Seventure Partners' Microbiome Portfolio is Reaching Critical Milestones in Current and Upcoming Clinical Trials
Paris, France – 14 December 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% fat loss and 9% 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.
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 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.