18 Dec 2017 --- Seventure Partners, one of Europe’s leaders in financing innovation, and a world-leader in the venture investment in the microbiome sector, is seeing rapid progress from innovation into human trials, with five of its portfolio companies advancing their human microbiome products with varying modalities and therapeutics targets in clinical trials.
The first Seventure portfolio company to start a clinical trial was LNC Therapeutics, a research and development company, which specializes in the treatment of chronic metabolic diseases, including obesity. The company completed a clinical trial in 2014 under its Obeminale program for its product Stablor, the first in-class medical food which aims to modulate obesity-related bacteria of the Microbiome. In June 2014, using data from two clinical studies and also real patient usage, the company announced promising safety and efficacy results, including an indication that Stablor could lead to an 18 percent fat loss and 9 percent weight loss.
As a result of the Obeminale program, LNC Therapeutics has made substantial discoveries regarding the modulation of the microbiome and the role specific new families of bacteria play, such as Christensenella genus, in the inflammation of the gut in metabolic diseases. As a result of the trial data, LNC Therapeutics is also launching the Temys Project, aiming to develop other biopeptide therapies for obesity and cardiometabolic diseases. They recently announced their achievement in raising €6.5 million in series C funding, which will help them progress these new drug candidates through clinical trials.
The microbiome, which consists in all the micro-organisms that reside in and on the human body, is an exciting and fast-developing new field at the interface of pharmaceuticals and nutrition, offering abundant opportunities for developing new medicines. The composition and functionality of the bacterial ecosystem forming a large part of the microbiome, in the gut and elsewhere, has been linked to various health conditions, among which acne, psoriasis and allergies, gastrointestinal ailments, Crohn disease, obesity, diabetes, autism, depression or cancer.
There are approximately 10 times more bacteria than human cells in the body, and over a hundred times more bacterial genes than human ones. The multitude of biological processes and indications affected by the bacterial ecosystem within the human microbiome, makes its balance critical to health. Understanding and maintaining and adequate balance of species within this complex ecosystem is an important goal for future medical progress, especially in the area of preventing and treating chronic diseases.
Fecal transfer was one of the earliest therapeutic applications in the microbiome field. Maat Pharma, the pioneering French company developing autologous fecal microbiota-transfer treatments for serious complications in Acute Myeloid Leukemia (AML) and bone and joint infections with unmet medical needs, announced in November 2016 results from the first safety assessment of its Phase Ib ODYSSEE trial. This aimed to correct dysbiosis complications with autologous fecal microbiota transfer in AML; results confirmed that no safety issues were identified. More recently, in July this year, the company announced the completion of patient recruitment to the trial, signifying rapid advancement within just 33 months since launching and results are expected within Q4 2017.
Applications in gut-based diseases have also emerged as a key area for microbiome-based therapies. Enterome, a front runner in the development of pharma and diagnostics based on the gut microbiome, began its Phase I randomized, double blind, placebo-controlled trial of lead candidate EB8018 for the treatment of Crohn's Disease in December 2016. EB8018, a small molecule candidate drug, inhibits inflammation by blocking the FimH adhesin in Escherichia Coli and some other bad bugs, which has been found to be over-abundant and trigger an abnormal mucosal immune response in Crohn’s patients. The company recently announced the results from this Phase I study, which aimed to assess safety and tolerability of EB8018 in 56 healthy volunteers; the drug candidate was well tolerated across a wide range of doses, allowing Enterome to initiate a Phase 1b trial in Crohn’s disease patients. The Company expects these results to support their plans to commence Phase II trials in 2018.
Following its recent series A financing, Anaeropharma Science in Tokyo, Japan, has entered a Phase Ib/IIa trial in the U.S. to develop a novel, genetically-enhanced bacteria to kill tumours. The Company’s lead product APS001F is an anaerobic bacterium (Bifidobacterium longum) that only thrives in the hypoxic core of advanced solid tumors. Patients are also given a cytotoxic agent that is only activated when it encounters the enzyme cytosine deaminase secreted by the bacteria. The drug can then kill tumour cells from the core outwards.
Vedanta Biosciences recently announced the initiation of its Phase Ia/Ib clinical trial for its lead oral product candidate, VE303, following the award of a $5.4 million CARB-X grant. VE303 is a novel human microbiome drug candidate, made of a rationally-defined live bacterial consortia to treat Clostridium difficile (C. difficile) and other bacterial infections. The company also recently announced that it would be advancing its cancer immunotherapy and infectious disease products (live biotherapeutics which have been shown to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy). IND filing for the lead product candidate is planned for 2018.
Isabelle de Cremoux, CEO and Managing Partner of Seventure Partners, said: “Undoubtedly, interventions in the microbiome will play a vital role in innovative therapies of the future. Our portfolio companies are reaching important clinical trial milestones, which will prove the potential for the microbiome. We also have three other companies in pre-clinical stages, Biomx, Targedys and Eligo, meaning an exciting future for this rapidly-growing area of research. The Health for Life Capital Fund has been pivotal in supporting innovative companies in the microbiome field and we look forward to reporting on our portfolio’s progress.”
Seventure will announce new microbiome investment news in the new year.
With over €660m in assets under management as of the end of 2016, Seventure Partners is a leading venture capital firm in Europe. Since 1997, Seventure Partners has invested in innovative businesses with high growth potential in two fields: Digital technologies in France and Germany, and Life sciences across Europe and North America.
Back in September, NutritionInsight reported that LNC Therapeutics, a company specialized in the research and development of gut microbiota directed drugs for the treatment of obesity and associated cardiometabolic diseases, has raised a €6.5 million (US$7.67 million) Series C funding round. This new round, co-led by Seventure Partners, brings together a consortium of investors and a family office. Additionally, the company has appointed a new chief scientific officer, Dr. Sandrine Claus, to lead the gut microbiota project.
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