Florey Biosciences spins out of Harvard Wyss Institute to develop a medical food aimed at managing impacts of antibiotic use

• The synthetic biology company engineers probiotics for human health, starting with a novel technology intended for the management of conditions associated with antibiotic treatment

• Florey completed a pre-seed financing led by Seerave Ventures

• Peter Barton Hutt, former Chief Counsel of FDA, and Mark B. Smith, co-founder of OpenBiome and Finch Therapeutics, joined Florey Board

  Cambridge, MA - 1 October, 2024 - Florey Biosciences, a synthetic biology company spun out of the Wyss Institute for Biologically Inspired Engineering at Harvard University, today announced that it has secured pre-seed funding and is unveiling its lead program, a probiotic medical food designed for the management of antibiotic damage to the gut microbiome.

  While often essential and sometimes life-saving, antibiotics can disrupt the beneficial microbes in the gut, collectively known as the microbiome. Florey Biosciences is creating innovative products aimed at addressing unmet needs in the management of medical conditions linked to antibiotic use. 

  The scale of the challenge that Florey aims to address is substantial. According to the CDC, in 2022, American healthcare professionals wrote over 236 million antibiotic prescriptions — equivalent to over 700 prescriptions per 1,000 persons in the United States. Florey is committed to supporting antibiotic stewardship efforts and aims to provide the public and clinicians with novel tools for managing the unintended impacts of antibiotics.

  "Widespread medical and scientific research has shown that the community of microbes living in our guts plays a crucial role in human health, and that disrupting this ecosystem can have significant unintended consequences," said Andrés Cubillos-Ruiz, PhD, co-founder and CEO. "We believe that our technology enables a new approach for managing the deleterious effects of antibiotics, while preserving their essential clinical activity.” 

  Florey’s technology platform was developed to efficiently deliver bioactive proteins to the gut in an oral formulation. Florey’s lead product, FLR-101, is an engineered yeast strain for use alongside antibiotics. It is being developed as a medical food for the dietary management of antibiotic perturbations of the gut microbiome. The underlying food-grade strain is well characterized and already produced commercially in a cost-efficient and scalable way.

  Florey was co-founded by Andrés Cubillos-Ruiz, fellow MIT-trained synthetic biology engineer, Raphaël V. Gayet, PhD, and James J. Collins, PhD, Termeer Professor of Medical Engineering & Science at MIT and core founding faculty member at the Wyss Institute. "Florey is the result of the Wyss Institute's technology translation program, which supported the maturation of both the technology and the underlying business plan," explained Collins. The proof-of-concept validating Florey’s approach, developed at the Wyss Institute, was published in Nature Biomedical Engineering.

  At its founding, Florey teamed with Seerave Ventures, the investment arm of the Seerave Foundation, which is providing operational and strategic support along with pre-seed funding. "Partnering with Seerave Ventures aligns with our mission and our sense of urgency for improving the standard of care for patients," said Gayet, Chief Scientific Officer of Florey.

  “We see our support of Florey as a key part of our efforts to meaningfully improve patients’ lives within the next five years,” said Manuel Fankhauser, PhD, CEO of the Seerave Foundation.

  Florey is preparing to launch in vivo safety studies, which are intended to pave the way for human trials.

  Peter Barton Hutt and Mark Smith join Florey Board

  Peter Barton Hutt, LLB, Senior Counsel at Covington & Burling LLP, has joined the Board of Directors of Florey Biosciences. Universally regarded as one of the architects of modern food and drug regulation, Hutt is a former Chief Counsel of the FDA, where he created the regulatory framework for medical foods like FLR-101. Hutt also oversaw the establishment of food nutrition labels, new regulatory paradigms for over-the-counter drugs, GRAS food ingredients, and medical devices, among others. He was also instrumental in establishing the doctrine that physicians may prescribe drugs for “off-label” use.

  Mark B. Smith, PhD, Venture Lead at the Seerave Foundation, has also joined the Board of Directors on behalf of Seerave. Smith was a co-founder of OpenBiome and Finch Therapeutics (FNCH), and is a recognized leader in the microbiome field, with over 50 peer-reviewed publications. 

  “With Peter and Mark joining the Florey Board, we will have their expertise in the room with us to shape how we will work to bring our innovations to patients,” said Cubillos-Ruiz. “Peter's six decades of food and drug law leadership provides a deep well of knowledge to guide our strategy, while Mark's hands-on experience building multiple successful companies is accelerating our progress. We are privileged to welcome them both to our board.”

  For more information about Florey Biosciences and its lead medical food program to manage the impact of antibiotics on the gut microbiome, please visit www.floreybiosciences.com. 

  About Florey Biosciences

  Florey Biosciences is a biotechnology company dedicated to delivering on the health promises of probiotics. Founded by a team from the Wyss Institute for Biologically Inspired Engineering at Harvard University, Florey is developing engineered probiotics designed to support and enhance the human microbiome. For more information, visit www.floreybiosciences.com.

  Media Inquiries: contact@floreybiosciences.com