Iovance Biotherapeutics (NASDAQ:
IOVA) perks up
4% premarket on light volume in reaction to
positive developments on the regulatory pathway for Fast Track- and Breakthrough Therapy-tagged LN-145.
Based on FDA feedback from its End of Phase 2 meeting with the agency, the company says its ongoing Phase 2
innovaTIL-04 study in cervical cancer may be sufficient to support a U.S. marketing application based on a clearer definition of the patient population, specifically, patients who have progressed following first-line systemic treatment for recurrent/metastatic cervical cancer. This population comprises almost all of the advanced patients enrolled in the trial to date.
LN-145 is a tumor-infiltrating lymphocyte therapy derived from the patient’s own immune cells (T lymphocytes). The cells are isolated from the patient’s tumor, expanded in the laboratory, then infused back into the patient where they recognize and kill cancer cells. Patients also receive pre-conditioning therapy to reduce the immune suppressive environment of the cancer and up to six doses of interleukin 2 (IL-2) after LN-145 infusion to support the growth and activation of the TIL therapy.
The company expects to file its BLA in H2 2020.
