On December 16, 2022 Zhejiang Daoer Biotechnology Co., Ltd. A clinical-stage biopharmaceutical company developing innovative biotherapeutics, reported that a clinical trial collaboration agreement with Merck & Co. A clinical trial of combination therapy with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (Press release, Doer Biologics, DEC 16, 2022, View Source [SID1234625370]).
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According to the agreement, Daoer Bio will conduct clinical trials based on the clinical protocol agreed and finalized by both parties to evaluate the combination of DR30303 and KEYTRUDA in the treatment of Claudin18.2 positive, locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/ GEJ) patient safety and efficacy.
Dr. Huang Yanshan, founder and CEO of Doer Bio, said: "DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein developed by Doer Bio based on its proprietary SMART-VHHBody platform ( VHH-Fc). We believe that DR30303 exhibits strong affinity and highly selective binding to Claudin18.2, while enhancing antibody-dependent cellular cytotoxicity (ADCC) activity, and has a low risk of immunogenicity. Its small The molecular weight of DR30303 may allow DR30303 to penetrate into solid tumors faster and deeper. We believe that DR30303 may be a potential best-in-class anti-Claud in 18.2 antibody." Dr. Yong Liang, Chief Operating Officer of Doyle Bio, commented on this DAO: "DR30303 has demonstrated a favorable safety profile in ongoing monotherapy trials and an encouraging anti-tumor signal in patients with Claudin18.2-positive solid tumors. We are very excited to be exploring DR30303 with KEYTRUDA combination therapy for Claudin18.2-positive gastric cancer or gastroesophageal junction cancer (GC/GEJ) patients."
KEYTRUDA is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Lowe, NJ, USA.
About DR30303
DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein (VHH-Fc) developed by Doyle Bio based on its proprietary SMART-VHHBody platform. Due to its tumor specificity and abnormally high expression in gastric and pancreatic cancers, Claudin18.2 is an attractive target for cancer therapy. DR30303 showed strong and highly selective binding to the Claudin18.2 target, enhanced antibody-dependent cellular cytotoxicity (ADCC) activity by engineering its Fc, and algorithm-based T cell epitope prediction showed its have a lower risk of immunogenicity. Preclinical studies have shown that DR30303 has shown strong anti-tumor activity and good pharmacokinetics when administered alone or in combination with chemotherapy drugs or PD-1 inhibitors in various mouse tumor models academic characteristics.