German biotechnology company Allogenetics has raised approximately $4.4 million in a Pre-Series A financing round to advance an ex vivo gene therapy designed to reduce organ rejection and potentially eliminate the need for lifelong immunosuppressive treatment following transplantation. Allogenetics plans to use the proceeds to move its lead program, ALG-115, through IND-enabling studies and toward first-in-human testing in lung transplantation. The company currently expects clinical development to begin between the end of 2027 and early 2028.

Allogenetics is pursuing a different strategy from conventional transplant medicine by modifying the donor organ before it is implanted into the recipient. ALG-115 is administered ex vivo, with the objective of reducing expression of major histocompatibility complex (MHC) class I and class II molecules on cells within the donor organ.

These molecules play an important role in antigen presentation and recognition by the immune system. By reducing their expression, Allogenetics aims to alter how the recipient’s immune system responds to the transplanted tissue while retaining sufficient immune function. The ultimate goal is to prevent rejection without requiring recipients to remain on immunosuppressive medicines indefinitely.

“By tackling key challenges in organ transplantation from a different angle, we believe our new concept has the potential to change the treatment paradigm and address major challenges such as graft rejection and the side effects of long-term immunosuppression,” says Oliver Ernst, PhD, Chief Executive Officer of Allogenetics.

Organ transplantation has advanced considerably, but maintaining a functioning graft over the long term remains difficult. Patients typically depend on immunosuppressive drugs to prevent their immune systems from attacking the transplanted organ. While effective at reducing rejection, chronic immunosuppression can expose patients to significant adverse effects and creates a lifelong treatment and adherence burden. Allogenetics is attempting to shift the intervention point from the recipient to the organ itself. Rather than suppressing the patient’s immune system systemically, the company’s approach seeks to make the transplanted tissue less recognizable as a target for immune-mediated rejection.

The company says ALG-115 has generated encouraging results in preclinical studies, including an eight-year survival outcome in a pig model of lung transplantation without the use of immunosuppressants. Allogenetics believes these findings support further development of its organ-directed approach and provide a foundation for advancing ALG-115 toward clinical testing. The initial clinical focus will be lung transplantation, where long-term graft function and rejection remain significant challenges.

The company’s near-term development plan centers on completing the studies necessary to support an IND and preparing ALG-115 for first-in-human evaluation. If successful, the approach could represent a shift away from managing rejection primarily through lifelong systemic immunosuppression and toward modifying the transplanted organ before it reaches the patient.

For more information, visit https://www.allogenetics.com/.