Although the virtual event world is far from ideal, the platforms are getting more user friendly and we did succeed in appreciating the excellent science that was on offer.

Here’s a summary of some of the highlights on days 1 and 2 of the event.

Day 1

In the microbiome field, discovery and pre-clinical development of drug candidates are highly complex. This stream of talks began on the topic of discovery. Tom Van de Wiele, CSO at ProDigest, presented on “Delivery, survival, engraftment and activity of live biotherapeutic products in the GI tract”. Van de Wiele explained how to address various questions about a candidate live biotherapeutic product (LBP) using state-of-the-art model systems to simulatethe physiology and microbiology of the gastrointestinaltract: How does the LBP survive or engraft? What is its effect on the microbiome? What is its mode of action in host health? He described how the models can simulate interindividual variability so that in vivostudies can be planned accordingly.

Moving on to the topic of small molecules and microbiome chemistry, participants heard from Nicole McKnight, CEO of Stellate Therapeutics, a company which discovers small molecules produced by bacteria of the human gut to address neurological diseases. By using what they call “co-evolved molecules”, they aim to de-risk the drug development process. That’s because in conventional drug development, the biological effects are tested in humans relatively late in the clinical trials process; whereas Stellate conducts human observationalstudies on patient samples during the preclinical phase. Their lead candidate, STL-101,is a synthetic form of queuine(produced by gut bacteria), as a disease-modifying therapy for Parkinson’s disease that acts through neuroprotection.

This was followed by a presentation by Shiri Meshner, VP of R&D at Biomica. Shiri explained how they use computational predictive biology for discovery and development of novel therapies for microbiome-related humandiseases. Using databases generated via data integration plus proprietary computational algorithms for miningthe data, they have discovered candidates in immuno-oncology, inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), and antimicrobial resistance applications.

Lutz Krause of Microba presented on “Using a human-first, data-driven approach to therapeutic discovery”. Their approach to microbiome drug discovery makes use of a large proprietary human dataset. With this, they interrogate the ‘novel microbiome’, focusing on the 71% of the human microbiome that is currently considered unculturable. Once they identify leads, they focus on genome-directed isolation then preclinical validation. Currently they have a candidate single strain for patients with ulcerative colitis, and discovery to preclinical validation completed within 18 months.

Rob Finn from European Molecular Biology Laboratory&European Bioinformatics Institute (EMBL-EBI) spoke on “Magnifying the human gut microbiome”. He noted that most gut species lack isolate genomes, and described MGnify, afree resource for archiving, assembly, analysis, and browsing of microbiome data. MGnify constitutes the largest single collection of public gut microbiome genomesand is constantly being expanded to include additional genomes, including phage annotations. He also described the institution’s work on phages specifically: they have a dual approach to discovering human phage diversity, using isolate genomes and metagenomics. This has resulted in the ‘gut phage database’, soon to be published in Cell.

Day 2

In day 2 of the conference, participants heard from Alice Rouanet of Pharmabiotic Research Institute: “Development of microbiome-based medicinal products in Europe: Regulatory considerations”. She began with a definition of microbiome-based medicinal products, a “spectrum of pharmaceutical products emerging from the better understanding of the interaction between the microbiotas and their host”.A product’s purpose arises from its intended use and its target population, which leads to its regulatory status and the requirements for being offered on the market. Ultimately, she says, regulatory challenges for microbiome-based medicinal products arise from the fundamental challenges of microbiome sciencein that quality, safety, and efficacy must be adequately demonstrated.

Gregory Amos of NIBSC (the UK’s Official Medicines Control Laboratory) then spoke on a hot topic globally: “Developing Standards for the Microbiome Field”. He explained that microbiome standards are reference reagents that allow for comparison of measurements across laboratoriesand which support the development of microbiome diagnostics and therapeutics. His institution is leading 12 World Health Organization endorsed projects in order to establish WHO referencereagents for analysis of the microbiome. The NIBSC‘ground truth’ reference reagents are intended to analyse and evaluate microbiome analytical pipeline performance at different steps, while leaving open the user’s choice of pipeline. A challenge is to establish consensus thresholds for users to ensure harmonization on a global scale.

