On December 12, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has recently received the approval from the Human Research Ethics Committee (HREC) in Australia, and the acknowledgement from Australia’s Therapeutic Goods Administration (TGA) on the Phase I clinical trial of CS3005 (Press release, CStone Pharmaceauticals, DEC 12, 2019, View Source [SID1234552336]). This Phase I trial is an open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CS3005 in patients with advanced solid tumors.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The tumor microenvironment (TME) is a cellular space in which the tumor dynamically interacts with the surrounding blood vessels, immune cells, stromal components, signaling molecules, and the extracellular matrix. Studies showed that multiple compensatory immunosuppressive mechanisms exist in the TME not only contribute to the development of tumors but also affect the response to immunotherapies. The adenosine signaling pathway plays a critical role in immune modulation and is an important compensatory resistance mechanism against immune checkpoint inhibitors.
Discovered by CStone, CS3005 is an adenosine A2a receptor antagonist that modulates the tumor immune microenvironment. CS3005 could potentially activate antitumor immunity and improve the response to immune checkpoint inhibitors by blocking the binding of adenosine with adenosine A2a receptors and thereby reversing the immunosuppressive mechanism. At present, no adenosine A2a receptor antagonist has been approved for cancer treatment anywhere in the world.
"I am pleased that the clinical trial of CS3005 has been approved in Australia. This drug candidate is the Company’s first tumor immune microenvironment modulator entering clinical development as we have begun to roll out CStone’s Pipeline 2.0," said Dr. Frank Jiang, Chairman and CEO of CStone. "Immuno-oncology therapy has brought new hope to cancer patients in recent years, yet many patients fail to respond to those treatments. We are hopeful that the research and development of tumor microenvironment modulators will allow immunotherapies to benefit more patients."
CStone’s Chief Scientific Officer, Dr. Jon Wang, noted: "Early studies on adenosine A2a receptor antagonists have shown good safety profiles and antitumor activities, either as monotherapies or in combination with immune checkpoint inhibitors, in patients with advanced solid tumors. Interestingly, adenosine A2a receptor antagonists have also demonstrated antitumor activities in patients with low PD-L1 expressing tumors or who are resistant/refractory to anti-PD-(L)1. These observations implicate possible benefits to patients with solid tumors. CS3005 also adds to the depth and flexibility of CStone’s strategy in immuno-oncology combination therapy."