SAN DIEGO, April 28, 2020 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it is acquiring Tocagen's retroviral replicating vector platform (RRV) in its entirety, including its investigational gene therapy and drug regimen for oncology: Toca 511 and Toca FC (now known as DB107), and several early-stage development programs, including programs targeting PD-L1 and other immunooncology targets. This acquisition is pending the close of Tocagen's anticipated merger with Forte Biosciences. These programs greatly expand Denovo's product portfolio into gene therapy and immunooncology, yet remain consistent with Denovo's precision medicine approach.
The lead acquired asset, DB107, is an innovative approach utilizing a proprietary gene therapy platform, RRV, combined with a prodrug, to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high grade glioma and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. Although the Phase 3 trial results were negative overall, there were subsets of patients who showed signs of beneficial activity of DB107. After the acquisition, Denovo will use its unique biomarker platform to search for pharmacogenomic predictor for DB107 efficacy.
"With this strategic acquisition, Denovo gains a pioneering gene therapy platform with unlimited potential. Together with Denovo's world leading precision medicine capabilities, the RRV platform along with lead product candidate DB107 presents us with an unprecedented opportunity to effectively target a wide range of oncology indications," said Wen Luo, Ph.D., Denovo's Chief Executive Officer. "DB107's Phase 3 trial aimed to treat recurrent high grade glioma, which primarily consists of glioblastoma (GBM). This asset, together with our DB102 asset to be tested in the front-line treatment of GBM, positions Denovo as a leader in the field of neuro-oncology that continues to have a high unmet need."
"We are pleased to have a company with the capabilities of Denovo Biopharma acquiring our gene therapy platform technology to build upon the work that was done by our employees and investigators, as well as the patients in our clinical trials," said Marty J. Duvall, Tocagen's Chief Executive Officer.
About Denovo Biopharma
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients' responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and will start a Phase 2B study in Glioblastoma (GBM) for its lead product candidate, DB102, which was in-licensed from Eli Lilly. The company has five additional late stage programs targeting major unmet needs: DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer's Disease, DB106 for acute myeloid leukemia (AML) and DB107 for recurrent high grade glioma. For additional information please visit www.denovobiopharma.com.
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
SOURCE Denovo Biopharma LLC