XOMA 213 (formerly LFA 102) is a first-in-class allosteric inhibitor of prolactin action. It is a humanized IgG1-Kappa monoclonal antibody that binds to the extracellular domain of the human prolactin receptor with high affinity at an allosteric site. The antibody has been shown to inhibit prolactin-mediated signaling, and it is potent and similarly active against several animal and human prolactin receptors.
We discovered XOMA 213 under our collaboration with Novartis AG (“Novartis,” formerly Chiron Corporation), and we exercised our right to bring the product back into our portfolio to develop it for diseases of hyperprolactinemia. In particular, we are developing our product for prolactinoma, a condition of benign tumors on the pituitary gland that leads to hyperprolactinemia-induced sexual dysfunction, infertility, and osteoporosis, as well as anti-psychotic-induced hyperprolactinemia, a side effect seen in patients treated with commonly used antipsychotics, antidepressants, and pain medications.
For 20 percent of the 140,000 prolactinoma patients in the United States, existing therapies are poorly tolerated or not amenable to treatment with existing therapy. Anti-psychotic-induced hyperprolactinemia is a side effect seen in patients treated with commonly used antipsychotics, antidepressants, and pain medications. As patients exhibit the same signs and symptoms as prolactinoma, compliance with anti-psychotic therapies is poor. Currently available therapies to address these side effects can worsen psychosis.
We initiated a Phase 2 POC study for XOMA 213 in June 2016, which, if successful, will allow us to advance the compound into a Phase 2 study for prolactinoma and potentially into anti-psychotic medication-induced hyperprolactinemia. More information on the XOMA 213 clinical trial may be found at www.clinicaltrialsregister.eu.