5 press releases, one biotech: Gilead alums debut OrsoBio with frenzy of metabolic programs

OrsoBio is shouting its launch news from the rooftops. The new metabolic-disorder-focused biotech was so excited, it issued press releases announcing various asset acquisitions not once, not twice, not thrice but, well, four times. Four press releases.

And that's not even counting the Nov. 1 announcement that the company had launched. While the press blitz may seem a little overzealous, here we are writing about it. So let’s unpack the breaking news.

OrsoBio launched Tuesday with Mani Subramanian, M.D., in the CEO seat, and Rob Myers, M.D. serving as chief medical officer. Both are alums of Gilead, where they worked on liver diseases—Subramanian as senior vice president and therapeutic area head for liver diseases, while Myers oversaw clinical development in liver fibrosis.

The company was incubated by Samsara BioCapital. The California venture capital firm also contributed to a $300 million round for inflammatory-disease-focused Acelyrin in September.

While the fundraising for OrsoBio was not disclosed, we know that Subramanian and Myers didn’t leave Gilead empty-handed.

OrsoBio has built its pipeline thanks to a clutch of early deals detailed Wednesday morning, although financials were not disclosed for any of the assets. The deals include the acquisition of the liver-targeted mitochondrial protonophore TLC-6740 from Foster City, California-based Gilead Sciences. The therapy is already moving into studies that could support an application to start testing in patients, initially for severe lipodystrophies, a group of rare conditions that cause the body to lose fat in some areas while gaining it in others, such as the liver.

A first-in-human trial for TLC-6740 is expected to initiate in 2023. The deal was originally signed back in 2020, according to OrsoBio’s release. The therapy could ultimately hold the key to nonalcoholic steatohepatitis (NASH)—the stubborn fatty liver disease that has befuddled big and little pharmas alike. Preclinical data will be presented at an upcoming conference, Subramanian said in the release.

But that’s, of course, not all. OrsoBio also acquired therapies from three more companies and a university: Shionogi, Phenex Pharmaceuticals, Astellas unit Mitobridge and Yale University.

The Shionogi deal involves worldwide rights to the newly renamed TLC-3595, which is phase 2 ready, according to OrsoBio's release. The therapy is under development for Type 2 diabetes, specifically for increasing fatty acid oxidation, reducing lipid accumulation and improving insulin sensitivity in skeletal muscle and the liver.

A phase 2a is expected to commence for insulin resistance in the first half of next year, Myers said in the related press release.

OrsoBio also picked up a collection of ACMSD inhibitors from Mitobridge, including TLC-065, which aims to improve mitochondrial function. The biotech hopes the therapy, which is still in preclinical testing, could someday be used for a number of metabolic and inflammatory hepatic and renal diseases.

Finally, OrsoBio snagged Phenex’s liver X receptor inverse agonist program, including lead candidate TLC-2716. The prospect is in phase 1 testing for severe dyslipidemias, with data expected in early 2023. Dyslipidemia is a condition characterized by abnormal levels of lipids in the blood. Lipids can build up over time and cause heart attacks or strokes. OrsoBio also has eyes on metabolic disorders like severe hypertriglyceridemia, familial hypercholesterolemia and NASH.

All of that means two clinical and two preclinical assets to start off with along with a mandate to go after one of the trickiest diseases in biotech. Needless to say, we expect our inboxes will be flooded should OrsoBio succeed.