This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.

Start Date29 Sep 2020

Sponsor / Collaborator

Elevation Oncology, Inc.

NCT03241810

/ TerminatedPhase 2

Randomized Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer (Merrimack Pharmaceuticals Inc.)

This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.

Start Date15 Aug 2017

Sponsor / Collaborator

Elevation Oncology, Inc.

NCT02538627

/ TerminatedPhase 1

A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

Start Date01 Aug 2015

Sponsor / Collaborator

Merrimack Pharmaceuticals, Inc.

100 Clinical Results associated with Seribantumab

100 Translational Medicine associated with Seribantumab

100 Patents (Medical) associated with Seribantumab

Literatures (Medical) associated with Seribantumab

01 Jan 2025·Current medicinal chemistry

The Therapeutic Significance of HER3 in Non-small Cell Lung Cancer (NSCLC): A Review Study

Review

Author: Ding, Ke ; Zhang, Jinwei ; Trinder, Amelia

HER3 (Human Epidermal Growth Factor Receptor 3) is frequently overexpressed in various cancers, including non-small cell lung cancer (NSCLC), with a prevalence of 83% in primary tumors. Its involvement in tumorigenesis and resistance to targeted therapies makes HER3 a promising target for cancer treatment. Despite being initially considered “undruggable” due to its lack of catalytic activity, significant progress has been made in the development of anti-HER3 therapeutics. Monoclonal antibodies such as lumretuzumab, seribantumab, and patritumab have shown potential in targeting HER3 to overcome resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.

05 Nov 2024·Circulation

ErbB3 Governs Endothelial Dysfunction in Hypoxia-Induced Pulmonary Hypertension

Article

Author: Zhang, Junting ; Chen, Yuan ; Yang, Xusheng ; Li, Yiying ; Deng, Lin ; Chen, Rongchang ; Nie, Xiaowei ; Bian, Jin-Song ; Tan, Jianxin ; Chen, Jingyu

BACKGROUND::

Pulmonary hypertension, characterized by vascular remodeling, currently lacks curative therapeutic options. The dysfunction of pulmonary artery endothelial cells plays a pivotal role in the initiation and progression of pulmonary hypertension (PH). ErbB3 (human epidermal growth factor receptor 3), also recognized as HER3, is a member of the ErbB family of receptor tyrosine kinases.

METHODS::

Microarray, immunofluorescence, and Western blotting analyses were conducted to investigate the pathological role of ErbB3. Blood samples were collected for biomarker examination from healthy donors or patients with hypoxic PH. The pathological functions of ErbB3 were further validated in rodents subjected to chronic hypoxia- and Sugen-induced PH, with or without adeno-associated virus-mediated ErbB3 overexpression, systemic deletion, or endothelial cell–specific ErbB3 knockdown. Primary human pulmonary artery endothelial cells and pulmonary artery smooth muscle cells were used to elucidate the underlying mechanisms.

RESULTS::

ErbB3 exhibited significant upregulation in the serum, lungs, distal pulmonary arteries, and pulmonary artery endothelial cells isolated from patients with PH compared with those from healthy donors. ErbB3 overexpression stimulated hypoxia-induced endothelial cell proliferation, exacerbated pulmonary artery remodeling, elevated systolic pressure in the right ventricle, and promoted right ventricular hypertrophy in murine models of PH. Conversely, systemic deletion or endothelial cell–specific knockout of ErbB3 yielded opposite effects. Coimmunoprecipitation and proteomic analysis identified YB-1 (Y-box binding protein 1) as a downstream target of ErbB3. ErbB3 induced nuclear translocation of YB-1 and subsequently promoted hypoxia-inducible factor 1/2α transcription. A positive loop involving ErbB3-periostin-hypoxia–inducible factor 1/2α was identified to mediate the progressive development of this disease. MM-121, a human anti-ErbB3 monoclonal antibody, exhibited both preventive and therapeutic effects against hypoxia-induced PH.

CONCLUSIONS::

Our study reveals, for the first time, that ErbB3 serves as a novel biomarker and a promising target for the treatment of PH.

