In the first of my blog posts for the year, I thought I would reflect on 2023 for the microbiome field, and explore what the field’s future may hold.
2023 was a tough year for everyone in drug development, including us in the microbiome field!
Despite the challenges presented by the financial markets and investment landscape, I was proud to see how microbiome biotechs persevered and what many achieved.
Whilst we saw several biotechs downsize/close down their microbiome operations in 2023 (Finch Therapeutics, Seres Therapeutics, Evelo Biosciences), we also saw some promising investment rounds, (Eligo Bioscience’s $30M, Vedanta’s huge $106.5M and Freya’s $38M) and acquisitions such as Boehringer Ingelheim’s acquisition of T3 Pharma.
These successful fundraisers should serve as beacons of promise for the industry, and act as examples of great leadership, science, and adaptability to market forces.
Of course, we were all happy to hear 2023’s many positive clinical read-outs and the market authorization of Seres Therapeutics’ donor-derived product, VOWST, which along with REBYOTA’s approval in 2022, demonstrated commercialized microbiome therapeutics as a reality. And VOWST’s reported net sales of $7.6 Million sales in Q3 demonstrated commercialized microbiome therapeutics as a revenue-generating reality too!
I was particularly excited to see Vedanta’s and MRM Health’s positive clinical readouts in 2023, which are both paving the way for the next generation of microbiome therapeutics!
So, what can we expect 2024 to have in store?
On the investment side, with inflation expected to decrease in the coming year, I predict a surge in investment within the biotech sector which will positively impact the microbiome biotech landscape. With government initiatives set to support the growth of innovative biotech markets, like those in South Korea, and France, the microbiome field is sure to see a boost in 2024.
Clinical read-outs will also play a role in boosting economic interest in the microbiome sector.
As the field gears up for the next generation of microbiome therapeutics, key read-outs will include
- Sweden’s Infant Bacterial Therapeutic’s Phase 3 candidate indicated for infant necrotizing enterocolitis, expected in Q2;
- Everimmune’s Phase 1/2 findings for their immunotherapy-enhancing candidate Oncobax AK, expected in Q4; and
- MRM Health’s Phase 2/3 development trial forMH-002.
Other clinical read-outs I am excitedly anticipating include Biomica, Bloom Science, and Siolta Therapeutics.
Regarding regulation, I do not expect any significant change, rather I expect 2024 to be a year of regulatory stabilization. The US FDA’s growing number of IND dossier approvals will continue to clarify expectations for manufacturing, and testing. Whilst the SoHO regulation will clarify material origins, GMP requirements for developing LBPs will remain unchanged.
The role of Biose Industrie in the future of the field
CDMOs, like Biose Industrie, play a crucial role in powering the microbiome drug development field by ensuring timely manufacturing, and precise regulatory compliance.
Our 2023 achievements, including a significant increase in production capacities and analytical capabilities, position us to lead the field in 2024.
Biose Industrie has strategically invested in enhancing its facilities and capabilities. Key investments include a new manufacturing line for drug substances, scaling up to 5000L, and expanded drug product manufacturing. In 2023, the company produced an impressive number of capsules, sachets, and tablets. Additionally, Biose has bolstered its analytical capabilities, conducting over 130,000 in-house analyses across various disciplines, crucial for IPC, release tests, and stability studies. The company’s technological advancements now allow the manufacturing of over 250 strains, catering to both oral, vaginal applications and new adventures into topical and lung delivery. Furthermore, Biose has continued to elevate its analytical technology with continuous developments in its analytical methods developments and QC laboratory and expanded these capabilities at its Boston applied Tech transfer laboratory.
Biose’s 2024 strategy is focused on anticipating market needs by expanding our industrial and analytical capabilities. Our acquisition of new land (an additional 7000m² to add to our existing 45 000m² in total at our center of excellence in France) for facility expansion solidifies our position as the world’s largest LBP GMP CDMO, ready to meet the growing demands of the microbiome sector.