Developing a Live Biotherapeutic Product: From Concept to Consortia
As microbiome development progresses beyond donor-derived products, rational selection and even the design of microbiome-based consortia present a host of research and development challenges, which will have to be fully understood to be overcome. The Pharmabiotics Conference keynote session will explore these challenges and outline how to develop a consortia-based product from hypothesis to a clinical candidate.
Donor-derived products represented the first generation of microbiome therapeutics in development. They were intended to reproduce the efficacy of faecal microbiota transplant demonstrated in hospital practice and literature. In 2022, the field saw two donor-derived microbiome-based medicinal products receive market authorisation from their respective national authorities – Rebyota (Ferring Pharmaceuticals, USA) and Biomebank’s product (Biomebank, Australia). Both products target recurrent C. difficile infection, but neither has defined quantities of microbiome components.
The approved products’ lack of compositional repeatability stems from the variability in donor stool. But what if donor stool could be optimised to ensure a defined quantity of strains in each dose? Or what if companies could synthetically culture microbial consortia without needing to depend on donors at all? These questions will be posed and discussed in the “From Concept to Consortia” Session at the 8th annual Pharmabiotics Conference (March 21-22, Lyon, France) – Register here.
Conceived and chaired by Tomas De Wouters, CEO of PharmaBiome, the “Concept to Consortia” session takes the audience on a microbiome drug development journey. Consulting key voices from the field, the talks will discuss the necessary considerations to develop the future of microbiome-based medicinal products.
Ken Blount, (Rebiotix, Ferring Pharmaceuticals) – Keynote Presentation.
Opening the session is Ken Blount, Vice President of Microbiome Research at Ferring Pharmaceuticals, and CSO of Rebiotix. Ken will outline the regulatory journey Rebyota took to achieve market authorisation. Sharing from his recent experience as Chair of the Microbiome Therapeutics Innovation (MTIG) in the United States, and his extensive experience in microbiome R&D. His talk is without a doubt a must-attend for biotech leaders looking to gain key insights into the US market for their microbiome product development strategy.
Patricia LePage, (INRAE) – Hypothesis Generation.
Generating a hypothesis is the basis for any scientific endeavour. In the case of microbiome drug development, a key question is: how do we derive hypotheses for therapeutic microbiome targets from clinical data? A researcher may approach this question from two perspectives: top-down (data-driven) or a bottom-up (microbiology driven). Patricia LePage has worked with clinical datasets of FMT and non-FMT treatments in the oncology and IBD fields and has leveraged both top-down and bottom-up approaches to construct microbiome hypotheses. In her talk she will contrast the advantages of these approaches.
Alice Cheng, (Standford University) – Constructing Synthetic Complex Microbiomes.
Translatability from preclinical models to clinical relevance is a challenge that faces all areas of science. The differences between mouse models of the human gut microbiome and a human gut microbiome are vast, a factor contributing to high failure rates of clinical trials. Alice Cheng aims to bridge the gap between preclinical models and the clinic with her group’s work on designing synthetic complex microbiomes in vivo. Her team at Stanford created a community of over 100 bacterial species that was successfully transplanted into mice. This technology opens the door to add, remove, and edit individual species, and will allow scientists to better understand the links between the microbiome and health. Thus, de-risking the drug development process and speeding up timelines in the process.
Karoline Faust, (KU Leuven) – Ecological Hypothesis Testing.
Microbiomes are complex systems, and so understanding how species interact is vital for creating an effective microbiome drug. Karoline Faust will discuss how to integrate ecological concepts and processes into microbiome drug development. Having explored and validated the hypothesis of microbiome keystone species, Karoline will detail the lessons learned from synthetic human gut communities.
Gabriel Leventhal, (PharmaBiome) – The Role of Ecological Concepts in the Design and Production of Consortia.
Building from Karoline’s presentation, Gabriel will dive into how the ecosystemic properties of the microbiome can be applied to microbiome drug development. Gabriel will discuss PharmaBiome’s approach to the microbiome, and their belief that “each intestinal microbiome is a network of interconnected, interdependent and metabolic functions that are essential for the host and the microbiome”. Speaking from his expertise in developing data-driven approaches for microbial ecology, Gabriel’s talk will illuminate the concepts behind co-culture development of consortia products.
Shiri Meshner, (Biomica) – Clinical Efficacy Testing for Consortia.
Starting from hypothesis, the session will close with a consortia-based product that is currently in the clinic. Shiri Meshner from Biomica will discuss the journey of their rationally designed consortia product, BMC128. The product is based on four bacterial strains that demonstrate specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.
Panel Discussion.
Uniting to finalise the session, the speakers will come together to summarise the key themes from their presentations. Chaired by Tomas De Wouters, speakers will discuss how their research can be applied to the drug development field, and the future of consortia-based therapeutics.
Hear all of these presentations in person by registering for your ticket HERE