01 Nov 2022·JCO precision oncology

Clinical Response to Seribantumab, an Anti–Human Epidermal Growth Factor Receptor-3 Immunoglobulin 2 Monoclonal Antibody, in a Patient With Metastatic Pancreatic Ductal Adenocarcinoma Harboring an NRG1 Fusion

Article

Author: Thavaneswaran, Subotheni ; Deegan, Maegan ; Chan, Wei Yen ; Jansen, Valerie M. ; Grady, John P. ; Asghari, Ray ; Thomas, David M.

News (Medical) associated with Seribantumab

25 Mar 2025

·www.prnewswire.com

Elevation Oncology to Present Preclinical Data for EO-1022 at the American Association for Cancer Research (AACR) Annual Meeting 2025

-- Abstract accepted for late-breaking poster presentation – -- EO-1022 is a potentially differentiated HER3 ADC being developed for the treatment of solid tumors, including breast and non-small cell lung cancers -- -- On-track to file an Investigational New Drug (IND) application in 2026 – BOSTON, March 25, 2025 /PRNewswire/ -- 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, today 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. EO-1022 is an antibody drug conjugate (ADC) containing seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody (mAb), which is site-specifically conjugated at glycan to the monomethyl auristatin E (MMAE) payload with a drug-to-antibody ratio (DAR) of 4. Elevation Oncology designed EO-1022, leveraging the advanced site-specific conjugation technology platform licensed from Synaffix B.V. Elevation Oncology is developing EO-1022 for the treatment of solid tumors that express HER3, including breast cancer and non-small cell lung cancer, and expects to file an IND application in 2026. "We are eager to share the first preclinical data for EO-1022 at the AACR Annual Meeting," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "With EO-1022, we are combining the most advanced site-specific conjugation technology platform with the clinically validated MMAE payload, which is widely used across ADC programs but has yet to be introduced into a HER3-targeting ADC in the clinic. We believe this unique combination will enable us to provide a new treatment option to patients with HER3-expressing solid tumors, including those who are refractory to other HER3-targeting agents in development. We look forward to advancing EO-1022 into clinical development next year." Details of the poster presentation at AACR 2025 are as follows: Title: Preclinical discovery and characterization of EO-1022, a site-specific glycan-conjugated anti-HER3 vc-MMAE ADC for treating solid tumors Abstract Presentation Number: LB004 Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1 Session Date and Time: Sunday, April 27, from 2 p.m. to 5 p.m. CT (3 p.m. to 6 p.m. ET) Location: Poster Section 50 The late-breaking abstract will become available on the AACR website beginning at 12:00 noon CT (1:00 p.m. ET) on April 25, 2025, and published in an online-only supplement to Cancer Research. About EO-1022 Elevation Oncology is developing EO-1022, a potentially differentiated HER3 ADC for the treatment of HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab's desirable internalization properties and advanced site-specific ADC technology which makes possible the use of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND application in 2026. 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 ADC expertise to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors. EO-1022 is currently progressing through preclinical development, with an investigational new drug (IND) application expected in 2026. For more information, visit . 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 and preclinical development activities, expected timing of announcements of preclinical results, potential benefits of product candidates, potential market opportunities for product candidates and the ability of 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 Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACRADC

