 18 Kavanagh Street, Southbank, VIC 3006

Scientia Clinical Research ABN 85 607 180 192 of Bright Building, Level 5, Corner High & Avoca Street, Randwick, NSW 2031

Project funding

Medical Research Future Fund (MRFF – MRFCTI000007)

Invitation for Expression of Interest

The BRIDGE consortium is extending an invitation for expressions of interest (EOI) pertaining to RNA-based candidates with the potential to significantly contribute to the prevention of SARS-CoV-2 infection, and the treatment of COVID-19. RNA based candidates for other therapeutic areas (infection, inflammation, and oncology) will be considered.

Upon selection of an RNA-based candidate, the BRIDGE consortium will propose a collaborative agreement offering expertise and support (including but not limited to funding, personnel, expert network access and other relevant aid) to advance the development of the selected candidate towards clinical trials. Please note that the BRIDGE program will not be acting as a grant-providing body but rather be looking to form a partnership with the researchers to develop the candidate molecule in collaboration with the BRIDGE program.

Suitability of candidates:

Candidates must be RNA-based.

COVID19 is the preferred therapeutic area; however, candidates for other therapeutic areas (infection, inflammation, and oncology) will also be considered.

They should have demonstrated proof-of-principle in vitro and in vivo (animal studies) at a Technology Readiness Level (TRL) 3 or higher.

We are open to candidates at various stages post-TRL3, provided they exhibit a high likelihood of therapeutic potential and merit further investigation for clinical development.

How to apply:

To submit your EOI, please complete the BRIDGE preliminary EOI submission form.

Instructions for application form completion:

  • Please provide a brief high-level summary of your candidate and its applications. Limit your responses to 300 words for each response.
  • Do not share any proprietary data in this application.
  • Applicants that are selected to progress further into the application process, will be requested to sign a confidentiality agreement before exchange of detailed information (including proprietary information).

Questions or queries can be directed to BRIDGE@kirby.unsw.edu.au

Application deadline:

Rolling deadline. Applications will be considered as received.