Bepirovirsen

GSK’s interest in Ochre Bio lies in the company’s platform that allows livers to stay alive for a few days for the extraction of tissue samples. GSK and Ochre Bio will work together in a $37.5 million partnership to pinpoint the drivers of liver disease. The new partnership, announced Wednesday morning, will see GSK access Ochre’s computational biology, cellular and perfused human organ platforms to generate human liver data sets that can be used to better understand the biology of the liver. The goal, of course, is to eventually develop therapeutics to address liver diseases. The companies did not specify what indications they plan to target, however, GSK said the collaboration would complement its disease area focus in hepatology. The U.K. pharma has clinical assets in primary biliary cholangitis, metabolic dysfunction-associated steatohepatitis, cholestatic pruritus and hepatitis B, the latter of which dominates a large portion of its early-stage pipeline. GSK is advancing bepirovirsen in a phase 3 trial for chronic hepatitis B as a functional cure for the infection. The pharma expects annual sales of 2 billion pounds sterling ($2.57 billion) for the med. Also in phase 3 from the liver portfolio is linerixibat for cholestatic pruritus in primary biliary cholangitis, a condition that causes intense itch that is not satisfied by scratching. “In addition to our programs in MASH to hepatitis B, we are committed to addressing unmet need in liver disease by generating unique data in human-derived systems. Ochre Bio’s platform will provide GSK with foundational data sets to create AI models allowing us to better understand liver function and disease for the development of novel medicines,” said Kim Branson, senior vice president and global head of AI and machine learning at GSK, in a Wednesday statement. GSK’s interest in Ochre lies in the biotech’s platform that allows livers to stay alive for a few days for the extraction of tissue samples. GSK’s in-house AI and machine learning experts will analyze the data from the partnership and use it to build better models and, thus, more precise experiments for developing new liver disease therapeutics. The $37.5 million deal will include both co-exclusive and nonexclusive data licenses, but full details were not released.

GSK is betting on a new approach to unravel the biology driving liver diseases through a multi-year data licensing agreement with Ochre Bio. The partnership grants GSK access to Ochre's datasets and technology to get a better understanding of liver disease mechanisms, while not compromising on biological complexity.The agreement comes less than two months after Ochre inked a deal with Boehringer Ingelheim potentially worth up to $1 billion to develop regenerative treatments for chronic liver diseases, including late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.Foundational datasetAt the core of the multi-year partnership with GSK, worth up to $37.5 million, is the co-creation of a foundational liver biology dataset leveraging Ochre's computational biology, cellular models and perfused human organ platforms. GSK also gains non-exclusive access to Ochre's library of historical liver data.The release announcing the deal Wednesday did not share any specific disease targets. Currently, GSK's liver-related clinical assets cover primary biliary cholangitis, MASH and hepatitis B, the latter accounting for multiple programmes in its pipeline, including the Phase III candidate bepirovirsen.Liver diseases have proved challenging for many drug developers, but Ochre says its platform will help cut down on the number of clinical failures through a deeper understanding of the human liver. As a scientific community, "we really haven't done a lot of work to characterise these [disease] processes in the same way that have in, say, oncology, or even neurodegenerative disease," said Jack O'Meara, the UK biotech's co-founder and CEO, nor has that disease data been applied to “better translational models" beyond mice.In an interview with FirstWord, O'Meara said of the new GSK deal that "we're going to co-create [a new dataset] using perturbation experiments, where we essentially use RNA to knock out specific genes and then study changes to phenotype as a result of those genes… So, really trying to understand the role of individual genes in the disease process and better characterise liver disease."Beyond the gene perturbation studies, Ochre will tap its organ perfusion platform to generate single-cell sequencing data to study how the liver performs in a device outside the body. "That data will also go into training more models for discovery purposes," O'Meara said.Causality earlier in discoveryOne of the biotech's first major projects was a partnership with the University of Oxford where Ochre sourced hundreds of biopsies of donor livers from a broad swathe of liver disease patients and used spatial sequencing technology to study how disease progressed in each individual sample. "Since then, we've sort of advanced our investment in this deep phenotyping approach and moved more and more into these perturbation atlases," O'Meara said, adding "the idea is to try and bring causality…earlier in the drug discovery process."Ochre hasn't disclosed any specific programmes of its own yet. Over the last couple of years, the company has been busy building out its basic biology platforms and the datasets to inform target selection. "We're going to have more to say on that soon," O'Meara said.