BEIJING, September 25-29, 2021 — The 24th National Conference on clinical oncology and the 2021 CSCO annual conference will be held online and offline in the form of seminar and MDT discussion. The theme of this conference is "focus on innovative research and lead the future of originality". The conference will invite well-known experts and clinicians to share their latest scientific achievements and to communicate their practical experience.
The latest clinical research results of Eucure Biopharma’s anti-CTLA-4 monoclonal antibody (YH001) were selected into the special session of clinical research data of innovative drugs at the 2021 CSCO annual meeting. The key data of this clinical research will be presented in the form of oral and poster presentation.
Offline oral presentation
Title: A FIH phase I dose escalation study of YH001, an anti-CTLA-4 mAb, in combination with Toripalimab in patients with advanced solid tumors
Seminar branch: [CSCO innovative special session 2] clinical research data of innovative drugs, special session 2 – session 1
Date: September 28, 2021 (Tuesday)
Time: 14:15 – 14:25(CST)
Location: Shanghai venue
Speaker: Vinod Ganju, Professor, PSEHOG (Peninsula Health &South Eastern Hematology and Oncology Group)
Online poster presentation
Title: A FIH phase I dose escalation study of YH001, an anti-CTLA-4 mAb, in combination with Toripalimab in patients with advanced solid tumors
Number: 10427
First author: Vinod Ganju, Professor, PSEHOG (Peninsula Health &South Eastern Hematology and Oncology Group)
Brief description:
This clinical research is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of YH001 (an anti-CTLA-4 monoclonal antibody (mAb)) combined with Toripalimab (Tuoyi®, an anti-PD-1 mAb) in subjects with advanced solid tumors.
As of September 21, 2021, 21 subjects with advanced solid tumors were recruited in the study to receive escalated doses of YH001: 0.05 mg/kg（n=2）, 0.1 mg/kg（n=3）, 0.3 mg/kg（n=3）, 1 mg/kg（n=5）, 2 mg/kg（n=5）and 4 mg/kg（n=3）combined with fixed dose of Toripalimab (240 mg, Q3W), respectivedly, in order to evaluate the efficacy and safety of dose escalation of YH001. In this clinical research, there were no dose-limiting toxicity (DLT) events observed. Of all doses tested, except for one grade 3 treatment-related adverse event (AE), no other grade 3 or above treatment-related AE were observed. There were no treatment-related death observed either. YH001 is also safe and tolerable at a high dose of 4mg/kg. Of the 16 evaluable patients, 2 patients achieved partial response (PR), in the 0.3mg/kg and 2mg/kg groups respectively, and 7 patients reached stable disease (SD).
YH001 combined with Toripalimab showed excellent safety and encouraging clinical efficacy which support further clinical development of YH001.
About YH001
YH001 is an IgG1 antibody against CTLA-4 that possesses enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 possessed higher affinity for CD80/86 expressing cells, superior ADCC activity and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756). In July 2021, U.S. Food and Drug Administration (FDA) has approved the phase II clinical trials for YH001 in the United States.
China Clinical trial of YH001 has started in January 2021. In the first-in-humann (FIH) monotherapy study in China, safety and efficacy of YH001 are evaluated in advanced tumor patients. It will provide data support for extending indications in other solid tumors including non-small-cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC) in the future so that to benefit more Chinese patients. Up until now it has completed three-dosage-group safety evaluations and shows good safety and tolerability.
About Eucure Biopharma
Eucure Biopharma, a subsidiary of Biocytogen, is a China based innovative biotechnology company with global vision, specializing in developing innovative antibody drugs with independent intellectual property rights. Relying on a strong clinical development team with extensive experience, the company has established a product pipeline for more than 10 targets. At present, three products have received clinical trial approvals in the US and China including that two products have obtained the phase II clinical approval from the FDA and have initiated the global phase II clinical trial, two products have entered the phase I clinical trial in China, four products have entered Phase I clinical stages in Australia. Three products are under co-development. These lay a solid foundation for the development of Eucure Biopharma. As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is focused on clinical development. Biocytogen is an international biotechnology company driven by innovative technology and committed to becoming the global birthplace of new drugs, with a mission to focus on technological innovation, continuously produce new drugs, and safeguard human health. For more information, please visit www.eucure.com.
