Cyclosporine

Aiming to overhaul transplant care with a safer immunosuppressant, LifeMind Therapeutics raked in $263 million on Thursday to begin a mid-stage study of its lead asset, LIFE-001. The company's raise includes $75 million from a series D, as well as an oversubscribed $188-million series E led by Milky Way Investments and backed by new investors including Bezos Expeditions, Gates Frontier and RA Capital Management. The two financings bring LifeMind's total investor funding to $558 million since it debuted with a $55-million series A in 2017. The biotech went on to pocket $50 million in a 2021 B round, then clinched a $175-million series C in 2022. Backers from the previous fundraises, including Google Ventures, LoLa Capital Partners, GSK, Invus and ARCH Venture Partners, also participated in the latest round. "We were fortunate to attract an exceptional syndicate of new and existing investors, including Bezos Expeditions and Gates Frontier, who share our belief that transplantation is ready for meaningful innovation," LifeMine CEO Greg Verdine told FirstWord.Safety advantagesLIFE-001 was discovered with LifeMine's Avatar-Rx platform, which digitally analyses fungal DNA for biosynthetic gene clusters that contain the genetic code for specialised variants of targets that confer drug resistance. In addition to small molecule discovery, the platform is also capable of chemoinformatic-assisted drug optimisation.With its lead candidate, LifeMine is hoping to bring to market a mechanistically unique calcineurin activation inhibitor (CNai) that avoids damaging organs, a concern with existing calcineurin inhibitors (CNis) given to transplant patients today, such as cyclosporin, voclosporin and tacrolimus. According to Verdine, while CNis are highly effective at preventing transplant rejection, the legacy drugs can cause substantial toxicity to the kidneys, cardiovascular system, nervous system, gastrointestinal tract and pancreas. The reason why CNis are associated with such serious side effects may stem from their mechanism of action, Verdine said. Drugs in the class bind calcineurin in conjunction with accessory proteins called immunophilins to form a complex that then inhibits calcineurin. "While that approach has been highly effective at preventing organ rejection, it's also believed to contribute to many of the toxicities associated with these therapies since the accessory proteins draw the drug into peripheral tissues and there drive on-target, off-tissue toxicity," Verdine explained. "We designed LIFE-001 to directly inhibit calcineurin activation without relying on accessory immunophilin proteins to address those longstanding limitations while preserving the proven efficacy of calcineurin inhibition."And so far, the company has been encouraged by the safety data generated by LIFE-001. In an ongoing Phase I study, more than 100 adults have been dosed with the experimental treatment, and no clinically meaningful renal, metabolic or cardiovascular safety signals have been seen, suggesting a substantially improved safety profile compared with existing CNis. With the series D and E funds, LifeMind plans to launch a Phase II kidney transplant study of LIFE-001, as well as a Phase Ib trial in patients with type 1 diabetes receiving islet cell transplants. Both are slated to launch in early 2027. The goal of the earlier-stage study, Verdine said, is to see if LIFE-001 can replace tacrolimus in the immunosuppressant regimen given to patients with diabetes receiving a transplant. "This will give us an early indication of the ability of LIFE-001 to preserve islet cell graft and function, which is often challenging with tacrolimus," he added. New addition to managementAlongside the financing, LifeMine announced that Yves Zinggeler has been appointed chief commercial officer. He previously served as vice president and general manager of Vertex Pharmaceuticals' US Cystic Fibrosis Business Unit.

LifeMine Therapeutics, a biotechnology company led by serial entrepreneur Greg Verdine, said Thursday it raised $263 million in a pair of venture financings that will push a novel, protective treatment for organ transplants deeper into later clinical testing.To find that new drug,codenamed LIFE-001, LifeMine looked to a billion-year-old place: the fungal genome. Its the same starting point that led to the first statin, penicillin, and a widely used immunosuppressant called cyclosporine. While these and many other medicines are derived from fungi, LifeMine has for years been working to make the discovery process more systematic and repeatable, amassing a database of genomic information in the hopes of uncovering promising drug prospects.LIFE-001 is the result of that work. It acts on an enzyme called calcineurin, which is historically tough-to-drug and activates the immune systems T cells. Multiple treatments, such as tacrolimusand cyclosporine,prevent the body from rejecting transplanted organs byblocking calcineurins activity in some way. But they work by forcing together two proteins that otherwise wouldnt latch onto one another, an indirect molecular glue mechanism that causes a number of other issues. Tacrolimus, often used in patients receiving a kidney transplant, is associated with serious side effects such as tremors, seizures and post-transplant diabetes mellitus.Through its discovery work, LifeMine has come up with a compound, LIFE-001,that instead directly inhibits calcineurin by binding to a site that wasnt previously seen in the enzymes structure.Importantly, the drug doesnt appear to get into the brain or other peripheral tissues, which could make it safer than existing treatments.LIFE-001 is also designed as a long-acting injectable, whichflattens out the pharmacokinetics, so you don't have this oscillation between too much and too little suppression,“ Verdine said in an interview.Serial biotech entrepreneur Greg Verdine is the CEO of LifeMine Therapeutics.Permission granted by LifeMine TherapeuticsLifeMine is evaluating the safety of LIFE-001 in an ongoing Phase 1 study. It plans to advance the experimental drug into a Phase 2 study involving people who have undergone a kidney transplant, as well as a Phase 1b trial of those receiving islet cell transplants to manage conditions such as type 1 diabetes or chronic pancreatitis. Data in islet transplant recipients could come by the end of 2027, while results from the kidney transplant study are expected in 2028.Following LIFE-001 is a second program for autoimmune disorders. Though LifeMine has explored the possibility of using its lead asset to treat conditions like Crohns disease and lupus nephritis, Verdine said it opted not to given the crowded and competitive landscape.Transplantation is a major opportunity that was hiding in plain sight that everyone just overlooked, he said.Though LifeMine is early in its development journey, the company is considering eventually selling LIFE-001 on its own, according to Verdine. LifeMine hasnt ruled out an initial public offering, either, though it would wait until accumulating data from its first two human studies.Formed in 2017, LifeMine is one of many drug startups co-founded by Verdine, a former Harvard University chemical biologist. Others include two publicly traded drug developers Parabilis Medicinesand Wave Life Sciences as well as Warp Drive Bio, which Revolution Medicinesacquired in 2018.In 2023, Verdines company inked a research collaboration with GSK. Including the venture funding announced Wednesday, the biotech has raised roughly $580 million in private financing.About $75 million of that total came from a Series D financing LifeMine raised in the fourth quarter of 2025. The rest is in the form of a $188 million Series E round led by Milky Way Investments and involving Jeff Bezos investment firm Bezos Expeditions, Gates Frontier, GV, RA Capital Management and Arch Venture Partners, among others. '