NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation. Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits NRG1-dependent activation and HER2 dimerization.

Start Date29 Mar 2021

Sponsor / Collaborator

Ottawa Hospital Research Institute

NCT04383210

/ TerminatedPhase 2

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

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.

100 Clinical Results associated with Seribantumab

100 Translational Medicine associated with Seribantumab

100 Patents (Medical) associated with Seribantumab

Literatures (Medical) associated with Seribantumab

01 Apr 2026·Clinical and Molecular Hepatology

ERBB3 blockade sensitizes hepatocellular carcinoma to regorafenib after first-line tyrosine kinase inhibitor resistance by inhibiting HIF1A-ABCB1 signaling

Article

Author: Tao, Baorui ; Yi, Chenhe ; Sun, Rongquan ; Geng, Yan ; Chen, Jinhong ; Lin, Jing ; Zhang, Bo ; Wang, Xiangyu ; Gu, Yinchen

Background/Aims: Regorafenib is recommended by guidelines and trials as a sequential second-line therapy following progression on first-line sorafenib or lenvatinib in hepatocellular carcinoma (HCC). However, efficacy is limited, highlighting the urgent need to screen suitable patients and develop sensitization strategies.Methods: Acquired sorafenib- or lenvatinib-resistant (SR or LR) HCC cell lines and organoids were established. Genome-wide CRISPR library screen was performed in SR or LR cell strains to identify synthetic lethal targets of regorafenib. RNA-seq and FITC-regorafenib efflux assay were used to elucidate ERBB3-driven downstream signaling. Preclinical mouse models of cell line- and patient-derived xenografts and clinical cohorts of HCC patients were employed to validate the efficacy of ERBB3-guided patient stratification.Results: Screening with CRISPR library, we showed that inhibition of ERBB3 was synthetic lethal with regorafenib in SR or LR cell strains and organoids. Mechanistically, SR or LR triggered feedback activation of ERBB3 signaling and mediated regorafenib efflux via ERBB3-HIF1A-ABCB1 cascade pathway, limiting sensitivity to regorafenib. Moreover, ERBB3-low tumors following SR or LR exhibited significant sensitivity to regorafenib, suggesting its potential as a predictive biomarker to screen optimal candidates for sequential therapy. Seribantumab, an ERBB3-targeting monoclonal antibody, inhibited ERBB3-HIF1A-ABCB1 cascade, and its combination with regorafenib exerted marked synergistic anti-tumor effects on ERBB3-high tumors resistant to sorafenib or lenvatinib both in vitro and in vivo.Conclusions: This study revealed that ERBB3 was a key resistance factor driving limited efficacy to sequential regorafenib, but also an effective therapeutic target whose inhibition enhanced regorafenib sensitivity after SR or LR.

01 Aug 2025·JCO Precision Oncology

CRESTONE: A Phase II Study of the Efficacy and Safety of the HER3 Monoclonal Antibody, Seribantumab, in Solid Tumors With Neuregulin-1 ( NRG1 ) Fusions

Article

Author: Srivastava, Jaya ; Lin, Jessica J. ; Cheema, Parneet K. ; Patel, Jyoti D. ; Reckamp, Karen L. ; Konduri, Kartik ; Bleeker, Jonathan ; Nguyen, Danny ; Deegan, Maegan ; Weiss, Matthias ; Waqar, Saiama N. ; Ma, Patrick C. ; Burkard, Mark E. ; Misleh, Jamal ; Nagasaka, Misako ; Haura, Eric B. ; Thavaneswaran, Subotheni ; Gadgeel, Shirish M. ; Elamin, Yasir Y. ; Kaufman, Jonathan ; Patil, Tejas ; Desai, Jayesh ; Schram, Alison M. ; Liu, Stephen V. ; Jansen, Valerie M. ; Carrizosa, Daniel R. ; Bauman, Jessica R.

PURPOSE:

Neuregulin-1 ( NRG1 ) fusions are rare but actionable oncogenic drivers in solid tumors. Seribantumab is a fully human anti-HER3 IgG2 monoclonal antibody. In this report, we present the antitumor activity and safety data of seribantumab from the CRESTONE study (ClinicalTrials.gov identifier: NCT04383210 ).

