At Biose Industrie we are proud that half of our employees are women – watch the video below to hear their thoughts on gender challenges within biotech.

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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.

Best Regards,

Adrien Nivoliez

The post The Year Ahead for Microbiome Therapeutics – Food for Thought for 2024 appeared first on Biose Industrie.

Head of Programs for LBP Development & Manufacturing

A few weeks back, Nadine, Richard, Adrien, and I had the pleasure of attending the Boston-based microbiome drug development conference “Microbiome Connect USA 2024”. Spanning 3 days the event promised the chance to connect with the microbiome field, and learn about its latest innovations, and it did not disappoint!

Women’s & Infant Microbiome Pre-day

Arriving at the conference, November 14^th, we attended the Women’s & Infant microbiome pre-day, a day of talks and panels dedicated to the work being undertaken to improve women’s health treatments and outcomes for infants. The talks ranged from regulatory considerations for microbiome-based technologies in paediatric use from the FDA to discussions on single-strain vs multi-strain approaches for vaginal dysbiosis.

Caroline Mitchell’s presentation was a personal highlight of the pre-day, providing a detailed analysis of microbiome interventions for bacterial vaginosis (BV). Mitchell described the lack of efficacy and innovation for existing bacterial vaginosis treatments, pointing out that options have remained stagnant since the 1980s, with antibiotics being the main treatment. Antibiotic usage leads to high rates of BV recurrence and rarely restores the vaginal microbiota to a healthy L. Crispatus dominance, Mitchell explained. The presentation explored a range of research projects which are developing antibiotic, microbiome-modulating alternatives, mentioning work by her eponymous lab as well as the Kwon Lab, Freya Biosciences, and the VMRC. It was exciting to see Biose’s partnership with the VMRC to develop an L. Crispatus derived LBP for BV be mentioned. The LBP is currently being tested for safety and efficacy in a phase 1 trial with results expected in 2025.

Day One – A Post Regulatory Approval Microbiome Market

On the morning of Day 1, we entered the buzzing conference room where Vedanta kicked off the official day one with a presentation on the future of the microbiome drug landscape. Dan Couto, Vedanta’s Chief Operating Officer, explored the field’s recent events including the closure of several developers, significant investments, and M&As. This led nicely into a panel discussion with MTIG, Rebiotix, BiomeBank, and Seres Therapeutics who discussed the field’s future in the context of the recent regulatory approvals.

Following the morning session, the agenda split into two tracks: “Emerging Pipeline & Therapeutic Updates” and “Bioprocessing & Data Strategies”. Emerging Pipeline & Therapeutics Updates covered a range of modalities for targeting a range of microbiomes, including a multi-strain product for targeting the lung microbiome from Biose partner Alveolus to a small molecule regulator of the gut microbiome by Axial Therapeutics. On the other track, Bioprocessing & Data Strategies presentations focused on the manufacturing side of microbiome drug development exploring CMC and cGMP manufacturing considerations and challenges, including one I was privileged to give on Biose’s world leading expertise in drug manufacturing.

My presentation described our global customer base, and how we leverage EU and US based facilities to ensure a close working relationship with our clients. I explained our end-to-end services, which extend from WGS data analysis for strain identification to regulatory support for CTD filing. A key focus of the talk was a scale-up case study on one of our clients. This project begun at our technology transfer facility in Boston. Where we worked to scale an extremely oxygen sensitive microbe from our clients’ flask-scale up to a 2000L reactor. This journey took several iterations, working up increasing scale and regulating the process until the microbe grew reliably and robustly. This kind of speciality work is only possible due to our extensive experience working with microbes, beginning in 1951!

The day ended with a screening of “Designer Shit”, followed by a panel discussion of the film. The movie followed the journey of Director Saffron Cassady, as she examined the world of faecal microbiome transplantation as a potential treatment for Ulcerative Colitis.

Day Two – Money, Microbiome and Manufacturing

At a time of uncertain investment for the biotech field at large, the morning panel of day two felt appropriate, focusing on what biotechs can do to engage investors and ensure their financial future in the market. Joyance Partners, Seventure, and Corundum Systems Biology all gave their input on this question giving a rounded view of investment strategy to the room full of microbiome researchers.

Once again, the program split into the two tracks, with Emerging Pipelines and Therapeutics continuing to showcase the diverse modalities biotechs are using to improve health outcomes, this time broadening to include clinical reads-outs for indications including rare liver disease, eczema, and cancer. Bioprocessing & Data Strategies shifted its focus to cover the “data” side of the track, with talks on multi-omics, proteomics, and biomarker development.

