Minerva Biotechnologies Announces Opening 1st-In-Human Phase I/II Trial of a MUC1* Targeting CAR T for Metastatic Breast Cancers at City of Hope

WALTHAM, Mass.--(BUSINESS WIRE)--Minerva Biotechnologies Corporation announced today that its trial of huMNC2-CAR44 T cells (NCT04020575) has now opened at City of Hope, Duarte, California. This is a first-in-human trial targeting the tumor-associated form of MUC1, called MUC1* (muk 1 star). MUC1* is the transmembrane cleavage product that is a growth factor receptor that drives growth of an estimated 93% of breast cancers. The antibody that targets Minerva’s CAR T to the tumor binds to an ectopic site that is only exposed after cleavage and release of the tandem repeat domain. Other attempts at targeting MUC1 with antibodies, ADCs, or CAR Ts have targeted the tandem repeat domain, which is cleaved in the tumor microenvironment and shed from the cell surface.

The huMNC2-CAR44 therapy was developed by, and is proprietary to, Minerva Biotechnologies. The targeting head of the CAR, the antibody MNC2, recognizes a unique conformation of MUC1 after cleavage by a specific enzyme in the tumor microenvironment. “The ability of our antibody to bind specifically to the cancerous form of MUC1 without binding to MUC1 on normal tissues is a real breakthrough,” said Dr. Cynthia Bamdad, CEO of Minerva Biotechnologies.

“Demonstration of safety and early signs of efficacy of huMNC2-CAR44 represent a significant milestone for Minerva. We have a broad, deep pipeline that includes next generation CAR Ts, with enhanced in vivo persistence, and the ability to target cells with much lower antigen density, allowing us to challenge the persistence issues seen elsewhere in the field. We can now progress these to the clinic with increased confidence. We are also developing therapeutics that target the onco-embryonic growth factor, NME7, that activates the MUC1* growth factor receptor across many different types of solid tumors and the preclinical results are very encouraging,” said Minerva Chief Business Officer, Michael Crowther.

We would like to express our gratitude to our collaborators, our scientists, and the patients and their physicians for their support and participation in this trial.

About the trial

NCT04020575 is a first-in-human trial of huMNC2-CAR44, an autologous CAR T therapy targeting MUC1* in metastatic breast cancer in patients with MUC1* reactive tumors. For more information about the trial, including the study description, inclusion/exclusion criteria, and intake contact information, visit: https://clinicaltrials.gov/ct2/show/NCT04020575 or contact Dr. Yuan Yuan 1-800-826-4673 or email [e-mail]