China Approves Bayer's New Drugs for Late-Stage Tumors and Acute Stroke Trials

Bayer recently received clinical trial approvals from the China Center for Drug Evaluation (CDE) for two innovative Class 1 drugs targeting late-stage solid tumors and acute ischemic stroke. These advances underscore Bayer's commitment to addressing critical medical needs through its extensive pipeline of novel therapeutic candidates.

One of the newly approved drugs is a diacylglycerol kinase alpha (DGKα) inhibitor, currently designated as BAY 2862789. This small-molecule drug, developed in collaboration with the German Cancer Research Center (DKFZ), is now in its first-in-human Phase 1 clinical trial. It is positioned to address the treatment of solid tumors by inhibiting the DGKα enzyme, which plays a pivotal role in T-cell and natural killer (NK) cell development and function. DGKα is notably overexpressed in various resistant cancers, aiding in cell proliferation and preventing apoptosis, thereby contributing to immune evasion in late-stage cancers. Targeting DGKα offers a dual anti-cancer strategy by both suppressing cancer cell growth and enhancing T-cell activity. Moreover, this inhibitor is expected to synergize effectively with PD-1/PD-L1 inhibitors, potentially providing new treatment avenues for stubborn cancers.

The second drug, BAY 3018250, is a protein-based therapeutic aimed at treating acute ischemic stroke and pulmonary embolism. This candidate is part of Bayer's cardiovascular disease research portfolio and has shown significant progress in international Phase 2 clinical trials for deep vein thrombosis (DVT). DVT can cause severe complications, including potentially fatal blockages in the lungs. BAY 3018250 works by dissolving blood clots, addressing thrombotic vascular occlusion—a major factor in ischemic stroke. The drug targets α2-antiplasmin (α2AP), a protein linked to a higher risk of ischemic events and the failure of recombinant tissue plasminogen activator (rt-PA) treatment. Studies indicate that anti-α2AP therapy can markedly reduce microvascular thrombosis, brain injury, edema, intracerebral hemorrhage, and mortality following ischemic stroke. With this new approval in China, BAY 3018250 will undergo clinical evaluation specifically for acute ischemic stroke, potentially offering a new therapeutic option for this serious condition.

These approvals mark significant milestones in Bayer's efforts to innovate and bring forward new treatments for challenging health conditions. BAY 2862789 and BAY 3018250 each represent cutting-edge approaches in oncology and cardiovascular medicine, respectively. The DGKα inhibitor, with its potential to enhance immune responses against cancer, and the α2AP-targeting protein drug, poised to mitigate stroke complications, highlight Bayer's ongoing dedication to advancing medical science and improving patient outcomes.