After three days of meeting with existing and new clients, listening to leading researchers discuss their work, the event came to a close. We all had a wonderful experience at Microbiome Connect and we cannot wait to return next year.

Presentation highlights:

Presentations we particularly enjoyed included:

• “Ambition to Provide Premature Infants With Approved Medication” – Robert Molander, COO, Infant Bacterial Therapeutics. Molander opened by describing the market opportunity for an effective infant necrotising enterocolitis (NEC) treatment, highlighting the high economic burden of the disease along with the high frequency. Their phase 3 candidate IB-9414 leverages reuteri to reduce inflammation and prevent dysbiosis in premature infants to prevent NEC development. Their phase 3 is currently the largest preterm randomised trial to date, IBT expect results for IB-9414 in 2024.
• “Development of AX -5006, a Small Molecule Inhibitor of CsgA Aggregation as a Potential Disease -Modifying Treatment for Parkinson’s Disease” – Becca Senter, Ph.D, Vice President, Head of Preclinical Research and Development, Axial therapeutics – Senter discussed Axial’s work on gut-brain candidates including small molecules to target autism-associated irritability, parkinson’s disease, and oncology. The presentation focused mostly on their lead candidate, AX-5006. Senter presented compelling results from Axial’s preclinical work which indicated that AX-5006 inhibits CsgA aggregation in mice models to alleviate Parkison’s motor-related symptoms. AX-5006 plans to enter the clinic in 2024.
• “AI-enabled, Metabolomics-based Drug Discovery Engine for Inflammatory Disease” – Hannah Wastyk, CEO, Interface Biosciences – Wastyk introduced Interface’s platform of AI-powered drug discovery, which combines the cultivation of important microbes in a proprietary growth media with an AI tool “CausalVision” to screen for microbe-produced metabolites with casual relationship to disease phenotypes. Interface’s first candidate is a topical Rx small peptide, RC13, which targets atopic dermatitis. Wastyk presented pre-clinical results which showed improved wound-healing in a scratch model and in vivo antibiotic activity.
• “Reinventing Humanity’s Relationship with Microbes” – Cheri Ackerman, CEO, Concerto Biosciences. Ackerman opened with a description of Concerto’s kChip technology, a high-throughput discovery platform for measuring microbe-microbe interactions. Ackerman explained the application of the kChip to discover a new candidate, ENS-003, to target vulvovaginal candidiasis. The LBP will modulate albicans, by down-regulating it’s virulence and shifting it to a commensal state. Concerto are currently screening the top performing bacterial combinations which regulate C. albicans.

Preclinical showcase presentation – Dr. Egle Katkeviciute, CSO and co-founder, Recolony – Katkeviciute presented their work to develop two anti-cancer candidates. The first is an LBP, RCLBP01, based on commensal bacteria which modulates T-cell activity to aid tumour clearance. Due to the approach only using commensal bacteria the therapeutic has high tolerability compared to other anti-cancer approaches. The company will be filing for an IND in 2025. Along with this LBP approach, Recolony are also developing a small molecule based on a RCLBP01-produced metabolite. Recolony forecast filing an IND for their small molecule late 2026.

The post LBPs for Bacterial Vaginosis, Small Molecules for Parkinson’s and Metabolomic-based drug discovery: A Roundup of Microbiome Connect USA 2024 appeared first on Biose Industrie.

South Korea has emerged as a leading hub for innovative microbiome research and development, with a thriving biopharmaceutical industry and cutting-edge research institutions. In this article, we will highlight seven South Korean microbiome developers that are poised to make significant advancements in 2024.

Korean Microbiome Developers

1. Genome & Co

Located in Seongnam-Si, Genome + Co is a global biopharma company which develops microbiome pharmaceuticals, along with consumer products and novel immune checkpoint inhibitors. Their discovery platform, GNOCLE™, combines a library of real-world clinical data, with multi-omic analysis and in vitro/vivo assays to identify novel microbiome targets.

Genome & Co’s pipeline consists of programs including stomach cancer, biliary tract cancer, autism spectrum disorder, infertility, and cancer rash. Collaborators for these programs include Merck, LG Chem, MSD, and Genome + Co’s subsidiary: Scioto Bioscience.  Genome & Co’s lead candidate, Gen-001, is a phase 2 single strain live biotherapeutic (LBP) to treat stomach cancer and biliary tract cancer. In May 2023, the company reported positive results from interim analysis of their phase 2 trial for Gen-001 combined with Avelumbab to treat stomach cancer. The company expects the full data to be released in late 2023, and stated they are seeking a licensing agreement for the candidate.

