On March 20, 2025 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 it has elected to discontinue development of EO-3021 (Press release, Elevation Oncology, MAR 20, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-discontinue-development-of-eo-3021-advancing-eo-1022-while-evaluating-strategic-options [SID1234651308]). EO-3021 is a Claudin 18.2 antibody-drug conjugate (ADC), which Elevation Oncology was developing for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers. Elevation Oncology will continue to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors, and, in parallel, is initiating a process to evaluate strategic options to maximize shareholder value.
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The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology’s Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of 22.2% (95% CI: 10, 39; 1 confirmed complete response and 7 confirmed partial responses) and a disease control rate (DCR) of 72.2% (95% CI: 55, 86) among 36 evaluable patients with gastric or GEJ cancer and Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+. In the safety analysis of all enrolled patients (n=85), treatment with EO-3021 was observed to be generally well-tolerated, with an adverse event profile consistent with previously reported data, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia.
"We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to other Claudin 18.2 ADCs in development," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on these data, we have decided to discontinue further development of EO-3021. I want to express my tremendous gratitude to the patients, physicians and site coordinators who participated in the EO-3021 clinical trial."
Mr. Ferra continued, "We are turning our focus to our potentially differentiated HER3 ADC, EO-1022, which incorporates glycan site-specific conjugation and is designed to address significant and emerging unmet needs in many HER3-expressing cancers. We look forward to presenting preclinical data supporting its potential at the AACR (Free AACR Whitepaper) Annual Meeting next month. In parallel, we are initiating efforts to evaluate strategic options for the company. With cash into the second half of 2026 and a disciplined operating strategy, we are well-positioned to advance EO-1022 while working to identify and capitalize on the best opportunities to maximize value for our stakeholders."
Corporate Update:
Elevation Oncology is implementing a workforce reduction of approximately 70%. The total cash payments and costs related to this reduction in force are estimated to be approximately $3 million, with a significant majority of these amounts expected to be paid though the end of June 2025. As part of this reduction, Elevation Oncology’s Chief Medical Officer, Valerie Malyvanh Jansen, M.D., Ph.D., will step down, effective March 31, 2025. Dr. Jansen will continue to support the company in a consulting capacity.
"I want to thank the employees who will be departing as part of this restructuring. Over the past five years, my colleagues have worked tirelessly to advance a novel pipeline of selective medicines, demonstrating a tremendous commitment to making a difference for people living with cancer. I am deeply appreciative of their dedication, support and contributions," added Mr. Ferra.
Based on its current operating plans, Elevation Oncology now expects that its cash, cash equivalents, and marketable securities of $93.2 million as of December 31, 2024, will be sufficient to fund its operations into the second half of 2026.