06 Mar 2025

·www.prnewswire.com

Elevation Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Achievements

-- Dosing ongoing in Phase 1 clinical trial cohorts evaluating Claudin 18.2 ADC EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/gastroesophageal junction (GEJ) cancer -- -- Expect to report initial data from combination cohorts in 4Q 2025 or 1Q 2026 -- -- On-track to report additional monotherapy data from dose escalation and expansion cohort of ongoing Phase 1 clinical trial in 2Q 2025 -- -- Preclinical data for HER3 ADC EO-1022 to be presented at American Association for Cancer Research (AACR) Annual Meeting 2025; plan to file an Investigational New Drug (IND) application in 2026 -- BOSTON, March 6, 2025 /PRNewswire/ -- 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, today announced financial results for the quarter and full-year ended December 31, 2024, and highlighted recent business achievements. "We continue to advance our Claudin 18.2 ADC program, EO-3021, for the treatment of advanced gastric/GEJ cancer in the earlier lines settings," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on the competitive anti-tumor activity and differentiated safety profile observed to date, we believe EO-3021 has the potential to benefit a broad patient population. Currently, we are evaluating EO-3021 in combinations with approved therapies in the first- and second-line settings, where we have a first-mover advantage and the opportunity to address significant markets, while also progressing our monotherapy cohort toward an additional data readout in the second quarter of 2025." Mr. Ferra continued, "In the first quarter, we introduced prospective Claudin 18.2 testing to the monotherapy dose expansion cohort of our ongoing Phase 1 trial. This will further enhance our understanding of the patients most likely to benefit from treatment with our ADC and ultimately inform the design of future registrational studies. In addition, we continue to develop our HER3 ADC EO-1022 for the treatment of a wide range of HER3-expressing solid tumors and look forward to sharing preclinical data at the AACR Annual Meeting next month. We believe both EO-3021 and EO-1022 have the potential to elevate cancer care and are eager to share updates on both programs as we move through 2025." Recent Business Achievements Claudin 18.2 ADC EO-3021: In January 2025, Elevation Oncology implemented prospective Claudin 18.2 expression testing as part of the patient screening process in its ongoing Phase 1 clinical trial of monotherapy EO-3021. The dose expansion portion of the trial is now enrolling patients with ≥ 25% of tumor cells at IHC 1+/2+/3+, representing a moderately broader population compared to the exploratory efficacy analysis, which will continue to include patients with ≥ 20% of tumor cells at IHC 2+/3+. In January 2025, Elevation Oncology initiated dosing in the combination cohorts of its Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first-line setting and with ramucirumab, a VEGFR2 inhibitor, in the second-line setting for the treatment of advanced gastric/GEJ cancer. In December 2024, Elevation Oncology presented preclinical proof-of-concept data supporting the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at the ESMO Immuno-Oncology Annual Congress 2024 (ESMO-IO). The in vivo data showed: Treatment with EO-3021 and DC101, a surrogate of VEGFR2 inhibitor ramucirumab, exhibited statistically superior tumor growth inhibition (TGI) compared to treatment with either EO-3021 or DC101 alone (TGI: 88.2% for EO-3021 in combination with DC101, compared to 20.1% for EO-3021 and 59.2% for DC101 alone). Treatment with EO-3021 and a PD-1 inhibitor exhibited statistically superior TGI compared to treatment with either EO-3021 or a PD-1 inhibitor alone (TGI: 79.9% for EO-3021 in combination with a PD-1 inhibitor, compared to 33.8% for EO-3021 and 25.0% for a PD-1 inhibitor alone). 