2. ImmunoBiome

ImmunoBiome is a North Gyeonsang Province-based biotech company seeking to develop novel LBPs to treat incurable disorders. In 2020, the company signed a CDMO contract with Biose Industrie. ImmunoBiome has two candidates listed on their public pipeline, with 10 domestic and 5 international patents to date. Their lead candidate, IMB001, is a patented single strain LBP with unique polysaccharides (RHP) on its’ surface which targets human melanoma and colon cancer. IMB001’s anti-cancer effects are facilitated through T-cell activation, sequestering of iron ions in the tumor microenvironment, and synergetic effect with immuno-oncology drugs. Their second candidate, IMB002 is a patented single strain LBP with different unique polysaccharides on its’ surface (CSGG) which targets inflammatory disorders (IBD, RA, Orphan disease).

3. CJ Biosciences

Founded as an independent subsidiary of CJ CheilJedang’s Red Bio, CJ Bioscience utilises it’s Ez-Mx platform to develop LBPs across a range of diseases. CJ Biosciences have 17 programsspanning the immune-oncology, gastrointestinal, liver, and neurological categories. In March 2023 CJ acquired 11 drug candidates from the UK-based biotech 4D-Pharma. The company’s lead candidate CJRB-205 is in phase 2 and targets irritable bowel syndrome.  In December 2022, CJ Biosciences’ submitted phase 1 clinical trial protocols for CJRB-101, an immuno-oncology asset to target solid tumours.

4. AtoGEN

Working to develop drugs, and functional food materials, the 2012 founded AtoGEN have 6 programs in development. Their pipeline consists of drugs to target bacterial vaginosis, cancer cachexia, NASH, asthma, and lung disease. In July 2023, AtoGEN completed a phase 1 clinical trial for Labthera-001, a single strain candidate, targeting bacterial vaginosis. The randomised control trial found 0 serious adverse events across 24 treated women. The trial protocol for this candidate described the drugs mechanism as temporary colonisation of the vagina to encourage a more normal microbiome.

5. GI Biome

Founded in 2018, GI Biome is a drug developer based in Seongnam-si, which aims to “lead the future of disease treatment by developing innovative microbiome” therapies.  GI Biome has 4 programs in its development pipeline, developed from their “GI-SCOVERY” platform, which include targets such as: cancer, metabolic disease, autoimmune disease, and inflammatory disease. In June 2023, their lead candidate GB-X01 combined with bevacizumab, a drug for colorectal cancer entered the clinic.  This single strain candidate has shown anti-tumour effects in a mouse model. The trial will be operated as a decentralised clinical trial. Biose are working with GI Biome to manufacture GB-X01.

6. HealthBiome

Based in Daejeon, and founded in 2017, Healthbiome is a bioventure company specialised the research and development of strict anaerobes as LBPs. Currently, all candidates are in preclinical stage and target the indications IBD, dementia, sarcopenia, and cancer. Two of HealthBiome’s candidates are single strain Akkermansia muciniphila strains (for cancer, IBD, and sarcopenia), and the other is a strain of Agathobaculum butryiciproducens (for dementia). HealthBiome has established its own GMP factory for the manufacture of their LBPs.

7. Liveome

Established in 2021, Liveome, a subsidiary of Medytox, are working to develop next-generation microbiome therapeutics. Liveome have 6 programs in development, targeting gastrointestinal disease, solid cancer, transplant related disease, and autoimmune disease. LIV001, Liveome’s lead candidate, targets gastrointestinal disease and entered the clinic in September 2023. In January 2023, Liveome won a patent for their engineered-LBP platform in Japan, which utilises gene editing to impart specific therapeutic function onto bacteria.

Conclusion

South Korea has positioned itself as a global leader in microbiome research and development, driving remarkable advancements in the field. As we look ahead to 2024, it is clear that South Korea will continue to shape the future of microbiome-focused innovations, furthering our understanding of the intricate relationship between the microbiome and human health. Biose will continue to contribute to and engage with South Korea’s microbiome industry as it furthers itself as the global microbiome CDMO.

