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C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial

C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial

c4 therapeutics宣布CFT8919临床试验中首位患者接受了初次投药
C4 Therapeutics ·  11/06 13:00

Clinical Development Initiated in Greater China by Partner Betta Pharmaceuticals

合作伙伴贝达制药在大中华区启动临床开发

WATERTOWN, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer (NSCLC), in Greater China.

马萨诸塞州沃特敦,2024年11月6日(GLOBE NEWSWIRE)——致力于推进靶向蛋白质降解科学的临床阶段生物制药公司C4 Therapeutics, Inc.(C4T)(纳斯达克股票代码:CCCC)今天宣布,其合作伙伴贝塔制药已为第一位患者服药 CFT8919,这是一种用于非小细胞的口服生物可利用的 EGFR L858R 变构降解剂大中华地区的肺癌(NSCLC)。

"We are pleased to see CFT8919, our fourth small molecule degrader to enter the clinic, begin the journey through clinical development in Greater China with our partner Betta Pharmaceuticals," said Len Reyno, M.D., chief medical officer of C4 Therapeutics. "CFT8919 may offer an exciting advancement in treating non-small cell lung cancer driven by an EGFR mutation, which is currently treated with EGFR tyrosine kinase inhibitors (TKIs) that offer a less durable response for patients with the EGFR L858R driver mutation than those with other driver mutations. We, along with our partner Betta Pharmaceuticals, believe CFT8919 may offer a novel targeted therapy for patients and physicians searching for treatment options."

C4 Therapeutics首席医学官伦·雷诺万博士表示:“我们很高兴看到,我们第四款进入临床的小分子降解剂 CFT8919 与我们的合作伙伴贝塔制药一起开始了大中华区的临床开发之旅。”“CFT8919 可能在治疗由表皮生长因子突变驱动的非小细胞肺癌方面取得令人兴奋的进展,表皮生长因子突变目前使用表皮生长因子酪氨酸激酶抑制剂(TKI)治疗,对表皮生长因子 L858R 驱动突变患者的反应不如具有其他驱动突变的患者那么持久。我们和我们的合作伙伴贝塔制药相信,CFT8919 可能为寻求治疗选择的患者和医生提供一种新的靶向疗法。”

C4T designed CFT8919 to be potent and selective against EGFR bearing an oncogenic L858R mutation and capable of overcoming common EGFR secondary mutations that render patients refractory to EGFR TKIs. The EGFR mutation is particularly common in NSCLC patients of Asian heritage. In China, where approximately 693,000 patients are diagnosed with NSCLC annually, approximately 50 percent of diagnoses are driven by the EGFR mutation. The EGFR L858R mutation is the second most common EGFR mutation, found in approximately 40 percent of patients diagnosed with an EGFR mutation in the U.S. and China.

C4万亿设计的 CFT8919 对携带致癌性 L858R 突变的表皮生长因子具有有效和选择性,能够克服使患者对表皮生长因子 TKI 产生难治性的常见表皮生长因子继发突变。表皮生长因子突变在亚洲血统的非小细胞肺癌患者中尤其常见。在中国,每年约有693,000名患者被诊断出患有非小细胞肺癌,大约50%的诊断是由表皮生长因子突变驱动的。表皮生长因子 L858R 突变是第二常见的表皮生长因子突变,在美国和中国诊断为表皮生长因子突变的患者中,约有40%存在表皮生长因子突变。

In 2023, C4T and Betta Pharmaceuticals entered into a strategic collaboration to develop, manufacture and commercialize CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. Under the terms of the agreement, C4T is eligible for up to $357 million in potential milestones plus royalties on net sales. C4T retains development and commercialization rights for CFT8919 in the United States, European Union and rest of the world.

