This section highlights FDA-related milestones and regulatory updates for drugs developed by Elevation Oncology (ELEV).
Over the past two years, Elevation Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EO-1022 and EO-3021. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EO-1022 - FDA Regulatory Timeline and Events
EO-1022 is a drug developed by Elevation Oncology for the following indication: For treating solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EO-1022
- Announced Date:
- April 25, 2025
- Indication:
- For treating solid tumors
Announcement
Elevation Oncology, Inc. announced that its On-track to file IND application in 2026
AI Summary
Elevation Oncology, Inc. announced promising preclinical data for its novel HER3 antibody-drug conjugate, EO-1022. This new cancer therapy is designed to treat several solid tumors that express the HER3 protein, such as breast cancer and non-small cell lung cancer. The company highlighted that EO-1022 has a unique design featuring site-specific glycan conjugation and a monomethyl auristatin E (MMAE) payload, which could offer improved stability and a better safety profile. The preclinical studies have shown that EO-1022 maintains a consistent drug-to-antibody ratio, potentially reducing the risk of toxicity from free payload.
Elevation Oncology also stated that it is on track to file an Investigational New Drug (IND) application for EO-1022 in 2026, marking a key step in advancing this treatment into clinical trials. This move reflects the company’s commitment to addressing significant unmet needs in cancer care.
Read Announcement- Drug:
- EO-1022
- Announced Date:
- April 25, 2025
- Indication:
- For treating solid tumors
Announcement
Elevation Oncology, Inc. announced new preclinical proof-of-concept data for its novel HER3 antibody-drug conjugate (ADC), EO-1022.
AI Summary
Elevation Oncology, Inc. has unveiled promising preclinical proof-of-concept data for its new HER3 antibody-drug conjugate (ADC), EO-1022. This novel treatment is designed for HER3-expressing solid tumors, such as breast cancer and non-small cell lung cancer. EO-1022 uses a fully human IgG2 anti-HER3 antibody that is site-specifically attached at glycan with the powerful MMAE payload. The data show that EO-1022 is highly stable in human serum, maintains a consistent drug-to-antibody ratio of 4, and releases very little free payload, which may lead to fewer side effects.
The encouraging in vitro and in vivo results suggest that EO-1022 has strong anti-tumor activity compared to other HER3 ADCs, potentially offering improved safety and better treatment outcomes. Elevation Oncology plans to file an Investigational New Drug (IND) application for EO-1022 in 2026, marking an important step toward clinical development.
Read Announcement- Drug:
- EO-1022
- Announced Date:
- March 25, 2025
- Indication:
- For treating solid tumors
Announcement
Elevation Oncology, Inc. announced that it will present preclinical data for its novel HER3 ADC, EO-1022, in a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25-30 in Chicago, Illinois.
AI Summary
Elevation Oncology, Inc. announced that it will present preclinical data for its novel HER3 antibody-drug conjugate (ADC), EO-1022, at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois, from April 25-30. EO-1022 is designed for the treatment of solid tumors, such as breast cancer and non-small cell lung cancer, by targeting HER3. The ADC uses seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody, which is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload, featuring a drug-to-antibody ratio of 4.
The data will be shared in a late-breaking poster presentation, highlighting EO-1022’s preclinical discovery and characterization. Elevation Oncology is on track to file an Investigational New Drug (IND) application for EO-1022 in 2026, marking an important step in its clinical development for patients with HER3-positive solid tumors.
Read Announcement
EO-3021 - FDA Regulatory Timeline and Events
EO-3021 is a drug developed by Elevation Oncology for the following indication: Claudin 18.2 targeting agent.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EO-3021
- Announced Date:
- December 5, 2024
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc. announced new preclinical data demonstrating the combination potential of EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC), with VEGFR2 or PD-1 inhibitors.
AI Summary
Elevation Oncology, Inc. has announced encouraging new preclinical data on EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC), that highlights its potential when combined with VEGFR2 or PD-1 inhibitors. The data showed that combining EO-3021 with a VEGFR2 inhibitor led to significantly improved tumor growth inhibition compared to each treatment alone. Similarly, when paired with a PD-1 inhibitor, the combination strongly enhanced tumor suppression, with most treated subjects achieving complete responses in preclinical models. These findings suggest that the combination approach could amplify EO-3021’s anti-tumor effects and support its further evaluation in patients with gastric or gastroesophageal junction cancer. Elevation Oncology plans to begin dosing in the combination arm of its ongoing Phase 1 trial in the fourth quarter of 2024, aiming to unlock the full potential of EO-3021 as a more effective treatment option for advanced cancers.