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Here are some of Biose Industrie’s talk highlights across the three tracks:

Discovery & Pre-clinical

• Prodigy Biotech is a developmental stage biotechnology company that leverages chicken-derived immunoglobulin-Y to target a range of diseases. Their CEO, Satish Chandran, presented a talk entitled “Editing the Microbiome”. Chandran’s talk covered the company’s platform and disease targets. Their lead program targets alcoholic liver disease. Identifying Enterococcus faecalis as a key species in the development of alcoholic hepatitis, Prodigy’s PRO-AH-001 lead candidate is a polyclonal antibody cocktail which targets Enterococcus faecalis and it’s cytolysin toxin. The efficacy of the product has been demonstrated in various pre-clinical models, including 3D cell-models and animal models. Chandran closed the talk by outlining the company’s future which include a pre-IND meeting with the FDA.

• Axial Therapeutics the biotech targeting neurological diseases and disorders through the modulation of the gut microbiome, presented a talk entitled “AX-5006, a Small Molecule Inhibitor of CsgA Aggregation as a Potential Disease-Modifying Treatment for Parkinson’s Disease”. Becca Senter, Ph.D., Head of Preclinical R&D, opened by highlighting the unmet need for Parkinson’s disease (PD), the 2^nd most common neurodegenerative disease in the world. Detailing the rationale behind AX-5006, Becca explained Axial had identified a link between bacterial amyloid production by gut bacteria and PD symptomology in mice models. AX-5006 is a small molecule inhibitor which inhibits the aggregation and expression of the CsgA protein – a protein important to the formation of bacterial amyloid sheets. The drug has improved motor symptoms and slowed disease progression in ASO mouse models of PD and has been well tolerated in other animals. Clinicals for the candidate are planned for 2024.

Translational & Clinical

• Sean Gibbon, PhD, Associate Professor from the Institute for Systems Biology discussed the intersection between systems biology approaches, microbiome analysis and precision health/nutrition to rationally engineer the human gut microbiome. Gibbon began by explaining the interplay between environment, genome, and microbiome results in host phenotype – drug response rates, disease presentation etc. Gibbon highlighted the challenge of analysing this complexity and identified microbiome-produced metabolites as being central to decoding it. Artificial intelligence approaches including machine learning and knowledge graphs were identified as key tools to translate microbiome data into actionable interventions for host health. Gibbons showcased a range of in silico microbiome modelling use-cases including: predicting individual-specific SCFA production profiles, rational design of personalised ecological therapeutics, and estimating engraftment potential of non-indigenous taxa.

Manufacturing & Process Development

• Kevin Roelofs, Associate Director, Strain Process Development for Novome Biotechnologies discussed their journey to improving lyophilization survival in Roelofs opened by explaining the importance of reducing water activity in bacterial cultures for their preservation, contrasting the respective merits of freezing and lyophilisation. Lyophilisation was chosen for Novome Biotechnologies’ live biotherapeutic product for benefits of improved formulation, improved patient experience and preferable storage conditions. However, their initial lyophilisation efforts resulted in low viability. Variable viability testing found differing survivability between supposedly identical strains. An essential gene, pap2, for B. vulgatus lyophilization survival was identified and genetic methods were applied to improve survival outcomes of their strains. Roelofs closed by describing how Novome Biotechnologies plans to use pap2 repaired strains for their process scale-up – their lab-scale model predicts improved performance in 50L manufacturing.

• Biose’s Claire Derlot, Ph.D., head of programs described the CMC challenges behind developing live biotherapeutic products. Derlot underlined Biose’s continued investment in its manufacturing capabilities, with over 80M EUR invested by 2024. Biose’s range of expertise was showcased across the entirety of the LBP development pipeline, beginning with WGS data analysis for strain identification all the way to commercial manufacturing. Derlot specifically underlined Biose’s encapsulation research including its delayed release evaluation and gastro-resistance evaluation. The presentation finished by providing an overview of Biose’s capabilities and know-how. Biose can characterize, scale-up and manufacture a variety of different strains, work with all types of bacteria (Aerobic, Anaerobic, GMO, Non-GMO, spore-forming), and can deliver bacterial products in a variety of forms (capsules, tablets, sachets, creams and oils) – all at a GMP level.

Conclusion

The 8^th Microbiome Movement: Drug Development was an engaging conference, which Biose Industrie were thrilled to support and participate in. Biose look forward to the next event to continue sharing our expertise with the field.