Participants heard from Françoise Le Vacon Chief Scientific Officerat Biofortis on “The Microbiome, as a companion for therapeutic products development”. She brought up the point that various new products in this space have the potential to impact the microbiome in a negative way. She predicted that “microbiome friendliness” could be of relevance to an array of new products, and asked whether we will have to take the microbiota into account for tomorrow’s toxicology. She described the issues of whether a drug affects the gut barrier, composition (dysbiosis), or immunomodulation; and at the same time, whether the gut microbiota in turn affects the drug pharmacokinetics(conversion, hepatic xenobiotic metabolism), pharmacodynamics(immunoregulatory or effector immune functions), or local tissue integrity.

After this came an interesting presentation by Eric van der Helm of SNIPR Biome, who described the challenge of finding products that achieve precision bacteria killing. The company uses antibacterial CRISPR technologyto selectively kill bacteriaand effectively “re-program”microbiomes. TheirCRISPR-Guided Vectors™ (CGVs) are developed as drugswhich target specific strains, leaving the commensal microbiome intact. Van der Helm shared a case Study on their candidate SNPR002to selectively kill harmful strains of E. coli.

The next talk focused on “Leveraging Gut Microbiota Cross-Talk with Immune System to Enhance Cancer Immunotherapy”, by Fabio Grassi, founder of MV BioTherapeutics SA. Their technology addresses responsiveness to cancer immunotherapy drugs, based on the discovery that adenosine triphosphate (ATP) released by gut microbes regulates the intestinal adaptive immune system. Their technology platforms focus on intestinal delivery of the ATP-degrading enzyme apyrase to modulate both the microbiota and immune system responsiveness. In his view, the advantages of apyrase-modified biotherapeuticsinclude the ability to modulate the intestinal microbiota, the use of strains that are already on the market, and oral delivery-which lowers costs and increases patient compliance.

Conrad Lichtenstein,Chief Scientific Officer at Nemesis Bioscience presented on “Nemesis Symbiotics for Inactivation of Anti-microbial Resistance Genes in the Microbiome”. The company is addressing global antibiotic resistance by developing Transmids©,which are DNA therapeutics administered before or with antibiotics to inactivate resistance in bacterial pathogens.Transmids, he explained,are are conjugative plasmids encapsidated in a phage coat, delivered by infection and by bacterial conjugation. Interestingly, transmids can make existing antibiotics work again, prevent spread of antibiotic resistance genes,and protect new antibioticsfrom the emergence of resistance. Data from one of their studies showed around 85% of the bacteria in the system acquire the transmid by infection and subsequent conjugation within 20 hours, with more than 99% of these resistant bacteria being returned to antibiotic sensitivityas a result.

According to Jenny Bailey, CEO and co-founder of Ferryx, iron is an important consideration for LBPs targeting the chronically inflamed gut; some bacteria increase their growth rate in response to iron, which can have different effects on a host. Ferryx has taken this into account in developing their lead drug candidate, Streptococcus thermophilusFX856, which has the ability to induce mucosal healing during a state of inflammationin the gut.

In a section of the program on “Manufacturing the Microbiome”, Biose Industrie Business Development Director, Richard Ellis presented on “Taking CMC to the next level and preparing for commercial manufacturing of Live Biotherapeutic products”.  Richard gave an in-depth presentation on the complexities of developing a solid process for manufacturing LBPs for clinical trials and also gave some brief glimpses into their ongoing late stage Phase III programs and how Biose Industrie is already equipped to manufacture LBPs at commercial levels.

MaaT Pharma’s Chief Medical Officer John Weinberg then talked about the company’s LBP MaaT013 for the treatment of acute graft-vs-hostdisease (GvHD). Starting from the finding that fecal microbiota transplant showed efficacy for steroid-resistant gut GvHD, they developed the MaaT013 “Microbiome Ecosystem Therapy” for restoringhomeostasis and the gut barrier. Based on preclinical and clinical studies, they believe the mechanism of actioninvolves restoration ofmicrobiome diversity, regeneration of thegut barrier, and control of inflammation.The drug candidate shows promising results for treating acute GvHDand is safe in these highly immuno-supressed patients. Phase II results are forthcoming.

