Sorron Biopharma's Breakthrough Anticancer Drug DB102 (Enzastaurin) Accepted for Two Presentations at ASCO 2019 Annual Meeting

Biobeat1 has learned that on May 14, 2019, Sohuon Biomedicine, a leader in precision medicine, announced that two research studies on DB102 (enzastaurin) had been accepted by the American Society of Clinical Oncology (ASCO) and would be presented at the ASCO Annual Meeting held from May 31 to June 2019.

Introduction to ASCO

The American Society of Clinical Oncology (ASCO) is the world’s largest and most influential oncology organization. Its annual ASCO Annual Meeting brings together leading experts in clinical oncology research from around the globe and is widely recognized as the most important oncology academic conference worldwide. The ASCO Annual Meeting features presentations of the latest basic and clinical cancer research, discusses current advanced international treatment modalities and therapies, is committed to translating research findings into clinical practice, and continuously strives to improve healthcare quality. This year’s ASCO Annual Meeting will be held in Chicago from May 31 to June 4.

DB102 Overview

DB102 (Enzastaurin) is a first-in-class small-molecule serine/threonine kinase inhibitor targeting key oncogenic pathways, including PKCβ, PI3K, and AKT. Initially developed by the renowned international pharmaceutical company Eli Lilly, DB102 underwent a series of clinical studies for various tumors, including Phase II and Phase III trials in diffuse large B-cell lymphoma (DLBCL). While the Phase II trial demonstrated certain efficacy in the first-line treatment of DLBCL, the Phase III trial for maintenance therapy failed to meet its expected therapeutic endpoints. Upon detailed analysis of the clinical results, Suoyuan Biomedicine identified a subset of patients who benefited from DB102 treatment. Consequently, Suoyuan acquired the entire DB102 project from Eli Lilly, securing full global rights for its development, manufacturing, and commercialization.

Following the handover of the DB102 project, Suoyuan Biomedicine leveraged its reverse whole-genome scanning platform technology to conduct large-scale genomic analysis on samples from the Phase III clinical trial of DB102. By integrating clinical indicators with big data analytics, the company identified a novel set of biomarkers, DGM1. Patients positive for DGM1 demonstrated a highly significant improvement in survival after treatment with DB102.Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL). The current international standard of care is the R-CHOP regimen, which combines rituximab (R) with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Rituximab (brand name: MabThera/Rituxan), a blockbuster monoclonal antibody developed by Roche, has seen rapid sales growth since its U.S. launch in 1997, with annual sales exceeding $7 billion by 2012. However, while R-CHOP yields excellent outcomes for DLBCL patients with lower prognostic risk, its efficacy remains suboptimal for those at high risk.Suoyuan Biomedicine discovered that high-risk patients who are DGM1-positive achieved significantly higher overall survival rates when treated with R-CHOP in combination with DB102, compared to those receiving R-CHOP alone. Based on these encouraging analytical results, and following approvals from the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), Suoyuan Biomedicine initiated an international, multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in 2018 to evaluate DB102 as a first-line treatment for DLBCL. This marked the first global Phase III trial of a first-in-class precision medicine-led new drug conducted by a Chinese pharmaceutical company.Furthermore, building on the analysis of DLBCL samples, Suoyuan also analyzed clinical trial data for DB102 in the treatment of glioblastoma multiforme (GBM). The analysis revealed that newly diagnosed GBM patients who are DGM1-positive benefit from a therapeutic regimen combining DB102 with temozolomide.

According to relevant statistics, the 4-year survival rate for patients with diffuse large B-cell lymphoma (DLBCL) is 55%, while the median overall survival for patients with glioblastoma multiforme (GBM) is only 15 months. No new therapies have been introduced for these two indications since the late 1990s. For patients with high-risk DLBCL and GBM, the current internationally recognized standard treatments—R-CHOP for DLBCL and temozolomide for GBM—demonstrate suboptimal efficacy, leaving a significant unmet clinical need. Suoyuan Biomedicine hopes that DB102, guided by DGM1, will provide more effective therapeutic options for these patients.

About Suoyuan Biomedicine

Suoyuan Biomedicine (Hangzhou) Co., Ltd. is a leading precision medicine enterprise that develops Class 1 novel drugs through a rapid and efficient model. Registered in the Hangzhou Economic and Technological Development Zone, China, the company has its clinical operations center in Beijing and a wholly-owned subsidiary, Denovo Biopharma LLC, in San Diego, California, USA. The core of precision medicine lies in the precise classification of patients with the same disease based on their genotypes or other biomarkers to determine the most appropriate medication, thereby maximizing therapeutic efficacy.Suoyuan Biomedicine licenses new drugs from major international pharmaceutical companies that have demonstrated safety in late-stage clinical trials and shown efficacy in subsets of patients. Leveraging its proprietary biomarker platform technology, the company conducts large-scale genomic analyses of DNA samples from clinical trials. By combining these data with clinical indicators and applying artificial intelligence algorithms such as machine learning, Suoyuan identifies biomarkers predictive of drug response. Using these newly discovered biomarkers as companion diagnostics to screen patients, Suoyuan Biomedicine can re-initiate clinical trials in sensitive patient populations. This approach optimizes efficacy, safety, and tolerability, increases the success rate of new drug development, and achieves the goal of developing innovative drugs at lower costs and in shorter timeframes.In addition to DB102 (enzastaurin), Suoyuan Biomedicine holds global rights to DB103 and DB104, two other innovative drugs that have reached late-stage clinical development. Both are first-in-class global innovations. DB103 (pomaglumetad), originally developed by Eli Lilly for the treatment of schizophrenia, is currently undergoing clinical trials in collaboration with world-renowned institutions Columbia University and the University of California, Los Angeles (UCLA), under funding from the NIH/NIMH. The company has also obtained clinical trial approval from the China National Medical Products Administration (NMPA). DB104 (liafensine) is an antidepressant drug licensed from ARMI/Bristol-Myers Squibb (BMS).