An Investigational New Drug Application for tetulomab injection has been opened with the U.S. Food and Drug Administration (FDA) for a second indication in the treatment of non-Hodgkin lymphoma (NHL). Tetulomab consists of the tumor-specific antibody HH1 that targets the CD37 antigen on the surface of NHL cells. The application is based on the results of a phase I, dose-finding trial of tetulomab in patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are ineligible for hematopoietic cell transplantation. Investigators plan to enroll 24 patients in the United States and Europe. The study uses a conventional 3+3 dose-escalating design to identify an optimal dose of tetulomab for patients pre-dosed with unconjugated cold HH1 anti-CD37 antibody. In approving this application, the FDA requested that an additional 3+3 cohort be included at the start of the phase II study to investigate a regimen involving an intermediate pre-dose of cold HH1 prior to tetulomab use in the DLBCL population.
Source: Nordic Nanovector press release, May 9, 2016.