huMNC2-CAR22 / Minerva Biotech - LARVOL DELTA

First-in-human autologous CAR-T for metastatic breast cancers to target growth factor receptor MUC1*. (ASCO 2024) - P1 | "All patients receive 300 mg/m 2 cyclophosphamide and 30 mg/m 2 fludarabine for 3 days prior to CAR-T treatment...Based on responses of initial huMNC2-CAR44 patients, inclusion criteria were amended to an Enrichment Trial Design...Based on IHC analysis of human breast cancer TMAs, the H-score restriction would include roughly 40% of breast cancers. The increased ability of huMNC2-CAR22 to kill low antigen expressing cancer cells may support future studies of patients expressing low levels of MUC1*."

IO biomarker • Metastases • P1 data • Breast Cancer • Novel Coronavirus Disease • Oncology • Solid Tumor • MUC1

Phase I first-in-human MUC1* targeted autologous CAR T cells for the treatment of metastatic breast cancers (AACR 2024) - "Purpose: First-in-human Phase I study for advanced MUC1* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which specifically bind to a cleaved form of MUC1 (MUC1*); evaluate the safety and preliminary anti-tumor activity. MUC1* (muk 1 star) is the growth factor receptor form of MUC1, created by cleavage and release of the N-terminal portion of MUC1. These data support a conclusion that the MUC1* antibody, huMNC2, is safe and could have high therapeutic value as a CAR T treatment for solid tumors with moderate to high antigen density. As the huMNC2-CAR22 (1XX) trial proceeds, we will assess if patient responses mirror our animal results that show that the 1XX mutations confer increased persistence, reduced exhaustion and the ability to kill tumors with low antigen density."

CAR T-Cell Therapy • IO biomarker • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • CD8 • MUC1

1st-in-human CAR T targets MUC1 transmembrane cleavage product (SABCS 2023) - P1 | "Background: huMNC2-CAR44 and huMNC2-CAR22 are autologous CAR T cell therapies under study in an ongoing 1st-in-human trial for metastatic breast cancers (NCT04020575), being performed at City of Hope...Patients receive cyclophosphamide (300 mg/m2/day) and fludarabine (30 mg/m2/day) for 3 days prior to CAR T cell infusion...Determine MTD/RP2D. Contact: City of Hope Comprehensive Cancer Center Joanne Mortimer, MD 1-800-826-4673 Minerva18625@coh.org"

Breast Cancer • HER2 Breast Cancer • HER-2 • MUC1 • PGR

Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*) (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: Minerva Biotechnologies Corporation | Trial primary completion date: Jan 2023 ➔ Jan 2025

Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • MUC1 • PGR

Phase I/II Trial of MUC1*-CAR-1XX T Cells (ASGCT 2023) - "Results to date of huMNC2-CAR44 Phase I/II trial validate this new target, MUC1*, for cellular therapies for the treatment of solid tumor cancers. We expect huMNC2-CAR22 to be a significant improvement over its predecessor, huMNC2-CAR44, based on its greatly increased persistence, reduced CRS in human as well as its ability to kill low antigen expressing cancer cells."

P1/2 data • Breast Cancer • Oncology • Solid Tumor • CD19 • MUC1

Minerva Biotechnologies Gets FDA Approval of IND for a MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers (Businesswire) - "Minerva Biotechnologies...announced today that the FDA has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR22, aka MUC1*-CAR-1XX, for the treatment of metastatic breast cancers. huMNC2-CAR22 targets MUC1* (muk 1 star), the growth factor receptor that drives the growth and metastasis of most solid tumor cancers....Unexpectedly, the 1XX mutations give the CAR T cells the added benefit of being able to recognize and kill the low antigen expressing cancer cells that lead to cancer recurrence."

IND • Breast Cancer • Oncology • Solid Tumor