Monitoring the Heartbeat of the Microbiome Therapeutics Space: Where Are We Today?

Blink your eyes, and you might miss it. The microbiome therapeutics arena is experiencing remarkable scientific expansion, with 575 IND applications filed in 2020 alone. By the end of 2021, we saw 64 companies with over 230 scientific approaches tackling diverse indications, with a total of $1.6 billion in capital invested in R&D.

Now in 2022, there are 1485 ongoing clinical studies targeting diverse disease indications, including gastrointestinal, infectious, autoimmune, metabolic, and oncological disorders.?A wide array of microbiome-based therapeutics are in mid-to-late-stage development. Seres Therapeutics and Rebiotix, a Ferring company are on the brink of market authorization with live biotherapeutic products (LBPs) for the treatment of recurrent C. difficile infection. If approved, these will be milestone achievements for the field – blazing a trail in the regulatory arena and building confidence in the industry.

The microbiome therapeutics space is expected to be the fastest growing market within the pharmaceutical industry, with the global market projected to expand from $306 million in 2021 to $3.2 billion by 2032.

To capture strategic insight into this rapidly evolving arena, and to secure valuable networking opportunities, join us at Kisaco Research’s 7th Annual Microbiome Connect USA in Boston, MA on the 15th-17th of November 2022. This event will showcase a dazzling array of cutting-edge drug developments in the microbiome drug development field. We’ll hear about novel breakthroughs in development, manufacturing, and the regulatory arena, presented by key players in the pharmaceutical, biotechnology, and academic arenas, alongside the FDA and investment firms.

With a finger on the pulse of the industry, Microbiome Connect covers insight on: clinically validating novel mechanisms of action, accelerating rational drug development strategies,?and establishing commercial-ready manufacturing platforms

The Microbiome Connect agenda includes dual tracks: Emerging Therapeutic Areas & Pipeline Updates and Advanced Bioprocessing Strategies for LBPs & Microbiome Therapeutics. Here’s a snapshot of what’s in store.

Emerging Therapeutic Areas & Pipeline Updates

A human-first discovery process is known to improve translatability of results between animal and human studies and is increasingly a strategy used within the industry. Finch Therapeutics is among those that use this approach, with a unique platform that leverages data from human microbiota transplantation studies, machine learning and molecular characterization techniques. Shrish Budree will provide an update on clinical data supporting Finch’s lead product candidate, CP101, for the prevention of recurrent C. difficile infection.

Savita Bernal of MaaT Pharma will discuss MaaT013, the company’s high-richness, high-diversity Microbiome Ecosystem Therapy. This therapeutic is being tested in a Phase 3 trial in patients with acute Graft-versus-Host-Disease with gastrointestinal involvement, a severe indication with a very high unmet need.

On the diagnostic front, we’ll hear from multiple organizations developing novel biomarkers and platforms for stratification, prediction, and prevention. Micronoma is developing a minimally invasive microbiome biomarker-based liquid biopsy diagnostic test for detection of early-stage lung cancer and other cancers. ?Pfizer is stratifying patients using microbiome signatures for precision approaches to cancer treatment. Mamome is exploring microbiome signatures to develop a preventative diagnostic for gestational diabetes.

While the majority of companies in the field target the gut microbiome, 11 companies modulate the skin microbiome, and we’ll hear updates from some of these players at the event. With six Phase 2 trials under their belt, AOBiome Therapeutics is tackling an array of inflammatory skin conditions by harnessing a single-strain, class-defining ammonia oxidizing bacteria to restore immune functionality and reduce disease-associated inflammatory pathways. At the event, Todd Krueger will share clinical results from their 547-patient Phase 2b trial in atopic dermatitis.

Georg Gerber of Harvard Medical School will describe their novel machine learning methods for predicting host disease status and biomarker discovery based on microbiome composition and metabolomic longitudinal data.

In another arena for microbiome applications, nonprofits are also benefiting from research into the microbiome. Each year, 2.5 million newborns die within their first month of life – most from preventable causes such as poor access to care. The Bill & Melinda Gates Foundation is tackling these issues with a variety of solutions, including maternal microbiome-directed research. Vanessa Ridaura of the Gates Foundation will give us an update.

