July 18, 2022

ETERN Announces Clinical Trial Collaboration with Merck to Evaluate ET0038 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

July 18th, 2022, Etern BioPharma (Shanghai) Co., Ltd. (ETERN) announces today it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) to evaluate clinical benefits of ET0038, ETERN's SHP2 inhibitor, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for cancer treatment.

Under this agreement, ETERN will conduct a clinical study based on an agreed and finalized protocol, to evaluate the safety, preliminary efficacy plus pharmacokinetics, pharmacodynamics of ET0038 in combination with KEYTRUDA® in patients for selected advanced solid tumors.

“ET0038 demonstrated promising antitumor effect in preclinical animal model. Early clinical trial data has showed consistent safety profile revealed in our research. It is believed ET0038 in combination with anti-PD-1 therapy will explore additional treatment option/benefit for doctors and patients. We hope this collaboration will enable us to further explore the potential additive benefit of ET0038 in combination with KEYTRUDA.” Etern Chief Medical Officer Dr. James He added.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

ET0038 is a highly potent and selective allosteric inhibitor of Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2) for the treatment of patients with advanced solid tumors harboring activating alterations in the mitogen-activated protein kinase (MAPK)-pathway. SHP2 is a key regulator in both MAPK pathway and programmed cell death protein 1 (PD-1) signaling. It is recruited to PD-1 following programmed death-ligand 1 (PD L1) stimulation and inhibits T cell activation. ET0038 exhibits an additive anti-tumor effect with PD-1 antibody in preclinical mouse models. ET0038 has received both agencies green light, and is currently in Phase I clinical trials in the US and in China.

ETERN is a clinical-stage biotech company focused on developing novel small molecule drugs to inhibit “undruggable” targets, a cutting-edge and highly sought-after area in pharmaceutical industry.