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Last month, Biose industrie had the privilege of speaking at Microbiome Connect: Asia. The two-day congress took place in Seoul, Korea, and was attended by microbiome enthusiasts across academia and industry alike. Given the rapidly growing APAC microbiome market, Biose were thrilled to hear from APAC voices on topics ranging from regulatory firsts to clinical updates.

Day One

The opening panel, “New Frontiers in Microbiome Therapeutics” discussed avenues for collaboration between the APAC and global market.  Genome & Company’s CEO, Jisoo Pae, joined the CEOs of BiomMe, Sang Sun Yoon, and GwangPyo Ko, KoBioLabs, to engage in a thought-provoking conversation covering national government initiatives across APAC countries, and the future of microbiome therapeutics research. Korea was identified as an “easier” territory to develop microbiome therapeutics within due to the regulatory leniency. The discussion also touched upon the importance of engaging with a CDMO in the early stages of drug development, loss of therapeutic efficacy of combined bacterial strains, and the importance of selecting the right target disease candidate. On the latter point, the cancer market was highlighted as being a promising target for LBP development.

The morning of day one placed regulatory considerations at centre-stage. Servatus’ Samantha Coulson, head of clinical research, explained the company’s platform and proceeded to discuss regulatory differences between LBP and probiotics. The key differences being, LBPs are approved by regulatory authorities based on clinical trials whereas probiotics are treated like food supplements. The intended use of the product was also cited as a clear differentiator, with LBPs having intended therapeutic use in a patient population. Coulson also highlighted the safety considerations of bacterial products, stating translocation of LBPs across mucosal barriers are an important risk associated with the modality. This led onto BiomeBank’s presentation regarding their world first authorisation for a donor-derived microbiome-based product. Mirjana Rapaic, Head of regulatory affairs, provided a vibrant talk on Biomebank’s journey to market authorisation, including their work to establish a CMC biological dossier and BiomeBank’s GMP manufacturing capabilities.

Day Two

Day two opened with “The Path to Commercialization”, a session discussing requirements for the LBP field to scale.  The session opened with a discussion between Corundum system biology, and Metagen Therapeutics on investment and market dynamics. Sou Miyake, Director of Business development, and Taku Nakahara, CEO, Metagen Therapeutics explained that globally the fundraising climate for the biotechnology is currently difficult but suggested that Japan is proving more open to investing in the field.

Following the panel, Biose’s Program Leader, Taous Saraoui–mazed, PhD took to the stand to discuss CMC challenges for LBP development.  Taous explained Biose’s background as the global LBP drug developer with its activity split between an Aurillac Lab and facility, and a technology transfer laboratory in Boston. Biose’s expertise as an end-to-end solution provider for R&D, DS & DP manufacturing was explored by describing Biose’s program pipeline. Taous showcased key elements of Biose’s offering, highlighting it’s integrated regulatory expertise, integrated QC laboratory, and integrated ICH compliant incubators for stability studies and storage.

Pipeline presentations

The rest of day-two consisted of clinical updates and platform presentations. The range of therapeutic targets being explored by the presenting companies was vast:

• Genome & Company described their SB-121 candidate targeting autism spectrum disorder-associated symptoms. SB-121 is a Lactobacillus and dextan microsphere which modulates host oxytocin signalling. Given the role of oxytocin in regulation of social behaviour the rationale is that stimulating oxytocin signalling with SB-121 will reduce ASD-associated maladaptive behaviours. Results from their phase 1b showed SB-121 was safe and well tolerated in patients, and improved ASD-associated maladaptive behaviours as measured by vineland-3 and social preference testing.
• ImmunoBiome’s presentation focused on their IMB002, LBP candidate, targeting inflammatory disorders including inflammatory bowel disease and rheumatoid arthritis. ImmunoBiome chose their candidates and targets using their proprietary Avatiome platform that simulates host-microbiome immune interactions. Their IMB002 candidate, a Bifidobacterium strain, induces regulatory T-cell response and suppresses inflammatory immune response. CsgG has been identified as a key effector molecule in this process. ImmunoBiome has been granted IP protection for the novel Bfidobacterium strain and its derived polysaccharides in Korea, Japan, Indonesia, and the USA respectively. Biose are currently conducting toxicity studies on IMB002.
• GI Biome focused on their GB-X01 phase 1 candidate which targets colorectal cancer. GB-X01 showed anti-tumorigenic effect as stand-alone treatment in colorectal cancer model mouse, showing a reduction of the tumour volume and tumour weight compared to control. When used as an add-on therapy, GB-X01 enhances the anti-tumour effect of bevacizumab while minimizing the efficacy variation between tests subjects. GB-X01 induces intra-tumoral activity of NK cells in a colon cancer model, which presented a unique option to be used in combination with NK cell therapy – where the biggest challenge for efficacy is intra-tumoral infiltration. In addition to having an additive effect to chemotherapy, GB-X01 also reduces side effects associated with chemotherapy, such as diarrhoea. GI Biome are currently running a phase 1 study to determine the tolerability and dose for GB-X01, as well as exploring endpoints.

