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NORWOOD, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) announced today that the abstract [No. 3151] for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) annual meeting being held from May 31-June 4, 2024 in Chicago has been released.
马萨诸塞州诺伍德,2024年5月23日(环球通讯社)--Corbus Pharmaceuticals Holdings,Inc.(纳斯达克:CRBP)(“Corbus”或“公司”)今天宣布,2024年5月31日至6月4日在芝加哥举行的2024年美国临床肿瘤学会(ASCO)年会上海报展示的摘要[第3151号]已经发布。
The ASCO abstract is titled: Clinical Update Related to the First-In-Human Trial of SYS6002 (CRB-701), A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate and will be presented as a poster [#296] on June 1, 2024 from 9:00 AM -12:00 PM by Dr. Jian Zhang, Fudan University Shanghai Cancer Center..
ASCO摘要的标题为:与SYS6002(CRB-701)的首次人体试验相关的临床更新,SYS6002是下一代靶向Nectin-4的抗体-药物偶联物,将于2024年6月1日上午9:00至下午12:00由复旦大学上海癌症中心张健博士以海报形式呈现。。
The poster will update data contained in the abstract [cut-off mid-January 2024] with approximately 3 months additional clinical data [cut-off end of April 2024] from dose escalation and PK cohorts. Dose escalation spans 7 dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/kg) and makes use of a Bayesian Optimal Interval (BOIN) design with accelerated titration.
海报将更新摘要[截止日期2024年1月中旬]中包含的数据,以及剂量递增和PK队列中大约3个月的额外临床数据[截止日期2024年4月底]。剂量递增跨越7个剂量水平(0.2、0.6、1.2、1.8、2.7、3.6和4.5 mg/kg),并利用贝叶斯最佳区间(BOIN)设计和加速滴定。
PK cohorts have been initiated at the 2.7mg/Kg & 3.6mg/Kg dose levels. The trial is evaluating the safety and tolerability of SYS6002 (CRB-701) to determine the Maximum Tolerated Dose (MTD) and/or the Phase 2 dose in patients with advanced solid tumors who have failed or were intolerant to standard treatment.
PK队列以2.7mg/Kg和3.6mg/Kg剂量水平开始。该试验正在评估SYS6002(CRB-701)的安全性和耐受性,以确定对标准治疗失败或不耐受的晚期实体瘤患者的最大耐受剂量(MTD)和/或2期剂量。
Patients were enrolled based on Nectin-4 staining, with the exception of metastatic urothelial cancer (mUC) urothelial cancer patients, who were considered to be Nectin-4 positive. Beyond determining safety and tolerability, the pharmacokinetic (PK) and preliminarily anti-tumor activity of SYS6002 (CRB-701) are reported.
根据Nectin-4染色招募患者,但转移性尿路上皮癌(mUC)尿路上皮癌患者除外,他们被认为是Nectin-4阳性。除了确定安全性和耐受性外,还报道了SYS6002(CRB-701)的药代动力学(PK)和初步抗肿瘤活性。
This study is being conducted by Corbus’s partner CSPC in China. Corbus has commenced a Phase 1 dose escalation study in the U.S. and dosed the first patient in April 2024..
这项研究由Corbus在中国的合作伙伴CSPC进行。Corbus已在美国开始进行第一阶段剂量递增研究,并于2024年4月给第一名患者服用了药物。。
About CRB-701
关于CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 with 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. SYS6002 (CRB-701) is currently being explored in a dose escalation on a Q3W schedule, with a view to reducing free-MMAE concentrations in plasma, reducing the associated toxicities that are known to dose limit the Nectin-4 ADC PADCEV® (enfortumab vedotin) Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance..
CRB-701(SYS6002)是靶向Nectin-4的下一代抗体-药物缀合物(ADC),具有位点特异性可切割接头,同源药物-抗体比为2,使用MMAE作为有效载荷。Nectin-4是尿路上皮癌中临床验证的肿瘤相关抗原。SYS6002(CRB-701)目前正在Q3W时间表上进行剂量递增研究,以降低血浆中游离MMAE浓度,减少已知剂量限制Nectin-4 ADC PADCEV®(enfortumab vedotin)的相关毒性。此外,通过在Q3W时间表上施用SYS6002(CRB-701),有机会增加临床便利性和患者依从性。。
About Corbus
关于Corbus
Corbus Pharmaceuticals Holdings, Inc. is a precision oncology 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 inverse agonist for the treatment of obesity.
Corbus Pharmaceuticals Holdings,Inc.是一家拥有多元化投资组合的精准肿瘤学公司,致力于通过将创新的科学方法引入众所周知的生物途径,帮助人们战胜严重疾病。Corbus的管道包括CRB-701,一种靶向癌细胞上Nectin-4表达以释放细胞毒性有效载荷的下一代抗体-药物缀合物,CRB-601,一种阻断癌细胞上表达的TGFβ活化的抗整合素单克隆抗体,以及CRB-913,一种用于治疗肥胖的高度外周限制性CB1反向激动剂。
Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook..
Corbus总部位于马萨诸塞州诺伍德。有关Corbus的更多信息,请访问corbuspharma.com。通过Twitter、LinkedIn和Facebook与我们联系。。
Forward-Looking Statements
前瞻性声明
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 restructuring, 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.
本新闻稿包含《1933年证券法》第27A节、《1934年证券交易法》第21E节和《私人证券诉讼改革法》修订版所指的某些前瞻性声明,包括与公司重组、试验结果、产品开发、临床和监管时间表、市场机会、竞争地位、可能或假定的未来经营成果、业务战略、潜在增长机会和其他具有预测性质的声明有关的前瞻性声明。
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..
这些前瞻性陈述基于对我们经营的行业和市场的当前预期、估计、预测和预测以及管理层当前的信念和假设。。
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.
这些陈述可以通过使用前瞻性表达来识别,包括但不限于“预期”,“预期”,“打算”,“计划”,“相信”,“估计”,“潜力”,“预测”,“项目”,“应该”,“将会”以及类似的表达和这些术语的负面影响。这些报表与未来事件或我们的财务业绩有关,涉及我们的运营、临床开发计划和时间表上的已知和未知风险、不确定性和其他因素,这可能导致实际结果、业绩或成就与前瞻性报表明示或暗示的任何未来结果、业绩或成就存在重大差异。
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..
这些因素包括公司向证券交易委员会提交的文件中规定的因素。警告潜在投资者不要过度依赖此类前瞻性声明,这些声明仅在本新闻稿发布之日起生效。公司没有义务公开更新任何前瞻性声明,无论是由于新信息、未来事件还是其他原因。。
INVESTOR CONTACT:
投资者联系人:
Sean Moran
肖恩·莫兰
Chief Financial Officer
首席财务官
Corbus Pharmaceuticals
Corbus Pharmaceuticals
smoran@corbuspharma.com
smoran@corbuspharma.com
Bruce Mackle
Bruce Mackle
Managing Director
总经理
LifeSci Advisors, LLC
LifeSci Advisors有限责任公司
bmackle@lifesciadvisors.com
bmackle@lifesciadvisors.com