EO-3021

Elevation Oncology reports Q3 2024 financial results and progress with EO-3021, a Claudin 18.2 ADC, including 42.8% confirmed ORR in gastric/GEJ cancer subset. The company plans to initiate combination dosing in Q4 2024 and present preclinical data at ESMO-IO 2024. Additionally, they expect to nominate a HER3-ADC development candidate in Q4 2024.

Elevation Oncology reports promising Phase 1 data for EO-3021, a Claudin 18.2 ADC, showing 42.8% confirmed ORR in gastric/GEJ cancer. The trial progresses into dose expansion, with additional monotherapy data expected in 1H 2025. Preclinical combination data with VEGFR2/PD-1 inhibitors will be presented at ESMO-IO 2024, and combination dosing initiation is planned for 4Q 2024. The company also aims to nominate a HER3-ADC development candidate in 4Q 2024.

Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.

In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.

The FDA granted fast track designation to EO-3021 (SYSA1801) for advanced or metastatic CLDN18.2-expressing gastric or gastroesophageal junction cancer. Initial phase 1 study data showed EO-3021 was well-tolerated with a 42.8% objective response rate in CLDN18.2-enriched gastric and gastroesophageal junction cancer patients. The study will expand to explore EO-3021 in combination with other treatments.

FDA grants fast track designation to Elevation Oncology's EO-3021 for advanced or metastatic gastric and gastroesophageal junction cancer, targeting Claudin 18.2-expressing tumors. EO-3021, an ADC with a DAR of two, aims to address unmet medical needs, with early trial results showing a 42.8% response rate and differentiated tolerability.

The FDA granted fast track designation to EO-3021, a differentiated ADC for advanced or metastatic gastric and GEJ cancer expressing CLDN18.2. EO-3021, currently in a phase 1 study, targets CLDN18.2 and delivers a cytotoxic payload, showing a 42.8% response rate in early results.

Elevation Oncology receives FDA Fast Track designation for EO-3021, an ADC targeting Claudin 18.2 in advanced gastric and gastroesophageal junction cancers. The drug showed a 42.8% response rate in Phase 1 trials and plans for further clinical studies. The company faces Nasdaq non-compliance but maintains a strong cash position.

Elevation Oncology announced the FDA granted Fast Track designation to EO-3021 for treating advanced or metastatic gastric and gastroesophageal junction cancer expressing Claudin 18.2. CEO Joseph Ferra expressed gratitude for the opportunity to expedite EO-3021's delivery and plans to advance through monotherapy dose expansion, reporting additional data from the ongoing trial in the first half of 2025, and initiating the combination portion of the study later this year.

Elevation Oncology receives FDA Fast Track designation for EO-3021, an ADC targeting Claudin 18.2 in advanced or metastatic gastric and gastroesophageal junction cancer. Early trial results show a 42.8% response rate with minimal toxicities.