Biotech company LifeMine Therapeutics has raised $263 million to support clinical development of LIFE-001, an experimental therapy designed to prevent organ transplant rejection.

The financing includes a $188 million Series E round and a previously completed $75 million Series D round. The funds will support planned Phase 2 development in kidney transplantation and a Phase 1b study in islet cell transplantation.

LifeMine is developing LIFE-001 as a next-generation calcineurin activation inhibitor (CNai), a new approach aimed at avoiding some of the toxicities associated with existing calcineurin inhibitors used to prevent transplant rejection.

New approach targets transplant immunosuppression

Calcineurin inhibitors, including tacrolimus and cyclosporin, have been widely used for decades to prevent the immune system from attacking transplanted organs. However, long-term use can be associated with complications including kidney damage and metabolic and cardiovascular effects.

LifeMine said LIFE-001 is designed to directly inhibit calcineurin activation without relying on immunophilin proteins, which are involved in the mechanism of current calcineurin inhibitors.

The company is evaluating LIFE-001 in a Phase 1 single ascending dose and multiple ascending dose study involving more than 120 adults.

Gregory Verdine, co-founder, president and chief executive officer of LifeMine, said: “As the first proof point of our discovery engine, LIFE-001 is designed to overcome the limitations of legacy calcineurin inhibitors through the direct inhibition of calcineurin activation without relying on intermediary immunophilin proteins.”

The company said no clinically meaningful renal, metabolic or cardiovascular safety signals have been observed to date in the ongoing Phase 1 study.

Funding will support clinical expansion

The Series E financing was led by Milky Way Investments, with participation from new investors including Bezos Expeditions, Gates Frontier and RA Capital Management.

Existing investors including GV, LoLa Capital Partners, GSK, Invus and ARCH Venture Partners also participated.

The company plans to use the funding to advance LIFE-001 into later-stage clinical studies, including a Phase 2 kidney transplant study and a Phase 1b islet cell transplant study expected to begin in early 2027.

Andrew Cameron, surgeon-in-chief at Johns Hopkins Hospital, said: “Calcineurin inhibition remains the gold standard for preventing organ rejection, but today’s therapies come with substantial toxicities that can compromise long-term patient outcomes because transplant recipients typically remain on these medicines for life.”

LifeMine expands leadership team

Alongside the financing announcement, LifeMine has appointed Yves Zinggeler as chief commercial officer.

Zinggeler joins from Vertex, where he served as vice president and general manager of the US cystic fibrosis business unit. The company said additional appointments in transplant clinical development and translational medicine have also strengthened its leadership team.

LifeMine said LIFE-001 represents the first clinical programme from its discovery platform, which uses genomic approaches inspired by fungal biology to identify potential medicines.

The company is now preparing for additional clinical studies as it continues development of LIFE-001 for organ transplantation.