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Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones

Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones

Elevation Oncology就其差異化ADC項目和即將到來的里程碑提供了更新
PR Newswire ·  01/13 12:30

-- 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 --

-- 在評估Claudin 18.2 ADC EO-3021與ramucirumab或dostarlimab聯合使用的I期臨牀試驗隊列中已啓動劑量給藥,針對晚期胃/胃食管交界(GEJ)癌症患者 --
-- 預計將在2025年第四季度或2026年第一季度報告聯合隊列的初步數據 --
-- 計劃在2025年上半年報告正在進行的I期臨牀試驗的劑量遞增和擴展隊列的額外單藥數據 --
-- 計劃在2025年上半年發佈HER3 ADC EO-1022的臨牀前數據,並在2026年提交新藥研究申請(IND) --

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.

波士頓,2025年1月13日 /PRNewswire/ -- Elevation Oncology, Inc.(納斯達克:ELEV)是一家創新的腫瘤學公司,專注於發現和開發選擇性癌症療法,以治療在一系列具有顯著未滿足醫療需求的實體腫瘤患者,今天宣佈項目更新和即將來臨的里程碑。

"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."

Joseph Ferra,Elevation Oncology的總裁兼首席執行官表示:「我們正在迅速推進EO-3021,以應對在治療晚期胃/GEJ癌症早期療法中存在的顯著未滿足需求,我們相信自己在改善護理標準方面具有獨特的能力。隨着2025年的到來,我們將更加專注,利用EO-3021的競爭抗腫瘤活性和差異化的安全性來探索一線和二線設置中的聯合治療方案。隨着我們的I期臨牀試驗正在進行,現在正在招募單藥和聯合隊列,我們處於領先位置,以探索EO-3021的引人注目的潛力,我們與衆不同的Claudin 18.2 ADC,以改善晚期胃/GEJ癌症患者的治療效果。」

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."

Ferra先生繼續說道:“我們期待在2025年上半年分享我們針對EO-3021的I期劑量遞增和擴展研究的額外數據。通過這次結果,我們旨在基於2024年8月報告的有希望的初步數據,鞏固EO-3021的強大抗腫瘤活性和更好的聯合潛力,同時獲得額外的見解,以幫助我們今後的臨牀開發工作。我們對EO-3021在應對有意義的市場機會方面的潛力感到興奮,並期待着一個具有變革意義的2025年。

Program Updates and Upcoming Milestones

項目更新與即將到來的里程碑

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.

EO-3021:Elevation Oncology正在開發EO-3021,這是一種差異化的、潛在的最佳抗體藥物偶聯物(ADC),用於治療可能表達Claudin 18.2的晚期、不可切除或轉移性實體腫瘤患者,包括胃/GEJ癌。

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.

2024年8月,Elevation Oncology報告了其正在進行的EO-3021一期臨牀試驗劑量遞增部分的有希望的初始單藥數據,顯示出競爭性的療效,在生物標誌物豐富的人群中確認的總體反應率(ORR)爲42.8%,並且具有差異化的安全性特徵,包括最低的血液毒性和肝毒性,以及沒有周圍神經病變/感覺減退。

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.

基於這些數據,Elevation Oncology將EO-3021的臨牀開發重點放在晚期胃/GEJ癌的一線和二線治療上,EO-3021的關鍵特性有可能提供差異化的好處,並滿足患者結果和安全性方面的未滿足需求。

Monotherapy:

單藥治療:

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.

Elevation Oncology單藥EO-3021一期臨牀試驗的劑量擴增部分正在進行中。截至2025年1月,Elevation Oncology已在患者篩查過程中實施前瞻性Claudin 18.2表達檢測,重點招募腫瘤細胞≥25%的IHC 1+/2+/3+患者。Elevation Oncology預計將在2025年上半年報告來自研究的劑量遞增和擴增部分的更多安全性和有效性數據。

Combination:

組合治療:

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.

Elevation Oncology的EO-3021一期臨牀試驗組合部分患者給藥正在進行中。組合隊列正在評估EO-3021與PD-1抑制劑dostarlimab在一線治療中的聯合使用,以及與VEGFR2抑制劑ramucirumab在二線治療中的聯合使用。

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.

通過將EO-3021和免疫檢查點抑制劑dostarlimab結合,Elevation Oncology旨在提供協同效益,可能爲患者帶來超越現有免疫療法和化療組合的改善結果。在一線治療中,免疫療法和化療藥物的組合是治療胃/GEJ癌症的標準方案。

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.