“Discovery of Pharmacological Agents Emitted by Intestinal Bacteria” was the topic presented by Todd Z. DeSantis, VP Informaticsat Second Genome. Bacteria producemetabolitesthat can alter human gene expression, which ends up affecting inflammationandmetabolismamong other things. In order to discover these biomolecules develop them into drugs, the company collectsclinical microbiome data, conductsmulti-technology meta-analyses, selects candidates in a data-driven manner,and finally screensthese candidates through in vitro and in vivo models of disease. They work in multiple disease areas, having pinpointed strains with therapeutic potential in IBD and other areas.

Alpha Biomics CSOMarcus Rauchspoke about “Leveraging the microbiome to deliver safer and more efficacious drug therapies”. They too are focused on IBD, addressing the problem that biologic drugs do not benefit all individuals with IBD who are taking them. Since the gut microbiome influences drug responses via both direct mechanismsand indirect mechanisms, they have developed RxSelex^TMas a precision medicine tool to predict efficacy for individuals. They gather patient stool and data, then use a predictive algorithm and produce a physician report on the patient’s drug response prediction. This technology is currently being validated through various studies.

Finally, Assaf Oron of BiomXprovided an introduction to how they develop disease modifying therapies based on phagesas precision medicines. Their “XMarker” platform aims to find a disease signature with high sensitivity and specificity, and provides high resolution – from SNV to gene, strain,and pathway level.The company currently has a collaboration with Johnson & Johnson with the goal of identifying responders to a key IBD drug.

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Adrien Nivoliez,PhD, CEO at Biose Industrie, says the US expansion was a natural progression for the company at this stage in the development of the industry, since several US-based companies are completing Phase 2 and even Phase 3 clinical trials for their drug products. He says,

“Many of Biose Industrie’s US clients are advancing their clinical programs quite quickly and need to address their unique manufacturing challenges. Whether they are in the early stages of process development or further down the line our new office allows us to respond to their needs and give them the high-quality support they have come to expect from us.”

Richard Ellis, Business Development Director who’s responsible for business development globally, adds,

“Boston is so important for the microbiome space because alot of the leading LBP companies are headquartered there. This move is strategic for us, so we can maintain our close relationship with the companies that are closest to bringing LBPs to market.”

Leading with scientific knowledge

The new office is led by Laurent Bouillaut, PhD, a 13-year resident of Boston who held previous roles in Clinical, diagnostic and process development for LBPs. Having already worked for several companies concerned with microbiomes—of the gut and of the skin—he brings a good grasp of the ideas, challenges, and existing projects in this scientific field.

Bouillaut’s previous experience as a microbiologist focused on isolating, fermenting and manufacturing live microbes, is serving him well in a role that requires both scientific knowledge and a penchant for innovation. “In the past, I worked with anaerobic bacteria in the gut, which were notoriously difficult to grow,” he says.

“My experience in Clostridium fermentation gave me an appreciation for the scientific challenges that can arise, and how to think ‘outside the box’ to solve problems.”

In taking on the role of Project and Business Manager for Biose Industrie’s new office, Bouillaut says,

“The Biose Industrie team is strong on scientific qualifications. I’m happy to join this group and work closely with colleagues in France to problem-solve on different projects.” 

Keeping pace with a growing industry

Bouillaut says that while Biose Industrie will continue to do its large-scale manufacturing in France whilst aiming to  expand their capabilities in Boston. 

In a few years’ time, the company could see a US-based manufacturing capacity that accommodates clinical trials up to Phase 1 and  Phase 2. 

“We already have one foot in the US market, and I’d like to make sure we put in both feet,”

says Bouillaut.

“Our activities here can be very responsive to what our US clients need.”

Meeting global challenges

Bouillaut says the plans for a Boston office existed long before the COVID-19 pandemic hit, but it’s especially critical to have someone in the US during this period of restricted activities. Bouillaut says, 

“Since COVID-19 pandemic began, travel between the US and France has not been as easy. Having this office established on US soil helps us stay more connected to our US clients and respond flexibly to their needs.” 