Advanced Bioprocessing Strategies for LBPs & Other Microbiome Therapeutics

With the field maturing, the global count on manufacturing facilities is blooming, with 35+ dedicated to microbiome therapeutics, and 25+ offering LBP contract manufacturing. For companies seeking insight from experienced players, check out the discussion with panelists from Vedanta Biosciences, Adiso Therapeutics and Seres Therapeutics on the pros and cons of diving into in-house manufacturing capabilities versus outsourcing to a contract development and manufacturing organization. Scaling up can introduce technological issues and unnecessary delays, and out-sourcing can be a source of logistical uncertainty.

We’ll hear from Dan Couto about the path that Vedanta Biosciences is taking, and the challenges involved. With their diverse microbiome therapeutics in various stages of clinical development, including Phase 2 trials, Vedanta Biosciences now has a large-scale cGMP facility for production of defined bacterial consortia from clinical development through commercial launch.

Servatus is another pioneer of in-house manufacturing for their novel LBPs, and they'll share a case study in which they used a hybrid approach which incorporates single-use technologies and stainless-steel equipment.

We’ll hear from Nikhil Sharma at BioCoreTex on computational modeling methods to ensure their process is effective at scale, a key component in de-risking the manufacturing process. Tomas deWouters of PharmaBiome will provide insight on reducing space requirements for scaled fermentation by using a co-culturing approach in their LBP manufacturing.

Tackling Industry-Wide Challenges

The revolutionary progress in the field has brought with it some challenges that need attention. ?A wide-spread issue complicating the landscape is cross-laboratory reproducibility, as multiple methodological variables – ranging from DNA extraction through bioinformatics analysis – can introduce bias and impact results. There is a pressing need to consider more industry-wide standardization.

National Institute of Standards and Technology (NIST) and Microbiome Therapeutics Innovation Group (MTIG) are among the organizations championing greater use of standards in the field. A pre-conference workshop co-hosted by MTIG and NIST will bring together stakeholders in the microbiome field from industry, academia, and government agencies to further the dialogue around developing greater standardization, assessing areas of consensus and tools for specific standards that could be adopted across the field. At the main conference, we’ll hear from Scott Jackson and Sheng-Lin Gibson of NIST, who will also discuss solutions, including highlighting the standards NIST is developing to support the commercial translation of microbiome science.

On another front, navigating a regulatory environment that is still gradually adapting to the rapid pace of development in the field can be a daunting task. With microbiome-based therapeutics being a new category of treatment, clearly established pathways to approval are a grey area. Companies can benefit from early discussions with the FDA. Join us for several talks by the FDA, including a fireside chat with Peter Marks & Paul Carlson of the FDA for guidance on filing for an IND and the distinctions between EU and U.S. LBP approaches, which can be challenging with the diverse policies and terminologies used in different countries.

Of course, no event would be complete without a panel discussion on market dynamics and the investment landscape. Glean insight from Denise Kelly of Seventure Partners and our other panelists on how to secure financing for your drug candidates by evaluating how clinical results have impacted investment into the space over time.

Wondering where the field is heading? In our closing panel, we’ll hear from industry experts on what’s in store for microbiome therapeutics, from newly targeted indications to progress in diagnostic applications.

Microbiome companies can also register their interest in a Biotech Showcase, which provides a unique forum to present your data in front of an audience of investors and industry leaders, as well as to participate in networking focused on investment and commercialization.

In its seventh year as a collaborative venue uniting the microbiome drug development field, Microbiome Connect USA has matured to over 300 attendees, graduating from an academic event into an industry-focused event, with a strong community of regular attendees.

This year Microbiome Connect USA is co-located with Phage Futures, creating an invaluable opportunity to network with peers and gain insights into the latest strategies to modulate the microbiome and impact microbiome function, alongside in-depth bacteriophage-specific case studies.

Hope to see you this year at Microbiome Connect USA!

Brought to you by Kisaco Research and Edge Bioscience Communications, 2022 associate media partner.

Edge Bioscience Communications provides professional scientific/medical writing to clients worldwide. Supporting clients with a competitive edge on a wide array of scientific content, including manuscripts and high-impact promotional material.

Platinum Partners for the 2022 Microbiome Connect USA conference: Microbiome Therapeutics Innovation Group, Bacthera, List Labs.