Conclusion

Microbiome Connect: Asia was an excellent opportunity to connect with the global microbiome drug development field. The quality of research was excellent, and the discussions held were important and necessary to further the field. We look forward to the next iteration of the conference and are grateful we were able to present.

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Biose Industrie, a contract development manufacturing organisation (CDMO) and a world-leader of live biotherapeutic product (LBP) process development and production, and SBT instruments, a bacteria-focused state-of-the-art industrial equipment supplier, announced a collaboration to implement rapid viable cell counts within Biose’s manufacturing process.

The emerging field of live biotherapeutics faces a number of challenges, especially related to the enumeration of microorganisms. Enumeration of microorganisms is conducted by live biotherapeutic manufacturers to analyze the bacterial composition of their product, throughout the manufacturing journey, for safety and quality purposes.

Traditional approaches to enumerating live biotherapeutic products, such as plate counting and MPN, often pose difficulty and are invariably time-consuming. Through leveraging impedance flow cytometry SBT instruments have developed technologies that greatly reduce the time and difficulty posed by such techniques, allowing for rapid viable cell counts.

In implementing SBT’s technologies within Biose’s manufacturing process, Biose and SBT will create a new industrial standard for enumeration of microorganisms. The implementation of rapid viable cell counts in both process and release testing aims to shorten the journey from clinical trials to market authorization for Biose’s innovative live biotherapeutic companies.

“This collaboration will further solidify Biose’s position as the world leading CDMO within the LBP space”

said Adrien Nivoliez, CEO of Biose Industrie.

“We are proud to lead the field in adopting new technologies to overcome key challenges of LBP manufacturing.”

“SBT instruments is committed to revolutionising the bacterial-enumeration paradigm”

Gustav Skands, CEO of SBT instruments, added.

“Live biotherapeutics present an opportunity to transform the lives of millions of patients, and the faster new medicines get to market, the more patients can be helped. I look forward to seeing this collaboration accelerate the journey of LBPs into the clinic.”

About Biose Industrie

Established in 1951 as a pioneer of industrial fermentation &freeze drying of living bacteria, Biose Industrie pursued its historical development as a cGMP pharmaceutical company dedicated to the manufacturing of microorganisms for drug substance and drug product. In 2017, Biose Industrie started a CDMO/CMO activity, specialized in process & analytical development and industrial manufacturing of microorganisms compliant with pharmaceutical standards and regulations for human health. Today Biose Industrie’s turnover is largely generated by international sales, over half of which are in the USA. Locally, Biose Industrie is at the forefront of the LBPs industrial scene and employs over 350 people and supported by L-GAM and BPI Finance with 80M€ of new CAPEX investments.

About SBT Instruments

SBT Instruments is a pioneering company that develops and produces state-of-the-art products for fast enumeration of microorganisms to support the rapidly growing industry of biotech and biopharma. The core detection principle employed by SBT Instruments is an electrically based flow cytometry technology, referred to as impedance flow cytometry. The technology can detect and enumerate bacteria on a single cell-basis without the use of any labels, stains, or dyes. SBT Instruments has implemented impedance flow cytometry in their flagship product, BactoBox.

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To start with could we get some background on Alveolus Bio?

Alveolus Bio is developing a first-of-its-kind inhaled live biotherapeutic, a little over a decade in the making. We’re a clinician-scientist led team that is trying to address neutrophilic inflammation in chronic lung disease, which in simple terms is severe and persistent inflammation.

We started as a university spin-out from the University of Alabama at Birmingham Heersink School of Medicine, which is renowned for its pulmonary research. Our founder, Dr. Vivek Lal, a physician scientist, studied the causative factors behind chronic lung inflammation and bacteria. His initial seminal findings, that of downregulation of neutrophilic inflammation by specific bacteria, encouraged him to further explore the involvement of bacteria in lung development, injury and health.

