On August 16, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that the first patient has been dosed in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers (Press release, Elevation Oncology, AUG 16, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-first-patient-dosed-in-the-phase-1-clinical-trial-evaluating-eo-3021 [SID1234634448]).

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 dosing of the first patient is a major milestone in evaluating EO-3021’s potential benefit for these patients," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "Claudin 18.2 has emerged as a promising therapeutic target in gastric cancer and other solid tumors. Based on preclinical and early clinical data, EO-3021 represents a potentially safer and more effective therapeutic option for patients with advanced solid tumors that likely express Claudin 18.2, including gastric and gastroesophageal junction cancers. We look forward to evaluating the potential of EO-3021 and expect to report preliminary data on safety and anti-tumor activity from our Phase 1 study during the first half of 2025."

Meredith Pelster, M.D., MSCI, Assistant Director of Gastrointestinal Research for Sarah Cannon Research Institute and a principal investigator in the Phase 1 study of EO-3021, added, "Targeting Claudin 18.2 with an antibody-drug conjugate represents a promising therapeutic option for patients. The initial clinical data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting point to a safe and tolerable therapy that can induce deep responses in patients with gastric cancer. EO-3021 has the potential to provide a much-needed treatment option for patients with advanced solid tumors likely to express Claudin 18.2."

EO-3021 is a potential best-in-class antibody-drug conjugate (ADC) that has been designed to selectively deliver a cytotoxic payload directly to Claudin 18.2-expressing cancer cells to minimize payload-associated toxicities and maximize anti-tumor activity. EO-3021 is a fully human monoclonal antibody that targets Claudin 18.2 and is site-specifically conjugated to the cytotoxic agent monomethyl auristatin E via a cleavable linker, with a drug-to-antibody ratio of 2.

Elevation Oncology’s Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study that is expected to enroll up to approximately 120 patients to evaluate the safety, tolerability, and preliminary anti-tumor activity of EO-3021 in advanced solid tumors likely to express Claudin 18.2. The dose escalation portion of the study will enroll patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers. The expansion portion of the study is expected to further evaluate EO-3021 in patients with advanced unresectable or metastatic gastric or gastroesophageal junction cancers. An additional objective of the study will be to assess the association of Claudin 18.2 expression and objective response. Elevation Oncology expects to report preliminary safety and anti-tumor data from its Phase 1 study during the first half of 2025.

CSPC Pharmaceutical Group Limited (HKEX: 01093), is also evaluating SYSA1801 (EO-3021) in an ongoing Phase 1 clinical trial in China (NCT05009966). Preliminary data from CSPC’s Phase 1 study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The findings showed promising early signs of EO-3021 activity, including an objective response rate of 47.1% in patients with gastric cancer (8 PRs, including 4 confirmed PRs) and a disease control rate of 64.7%, along with a well-tolerated safety profile in patients with resistant/refractory tumors expressing Claudin 18.2. Elevation Oncology has licensed the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China from CSPC.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformations, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.