Takeda and Debiopharm agree licencing deal for GI targeted novel microbiome therapeutics

A new study helps to explain how nerve cells sense the microbes in the gut and how they coordinate their function with other tissues in the digestive tract.

Swiss biopharmaceutical player Debiopharm has signed an exclusive license and research collaboration agreement with Takeda to develop novel microbiome therapeutics targeted to gastrointestinal disorders.

Under the agreement, Takeda will screen and optimise compounds obtained from Debiopharm’s Debio 1454/M discovery pipeline program to identify candidates for further development for the treatment of inflammatory bowel disease (IBD) and other gastrointestinal (GI) disorders.

“We are thrilled about this new collaboration with Takeda for our microbiome remodelling program, as we will gain more insights into how this novel class of compounds can potentially be used to help patients with chronic inflammatory gut diseases such as inflammatory bowel disease,” said Debiopharm CEO Bertrand Ducrey.

“This program could represent a real breakthrough for patients, while minimizing the potential for treatment resistance via its specifically targeted mode of action,” he explained.

Debiopharm’s 1454/M preclinical pipeline is focused on novel, narrow spectrum, microbiome remodelling agents that target a combination of pathogenic intestinal bacterial. After the initial screening by Takeda, drug candidates will be evaluated for their effectiveness against specific disease-causing microorganisms while preserving the natural balance of the microbiota.

“Over the past five years, Takeda has built a leading network of R&D partnerships to leverage the cutting-edge understanding of the gut microbiome in promoting mucosal homeostasis and the role of pathobionts as potential disease drivers,” said Gareth Hicks, Ph.D., Head of the GI Drug Discovery Unit at Takeda.

“We are excited to invest further in microbiome research as we work with Debiopharm to explore the potential for this highly innovative program to provide improved treatment opportunities for patients with chronic GI inflammatory disorders.”

Takeda continues to bet on microbiome for GI disorders

The deal with Debiopharm is the latest in a long line of deals the Japanese pharma giant has made in the microbiome space.

In 20018 the firm signed a global deal with French microbiome biotech Enterome for the licencing, co-development and co-promotion of Enterome’s lead investigational drug candidate EB8018 in patients with Crohn’s disease, with the potential to expand to other gastrointestinal (GI) disorders.

One year previously in 2017, Finch Therapeutics granted Takeda exclusive global rights to develop and sell its microbiome candidate FIN524, a live biotherapeutic product composed of cultured bacterial strains that have been linked to favourable clinical outcomes in studies of microbiota transplantations in IBD. In 2019 Takeda and Finch an expansion of the collaboration, allowing the company to develop microbiome-based therapeutics using Finch’s Human-First Discovery platform.

Under the terms of the expanded agreement, Finch and Takeda will utilize Finch’s platform to target Crohn’s disease.

Takeda also entered into a strategic collaboration with NuBiyota in 2017, for the development of Microbial Ecosystem Therapeutic products for gastroenterology (GI) indications. Earlier this year Takeda reported that it had opted in to continue development of TAK-039 with NuBiyota after positive clinical findings.

“We’ve seen clinical data from our partner, NuBiyota, and that clinical data was in Clostridium difficile enterocolitis, where we’ve seen efficacy at or greater than what’s been seen with fecal matter transplantation, so we’ve opted in,” said Andy Plump, President, Research and Development at Takeda in a Q4 2019 earnings call.

Debiopharm pipeline

Switzerland-based Debiopharm develops therapies to target oncology and infectious diseases through the identification of high-potential compounds and technologies for in-licensing in order to demonstrate clinical safety and efficacy before working with large pharmaceutical commercialization partners around the world.

Its Debio 1454M program includes novel microbiome therapeutics for the treatment of gastrointestinal (GI) disorders.

Currently in drug candidate identification stage, 1454M aims to identify effective treatment against inflammatory bowel disease (IBD) and other GI disorders and is focused on novel, narrow spectrum, microbiome remodeling agents targeting a combination of intestinal species implicated in the pathogenesis of GI disorders.

Related clinical pipelines focused on bacterial infections are Fabl inhibitors targeting N. gonorrhoeae (1453) and A. baumannii (1454S), both of which are in preclinical development stages and have a combined $4.7 million in grand funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).

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