BryoLogyx Inc. has entered into two agreements with Neurotrope, Inc. to acquire Neurotrope’s preclinical data and drug product bryostatin-1 for an immuno-oncology application, and to supply Neurotrope with synthetic bryostatin-1 for clinical trials and commercialization for the treatment of Alzheimer’s disease and other neurodegenerative diseases. Neurotrope has been developing bryostatin-1 under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Financial terms were not disclosed.

Neurotrope will transfer to BryoLogyx the right to develop bryostatin¬ 1 for the potential treatment of CD22+ B-cell acute lymphoblastic leukemia (ALL). Bryostatin-1 has been shown to increase CD22 expression levels in leukemia patients, and in a mouse model, resulting in improved treatment response and durability. Neurotrope will also transfer the Investigational New Drug application that’s in development. BryoLogyx will be responsible for the IND going forward and will pay a fee on gross revenues generated by the commercial sale of bryostatin-1 product sold by BryoLogyx for the treatment of ALL.

“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.” The agreements should position BryoLogyx to begin clinical trials with the NCI in late 2020.

Under a supply agreement, BryoLogyx will supply specified amounts of synthetic, GMP-grade bryostatin-1 for manufacture of drug product to be used 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,” said Christopher Conway, AMRI President. “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.”