Agreements will Accelerate BryoLogyx’s Path to Clinical Proof-of-Concept Study
GMP-Certified Bryostatin-1 to be Synthesized by Albany Molecular Research Inc.
DANVILLE, Calif.–(BUSINESS WIRE)–BryoLogyx Inc. today announced it has entered into two agreements with Neurotrope, Inc. (Nasdaq: NTRP) to acquire Neurotrope’s preclinical data package and drug product for use of bryostatin-1 in an immuno-oncology application, and to supply Neurotrope with synthetic bryostatin-1 for use in 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). Specific financial terms were not 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.” The agreements should position BryoLogyx 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 in a mouse model, resulted in improved treatment response and durability. Neurotrope will also transfer to BryoLogyx the Investigational New Drug (“IND”) application that is in development. 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, under a supply agreement, BryoLogyx will supply Neurotrope with 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.”
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 the Company from Stanford. This technology holds great promise for development of commercial scale quantities of bryostatin-1 at a cost much less than the cost of extracting natural bryostatin-1 from marine sources, which has proven prohibitive for commercial development.
About AMRI
AMRI, a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing. www.amriglobal.com
About BryoLogyx
BryoLogyx Inc. is advancing a new class of cancer immunotherapeutics. The Company’s lead compound, bryostatin-1, is being developed as a cornerstone of cancer immunotherapies to amplify the immune response, increase treatment durability, and improve outcomes. BryoLogyx has exclusive rights from Stanford University to intellectual property covering the synthesis and methods of use of bryostatin-1 in cancer and other diseases. Learn more at www.bryologyx.com.
Contacts
Thomas M. Loarie
CEO, BryoLogyx
tloarie@bryologyx.com
Peter Steinerman
Steinerman Biomedical
prsteinerman@gmail.com