Boehringer Ingelheim and Enleofen Ink $1 Billion+ Fibrosis Deal

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Germany’s Boehringer Ingelheim and Singapore’s Enleofen announced a deal for fibro-inflammatory diseases. In the deal, Boehringer acquired worldwide exclusive rights to Enleofen’s preclinical interleukein-11 (IL-11) platform.

IL-11 is a type of protein, a cytokine, that cells use to communicate. It is linked to fibro-inflammatory diseases. Blocking the action of IL-11 has showed promise in treating diseases of the liver, lung, kidney, retina, bowel, heart and skin related to fibrotic conditions.

Enleofen spun out of the National Heart Centre Singapore (NHCS) at SingHealth and Duke-NUS Medical School under the SingHealth Duke-NUS Academic Medical Centre (AMC), Singapore. It exclusively licensed a group of patents and a number of antibody compounds from AMC when it was founded in 2017.

Since then, Enleofen has developed an extensive anti-IL-11 antibody platform and moved its drug development programs towards the clinic. Under the terms of the deal, Boehringer will develop the platform more with plans to jointly work with AMC scientists to accelerate it into the clinic. It will begin with therapies for NASH and ILDs, which are two of Boehringer’s core disease focus areas.

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Nonalcoholic steatohepatitis (NASH) is similar to cirrhosis of the liver, but in people who don’t drink. It is considered an area of huge unmet need linked to fatty liver disease and the obesity epidemic. Interstitial lung disease (ILD) is an umbrella term to describe diseases that cause scarring, or fibrosis, of the lungs. Examples include idiopathic pulmonary fibrosis, hypersensitivity pneumonitis and sarcoidosis.

“The impressive preclinical studies at Enleofen have revealed the potential of IL-11 blockade to treat a broad range of diseases,” said Clive R. Wood, corporate senior vice president and global head of Discovery Research at Boehringer. “We are excited to have these monoclonal antibodies in our pipeline and have the opportunity to accelerate their path to many patients whose needs are not met by current treatments.”

No financial details were disclosed, although the companies did say that Enleofen could be eligible for payments to exceed $1 billion per product in upfront and success-based development and commercialization milestones.

“Enleofen is very excited to engage Boehringer Ingelheim, a leader in anti-fibrotic therapy R&D to develop further anti-IL-11 therapies to begin to address the unmet medical needs of patients worldwide,” said Stuart Cook, director and co-founder of Enleofen. “The preclinical data across a range of conditions are unprecedented and this new approach of targeting IL-11 could be a game changer.”

The initial discovery science and drug target validation on Enleofen’s platform was by Cook and Sebastian Schäfer at the National Heart Centre Singapore and DUKE-NUS, which was then licensed to Enleofen.

In September 2019, Enleofen published data showing that blocking IL-11 could treat idiopathic pulmonary fibrosis. The research was published in the journal Science Translational Medicine.

“Progressive lung scarring, called fibrosis, is a very serious condition that makes it difficult to breathe,” Cook said at the time. “We discovered that the IL-11 protein is critical for fibrotic lung disease and that therapeutically inhibiting IL-11 can reverse lung disease in mice.”

Risk factors for IPF are smoking, old age and family history. The research found that the IL-11 protein accumulated in high levels in IPF patients’ lung, especially when there is very poor lung function. IL-11 caused lung fibroblasts to over-activate, causing them to invade and destroy lung tissue and prevent oxygen from being transported to the rest of the body.

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