Minerva Biotechnologies Announces FDA Acceptance of IND Application for huMNC2-CAR44 T cells to Treat Metastatic Breast Cancer

June 24, 2019 |

1 min read

Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain.

June 24, 2019 13:00 UTC

WALTHAM, Mass.--(BUSINESS WIRE)-- Minerva Biotechnologies Corporation, a biopharmaceutical company focused on developing immunotherapies for cancer and cellular therapies in regenerative medicine, announced today that the U.S. FDA (Food and Drug Administration) has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR44, an autologous CAR T cell therapy for solid tumors. huMNC2-CAR44 targets MUC1* (muk one star), a cleaved form of MUC1 present on over 75% of solid tumor cancer cells. Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7_AB binds to and dimerizes its truncated extracellular domain.

Minerva intends to commence clinical trials in breast cancer before the end of 2019. “We are delighted that we will soon be able to begin human clinical trials for metastatic breast cancer,” said Minerva CEO Dr. Cynthia Bamdad. “Over 95% of breast cancers are positive for MUC1*, and this cancer immunotherapy has the potential to bring hope to the many thousands of patients battling this terrible disease.”

Minerva’s chimeric antigen receptor (CAR) technology genetically engineers the patient’s own immune cells to recognize and kill specific types of cancer cells. The homing device on the CAR is an antibody that can distinguish the tumor-associated cleavage product, MUC1*, from the normal, full-length MUC1. Previous attempts to make cancer therapeutics that target MUC1 have failed, we believe, because they have targeted the a portion of full-length MUC1, which on tumor cells is cleaved, then shed and released form the cancer cell surface. Minerva has an extensive patent portfolio covering the part of MUC1 that remains on cancer cells (MUC1*) which is a powerful growth factor receptor, its activating ligands, and next generation CAR T technology.