Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701)
Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701)
NORWOOD, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology and obesity company with a diversified portfolio, announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK. The three-part Phase 1 trial is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors associated with high Nectin-4 expression. The Part A dose escalation of the Phase 1 study is evaluating four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg) and will be followed by Part B (dose optimization) and Part C (dose expansion) that will determine recommended/optimized doses and seek preliminary efficacy signals.
馬薩諸塞州諾伍德，2024年10月16日(GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (納斯達克: CRBP) ("Corbus"或"公司"), 一家擁有多樣化投資組合的腫瘤和肥胖相關公司，今日宣佈其CRb-701 (SYS6002)橋接第1期臨床試驗劑量遞增部分已完成招募工作。這項open label研究的劑量遞增部分(NCT06265727)正在美國和英國進行。這個分爲三個部分的第1期試驗正在評估CRb-701在與高Nectin-4表達相關的晚期固體腫瘤患者中的安全性、藥代動力學和療效。第1期研究的A部分劑量遞增正在評估四個預定劑量(1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg和4.5 mg/kg)，隨後將進行B部分(劑量優化)和C部分(劑量擴展)，確定推薦/優化劑量並尋找初步療效信號。
The company expects to share the first data from dose escalation in Q1 2025.
公司預計將於2025年第一季度分享劑量遞增的第一批數據。
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer.
關於CRb-701
CRb-701 (SYS6002)是一個瞄準Nectin-4的下一代抗體藥物結合物(ADC)，包含具有特定位點的可切割連接劑和藥物抗體比爲2的均一藥物，以MMAE作爲載體。 Nectin-4是尿道癌中臨床驗證的腫瘤相關抗原。
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus' pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Facebook, LinkedIn and X.
關於Corbus
Corbus Pharmaceuticals Holdings, Inc.是一家腫瘤學和肥胖症企業，擁有多元化的投資組合，並致力於通過引入創新的科學方法來幫助人們戰勝嚴重疾病。Corbus'產品管道包括CRb-701，一個針對腫瘤細胞上Nectin-4表達的下一代抗體藥物結合物，用於釋放細胞毒性荷載；CRb-601，一種抗整合素單克隆抗體，可阻止腫瘤細胞上TGFβ的激活；以及CRb-913，一種高度外周限制的CB1受體反向激動劑，用於肥胖症治療。Corbus總部位於馬薩諸塞州諾伍德。有關Corbus的更多信息，請訪問corbuspharma.com。請與我們聯繫 Facebook, LinkedIn和頁面。X.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
前瞻性聲明
本新聞稿包含關於公司試驗結果、產品開發、臨床和監管時間表、市場機會、競爭地位、可能或假定的未來業務結果、商業戰略、潛在的增長機會以及其他預測性質的聲明，這些聲明符合1933年證券法第27(A)節和1934年證券交易法第21(E)節和私人證券訴訟改革法案的修改，這些聲明基於我們所在行業和市場的當前預期、估計、預測和投射，以及公司管理層的當前信念和假設。
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
這些聲明可能通過使用前瞻性表達式識別，包括但不限於「期望」，「預計」，「打算」，「計劃」，「認爲」，「估計」，「潛在」，「預測」，「項目」，「應該」，「會」 和類似的表達式以及這些術語的否定形式。這些聲明涉及未來事件或我們的財務表現，並涉及我們的運營，臨床開發計劃和時間表上已知和未知的風險，不確定性和其他因素，可能導致實際結果，績效或成就與前瞻性聲明中表達或暗示的任何未來結果，績效或成就實質上不同。此類因素包括在公司提交的與證券交易委員會的文件中所述。未來投資者應該注意不過分依賴這些前瞻性陳述，這些陳述僅在本新聞稿發佈之日有效。公司不承擔更新任何前瞻性陳述的義務，無論是因爲新信息，未來事件還是其他原因。
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
所有產品名稱，標誌，品牌和公司名稱均爲其各自所有者的商標或註冊商標。其使用不意味着這些公司的隸屬或認可。
INVESTOR CONTACT:
投資者聯繫：
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Sean Moran
致富金融(臨時代碼)官
Corbus製藥公司
smoran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
Bruce Mackle
董事總經理
LifeSci Advisors，LLC
bmackle@lifesciadvisors.com
譯文內容由第三人軟體翻譯。
