VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel Toll-like receptor 8 (TLR8) immunotherapies, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.
Earlier this year, the FDA had already granted Orphan Drug designation to motolimod for the treatment of ovarian cancer.
Classified as one of the most lethal gynecologic cancers, ovarian cancer registers an estimated 22,240 new cases every year in the US alone. Women who have recurrent ovarian cancer, usually relapse after 6-12 months of treatment, urging the medical community to develop new and improved therapeutic options.
TLR receptors are present in cells of the innate immune system, recognizing structurally conserved molecules derived from microbes and activating human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells. This results in the production of immune mediators responsible to begin innate and adaptive immune responses. Motolimod is a novel agonist specific for TLR8, one of the 13 known TLRs, currently being tested in two randomized, placebo-controlled Phase 2 trials. So far, preclinical results have demonstrated that combining motolimod with PLD, a formulation of doxorubicin which has a prolonged circulation time and unique toxicity profile, provides a synergistic effect in stimulating a variety of immune pathways associated with antitumor activity.
VentiRx has completed enrollment of over 290 patients in the GOG-3003 clinical trial of motolimod in combination with PLD in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy, with a primary endpoint set as overall survival.
Additionally, a second trial, Active8, is testing motolimod in patients with locally advanced and metastatic squamous cell carcinoma of the head and neck.
“The Fast Track designation is an important regulatory milestone for the motolimod program and underscores the potential for this novel agent to address a significant unmet medical need for women with ovarian cancer who have progressed on or recurred after receiving platinum-based chemotherapy. We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer,” Robert Hershberg, MD, PhD, President and CEO of VentiRx said in a PR NewsWire press release.