COVID-19 has not significantly slowed down Biose Industrie’s overall business, since the biotechnology companies developing LBPs are more driven than ever to demonstrate the efficacy of their products and bring them to market.

“So far, our large facility in France has been operating safely at 100% capacity,” Bouillaut says. “Things are running well, and this office in Boston helps us make the France-US connection as smooth as possible. With good communication, we’re able to face the challenges of this global situation we’re all dealing with.”

Regulatory challenges also exist in the field of LBPs, but the company has a plan for meeting those as well. Biose Industrie’s manufacturing practices (GMP) and facilities already pass muster with the European regulatory agencies, and the company is also making good progress toward its goal of becoming FDA approved.

Bouillaut says,

“We are working with our US clients and with the FDA to make sure everything is very well aligned, and we’re on our way to FDA approval in the next couple of years.”

Through all of this, he says, it’s exciting to help Biose Industrie’s clients bring live biotherapeutic products closer to the market and to the patients who need them.

Bouillaut adds,

“The industry is growing quickly. Every week brings some new data or milestone that shows progress in this space, and we are proud to be on the forefront.”

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Biomica’s immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity.

Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

Elran Haber, CEO of Biomica stated:

“We are pleased with the continual advancements achieved with the production of our leading drug candidate, BMC128. The success seen in the R&D phase indicates that the production of these microbes is not only feasible but can be done efficiently in large scale. We will now be able to produce these microbes, which have demonstrated efficacy in pre-clinical trials, in large quantities in preparation for our proof-of-concept clinical trials in 2021.”

Ofer Haviv, Chairman of Biomica and President & CEO of Evogene stated:

“This is an additional important developmental milestone for Biomica. I am very proud of the progress that Biomica has achieved in 2020, and particularly that of its advancing immune-oncology program. We see significant opportunity in this program which has the potential to bring new solutions for patients currently uncurable under available therapies.”

About BMC128

Developed as a Live Bacterial Product (LBPs), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

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Biose Industrie knows this well. For several years CEO Adrien Nivoliez has watched for rising stars in the research community and has initiated collaborations with these early career researchers to answer questions about bacterial behaviour and mechanisms of action and strain characterisation is an area in which we would like to bring further value to our clients.

Recently the company supported the thesis project of Dr. Cyril Poupet—with the results now published in the journal Microorganisms. The most recent publication is titled: Curative Treatment of Candidiasis by the Live Biotherapeutic Microorganism Lactobacillus rhamnosus Lcr35® in the Invertebrate Model Caenorhabditis elegans: First Mechanistic Insights.

The collaboration began after Poupet’s internship at Biose Industrie with project manager Dr. Claire Derlot, focusing on optimizing the fermentation and lyophilization process for live microorganisms via real-time monitoring of biomass and adjustment of physico-chemical parameters during bacterial growth. Poupet then turned his attention to a thesis under the supervision of Prof. Stéphanie Bornes at the University of Clermont Auvergne. He wanted to take a close look at the antimicrobial properties of the Live Biotherapeutic Product Lactobacillus rhamnosus Lcr35® (recently re-named Lacticaseibacillus rhamnosus).

“The thesis was carried out with very strong relationships with Biose Industrie,” Poupet says. “It has been an extraordinary experience for me, at the border between fundamental and applied academic research and industrial research.”

Antifungal activities of L.rhamnosusLcr35®

“In general, the mechanisms of action of live biotherapeutic species are poorly characterized,” says Poupet. “But understanding their mechanisms of action is strategic for the development of new therapeutics for humans.”

Poupet notes recurrence of Candida albicans infections is associated with greater resistance to antifungal drugs, which necessitates the development of new antifungals. For his research project, he studied the live microorganism L.rhamnosus Lcr35®, whose antifungal potential hadalready been demonstrated using preclinical models (cell cultures, laboratory animals). The study was designed to find out how L.rhamnosus Lcr35® resisted C. albicans in two different experimental models: the in vitro Caco-2 cell model and the in vivo Caenorhabditis elegans model.

He explains,

“In Caco-2 cells, we showed that the strain Lcr35® significantly inhibited the growth and adhesion of the pathogen. Moreover, in addition to having a pro-longevity activity in the C. elegans model, Lcr35® protects the animal from the fungal infection, even if the yeast is still detectable in its intestine.”