PATIENTS AND METHODS:

This was a prospective phase II clinical study in which patients with advanced solid tumors harboring an NRG1 fusion received seribantumab at a dose of 3,000 mg intravenously once weekly. The primary end point was objective response rate (ORR) by RECIST v1.1. Secondary end points included safety, duration of response, progression-free survival (PFS), overall survival (OS), and disease control rate (DCR). The study was terminated before full enrollment because of sponsor decision, unrelated to safety or efficacy.

RESULTS:

A total of 54 patients with nine different tumor types featuring 19 different NRG1 fusion partners were enrolled. For the 29 patients included in the primary efficacy analysis, the investigator-assessed ORR was 34.5% (95% CI, 17.9 to 54.3), with a DCR of 79% (95% CI, 60 to 92). The median PFS was 5.4 (95% CI, 3.9 to 10.8) months; the median OS was 20.3 (95% CI, 10.2 to not reached) months. In patients with non–small cell lung cancer, eight of 22 achieved response (ORR, 36.4%). Adverse events (AEs) were mostly grade 1 or 2. The most common treatment-related AEs were diarrhea (39%), fatigue (32%), and nausea (22%).

CONCLUSION:

These results support the antitumor activity and safety of seribantumab in patients with advanced solid tumors harboring NRG1 fusions.

05 Nov 2024·Circulation

ErbB3 Governs Endothelial Dysfunction in Hypoxia-Induced Pulmonary Hypertension

Article

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

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.

News (Medical) associated with Seribantumab

25 Apr 2025

·www.prnewswire.com

Elevation Oncology Presents Preclinical Proof-of-Concept Data for EO-1022 at the American Association for Cancer Research (AACR) Annual Meeting 2025

-- EO-1022 is a potentially differentiated HER3 ADC designed to address significant unmet needs across multiple solid tumors -- -- On-track to file IND application in 2026 -- BOSTON, April 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 new preclinical proof-of-concept data for its novel HER3 antibody-drug conjugate (ADC), EO-1022. The data will be presented 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. "We designed EO-1022 with several notable features, including glycan site-specific conjugation and MMAE payloads, in order to address the significant need for a novel HER3 ADC that can potentially deliver improved efficacy and safety to patients with a range of solid tumors," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Today, we are excited to share preclinical proof-of-concept data for EO-1022, which indicate enhanced stability and anti-tumor activity than benchmark HER3 ADCs in the models tested in vitro and in vivo. We believe these findings support the potential of EO-1022 in treating multiple HER3-expressing cancers and look forward to progressing this program toward the clinic." EO-1022 is an ADC containing seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody, 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 site-specific ADC 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. Elevation Oncology expects to file an Investigational New Drug (IND) application for EO-1022 in 2026. In a poster titled, "Preclinical discovery and characterization of EO-1022, a site-specific glycan-conjugated anti-HER3 vc-MMAE ADC for treating solid tumors," Elevation Oncology scientists will present in vitro and in vivo data that show: EO-1022 is highly stable in human serum, with a homogenous DAR of 4 and minimal free payload compared to seribantumab-vcMMAE and patritumab-DXd, two benchmark HER3 ADCs, both of which use stochastic conjugation. These findings illustrate that a key feature of EO-1022 is minimal systemic exposure to free payload, potentially resulting in reduced payload-associated toxicity in patients and an improved safety profile. EO-1022 exhibits potent in vitro cytotoxicity that is dependent on HER3 expression levels. EO-1022 elicits anti-tumor activity in in vivo models of low, medium and high HER3 expression levels, including in a patient derived xenograft (PDX) model of low HER3-expressing EGFR-mutant lung cancer. The poster presentation is now available in the "Publications" section of Elevation Oncology's website: . 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 antibody-drug conjugate (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 regulatory filings, 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

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

100 Deals associated with Seribantumab

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D11777	Seribantumab	-	DB11857

