Rebiotix, Inc.

To avoid the pitfalls of microbiome drug development, Florey is aiming to get FLR-101 into the world as a medical food instead. Antibiotics are one of the most common medicines in the world, with about 236 million prescriptions in the U.S. in 2022 alone, according to the Centers for Disease Control and Prevention. These drugs are great for clearing out bacterial infections but also have an unintended side effect: They wreak havoc on the healthy microbes that call our guts home.“There's a lot of research and clinical data that shows that the disruption of the beneficial microbes in your gut actually is a high risk factor for many diseases,” Andrés Cubillos-Ruiz, Ph.D., a microbiologist and synthetic biologist at the Wyss Institute for Biologically Inspired Engineering at Harvard University, told Fierce Biotech in an interview. “This is a huge problem that is still a highly unmet need.”Florey Biosciences, a company spun out of Cubillos-Ruiz’s work in the MIT and Wyss Institute lab of James Collins, Ph.D., seeks to fill this unmet need with genetically modified microbes and a unique regulatory approach. The company launched Oct. 1 with pre-seed funding from Seerave Ventures, the investment arm of the microbiome-focused Seerave Foundation, according to a release. The team hopes to close out a seed funding round by mid-2025, Cubillos-Ruiz said. In addition to Cubillos-Ruiz, who is CEO, and Collins, Raphaël Gayet, Ph.D., is also a co-founder. Collins is a synthetic biologist known for his entrepreneurial spirit; he’s a co-founder of the Flagship Pioneering-launched Cellarity as well as the publicly traded Synlogic Therapeutics and Senti Biosciences, among others.Florey’s lead program is a genetically modified yeast called FLR-101. This yeast produces an enzyme that breaks down beta-lactam antibiotics, which make up about 50% of all antibiotics used, Cubillos-Ruiz said. Because the yeast is localized to the gut, its anti-antibiotic activity shields the microbiome there while the antibiotic is still able to clear an infection elsewhere in the body. The team first tested this approach using modified bacteria in a 2022 paper, and has now improved upon the method.“We have technologies that prevent these genes from jumping into bacteria,” Cubillos-Ruiz said, so that the yeast’s antibiotic-destroying power can’t be picked up by other microbes.When it came to forming a strategy for Florey, Cubillos-Ruiz learned from predecessors like Seres Therapeutics and Rebiotix (acquired by Ferring Pharma) about the perils of developing drugs for the microbiome. “You were going to incur huge development costs, and then you're going to create a product that doesn't have the market access and the market opportunity,” he said. To avoid those pitfalls, Florey is aiming to get FLR-101 into the world as a medical food instead of as a drug.Medical foods are products that are meant to be taken orally for the management of a disease or condition under the supervision of a physician but that don’t require a prescription. While drugs require studies of safety and efficacy, reporting of side effects and a thorough label review before hitting the market, medical foods do not.There is no formal stamp of approval that the FDA gives to medical foods, but the agency does provide guidelines for the products. Once FLR-101 is recognized as safe to consume, it could be put on the market right away along with the countless other probiotics that claim to support gut health.However, in order to market the modified yeast as being able to manage the microbiome dysfunction that comes from antibiotic use, Florey plans to run human trials to test whether FLR-101 paired with antibiotics leads to less microbiome damage than antibiotics alone. If successful, Florey would be able to add that information to FLR-101’s label and distinguish it from the other probiotics alongside it on the shelf. To bolster FLR-101’s chances of successfully navigating the medical foods regulatory pathway, Florey is adding Peter Hutt, former chief counsel of the FDA, to its board of directors, the company said in the release. At the FDA, Hutt helped craft the medical food regulatory framework, and he also played a pivotal role in the creation of nutrition labels, according to the release.“We have all the pieces of the puzzle to have a biotech product that, in its core, its technology is highly advanced, but we can put it in the market using different ways,” Cubillos-Ruiz said.Putting out products as consumer goods rather than prescription drugs presents a marketing challenge: How do you make sure patients, physicians and pharmacists know about your product? Cubillos-Ruiz sees an opportunity in FLR-101’s partner, antibiotics.“There is a big push from government agencies and within medical societies to be better antibiotic stewards,” he said. Hospitals don’t want readmissions of patients who develop health problems due to antibiotic-weakened gut microbiomes, and antibiotics tend to have slim profit margins. Pairing the drugs with a proven probiotic could be a way to boost revenues, Cubillos-Ruiz suggested.The company is currently preparing in vivo safety studies in preparation for human trials, Florey said in the release. If all goes well, Florey hopes to launch its flagship product in three years, Cubillos-Ruiz said.First-time biotech CEO Cubillos-Ruiz thinks that in 10 years, we’ll all look back and wonder how we could let antibiotics run roughshod over our gut microbes for so long. It will be like “going to a beach day and not using sunscreen to protect yourself from the sun,” he said.

