The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to bemdaneprocel, a cell therapy BlueRock Therapeutics, a subsidiary of Bayer, is developing to treat Parkinson's disease.

Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year.At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement.One year assessment of all participants demonstrated feasibility of transplantation, cell survival, and engraftment.Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.BERLIN and CAMBRIDGE, Mass., Aug. 28, 2023 /PRNewswire/ -- Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today details of the positive data from the Phase I clinical trial for bemdaneprocel (BRT-DA01), a stem cell derived investigational therapy for treating Parkinson's disease. The data were presented at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study's low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case. Both resolved without sequelae. In addition, 18F-DOPA PET imaging scans demonstrated evidence of cell survival and engraftment in both low and high dose cohorts

BlueRock and bit.bio link to develop regulatory T cell-based therapies.