Read Announcement- Drug:
- EO-3021
- Announced Date:
- December 5, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc announced that its On-track to initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024 --
AI Summary
Elevation Oncology has announced that it is on track to begin the combination dosing portion of its ongoing Phase 1 clinical trial for EO-3021 in the fourth quarter of 2024. EO-3021, a Claudin 18.2 antibody-drug conjugate, is being evaluated for its potential to treat patients with gastric or gastroesophageal junction cancer when paired with other therapies. Recent preclinical data has shown that combining EO-3021 with either a VEGFR2 inhibitor or a PD-1 inhibitor results in significantly enhanced anti-tumor activity compared to using the agents separately.
With established clinical supply partnerships with Lilly and GSK, the upcoming trial will assess the EO-3021 combination with ramucirumab and dostarlimab in different treatment settings. This combination approach aims to maximize the therapeutic potential of EO-3021 and may offer improved treatment options for patients facing advanced cancers.
Read Announcement- Drug:
- EO-3021
- Announced Date:
- September 23, 2024
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
AI Summary
Elevation Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead candidate EO-3021. This antibody drug conjugate (ADC) specifically targets Claudin 18.2, a protein expressed in gastric and gastroesophageal junction (GC/GEJ) cancers. EO-3021 is aimed at patients with advanced or metastatic GC/GEJ cancer whose condition has worsened after previous treatment.
The Fast Track status is intended to speed up the development and review process for therapies addressing serious or life-threatening conditions. Early clinical data from the ongoing Phase 1 trial showed promising results, including a confirmed overall response rate of 42.8% in a subset of patients, along with a favorable tolerability profile. This designation highlights the potential of EO-3021 to meet significant unmet needs in this patient population and may help expedite its path toward regulatory approval.
Read Announcement- Drug:
- EO-3021
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc announced to provide additional data in 1H 2025
AI Summary
Elevation Oncology announced an expansion of its ongoing Phase 1 clinical trial evaluating EO-3021, a promising antibody drug conjugate for advanced gastric or gastroesophageal junction cancer. The study now includes two combination cohorts, one pairing EO-3021 with the VEGFR2 inhibitor ramucirumab for second-line patients and the other pairing EO-3021 with the PD-1 inhibitor dostarlimab for first-line treatment. Dosing for these combination treatments is expected to begin by the end of 2024, following supply agreements with Eli Lilly and GSK.
The company is also continuing its monotherapy trial, with initial safety and efficacy results anticipated by mid-third quarter 2024. Importantly, additional data from this trial is scheduled for release in the first half of 2025, which will offer more insights into the potential benefits and safety profile of EO-3021.
Read Announcement- Drug:
- EO-3021
- Announced Date:
- June 27, 2024
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc. announced plans to expand its ongoing Phase 1 clinical trial to include two combination cohorts evaluating EO-3021 for the treatment of advanced gastric or gastroesophageal junction cancer.
AI Summary
Elevation Oncology, Inc. announced an expansion of its ongoing Phase 1 clinical trial to include two combination cohorts for advanced gastric and gastroesophageal junction cancer. The company plans to investigate EO-3021 paired with two different agents. One cohort will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, for second-line patients. The other cohort will study EO-3021 combined with dostarlimab, a PD-1 inhibitor, in the front-line treatment setting. Clinical supply agreements have been secured with Lilly and GSK to support these two combinations, and dosing in the combination portion of the trial is expected to begin by the end of 2024. These efforts aim to address unmet needs in treating these cancers by potentially offering improved safety and efficacy compared to current therapies, with the combination approach intended to deliver synergistic benefits for patients.
Read Announcement- Drug:
- EO-3021
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- Claudin 18.2 targeting agent
Announcement
Elevation Oncology, Inc announced that On-track to provide update from ongoing Phase 1 clinical trial evaluating monotherapy EO-3021 by mid-3Q 2024,
AI Summary
Elevation Oncology announced an update on its ongoing Phase 1 trial for the EO-3021 monotherapy, with initial safety and efficacy results expected by mid-third quarter 2024. The company is evaluating EO-3021, a potential best-in-class antibody drug conjugate that targets Claudin 18.2, in advanced solid tumors. This update will provide critical insights into the drug’s performance as a single agent and set the stage for future development.
Additionally, Elevation Oncology is expanding the trial to include two combination cohorts. In these arms, EO-3021 will be paired with ramucirumab for second-line gastric or gastroesophageal junction cancer and with dostarlimab for front-line cases. The dosing for these combination studies is set to begin by the end of 2024, further broadening the development pathway for EO-3021 in addressing significant unmet medical needs in oncology.
Read Announcement
Free ELEV Stock Alerts