European Microbiome Innovation for Health and Microbiome Therapeutics Innovation Group Announce New Collaboration Agreement Paris, France, September 23, 2024, 2:00 pm CET - The European Microbiome Innovation for Health (EMIH) association today announced an agreement between the Microbiome Therapeutics Innovation Group (MTIG) and EMIH for a collaboration to advance microbiome drug development, explore synergies between international regulators, and convene cross-continental meetings to incorporate the perspectives of a wide-range of drug developers. This new collaboration will incorporate diverse perspectives with the goal of further accelerating microbiome therapeutic product development to expand availability of life-changing and life-saving regulatory approved microbiome therapies to patients. A main priority of the agreement is to harmonize regulatory frameworks from multiple regions to create a more cohesive approach in seeking the necessary policy and regulatory solutions for the issues faced by MT drug developers. “MTIG’s founding principal is to accelerate patients’ access to innovative microbiome therapeutics through our communal efforts,” said Dr. Nikole Kimes, Chairman of MTIG and CEO of Siolta Therapeutics. “The EMIH represents innovative microbiome companies aligned with this core mission, and we look forward to sharing insights with one another to amplify our collective voice and transform the lives of patients on both sides of the Atlantic.” Hervé Affagard, President of EMIH and CEO and co-founder of MaaT Pharma, stated "As leading associations in the microbiome field, we understand that our strength lies in collaboration. By joining forces with MTIG, we will accelerate the development and delivery of microbiome therapies, ensuring that groundbreaking treatments reach those who need them most, swiftly and safely. This partnership embodies our shared commitment to harmonizing regulatory frameworks, and we look forward to working closely with MTIG." EMIH and its members are dedicated to advancing knowledge and fostering the development of bioproductions, diagnostics, and medical devices based on the microbiome for human health. The organization is committed to ensuring equitable access to these innovations by adhering to regulatory frameworks that uphold the highest quality standards, while maintaining an economic balance to support ongoing therapeutic innovation. All pharmaceutical and biotechnology companies seeking regulatory approvals in Europe for microbiome bioproductions, diagnostics, and medical devices are eligible for membership consideration in EMIH. If you are interested in learning more, please contact EMIH here. About The Microbiome Therapeutics Innovation Group The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients. Today, MTIG is comprised of eleven microbiome therapeutics companies: BiomeSense, Biose Industrie, Freya Biosciences, MaaT Pharma, Microba Life Sciences, Rebiotix Inc., a Ferring Company, Seres Therapeutics, Siolta Therapeutics, and Vedanta Biosciences. For more information, visit www.microbiometig.org About European Microbiome Innovation for Health The European Microbiome Innovation for Health (EMIH) is an independent coalition within the European Union, the United Kingdom, and Switzerland, currently comprising 20+ major players from the public and private sectors. From the laboratory to the patient’s bedside, EMIH covers the entire value chain of the microbiome industry. Its goal is to position Europe as a global leader in the development, production, and commercialization of microbiome-based therapeutic innovations. EMIH members include Bioaster, Biocodex, BioGaia, Biofortis, Biose Industrie, Eligo Bioscience, GMT Science, INRAe, Lallemand Health Solutions, Life Avocats, Enosis Santé, EnteroBiotix, Pelican Health, MaaT Pharma, mbiomics, Microbiotica, Microbiome Foundation, MRM Health, Nexbiome, Novobiome, Seventure Partners and SwipeBiome. For more information, please visit www.europeanmicrobiome.org Contact for European Microbiome Innovation for Health Email: p.richaud@europeanmicrobiome.org Attachment EMIH MTIG PR Final_240923

WASHINGTON, July 20, 2023 /PRNewswire/ -- The Microbiome Therapeutics Innovation Group (MTIG) today announced the addition of MaaT Pharma to its coalition of companies leading the research and development of FDA-approved microbiome therapeutic drugs and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. MaaT Pharma is a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies™ (MET) dedicated to improving survival outcomes for patients with cancer. MaaT Pharma's products, Microbiome Ecosystem Therapies (MET) aim to leverage the full functional diversity of a large microbiome ecosystem. The Company currently has two drug candidates in clinical development. MaaT013, the Company's lead asset, is currently being evaluated in Phase 3 clinical trial in the treatment of aGvHD (Acute Graft-versus-Host Disease) and in an investigator-sponsored trial Phase 2 Proof of Concept study to enhance responses to immunotherapy, in metastatic melanoma. The Company's second asset is MaaT033, an oral formulation designed for outpatients undergoing allo-HSCT and aimed to improve overall survival. "We are pleased to welcome MaaT Pharma to our diverse coalition of microbiome-based companies. Microbiome medicines hold great potential for the treatment of oncology diseases and Hervé Affagard's team is dedicated to bringing therapies that improve survival in cancer," commented MTIG Chairman & CEO of Siolta Therapeutics, Nikole Kimes, Ph.D. "We look forward to working alongside MaaT Pharma's world-leading scientists as we seek to implement tangible policy solutions that accelerate the development and integration of life-saving FDA approved microbiome therapies into clinical practice." MaaT Pharma Chief Executive Officer Hervé Affagard added, "We are very proud to join the Microbiome Therapeutics Innovation Group as we share the group's mission of advancing microbiome-based therapies to improve clinical outcomes for patients. We eagerly anticipate a productive and collaborative partnership with MTIG and its members to accelerate the transformation of fundamental research into market-ready microbiome innovations." All pharmaceutical and biotechnology companies pursuing regulatory approvals for microbiome therapeutics and microbiome-based products are eligible for consideration of membership in MTIG. If you are interested in learning more about becoming a member of MTIG, please contact us here. For more information about MaaT Pharma, visit . About The Microbiome Therapeutics Innovation Group The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients. Today, MTIG is comprised of twelve microbiome therapeutics companies: Bacthera, BiomeSense, Bio-Me, Genetic Analysis, Maat Pharma, Microba Life Sciences, Rebiotix, Inc., a Ferring Company, Seres Therapeutics, Servatus Biopharmaceuticals, Siolta Therapeutics, and Vedanta Biosciences. For more information, visit . About The Conafay Group The Conafay Group (TCG), led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for MTIG. TCG specializes in representing life sciences companies, universities, and other organizations in the biomedical sector before the federal government and associated stakeholders. For more information, visit: . SOURCE Microbiome Therapeutics Innovation Group (MTIG)