R&D Status

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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
Bile Duct Neoplasms	Phase 2	South Korea	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
Bladder Cancer	Phase 2	South Korea	Elevation Oncology, Inc.	29 Sep 2020
Breast Cancer	Phase 2	Australia	Elevation Oncology, Inc.	29 Sep 2020
Breast Cancer	Phase 2	South Korea	Elevation Oncology, Inc.	29 Sep 2020

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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)	jkwijorpyo = bqxtdchxkq bxkyqjnecq (yzpuqvyvut, oytjikrinc - avielaymlc) View more	-	03 Apr 2025
				Seribantumab (Cohort 2)	jkwijorpyo = ogmoiprqyc bxkyqjnecq (yzpuqvyvut, mvlyuxbsuz - pehmygfhxi) View more
WCLC2024	Not Applicable	NRG1 Fusion Positive non-small cell lung cancer	-	Seribantumab	hfctywcrsb(syaslupdkd) = ruwaxjzulq wplgzzhohz (uaclustfer )	-	09 Sep 2024
NCT04383210 (CRESTONE, AACR2023) Manual	Phase 2	Solid tumor Second line NRG1 Expression	51	seribantumab 3g	loyfsxseun(wrxjaivaqm) = jpimohntls eqsammtjmv (sannvleusi ) 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	kanxlclilv(gavgivwfzz) = gkdfkzkszh onkooqxexa (tkrthgrdge )	-	02 Jun 2022
NCT00734305 (Pubmed) Manual	Phase 1	Solid tumor	44	Seribantumab (dose escalation)	iurenerawy(ucmszlqruo) = maximum tolerated dose was not reached. onutfdezxp (dncgsqzuvb ) View more	Positive	01 Dec 2021
				Seribantumab (dose expansion)
NCT02387216 (SHERLOC, CTgov)	Phase 2	Adenocarcinoma \| Adenocarcinoma of Lung \| Locally Advanced Lung Non-Small Cell Carcinoma	153	Docetaxel+MM-121 (Arm A (Experimental): MM-121 in Combination With Docetaxel)	cjnftasfuf(lobzbpjszo) = lqmsvgjbhw jxdjxatuzp (bbwszqjwbm, urazsptwtm - odtczzihjo) View more	-	12 Oct 2021
				Docetaxel (Arm B (Comparator): Docetaxel Alone)	cjnftasfuf(lobzbpjszo) = uubiwcnxem jxdjxatuzp (bbwszqjwbm, cjoadtrjrc - zupddkpybt) 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)	snuovptxyb = xgaaetdiku rgiidniaae (pejxgzlwht, snpmxtxcod - zazlobuvbq) View more	-	02 Sep 2020
				Placebo+Fulvestrant (Arm B (Control): Placebo and Fulvestrant)	snuovptxyb = jjlftpgxzv rgiidniaae (pejxgzlwht, xrpfpwqrmo - jmszrmfivq) View more
NCT02387216 (Pubmed \| Oncologist)	Phase 2	EGFR-mutated non-small Cell Lung Cancer	153	Seribantumab + Erlotinib	fojvwnrixo(zdrdzxisxp) = hezxntdodq wnspmudqfq (siaumpwvsd ) View more	-	01 Aug 2019
				Erlotinib alone	fojvwnrixo(zdrdzxisxp) = eewprtpbxg wnspmudqfq (siaumpwvsd ) 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	srdysnjyos(ylvgwcxwvl) = ieqixhrwvi rvzdrcyqls (srhpfzmpfq ) View more	Negative	02 Jun 2019
				docetaxel 75 mg	srdysnjyos(ylvgwcxwvl) = aaqprtkwml rvzdrcyqls (srhpfzmpfq ) View more
NCT01447706 (Pubmed \| J Clin Oncol)	Phase 2	Platinum-Resistant Ovarian Carcinoma HRG mRNA \| low HER2	223	Seribantumab plus paclitaxel	aypyzpajkd(jkhxskzubj) = vijlavaayy rrjyjgfbvm (yrbsjzbmsh )	-	20 Dec 2016
				Paclitaxel alone	aypyzpajkd(jkhxskzubj) = jhecfrabol rrjyjgfbvm (yrbsjzbmsh )

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