Disruptive treatment that enhances immunity against bacterial infections

Summary

RemAb Therapeutics (RemAb) is developing RA-01, a breakthrough drug for curing bacterial infectious diseases. This novel technology, which offers an alternative to antibiotics, elicits immunity against a broad range of Gram-negative bacteria.

Some of the advantages that set it apart from existing approaches include the fact that it uses a novel target, it does not generate antimicrobial resistance, it acts immediately, it can be synthetically produced and has an excellent safety profile.

RA-01 is a polymeric glycoconjugate that can specifically bind and remove inhibitory anti-Gal antibodies involved in the growth of hospital-acquired bacterial infections. The regulatory roadmap, including pharmaceutical quality, nonclinical safety-tox. program, as well as, the design of a FIH was recently validated by the AEMPS.

Achievements

  • In 2018, RemAb Therapeutics was created as a spinoff of IDIBELL
  • Between 2019 and 2020, technology protection patents were granted by EPO, Russia, Japan and China. The rest of the jurisdictions are currently under examination.
  • In 2019, preclinical regulatory and early clinical trials design were validated by the AEMPS.

The technology has been awarded and validated by several competitive programs including:

  • Caixaimpulse Validate 2016
  • SME Phase 1, European Commission, November 2018
  • HeadStart program, EIT Health, 2018
  • Start-up Capital program, ACCIÓ, GentCat, 2018
  • KSA grant, Ministry of Education, Kingdom of Saudi Arabia, 2019. Selection process managed by the American Association for the Advancement of Science (AAAS).

Next Steps

The CaixaImpulse Consolidate grant will partially support valorisation actions related to the formal preclinical regulatory program of RA-01 and the preparation of the FIH, including:

The Preclinical toxicology- pharmacology program.

The Drug Product Development and large-scale production of medicine lot.

The preparation and submission of regulatory documentation for Clinical Trial Application.

We expect to enter the market by 2025. In 2023, along with Phase 2 Clinical Trial, international assessment for licensing will begin.

Team

Head of the Innate Immunity and Pathology of the Critical Patient research group

Rafael Mañez Mendiluce

IDIBELL - Fundació Institut d’Investigació Biomèdica de Bellvitge

Project leader

Project manager

Daniel Bello

RemAb Therapeutics

Technician

Sara Olivera Ardid

RemAb Therapeutics

Project coordinator

Pablo Madrazo

RemAb Therapeutics

Partners

Validate-16
Consolidate-19

Scientific Area

Preventive medicine

Business area

Therapeutic

Research center

IDIBELL