BryoLogyx, Inc. today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), to conduct a Phase I clinical trial with bryostatin-1 in pediatric and young adult patients with relapsing or refractory CD22 expressing acute lymphoblastic leukemia (ALL) and lymphoma. The study, expected to start later this year, will be the first in patients to evaluate the ability of bryostatin-1 to upregulate expression of CD22, a cancer immunotherapy target often downregulated following antibody drug conjugate or CAR T adoptive therapies. The Company is planning future clinical trials with bryostatin-1 to evaluate its ability to upregulate other antigen targets associated with B cell hematological malignancies.
"This CRADA provides an accelerated path to demonstrating clinical proof-of-concept for our innovative approach that enhancing the response to cancer immunotherapy can be achieved by increasing expression of antigen targets," said Thomas M. Loarie, CEO of BryoLogyx. "Our collaboration builds on NCI’s pioneering work showing that relapse in patients undergoing ALL treatment with a CD22-directed CAR T therapy is associated with reduced CD22 antigen expression; and that in preclinical studies, bryostatin-1 upregulates CD22 density on the cancer cell, improves CAR T functionality, duration of response, and survival in CAR T-treated human xenograft models."
Under the CRADA, NCI researchers will test bryostatin-1 to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ ALL and lymphoma, while specifically evaluating its safety, defining the optimal biologic dose required to lead to an increase in CD22 site density, and anti-leukemic properties.
Mr. Loarie noted that BryoLogyx plans to follow this CRADA study with additional trials to expand the understanding of how bryostatin-1 increases tumor antigen expression and amplifies the immune response to several immune-oncology therapies in a variety of hematologic cancers.
The CRADA follows recent agreements entered into by BryoLogyx with Neurotrope to acquire a preclinical data package for a BryoLogyx-sponsored IND, along with study drug for the clinical trial.
BryoLogyx Inc. is advancing a new class of cancer immuno-therapeutics. 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 invested heavily to scale the patented bryostatin-1 synthesis technology from Dr. Paul Wender at Stanford University, and has exclusive rights from there to intellectual property covering the synthesis and methods of use of bryostatin-1 in cancer and other diseases; this agreement has at present made the Company the sole global source of synthetic bryostatin-1. 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.
Learn more at www.bryologyx.com.
Thomas M. Loarie