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BlueRock\u2019s Cell Therapy to Treat Heart Failure","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"BlueRock Therapeutics","sponsor":"Bayer AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bluerock\u2019s Neuronal Stem Cell Therapy for Parkinson\u2019s Disease is First to Show Positive Results in Phase I Clinical Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"BlueRock Therapeutics","sponsor":"Bit Bio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BlueRock Therapeutics and Bit.Bio Announce Collaboration and Option Agreement for the Discovery and Manufacture of Regulatory T Cell (Treg) Based Therapies","therapeuticArea":"Immunology","highestDevelopmentStatus":"Discovery Platform","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Discovery Platform"},{"orgOrder":0,"company":"BlueRock Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BlueRock\u2019s Phase I Study with Bemdaneprocel in Patients with Parkinson\u2019s Disease Meets Primary Endpoint","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"BlueRock Therapeutics","sponsor":"Fujifilm Cellular Dynamics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BlueRock Therapeutics Exercises Exclusive Option to License IPSC Cell Therapy Candidate OpCT-001 for Treating Primary Photoreceptor Diseases from FUJIFILM Cellular Dynamics and Opsis Therapeutics","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"BlueRock Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BlueRock Therapeutics Phase I Clinical Trial for Parkinson\u2019s Disease Continues to Show Positive Trends at 18 Months","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"}]
Find Clinical Drug Pipeline Developments & Deals by BlueRock Therapeutics
Bemdaneprocel (BRT-DA01) is an investigational allogeneic stem cell derived cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease.
Under the agreement, BlueRock exercised its option to exclusively license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for the treatment of primary photoreceptor diseases.
BRT-DA01 (bemdaneprocel) is an investigational therapy comprised of dopamine producing neurons derived from pluripotent stem cells, is surgically implanted into the brain of a person with Parkinson’s disease.
Under the agreement, bit.bio will use its machine learning powered discovery platform to identify transcription factor combinations for reprogramming iPSCs into Tregs, for the discovery and manufacture of iPSC-derived regulatory T cells for use in creating therapeutics.
Lead Product(s):
iPSC-derived T-cell Based Therapy
BRT-DA01 (bemdaneprocel), is an investigational therapy comprised of dopamine producing neurons derived from pluripotent stem cells, is surgically implanted into the brain of a person with Parkinson’s disease.
The agreement has an option to negotiate for a non-exclusive world-wide license to BioCardia biotherapeutic delivery product candidates for certain cell types for cardiac indications and is time limited.
The primary objective of the Ph1 trial is to assess the safety and tolerability of BRT-DA01 transplantation at one-year post-transplant. The secondary objectives are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant.
The purpose of the Ph1 clinical trial is to evaluate the safety, tolerability and preliminary efficacy of DA01. DA01 is being clinically evaluated in a subset of patients with advanced Parkinson’s disease, where regular medications are no longer fully effective.
The primary objective of the Ph1 trial is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives, are to assess the evidence of transplanted cell survival and motor effects at one and two-years post-transplant.
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