92% (11/12) of mice treated with the combination of EO-3021 and a PD-1 inhibitor achieved a complete response (CR), compared to 50% (6/12) mice treated with EO-3021 monotherapy and 17% (2/12) mice treated with a PD-1 inhibitor alone. HER3 ADC EO-1022: In December 2024, Elevation Oncology nominated EO-1022 as its HER3 ADC development candidate for the treatment of HER3-expressing solid tumors including breast cancer and non-small cell lung cancer. EO-1022 is designed to be a differentiated HER3 ADC, leveraging seribantumab's desirable internalization properties, the latest site-specific ADC technology and the MMAE payload. Expected Upcoming Milestones EO-3021: Report additional safety and efficacy data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose escalation and expansion cohorts, in the second quarter of 2025. Report initial data from the combination cohorts of the Phase 1 clinical trial of EO-3021 in the fourth quarter of 2025 or the first quarter of 2026. EO-1022: Present preclinical data for EO-1022 at AACR Annual Meeting in the second quarter of 2025. File an IND application for EO-1022 in 2026. Fourth Quarter and Full Year 2024 Financial Results As of December 31, 2024, Elevation Oncology had cash, cash equivalents and marketable securities totaling $93.2 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $44.2 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first half of 2024, partially offset by cash used to fund operating activities. Research and development (R&D) expenses for the fourth quarter of 2024 were $6.6 million, compared to $4.7 million for the fourth quarter of 2023. The increase in R&D expenses in the fourth quarter of 2024 was primarily due to increased clinical trial expenses for the lead program EO-3021. For the year ended December 31, 2024, R&D expenses were $28.6 million, compared to $25.4 million for the year ended December 31, 2023. The increase was primarily driven by continuous investment in the lead and pipeline programs. General and administrative (G&A) expenses for the fourth quarter of 2024 were $4.0 million, compared to $3.3 million for the fourth quarter of 2023. The increase in G&A expenses in the fourth quarter of 2024 was primarily due to increased personnel costs, including stock compensation expenses. For the year ended December 31, 2024, G&A expenses were $16.1 million, compared to $14.9 million for the year ended December 31, 2023. The increase was primarily due to increased professional fees and personnel expenses, partially offset by a decrease in premiums paid on directors' and officers' insurance. Net loss for the fourth quarter of 2024 was $10.4 million, compared to $7.9 million for the fourth quarter of 2023. Financial Outlook Elevation Oncology expects that its cash, cash equivalents and marketable securities as of December 31, 2024, will be sufficient to fund its current operations into 2026. 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 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 Claudin 18.2 ADC and is currently being evaluated in a Phase 1 trial (NCT05980416) as a monotherapy, and in combinations with dostarlimab or ramucirumab, in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma. We are also advancing EO-1022, a HER3 ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . 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 and preclinical development activities, expected timing of announcements of clinical and preclinical results, potential benefits of product candidates, potential market opportunities for product candidates, the ability of product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. 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 Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Financial StatementAACRClinical Result