2023 年,C4万亿和贝达制药达成战略合作,在大中华区(包括香港特别行政区、澳门特别行政区和台湾)开发、制造和商业化 CFT8919。根据协议条款,C4万元有资格获得高达3.57亿美元的潜在里程碑加上净销售额的特许权使用费。C4万保留 CFT8919 在美国、欧盟和世界其他地区的开发和商业化权利。

About CFT8919
CFT8919 is an orally bioavailable allosteric BiDAC degrader that is designed to be potent and selective against EGFR bearing an oncogenic L858R mutation. In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer. Importantly, CFT8919 retains full activity against additional EGFR mutations that confer resistance against approved EGFR inhibitors including L858R-C797S, L858R-T790M, and L858R-T790M-C797S.

关于 CFT8919
CFT8919 是一种口服生物可利用的变构的 bidAC 降解剂,旨在对携带致癌 L858R 突变的表皮生长因子具有有效和选择性。在临床前研究中,CFT8919 活跃于 L858R 驱动的非小细胞肺癌的体外和体内模型。重要的是,CFT8919 对其他表皮生长因子突变保持了全部活性,这些突变会对批准的表皮生长因子抑制剂(包括 L858R-C797S、L858R-T79000万和 L858R-T79000万和L858R-T79000万.C797S)产生耐药性。

About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T's degrader medicines are designed to harness the body's natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit .

关于 C4 疗法
C4 Therapeutics(C4T)(纳斯达克股票代码:CCCC)是一家临床阶段的生物制药公司,致力于兑现靶向蛋白质降解科学的承诺,创造改变患者生活的新一代药物。C4万亿正在通过临床研究推进靶向肿瘤学项目,并利用其TORPEDO平台高效设计和优化小分子药物,以解决难以治疗的疾病。C4T的降解剂药物旨在利用人体的天然蛋白质回收系统快速降解致病蛋白,从而有可能克服耐药性、不可药物靶标和改善患者预后。欲了解更多信息,请访问。

Forward-Looking Statements
This press release contains "forward-looking statements" of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; our ability to achieve milestones and receive potential royalty payments from our collaboration partner, Betta Pharmaceuticals; and our ability to fund our future operations. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of preclinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that sufficient capital to fund our future operations will be available to us on acceptable terms or at the times required. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in C4 Therapeutics' most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.

前瞻性陈述
本新闻稿包含1995年《私人证券诉讼改革法》所指的C4 Therapeutics, Inc.的 “前瞻性陈述”。这些前瞻性陈述可能包括但不限于关于我们为患者开发潜在疗法的能力、治疗方法的设计和潜在疗效、我们实现里程碑和从合作伙伴贝塔制药那里获得潜在特许权使用费的能力,以及我们为未来运营提供资金的能力的明示或暗示陈述。本新闻稿中的任何前瞻性陈述均基于管理层当前对未来事件的预期和信念,并存在许多风险和不确定性,这些风险和不确定性可能导致实际业绩与此类前瞻性陈述中列出或暗示的业绩存在重大不利差异。这些风险和不确定性包括但不限于:与临床前和临床研究的启动、时机、进展和进行以及候选产品的其他开发要求相关的不确定性;我们的任何一种或多种候选产品的开发成本更高或可能无法成功开发和商业化的风险;以及在可接受的条件或要求的时间向我们提供足够资金来资助我们未来运营的风险。有关这些风险和不确定性以及其他重要因素的讨论,其中任何一个都可能导致我们的实际业绩与前瞻性陈述中包含的有所不同,请参阅C4 Therapeutics向美国证券交易委员会提交的最新10-k表年度报告和/或10-Q表季度报告中题为 “风险因素” 的章节。本新闻稿中的所有信息均截至发布之日,除非法律要求,否则C4 Therapeutics没有义务更新这些信息。

Contacts:
Investors:
Courtney Solberg
Senior Manager, Investor Relations
CSolberg@c4therapeutics.com

联系人:
投资者:
考特尼·索尔伯格
投资者关系高级经理
CSolberg@c4therapeutics.com

Media:
Loraine Spreen
Senior Director, Corporate Communications & Patient Advocacy
LSpreen@c4therapeutics.com

媒体:
洛兰·斯普林
企业传播与患者宣传高级董事
LSpreen@c4therapeutics.com


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