通過EO-3021和ramucirumab的組合,Elevation Oncology旨在提供更好的耐受性和協同抗腫瘤活性,相較於已批准的ramucirumab和紫杉醇的組合。ramucirumab和紫杉醇的組合是二線胃/GEJ癌症治療的標準方案。

Elevation Oncology expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026.

Elevation Oncology預計將在2025年第四季度或2026年第一季度報告組合隊列的初步數據。

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.

EO-1022:Elevation Oncology正在開發EO-1022,一種差異化的HER3 ADC,用於治療HER3表達的固體腫瘤患者,包括乳腺癌、EGFR突變的非小細胞肺癌和胰腺癌。EO-1022結合了seribantumab,這是一種全人源抗HER3單克隆抗體,以及單甲基紫杉醇E(MMAE)載藥,通過特定位點的結合到糖鏈。它旨在利用seribantumab期望的內化能力和最新的特定位點ADC技術,爲表達HER3的固體腫瘤患者提供安全、有效的選擇。

Elevation Oncology expects to present preclinical data for EO-1022 in the first half of 2025 and to file an IND application in 2026.

Elevation Oncology預計將在2025年上半年展示EO-1022的臨牀前數據,並計劃在2026年提交IND申請。

Financial Guidance

財務指導

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.

Elevation Oncology預計截至2024年9月30日的現金、現金等價物和可交易證券將足以支持其當前運營到2026年。

About Elevation Oncology, Inc.

關於 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 .

Elevation Oncology是一家創新的腫瘤公司,專注於發現和開發選擇性癌症療法,以治療具有顯著未滿足醫療需求的各種實體腫瘤患者。我們正在利用我們的ADC專業知識來推進一個新型管線,最初針對兩個已在臨牀驗證的腫瘤學靶點,即Claudin 18.2和HER3。我們的主要候選藥物EO-3021是一個潛在的最佳類藥物,Claudin 18.2 ADC,目前正在進行一項1期試驗(NCT05980416),作爲單一療法,以及與dostarlimab或ramucirumab聯合治療,在表達Claudin 18.2的晚期、不可切除或轉移性胃/食管腺癌患者中進行評估。我們還在推動EO-1022,一個用於治療表達HER3的實體腫瘤患者的HER3 ADC,正在進行臨牀前開發。更多信息,請訪問。

Forward-Looking Statements

前瞻性聲明

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.

本新聞稿包含根據1995年《私人證券訴訟改革法》「安全港」條款的意義下的前瞻性聲明,包括但不限於預期的臨牀和臨牀前開發活動、臨牀和臨牀前結果的預期公告時間、產品候選者的潛在好處、產品候選者的潛在市場機會、產品候選者治療其預期指徵的能力,以及Elevation Oncology對其資金持續時間的預期。除了歷史事實的聲明之外,所有聲明均可視爲前瞻性聲明。這些前瞻性聲明可能伴隨有諸如「旨在」、「預期」、「相信」、「可能」、「估計」、「期待」、「預測」、「目標」、「打算」、「或許」、「計劃」、「可能」、「潛在」、「將」、 「會」和其他類似意思的詞語和術語。雖然Elevation Oncology相信前瞻性聲明中所反映的預期是合理的,但Elevation Oncology不能保證未來事件、結果、行動、活動水平、績效或成就,以及生物技術開發和潛在監管批准的時間和結果本質上是不可確定的。前瞻性聲明面臨風險和不確定性,可能使Elevation Oncology的實際活動或結果與任何前瞻性聲明中表達的內容存在顯著差異,包括與Elevation Oncology推進其產品候選者的能力、臨牀前研究和臨牀試驗的時間和結果、產品候選者的批准和商業化、潛在監管指定的接收和時間、Elevation Oncology的資金開發活動的能力和實現開發目標的能力、Elevation Oncology保護知識產權的能力、Elevation Oncology與第三方建立和維持合作關係的能力以及Elevation Oncology不時向證券交易委員會提交的文件中「風險因素」部分描述的其他風險和不確定性。這些前瞻性聲明僅在本新聞稿的日期有效,Elevation Oncology不承擔任何義務修訂或更新任何前瞻性聲明,以反映該日期之後的事件或情況。

Elevation Oncology Investor and Media Contact

Elevation Oncology 投資者及媒體聯繫人

Gracie Tong
Senior Director, Investor Relations and Corporate Communications
[email protected]

Grace Tong
高級總監,投資者關係和企業傳播
[email protected]

SOURCE Elevation Oncology

來源 Elevation Oncology

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