13 Jan 2025

·www.prnewswire.com

Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones

-- Initiated dosing in Phase 1 clinical trial cohort evaluating Claudin 18.2 ADC EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/gastroesophageal junction (GEJ) cancer -- -- Expect to report initial data from combination cohort in 4Q 2025 or 1Q 2026 -- -- On-track to report additional monotherapy data from dose escalation and expansion cohorts of ongoing Phase 1 clinical trial in 1H 2025 -- -- Plan to present preclinical data for HER3 ADC EO-1022 in 1H 2025 and file an Investigational New Drug (IND) application in 2026 -- BOSTON, Jan. 13, 2025 /PRNewswire/ -- 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, today announced program updates and upcoming milestones. "We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings. With our Phase 1 clinical trial ongoing and now enrolling both monotherapy and combination cohorts, we are in a leading position to explore the compelling potential of EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes for people living with advanced gastric/GEJ cancer." Mr. Ferra continued, "We look forward to sharing additional data from our Phase 1 dose escalation and expansion study of EO-3021 in the first half of 2025. With this readout, we aim to build on the promising initial data reported in August 2024, reinforcing EO-3021's robust anti-tumor activity and potential better combinability, while garnering additional insights to inform our go-forward clinical development efforts. We are enthusiastic about the potential of EO-3021 in addressing meaningful market opportunities and look forward to a transformative 2025." Program Updates and Upcoming Milestones EO-3021: Elevation Oncology is developing EO-3021, a differentiated, potentially best-in-class antibody drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric/GEJ cancer. In August 2024, Elevation Oncology reported promising initial monotherapy data from the dose escalation portion of its ongoing Phase 1 clinical trial of EO-3021, demonstrating competitive efficacy, with a 42.8% confirmed overall response rate (ORR) in a biomarker-enriched population, and a differentiated safety profile, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia. Based on these data, Elevation Oncology is focusing the clinical development of EO-3021 on the first- and second-line treatment of advanced gastric/GEJ cancer, where EO-3021's key attributes can potentially provide differentiated benefits and address unmet needs in both patient outcomes and safety. Monotherapy : The dose expansion portion of Elevation Oncology's Phase 1 clinical trial of monotherapy EO-3021 is ongoing. As of January 2025, Elevation Oncology has implemented prospective Claudin 18.2 expression testing as part of the patient screening process, focusing enrollment on patients with ≥25% of tumor cells at IHC 1+/2+/3+. Elevation Oncology expects to report additional safety and efficacy data from the dose escalation and expansion portions of the study in the first half of 2025. Combination: Patient dosing is ongoing in the combination portion of Elevation Oncology's Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first line setting and with ramucirumab, a VEGFR2 inhibitor, in the second line setting. By combining EO-3021 and dostarlimab, an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with the existing combination of immunotherapy and chemotherapy. The combination of an immunotherapy and chemotherapy agent is the standard of care for the treatment of gastric/GEJ cancer in the front-line setting. With the EO-3021 and ramucirumab combination, Elevation Oncology aims to deliver improved tolerability and synergistic anti-tumor activity compared to the approved combination of ramucirumab and paclitaxel. The combination of ramucirumab and paclitaxel is the standard of care for the treatment of second-line gastric/GEJ cancer. Elevation Oncology expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026. EO-1022: Elevation Oncology is developing EO-1022, a differentiated HER3 ADC for the treatment of patients with HER3-expressing solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 combines seribantumab, a fully human anti-HER3 monoclonal antibody, and a monomethyl auristatin E (MMAE) payload with site-specific conjugation to glycan. It is designed to leverage seribantumab's desirable internalization capability and the latest site-specific ADC technology to deliver a safe, effective option for patients living with solid tumors that express HER3. Elevation Oncology expects to present preclinical data for EO-1022 in the first half of 2025 and to file an IND application in 2026. Financial Guidance Elevation Oncology expects that its cash, cash equivalents and marketable securities as of September 30, 2024, will be sufficient to fund its current operations into 2026. 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 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, Claudin 18.2 ADC and is currently being evaluated in a Phase 1 trial (NCT05980416) as a monotherapy, and in combinations with dostarlimab or ramucirumab, in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. We are also advancing EO-1022, a HER3 ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit . 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 and preclinical development activities, expected timing of announcements of clinical and preclinical results, potential benefits of product candidates, potential market opportunities for product candidates, the ability of product candidates to treat their targeted indications and Elevation Oncology's expectations about its cash runway. 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 Gracie Tong Senior Director, Investor Relations and Corporate Communications [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1ImmunotherapyADCClinical Result

100 Deals associated with Seribantumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11777	Seribantumab	-	DB11857

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bile Duct Neoplasms	Phase 2	United States	Elevation Oncology, Inc.	29 Sep 2020
Bile Duct Neoplasms	Phase 2	Australia	Elevation Oncology, Inc.	29 Sep 2020
Bile Duct Neoplasms	Phase 2	Canada	Elevation Oncology, Inc.	29 Sep 2020
Bladder Cancer	Phase 2	United States	Elevation Oncology, Inc.	29 Sep 2020
Bladder Cancer	Phase 2	Australia	Elevation Oncology, Inc.	29 Sep 2020
Bladder Cancer	Phase 2	Canada	Elevation Oncology, Inc.	29 Sep 2020
Breast Cancer	Phase 2	Australia	Elevation Oncology, Inc.	29 Sep 2020
Colorectal Cancer	Phase 2	United States	Elevation Oncology, Inc.	29 Sep 2020
Colorectal Cancer	Phase 2	Australia	Elevation Oncology, Inc.	29 Sep 2020
Colorectal Cancer	Phase 2	Canada	Elevation Oncology, Inc.	29 Sep 2020

