Mesothelioma Immunotherapy Receives Orphan Drug Designation

A novel therapy for mesothelioma has been given orphan drug designation by the U.S. Food and Drug Administration.  Avenge Bio, a biotechnology company working on a new treatment platform for immunotherapy, announced it was granted the designation for its drug  AVB-001 in June. It is currently enrolling patients in ongoing phase 1 and phase 2 clinical trials for the treatment of advanced ovarian cancer, primary peritoneal mesothelioma and fallopian tube cancer. AVB-001 is a new treatment being developed by Avenge Bio using its LOCOcyte immunotherapy platform to treat solid tumors. It’s a first-in-human, single-arm, open-label, dose-escalation and expansion trial that is looking to assess the safety and tolerability for certain cancer patients.  Clinical Trials Now Enrolling Avenge Bio is now enrolling an estimated 44 patients into its two-part clinical trial. The first phase is a dose escalation phase to determine the maximally tolerated dose and will be used for phase 2, a dose expansion phase.  The drug will be administered in up to 20 additional adult patients with “platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube,” according to the company’s clinical trial information. There may be additional cohorts opened in phase 2 for “monotherapy or as an exploratory combination strategy.” The study began in December 2022 and is estimated to be completed in August 2026. Among oth...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Tags: Clinical Trials/Research/Emerging Treatments Source Type: news