Elevation Oncology Announces Planned Combination Strategy for EO-3021 in Patients with Gastric or Gastroesophageal Junction Cancer
Elevation Oncology announces plans to expand its Phase 1 clinical trial of EO-3021, targeting advanced gastric or gastroesophageal junction cancer. The trial will now include combination cohorts with ramucirumab (a VEGFR2 inhibitor) and dostarlimab (a PD-1 inhibitor), thanks to clinical supply agreements with Lilly and GSK. Dosing for these combinations is expected to start by the end of 2024.
The company aims to improve treatment outcomes by combining EO-3021 with these agents, potentially offering better safety and efficacy profiles. Initial data from the EO-3021 monotherapy trial is anticipated by mid-Q3 2024, with more data expected in the first half of 2025.
- Elevation Oncology has entered clinical supply agreements with Lilly and GSK, enhancing their ability to test EO-3021 in combination therapies.
- The company is on track to initiate dosing for the combination portion of the Phase 1 trial by year-end 2024.
- Initial safety and efficacy data from the monotherapy trial are expected by mid-Q3 2024, with additional data in 1H 2025.
- Elevation Oncology will assume all costs associated with the combination study, which may impact financials.
- The company's stock performance might be affected by delays or negative results from the Phase 1 trial.
Elevation Oncology's strategic move to combine EO-3021 with ramucirumab and dostarlimab showcases an innovative approach in tackling advanced gastric or gastroesophageal junction cancer. The importance of combination therapies in oncology cannot be overstated, especially given their potential to enhance treatment efficacy and safety profiles.
EO-3021 is a specialized antibody-drug conjugate (ADC) targeting Claudin 18.2, a protein prevalent in gastric and gastroesophageal junction adenocarcinomas. By having a differentiated design with site-specific conjugation, EO-3021 aims for better stability and minimal toxicities, an essential factor for combination therapies that often face challenges related to side effects.
The inclusion of ramucirumab, a VEGFR2 inhibitor and dostarlimab, a PD-1 inhibitor, as combination partners is particularly noteworthy. VEGFR2 inhibitors help in blocking the blood supply to tumors, while PD-1 inhibitors unleash the immune system to attack cancer cells. This dual mechanism may lead to deeper and more durable responses in patients.
However, it's essential to remain cautious. The combination therapy's success hinges on the synergy between EO-3021 and its partners, which will be evaluated during the trial. The primary endpoints of safety and anti-tumor activity will be important in determining the future viability of these combinations.
Elevation Oncology's plan to expand its Phase 1 trial to include combination cohorts for EO-3021 is likely to broaden its market opportunity significantly. Gastric and gastroesophageal junction cancers represent areas with substantial unmet medical needs and introducing a new combination therapy could position Elevation Oncology as a competitive player in this market.
Entering into clinical supply agreements with industry giants Eli Lilly and GSK is a strategic move, indicating confidence from major pharmaceutical players in EO-3021's potential. Such partnerships can provide not only essential drugs for combination but also a form of validation for Elevation Oncology’s approach.
If the trials are successful, Elevation could see an expanded addressable market, particularly in front-line settings where dostarlimab has shown promise. The combination therapy could offer a new standard of care, which is critical for pricing power and insurance reimbursement negotiations.
Investors should monitor milestone updates, especially the mid-3Q 2024 and 1H 2025 data releases, as these will provide early indicators of the combination therapy's commercial viability.
-- Plan to evaluate EO-3021 in combination with ramucirumab and dostarlimab; entered into clinical supply agreements with Lilly and GSK, respectively --
-- Expect to initiate dosing in combination portion of the Phase 1 trial by year-end 2024 --
-- Combination cohorts broaden market opportunity for EO-3021 to address unmet needs across second- and first-line gastric or gastroesophageal junction cancer settings --
-- On-track to provide update from ongoing Phase 1 clinical trial evaluating monotherapy EO-3021 by mid-3Q 2024, with additional data in 1H 2025 --
"EO-3021 has the potential to change the treatment paradigm for tumors that express Claudin 18.2, including a majority of gastric and gastroesophageal junction adenocarcinomas," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "Based on safety data from preclinical and clinical trials, we believe EO-3021 benefits from a differentiated safety profile and will be readily combinable. We also know that combination-based regimens are a mainstay of cancer care, and that the combination of two therapies with distinct mechanisms of action often enables patients to achieve deeper, more durable responses. As such, we are excited to begin evaluating EO-3021 together with ramucirumab, a VEGFR2 inhibitor, and with dostarlimab, a PD-1 inhibitor, in the second- and first-line settings, respectively. In parallel, we continue to advance our Phase 1 trial of EO-3021 monotherapy toward initial safety and efficacy data by mid-third quarter."
Clinical Development Plans for EO-3021 in Combination
EO-3021 is a differentiated, potential best-in-class antibody drug conjugate (ADC) targeting Claudin 18.2. EO-3021 was designed with site-specific conjugation at glutamine (Q295), with the goal of increasing the stability of the linker-payload and minimizing the potential for free monomethyl auristatin E (MMAE) compared to traditional cysteine-based conjugation. In preclinical studies and the Phase 1 clinical trial conducted by Elevation Oncology's partner, data showed a favorable tolerability profile, with limited MMAE-related toxicities.
Initial development of EO-3021 in combination will explore two regimens for the treatment of gastric or gastroesophageal junction cancer:
- EO-3021 in combination with ramucirumab in second-line patients: Ramucirumab is a monoclonal antibody that targets VEGFR2 and is approved for use in combination with paclitaxel for the treatment of second-line gastric or gastroesophageal junction cancer with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With EO-3021, Elevation Oncology aims to introduce a combination agent that, when paired with ramucirumab, can potentially deliver improved safety and efficacy as compared to the approved combination of ramucirumab and paclitaxel.
- EO-3021 in combination with dostarlimab in front-line patients: Dostarlimab is approved alone and in combination with chemotherapy for certain types of dMMR and MSI-H endometrial cancer in the US; it also has an accelerated approval in certain dMMR solid tumors. By combining EO-3021 and an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with existing immunotherapy regimens for gastric or gastroesophageal junction cancer in the front-line setting.
Each combination cohort will include a dose escalation and expansion portion, evaluating the combination of EO-3021 and ramucirumab or EO-3021 and dostarlimab. The primary endpoints will include safety and anti-tumor activity. Elevation Oncology plans to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024.
In June 2024, Elevation Oncology entered into clinical supply agreements with Lilly and GSK to supply their respective compounds for these combination cohorts. Elevation Oncology will sponsor and conduct all clinical development of both combinations and will assume all costs associated with the study. All companies will retain commercial rights to their respective compounds.
Elevation Oncology continues to enroll patients in the monotherapy cohort of its ongoing Phase 1 clinical trial (NCT05980416) and remains on track to share initial safety and efficacy data by mid-third quarter 2024, with additional data in the first half of 2025.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021 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 transformation, 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 (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.
Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside
About Elevation Oncology, Inc.
Elevation Oncology is 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. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit www.ElevationOncology.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Hannah Deresiewicz, 212-362-1200
EVP, Managing Director, Precision AQ
hannah.deresiewicz@precisionaq.com
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