His line of research led to a collaboration with our Chief Medical Officer, Dr. Amit Gaggar. Dr. Gaggar is a renowned pulmonologist with a clinical and background in COPD and cystic fibrosis. Their work together implicated changes in bacteria populations in adult and pediatric lung diseases. When they dug into it, they found not only are certain bacteria types lacking, but neutrophilic inflammation and tissue damage was also running rampant. With Alveolus’ lead asset for COPD, we’re specifically targeting this neutrophilic inflammation present in the lungs.

How is Alveolus going about targeting neutrophilic inflammation?

Based off Dr. Lal’s work we identified a few different strains that are effective in reducing inflammation. This raised the question; how can you inhale them to reach distal parts of your lungs? We partnered with the folks who made inhalable biologics including inhalable insulin. We encapsulate the strains into a capsule, which you break and inhale using an off the shelf, FDA cleared inhaler. When inhaled, the bacteria produce anti-inflammatory metabolites and are then cleared by the lungs.

What advantages does approaching COPD using LBPs have over standard of care treatments?

The current standard of care for COPD includes steroids. These come with a whole host of side effects, especially with use over an extended period. Given the fact that we’re using natural, non-GMO bacteria, we don’t anticipate those steroid-like side effects. What we’ve found in a lot of the animal data is that our asset is performing just as well as the standard steroids, if not better, in significantly reducing a lot of these inflammatory biomarkers. We’re also seeing lung structure improving as well. Of course, human trials will be the real test, but it’s a step in the right direction.

What led to the decision to engage with the CDMO versus manufacturing in-house for your candidate?

As a start-up, the simple answer is we don’t have the capital funds to establish in-house manufacturing, especially at scale. More so we wanted work with somebody who has a track record in producing bacteria, somebody who is not doing it just for us, but also has for other companies. We realized that if we engage with a CDMO, not only will it be more cost favorable in getting to market, but we would also have the know-how and the resources to get us there faster.

 And why, of all the CDMOs, did you engage with Biose Industrie?

Biose has a great reputation as far as producing Live Biotherapeutics that’s currently used in numerous clinical trials for microbiome companies, and we wanted to work with the best.

 What advice would you give to other biotech’s selecting a partner with whom to develop their products?

You want to go with a company that has the know-how from a GMP standpoint and can reliably scale you up. Thinking ahead, you want to select a partner who is active and knowledgeable in that space too, to eventually have a successful pre-approval inspection for the BLA. I can’t stress that enough because companies can fail by picking the wrong partners. It’s incredibly important to pick somebody who has worked with companies through every stage of the approval process, even if it comes with a premium.

What is the biggest manufacturing challenge for your product?

One challenge is making our bacteria in a pathogen-free setting. I would say it’s also making it in quantity.

What is a highlight of collaborating with Biose Industrie on your candidates?

 Biose knows how to work with bacteria. Not many CDMO’s want to introduce bacteria into their manufacturing operations. They have the expertise to really help us scale up and to make sure that we are a priority. They help us find ways to think outside of the box to reduce our overall costs or reduce our overall time to production.

 What does the future hold for Alveolus? When do you expect to enter the clinic?

Alveolus is getting ready for prime time here. We are filing the IND in the next year and planning to enter into the clinic shortly after – it all depends on funding.

To find out more about the work Alveolus is doing please feel free to visit their website here.

The post Targeting Lung Inflammation with an LBP, A Discussion with Alveolus Bio and Biose Industrie their CDMO partner appeared first on Biose Industrie.

Biose had the privilege of making a joint presentation alongside our client Bloom Science. Biose’s Head of Programs, Claire Derlot, and CEO of Bloom Science, Christopher Reyes took to the stage to talk about Bloom’s breakthrough work to develop live biotherapeutics for neurological diseases. Bloom’s lead candidate, BL-001, is a rationally selected consortia product which aims to treat the CNS indications: Dravet Syndrome and Developmental Epileptic Encephalopathies. It’s primary mechanism of action is increasing GABA levels in the hippocampus, reducing hyperexcitability. In multiple murine seizure models, BL-001 treatment significantly reduced seizures.

Claire outlined the collaboration between Bloom and Biose, to bring the LBP to GMP certified clinical release. The described journey extended all the way from confirmation runs of Bloom’s strains on a pilot scale of 20L and 150L bioreactors, up to the current clinical batches at 2000L and 3500L. Describing the benefits of the partnership Christopher identified de-risking of CMC, overcoming technical formulation challenges and regulatory filling support as key advantages of the collaboration.

