DANVILLE, Calif.—BryoLogyx Inc. reported that the company has entered into two agreements with Neurotrope, Inc., the first being the acquisition of Neurotrope’s preclinical data package and drug product for use of bryostatin-1 in an immuno-oncology application. The second agreement will see BryoLogyx supply Neurotrope with synthetic bryostatin-1 for use in clinical trials and commercialization, for the treatment of Alzheimer’s disease and other neurodegenerative diseases. No specific financial terms of the agreements were disclosed.
“BryoLogyx is capitalizing on recent advances demonstrating that bryostatin-1 has great promise in amplifying the immune response to cancer immunotherapies by multiple mechanisms, including increasing tumor antigen expression,” said Thomas M. Loarie, CEO of BryoLogyx. “These two agreements with Neurotrope will accelerate our drive to clinical trials to demonstrate proof-of-concept in patients.”
Neurotrope has been developing bryostatin-1 under a Cooperative Research and Development Agreement with the National Cancer Institute (NCI). BryoLogyx believes that the agreements should position the company to begin clinical trials with the NCI in late 2020.
Under the first agreement, Neurotrope will transfer to BryoLogyx the right to develop bryostatin‑1 for the potential treatment of CD22+ B-cell acute lymphoblastic leukemia (ALL). Relapsed ALL in CD22 CAR-T treated patients has been associated with reduced CD22 antigen density. Bryostatin-1 has been shown to increase CD22 expression levels in leukemia patients, and resulted in improved treatment response and durability in a mouse model.
Neurotrope will also transfer to BryoLogyx the Investigational New Drug (IND) application in development with the U.S. Food and Drug Administration. BryoLogyx will be responsible for the IND going forward, and will pay a nominal fee on gross revenues generated by the commercial sale of bryostatin-1 product sold by BryoLogyx for the treatment of ALL.
In return, BryoLogyx will supply Neurotrope with specified amounts of synthetic, GMP-grade bryostatin-1 for manufacture of drug product for use in clinical trials for treating Alzheimer’s and other neurological diseases. Bryostatin-1 will be chemically synthesized by Albany Molecular Research Inc. (AMRI) in collaboration with BryoLogyx.
“AMRI is privileged to be selected for this complex commercial synthesis, the first ever to be conducted for bryostatin-1. Bryostatin-1 is based from a rare marine resource; our ability to provide GMP-level material for a clinical studies program should greatly reduce the cost, and minimize related supply chain risks, for this promising therapeutic,” added Christopher Conway, president of AMRI.
BryoLogyx is currently the sole global source of synthetic bryostatin-1. The company has invested heavily to scale the patented bryostatin-1 synthesis technology developed by Dr. Paul Wender at Stanford University and licensed by BryoLogyx from Stanford. This technology holds great promise for development of commercial scale quantities of bryostatin-1 at significantly less cost than extracting natural bryostatin-1 from marine sources, which has previously proven prohibitive for commercial development.