Poupet’s project indeed uncovered clues about the mechanisms by which Lcr35® worked: by repressing genes of the p38 MAPK signalling pathway and genes involved in the antifungal response. He says,

“This suggested that the pathogen no longer appears to be detected by the worm immune system.”

Further research built on these results could lead to the development of novel antifungal therapies. Poupet notes, however, that it will be important to test these results in other models—human cells, non-human mammals, or even humans—since bacterial metabolism would likely change at human body temperature (37 °C) compared to the preferred temperature of C. elegans (20 °C), which was used for the experiments.

A new team member driving innovation

Shortly after the time of the paper’s publication, Poupet came on board with Biose Industrie in the role of CDMO engineer in research and development processes, responsible for optimizing the fermentation and lyophilization of specific microbes at laboratory scale (culture in flasks and bioreactors) all the way up to industrial scale (GMP production).

Poupet emphasizes that continual learning is part of what he enjoys about the role.

“Participating in understanding how these small living beings work in order to better tame them, and make them into effective tools in the fight against pathogens, is a real source of motivation,” he says.

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Nivoliez is embarking on a plan to build the LBP manufacturing capacity and expertise that will be needed down the road thanks to a recent €30 million round of funding for Biose Industrie, led by Cathay Capital.

“We need to continue to grow and innovate in order to maintain our position as the leading contract development and manufacturing organisation (CDMO) for LBPs. We intend to consolidate our position as the leader in this area” says Nivoliez. “This recent ‘vote of confidence’ from Cathay Capital will allow us to work on our plan over the next four years.”

Cathay Capital has become a minority shareholder in the company, joining initial investor Stanislas Desjonquères.

“Soon, this space will be not only a clinical reality but also a commercial reality, with drug market authorization just around the corner,”

says Nivoliez.

“We have already been growing our capacity and knowledge over the past several years, and now we are committed to extending our lead in the industry.”

Richard Ellis, Business Development Director at Biose Industrie, notes,

“Biose already has the biggest volumes for a CDMO by quite a long way, but we predict a huge lack of capacity in the LBP space in the years ahead.”

To address this, the company plans to increase its capacity in all areas, from development to commercial production. Ellis explains,

“We will acquire a huge 5000L reactor; a new clinical drug product line is already underway which offers anaerobically contained equipment to put the active ingredients into the delivery mechanism if necessary under anaerobic conditions (capsule, tablet, sachet, cream or oil); and a massive -20°Cfreezer warehouse to stock all of the Drug substance prior to encapsulation.”

The relevant technical knowledge, too, will be strengthened. Ellis says,

“We plan to expand our existing R&D facility, doubling its size to enable us to grow our process development knowledge. This will add critical value for our clients, because every individual strain requires a new process development study to ensure a scalable solution.”

The funding will also enable the France-based company to reinforce its presence in the United States and grow its service offering for China.

“Boston has long been an important centre for biotech, and for microbiome therapeutics specifically. We plan to open an office in September this year with a project manager based there,”

says Ellis. At the same time, the company will focus on FDA certification in order to produce commercial drugs for the US. China will also be a major area of growth in the coming decade, with rapidly accelerating developments related to gut microbiome therapeutics.

Fabien Wesse, Partner at Cathay Capital, says the COVID-19 pandemic has only increased the importance of the company’s objectives. He says,

“Biose Industrie’s ambitious project is more relevant than ever in this period we are going through. [The company’s leaders and investors] were visionary in investing massively, at a very early stage, in LBPs, one of the most promising areas of healthcare in years to come.”

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Founded in 1951, Biose Industrie has more than 60 years’ experience in the development and production of drugs from living bacteria. Since 2017, Biose Industrie has established itself as the reference CDMO (Contract development and manufacturing organisation) on the global market for Live Biotherapeutic Products (“LBP”), innovative drugs based on the human microbiota. 

The human microbiota consists of billions of beneficial microorganisms populating the organs (skin, stomach, lung, etc.) of a healthy individual. Today, hundreds of drug candidates using some of these microorganisms are being developed to cure diseases as diverse as Crohn’s disease, autism, certain cancers or CoVid-19, making the Human Microbiome a particularly promising area for the identification of new treatments. 

