VitsGen Therapeutics receives FDA ODD for FAP-Targeted Radiopharmaceutical 177Lu-FAP-VG11

CAR-T Digest - August 2020

26 October 2026: VitsGen Therapeutics receives FDA ODD for FAP-Targeted Radiopharmaceutical 177Lu-FAP-VG11

VitsGen Therapeutics announced that the U.S. FDA has granted Orphan Drug Designation to 177Lu-FAP-VG11 for the treatment of soft tissue sarcoma, marking a regulatory milestone for the company’s investigational FAP-targeted radiopharmaceutical
The designation supports the continued development of 177Lu-FAP-VG11 for STS, a heterogeneous group of cancers with limited treatment options in advanced disease. VitsGen plans to advance clinical development and generate evidence to assess the candidate’s therapeutic potential in STS and other FAP-expressing solid tumors
The program addresses an unmet need in advanced STS, where treatment options remain limited. Targeting fibroblast activation protein, which is expressed in the tumor microenvironment of multiple solid tumors, offers a differentiated approach to delivering radiation to tumor-associated tissues

177Lu-FAP-VG11 is a radionuclide drug conjugate comprising the FAP-targeting ligand FAP-VG11 chelated to lutetium-177. The radionuclide emits beta particles that induce DNA damage and cell death in targeted tissues, with additional potential antitumor activity through radiation crossfire and bystander effects. Preclinical studies reported increased tumor uptake and retention, an improved tumor-to-kidney uptake ratio, and enhanced tumor growth inhibition in animal models
Strategically, the designation advances VitsGen’s FAP-targeted radiopharmaceutical program and strengthens its efforts to develop RDCs for difficult-to-treat solid tumors. It also expands the regulatory progress of 177Lu-FAP-VG11 into the U.S. market, although its clinical safety and efficacy remain to be established