Standout presentations from the event included:

Staffan Stromberg, CEO – Infant Bacterial Therapeutics

Staffan’s talk was focused on navigating the roadmap to achieve success with pharmaceutical grade probiotics. Stromberg explored IBT’s Phase 3 asset LBP IBP-9414 for infant necrotising enterocolitis (NEC), which is the leading cause of premature infant death in the US. Positioning, IBP-9414 as a preventative for the high cost of surgical intervention for NEC, the launch is anticipated for 2025. Staffan highlighted IBT’s stringent regulatory approach for their Chemistry Manufacturing Control.

Randi Rich Head of Operations, Executive Manager & Co-founder – Freya Biosciences
Elleke Bosma, Director Microbiome Research – Freya Biosciences

Randi and Elleke discussed the need for microbiome therapeutics for women’s health conditions. Referencing high rates of infertility, endometriosis and premature birth, Freya identified a shared underlying cause: vaginal dysbiosis. The disruption of the immune system and vaginal microbiome interface leads to inflammation which results in disease – they explained. Randi presented Freya’s discovery platform, DYSCOVER, which uses metagenome sequencing of the vaginal microbiome and transcriptome profiling to identify proinflammatory markers in dysbiosis. The donor-derived program for manufacturing their FB101 was also discussed, following the path laid by Rebyota for donor-derived material and SER-109.

Alice Cheng, Clinical Assistant Professor – Stanford Health Care

Cheng discussed her work in engineering a synthetic complex bacterial community. Cheng opened with the limitations of simple communities for studying microbiome impacts on phenotypes in mice models, highlighting their failure to recapitulate phenotype. Describing her journey to produce a complex community, Cheng explained her use of the HMP dataset, and iteration to generate a human-resembling microbiome in gnotobiotic mice. The resultant community remained stable across generations and had a near-equivalent bile acid pool with the human microbiome. Cheng suggested ~100 strains may be sufficient to recapitulate the metabolic aspects of the native microbiota.

Jun Terauchi, Steering Committee Chair; CSO – Japan Microbiome Consortium; Metagen Therapeutics Inc.

Terauchi delivered a two-pronged talk on the Japan Microbiome Consortium, and Metagen Therapeutics. The first part of the presentation outlined the JMBC’s work to standardise protocols to facilitate microbiome drug commercialisation. He explained the multiplex nature of microbiome measurements creates significant room for error and variation, and that the JMBC is working to create international harmonisation standards to address this. Speaking as CSO for Metagen Therapeutics, Terauchi explained their reverse translational platform to develop FMT treatments for ulcerative colitis. Terauchi identified allergies and FMT for other indications as being future drug development targets for Metagen.

Shiri Meshner, Vice President R&D – Biomica Ltd.

Meshner discussed Biomica’s platform and clinical progress. Biomica’s PRISM platform uses computational big data for predictive function-based drug design. Describing the rationale for their lead candidate, she explained, BMC128 is designed from specific function enriched in responders to Immunotherapy anti PD-1. In preclinical studies, BMC128 significantly enhances tumour infiltration of activated immunocytes. Biomica’s first-in-human trials began in July 2022.

Sarah Lebeer, Professor – University of Antwerp

Lebeer explored the opportunity for a live biotherapeutic product to protect against SARS-CoV-2 and related viruses. Lebeer highlighted the target potential of the lactobacilli niche in the upper respiratory tract, for its potential to inhibit respiratory viruses. Drawing on research that found probiotics reduced the incidence of upper respiratory tract infections, LeBeer’s group developed a throat spray consisting of inhalable lactobacilli. Their early research showed temporary colonisation of their strains in the upper respiratory tract, which remain viable and immunostimulatory. The speaker stressed the need for confirmation in larger trials and the optimisation of nasal spray with AMBR2.

Conclusion

The recent Pharmabiotics Conference explored the cutting-edge of microbiome therapeutic development. Biose Industrie were thrilled to connect with current and potential clients. We look forward to next year’s conference!

The post Pharmabiotics 2023 Report – Standout LBP Development Presentations appeared first on Biose Industrie.

Our CEO Adrien Nivoliez and Business Development Manager Richard Ellis hosted an online panel discussion along with Mary Poor (VP CMC/Quality at Siolta Therapeutics) and Luc Dubois (Director at Validapro) to discuss developing a robust regulatory strategy for Live Biotherapeutic Manufacturing

Download the slides and watch the panel here in case you missed it live and do not hesitate to reach out to us at r.ellis@biose.com should you have any questions

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