Microbiome Movement – Drug Development Europe:
The most recent methods in developing drugs for the microbiome. an overview of the 5th European summit on microbiome movement drug development (MMDD)
Currently, hundreds of businesses worldwide are attempting to harness research on the human microbiome to develop novel clinical treatments; by 2020, at least €900M will have been invested in businesses that are microbiome-focused.
Held virtually on January 27–29, the Microbiome Movement Drug Development Summit Europe. gave attendees the chance to hear from some of the top businesses and see how they approach developing new drugs in this fascinating and developing field. With over 40 presenters, Biose Industrie was happy to be an Innovation Partner for this event.
Even though the world of virtual events is far from perfect, the platforms are becoming increasingly user-friendly, and we were able to recognize the good research that was presented.
Here is a rundown of some of the event’s first and second-day highlights.
First Day:
Microbiome Movement – Drug Development Europe:
Preclinical drug candidate development and discovery are extremely difficult processes in the realm of microbiomes. The first topic of discussion in this series was discovery.
Delivery, survival, engraftment and activity:
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Of live biotherapeutic products in the GI tract” was the topic of a presentation given by ProDigest’s CSO, Tom Van de Wiele. Van de Wiele described how to use cutting-edge model systems to mimic the physiology and microbiology. of the gastrointestinal tract to address several problems regarding a potential live biotherapeutic product (LBP): How does the LBP engraft or survive? What impact does it have on the microbiota? How does it affect the health of the host? He explained how interindividual variability can be simulated by the models, allowing in vivo research to be organized appropriately.
Microbiome Movement – Drug Development Europe:
Onto the subject of microbiome chemistry and small molecules, attendees heard from Nicole McKnight, CEO of Stellate Therapeutics, a business that finds small compounds made by gut bacteria in humans to treat neurological disorders. To reduce the risk associated with the medication development process, they employ what they refer to as “co-evolved molecules.
” This is due to the fact that Stellate does human observational studies on patient samples during the preclinical phase, whereas conventional drug development tests the biological effects on humans comparatively late in the clinical trials process. Their main contender, STL-101, is a synthetic version of queuine that is made by gut bacteria and functions as a neuroprotective medication to change Parkinson’s disease.
The presentation of Biomica Vice President of R&D Shiri Meshner came next. Shiri gave an explanation of how computational predictive biology is used to find and create new treatments for human diseases linked to the microbiome. In inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), immuno-oncology, and antibiotic resistance applications, they have found candidates using databases created by data integration and patented computational techniques for data mining.
Day Two:
Microbiome Movement – Drug Development Europe:
On the second day of the conference, Alice Rouanet from the Pharmabiotic Research Institute gave a talk titled “Regulatory considerations for the development of microbiome-based medicinal products in Europe.” The term “spectrum of pharmaceutical products emerging from the better understanding of the interaction between the microbiotas and their host” was used by the speaker to define microbiome-based medical products.The intended application and target market determine a product’s purpose, which in turn determines its regulatory status and the prerequisites for being sold on the market. In the end, she claims, the basic difficulties in microbiome science—namely, the need for sufficient evidence of quality, safety, and efficacy—give rise to regulatory issues for medications based on the microbiome.
Next, Gregory Amos of NIBSC (the UK’s Official Medicines Control Laboratory) gave a talk on “Developing Standards for the Microbiome Field,” a topic that is now very popular around the world. Microbiome standards, he clarified, are reference reagents that provide cross-laboratory comparability of data and aid in the advancement of microbiome diagnostics and treatments.
His organisation is in charge of 12 projects that have been approved by the WHO to create WHO reference materials for microbiome analysis. The purpose of the NIBSC “ground truth” reference reagents is to assess the performance of the microbiome analytical pipeline at various stages, while allowing the user to select the pipeline of their choosing. Setting up user consensus thresholds to guarantee worldwide harmonisation is a difficulty.