Biose Industrie provides pharmaceutical laboratories and biotechs worldwide with a complete and integrated service carrying out these drugs’ entire production process, from design to finished products.

Thanks to the investments carried out over the last 3 years under the leadership of Adrien Nivoliez, CEO of Biose Industrie, the company is today the undisputed leader in this market, both in terms of skills and production capacity. Thanks to these assets, Biose Industrie, based in Aurillac at the heart of the Cantal area, has already convinced many new first-rate customers among biotechs and pharmaceutical laboratories in Europe, but also in the United States and Asia, leading to an annual growth of its activity of more than 100% since 2017. 

Cathay Capital’s investment will accelerate the realization of Biose Industrie’s ambitious roadmap initiated 3 years ago and so increase its production capacities in all areas, from development to commercial production, strengthen its teams, and through scaling up its international expansion, it will broaden its offer, develop its turnover and consolidate its global leadership.

Cathay Capital will especially support Biose Industrie’s endeavors in the United States, an already key geography for the company, and in China, where developments around the microbiota are accelerating rapidly. 

Adrien Nivoliez, CEO of Biose Industrie, said:

“Over the last three years, we have established ourselves as the leading pharmaceutical CDMO for the development, and clinical and commercial production of microorganisms. Our aim is to shape the industrial structuring of the LBP market. 30 million euros will be invested over the next 4 years in our Aurillac industrial facility to strengthen our offer and industrial capacities. These capacity investments will lead to new production units but also to regulatory investments to support our FDA certification objective.”  

Fabien Wesse, Partner at Cathay Capital, added:

“Biose Industrie’s ambitious project is more relevant than ever in this period we are going through. Adrien Nivoliez and Stanislas Desjonquères were visionary in investing massively, at a very early stage, in LBP, one of the most promising areas of healthcare in years to come. Firmly established at the heart of the Cantal region, the company quickly seized global leadership thanks to its cutting-edge know-how and unique production capacities. We are delighted that they have chosen us as partners and minority shareholders to accompany them in this new phase of accelerated growth, particularly at the international scale. We will now support Biose Industrie through our global platform and expertise in the healthcare sector and the CDMO segment, which is a privileged investment area for us.”   

Stanislas Desjonquères, the company’s historical shareholder, concluded:

“The first role of shareholders is to provide the company with the financial means for its development, so as not to give up any strategic opportunities. This duty is even more important for Biose Industrie, whose growth, at the service of its biotech customers, contributes to accelerating research in therapeutic microbiota and to better treatment for patients against numerous diseases. We are delighted to welcome Cathay, with whom we share this common goal.”

AboutBiose Industrie

Biose Industrie is a Contract Development and Manufacturing Organization (CDMO), specialized in Live Biotherapeutic Products. Founded in 1951 by pharmacists and microbiologists, Biose Industrie has more than 60 years of experience in the development and production of live bacteria-based drugs. The company offers lab development specialised in microbiology andis Drug GMP certified for the manufacturing of API, clinical batches and commercial products. 

For more information, please visit https://www.biose.com/

About Cathay Capital

Cathay Capital Group is a global investment platform specialized in cross-border development with a focus on Northern America, Asia, Europe and Africa. The group identifies investment opportunities with the potential to impact the world and accompanies portfolio companies in their international expansion through its ecosystem of partners and the local expertise of its close to 100 employees based in Paris, Shanghai, Beijing, New York, San Francisco, Munich, Tel Aviv and Singapore. Founded in 2007, the Group has completed over 140 buyouts, growth and venture capital investments and manages €3.5 billion in assets, distributed in a range of investment strategies and vehicles.

For more information, please visit www.cathay.fr

Media contact 

Yoann Besse 

Tel: +33 (0)6 63 03 84 91 

yoann.besse@citigatedewerogerson.com

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Bharat Dixit, VP, Biopharmaceutical Development & Manufacturing at Morningside BioPharma Advisory, who has broad pharmaceutical industry experience in process and product development, says significant differences exist between traditional drug manufacturing and LBP manufacturing.