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04383210 (CRESTONE, CTgov)	Phase 2	Sarcoma \| Metastatic Solid Tumor \| NRG1 Fusion Positive Solid Tumors ... View more	54	Seribantumab (Cohort 1)	bzvqwsulyx = exmtsiqxmi mdtqykdxlu (yvwwtmmmmh, ttrrpqvqne - zfycfdpvdz) View more	-	03 Apr 2025
				Seribantumab (Cohort 2)	bzvqwsulyx = irlhslacmy mdtqykdxlu (yvwwtmmmmh, qnxnsmxtgx - hhaydjudqq) View more
WCLC2024	Not Applicable	NRG1 Fusion Positive non-small cell lung cancer	-	Seribantumab	zffhkgypve(qxrmmpqruy) = tenuuejzyh sxuxwdjrtt (kzaonqfhrb )	-	09 Sep 2024
NCT04383210 (CRESTONE, AACR2023) Manual	Phase 2	Solid tumor Second line NRG1 Expression	51	seribantumab 3g	pwwzzzbjfq(axwjsklfjc) = gxkcfbudva tblptxxysr (ilsseahopm ) View more	Positive	14 Apr 2023
NCT04383210 (CRESTONE, ASCO2022)	Phase 2	Sarcoma \| Metastatic Solid Tumor \| NRG1 Fusion Positive Solid Tumors ... View more	12	Seribantumab 3g QW	xnhncofuxq(hcossnugmb) = cgpysdpryu yrglyegufl (mcdblcbsel )	-	02 Jun 2022
NCT00734305 (Pubmed) Manual	Phase 1	Solid tumor	44	Seribantumab (dose escalation)	jehdbeyylp(petuovknfe) = maximum tolerated dose was not reached. pyrgkulzpa (zlqrkfkxly ) View more	Positive	01 Dec 2021
				Seribantumab (dose expansion)
NCT02387216 (SHERLOC, CTgov)	Phase 2	Adenocarcinoma \| metastatic non-small cell lung cancer	153	Docetaxel+MM-121 (Arm A (Experimental): MM-121 in Combination With Docetaxel)	toyevdgbma(ryducsjyry) = nofhtellmu mteauskvaj (bzdbmhzkbr, mfghnhrjkj - trxjxgvrnf) View more	-	12 Oct 2021
				Docetaxel (Arm B (Comparator): Docetaxel Alone)	toyevdgbma(ryducsjyry) = qpwdybrozz mteauskvaj (bzdbmhzkbr, zcrmgijydf - vvkohztwvb) View more
NCT03241810 (SHERBOC, CTgov)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	22	Fulvestrant+Seribantumab (Arm A (Experimental): Seribantumab and Fulvestrant)	qoalzfsqvk = muixzjmoof fyjkgokbpj (smkjxtxjxy, ffymqgyzec - xiuomsedri) View more	-	02 Sep 2020
				Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant)	qoalzfsqvk = aenazuiwoz fyjkgokbpj (smkjxtxjxy, guwvjekfts - gjzprekraz) View more
NCT02387216 (Pubmed \| Oncologist)	Phase 2	EGFR-mutated non-small Cell Lung Cancer	153	Seribantumab + Erlotinib	vjbpfjlxmo(ohztmpjtal) = dvaxlzehax onqciwnvjm (vszkdeafau ) View more	-	01 Aug 2019
				Erlotinib alone	vjbpfjlxmo(ohztmpjtal) = oqjsanjtyq onqciwnvjm (vszkdeafau ) View more
NCT02387216 (SHERLOC, ASCO 12019 \| ASCO 22019) Manual	Phase 2	Non-Small Cell Lung Cancer HRG positive	108	docetaxel 75 mg+MM-121 3000 mg	xociksswbz(genvcxrqfb) = yatndsgdeo chtokgwtyc (tvofpfszbp ) View more	Negative	02 Jun 2019
				docetaxel 75 mg	xociksswbz(genvcxrqfb) = yvqgghgnwr chtokgwtyc (tvofpfszbp ) View more
NCT01447706 (CTgov)	Phase 2	Peritoneal Neoplasms \| Ovarian Epithelial Carcinoma \| Platinum-Resistant Ovarian Carcinoma ... View more	223	Paclitaxel	iqvfwskszy(bgaamuuvlo) = vgdsdfeiup cpklgoumzj (mffhhhjdnv, kiqeniujoy - eriwgnmvoo) View more	-	12 May 2016

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