Microbiome Movement – Drug Development Europe:
Françoise Le Vacon, Chief Scientific Officer at Biofortis, spoke to the participants about “The Microbiome, as a companion for therapeutic products development.” She raised the issue of the potential harm that a number of recent goods in this industry could do to the microbiome. She queried whether the microbiota will need to be considered for tomorrow’s toxicity and projected that “microbiome friendliness” may be relevant to a variety of new products. In addition, she discussed whether the gut microbiota influences the drug’s pharmacokinetics (conversion, hepatic xenobiotic metabolism), pharmacodynamics (immunoregulatory or effector immune functions), or local tissue integrity. She also discussed whether a drug affects the gut barrier, composition (dysbiosis), or immunomodulation.
Following this, Eric van der Helm of SNIPR Biome gave a fascinating lecture in which he discussed the difficulty of developing solutions that precisely kill germs. The business effectively “re-programs” microbiomes by using antibacterial CRISPR technology to destroy bacteria only in specific cases. Their CRISPR-Guided VectorsTM (CGVs) are designed to target particular types of bacteria while sparing the commensal microbiome. Van der Helm presented a case study on their proposed SNPR002 to eradicate dangerous strains of Escherichia coli with selectivity.
The next presentation by MV BioTherapeutics SA founder Fabio Grassi was titled
“Leveraging Gut Microbiota Cross-Talk with Immune System to Enhance Cancer Immunotherapy.” Based on the finding that the intestinal adaptive immune system is regulated by adenosine triphosphate (ATP) generated by gut bacteria, their method targets the reactivity to cancer immunotherapy medications. Utilising intestinal administration of the ATP-degrading enzyme apyrase, their technology platforms aim to regulate the immune system’s responsiveness as well as the microbiota. As per his perspective, the benefits of apyrase-modified biotherapeutics encompass the capacity to regulate the gut microbiota, the utilisation of commercially available strains, and oral administration—a measure that diminishes expenses and boosts patient adherence.
Nemesis Symbiotics for Inactivation
Microbiome Movement – Drug Development Europe:
Anti-microbial Resistance Genes in the Microbiome was the topic of a presentation by Conrad Lichtenstein, Chief Scientific Officer at Nemesis Bioscience. By creating Transmids—DNA therapies given either before or with medicines to inactivate resistance in bacterial pathogens—the business is tackling the global issue of antibiotic resistance.He clarified that transmids are conjugative plasmids that are transmitted by bacterial conjugation and infection and are encapsulated in a phage coat.
Remarkably, transmids can restore the effectiveness of already-approved antibiotics, stop the transmission of genes that cause resistance to antibiotics, and shield newly developed drugs from developing resistance. According to data from one of their research, over 99% of the resistant bacteria were able to regain their antibiotic sensitivity after 85% of the system’s bacteria acquired the transmid through infection and subsequent conjugation within 20 hours.
Iron is a crucial factor for LBPs that target the chronically inflammatory gut, according to Jenny Bailey:
Microbiome Movement – Drug Development Europe:
CEO and co-founder of Ferryx. Certain bacteria respond to iron by speeding up their proliferation, which can have varying consequences on a host. This has been considered by Ferryx in the development of their lead medication candidate, Streptococcus thermophilus FX856, which has the capacity to promote mucosal repair in the event of intestinal inflammation.
Biose Industrie Business Development Director Richard Ellis spoke on:
Microbiome Movement – Drug Development Europe:
“Taking CMC to the next level and preparing for commercial manufacturing of Live Biotherapeutic products” during a segment of the programme on “Manufacturing the Microbiome.” In addition to providing a thorough overview of the challenges involved in creating a reliable method for producing LBPs for clinical trials, Richard also provided a quick overview of Biose Industrie’s current late-stage Phase III programmes and how the company is already set up to produce LBPs on a commercial scale.
Lastly:
Microbiome Movement – Drug Development Europe:
Assaf Oron of BiomX gave a brief overview of their approach to creating disease-modifying treatments using precision medications derived from phagesas. Their “XMarker” platform offers great resolution, ranging from SNV to gene, strain, and pathway level, and seeks to identify a disease signature with high sensitivity and specificity.The business and Johnson & Johnson are presently working together to find people who respond to a crucial IBD medication.