“They are quite distinct, both in terms of the expertise – how you adapt from one strain to other strain – and what kind of R&D processes you develop,” he says. “It’s necessary to develop the right tools, the right mindset, the right approach. LBPs are far different from developing a product expressed in a microbial (E. coli) or mammalian (CHO) expression system. 

Unique challenges of LBP manufacturing

Dixit sees adaptation of the facility and equipment as one of the major challenges of LBP manufacturing. He says,

“The majority of the LBP products (strains) are either facultative anaerobes or strict anaerobes. In the biologics world, most of the processes have been developed with the aerobic process in mind. Processes are not designed for anaerobes.”

Thus, it’s important for CDMOs and equipment manufacturers to think about building or customizing the equipment and even the framework for controlling the anaerobic process.

Secondly, he says, CDMOs face the challenge of dealing with the multivalent nature of many LBPs – or in other words, consortia-based products. Manufacturing several components (drug substances) separately and combining them at the end to create a final drug product is rare in the traditional pharmaceutical world, except for multivalent vaccines – but not uncommon for LBPs that are a consortia of defined bacterial strains.

“In developing a process, and keeping all these strains alive throughout the whole process, that’s an added difficulty compared to other biologics.

Moreover, he says,

“Every single strain is quite different, even though they might be from the same genus and species, there are differences at the strain level, in terms of the growth properties. So a process that might work for one strain of the same genus and a species at 100 liter, 500 liter scale,  may not be directly applicable to another strain, even though the strains are from the same class. That’s typically not the case for traditional biologics.”

Rising to the challenge

Adrien Nivoliez (PhD, MBA), CEO of the France-based Biose Industrie, is not one to shy away from these challenges. Nivoliez spent 13 years at the company before his appointment as CEO in 2017—and since then, he has led the company with a clear vision to make it into a fully integrated good manufacturing practice CDMO dedicated to LBPs.

Nivoliez, a trained microbiologist, says,

“LBP manufacturing was a natural progression, given my education and background: tying together biology, pharmaceuticals, and finance.” He successfully shaped the organization from a CMO into a CDMO that can work on any drug candidate microorganism – including anaerobic strains.

We have gained the capacity to work on a multitude of microorganisms,” he says. “We had to navigate through the increase in know-how regarding quality for process and for engineering.”

The company has grown from 60 to 160 employees over the past three years.

“We need to understand microbiology, understand the GMP world, and understand the regulatory needs to develop our clients’ projects.”

He says that becoming the go-to CDMO for LBPs came down to the team’s constant dedication to innovation.

“We put in the effort to understand the needs of the client: how we can provide what they need better and quicker? Because when you’re in development, every day is a new day that requires a new solution.”

Nivoliez adds,

“Every client brings unique challenges in the development of their LBP. Step by step we have to work through the development, to get to the delivery of the drug product.”

Enabling a new class of medicines

Those who have seen companies advance their LBPs over the past several years are optimistic about the possibilities of these drugs to address unmet needs in medicine.

Dixit says, “I see significant potential in the LBP field, and I think that there’s a lot more to come. This will become one of the major modalities of the therapeutic world in the coming years.”

Yet this new class of medicines will not come to fruition without expertise and innovation in the manufacturing processes. Nivoliez, for his part, enjoys helping support the growth and success of start-up companies by helping them through a critical stage of their drug development. He says,

“It’s great to help companies clear this hurdle: finding the process, to ensure the development and the stabilization of the microorganism drug candidate.”

Nor does the still-uncertain regulatory environment daunt Nivoliez. “In different countries we do have to create guidelines, establish laws, come up with new specifications. Companies will find new adaptations, new solutions.”

He maintains that microbiome medicinal products, including LBPs, are sure to be an important new category of medicines – and in time, it’ll be possible to see these drugs make a difference in people’s lives.

“There’s a very long evolutionary relationship of the microbes to the human body,”

Dixit adds.

“I do believe that this field is going to explode. What we need is more scientific evidence of underlying mechanisms of action, and a few positive readouts from ongoing late-stage LBP products to increase people’s confidence in these drugs.”

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