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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宣佈CFT8919臨床試驗中首位患者接受了初次投藥
C4 Therapeutics ·  11/06 13:00

Clinical Development Initiated in Greater China by Partner Betta Pharmaceuticals

合作伙伴貝達製藥在大中華區啓動臨床開發

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.

馬薩諸塞州沃特敦,2024年11月6日(GLOBE NEWSWIRE)——致力於推進靶向蛋白質降解科學的臨床階段生物製藥公司C4 Therapeutics, Inc.(C4T)(納斯達克股票代碼:CCCC)今天宣佈,其合作伙伴貝塔製藥已爲第一位患者服藥 CFT8919,這是一種用於非小細胞的口服生物可利用的 EGFR L858R 變構降解劑大中華地區的肺癌(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首席醫學官倫·雷諾萬博士表示:「我們很高興看到,我們第四款進入臨床的小分子降解劑 CFT8919 與我們的合作伙伴貝塔製藥一起開始了大中華區的臨床開發之旅。」「CFT8919 可能在治療由表皮生長因子突變驅動的非小細胞肺癌方面取得令人興奮的進展,表皮生長因子突變目前使用表皮生長因子酪氨酸激酶抑制劑(TKI)治療,對錶皮生長因子 L858R 驅動突變患者的反應不如具有其他驅動突變的患者那麼持久。我們和我們的合作伙伴貝塔製藥相信,CFT8919 可能爲尋求治療選擇的患者和醫生提供一種新的靶向療法。」

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.

C4萬億設計的 CFT8919 對攜帶致癌性 L858R 突變的表皮生長因子具有有效和選擇性,能夠克服使患者對錶皮生長因子 TKI 產生難治性的常見表皮生長因子繼發突變。表皮生長因子突變在亞洲血統的非小細胞肺癌患者中尤其常見。在中國,每年約有693,000名患者被診斷出患有非小細胞肺癌,大約50%的診斷是由表皮生長因子突變驅動的。表皮生長因子 L858R 突變是第二常見的表皮生長因子突變,在美國和中國診斷爲表皮生長因子突變的患者中,約有40%存在表皮生長因子突變。

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,C4萬億和貝達製藥達成戰略合作,在大中華區(包括香港特別行政區、澳門特別行政區和臺灣)開發、製造和商業化 CFT8919。根據協議條款,C4萬元有資格獲得高達3.57億美元的潛在里程碑加上淨銷售額的特許權使用費。C4萬保留 CFT8919 在美國、歐盟和世界其他地區的開發和商業化權利。

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.

關於 CFT8919
CFT8919 是一種口服生物可利用的變構的 bidAC 降解劑,旨在對攜帶致癌 L858R 突變的表皮生長因子具有有效和選擇性。在臨床前研究中,CFT8919 活躍於 L858R 驅動的非小細胞肺癌的體外和體內模型。重要的是,CFT8919 對其他表皮生長因子突變保持了全部活性,這些突變會對批准的表皮生長因子抑制劑(包括 L858R-C797S、L858R-T79000萬和 L858R-T79000萬和L858R-T79000萬.C797S)產生耐藥性。

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 .

關於 C4 療法
C4 Therapeutics(C4T)(納斯達克股票代碼:CCCC)是一家臨床階段的生物製藥公司,致力於兌現靶向蛋白質降解科學的承諾,創造改變患者生活的新一代藥物。C4萬億正在通過臨床研究推進靶向腫瘤學項目,並利用其TORPEDO平台高效設計和優化小分子藥物,以解決難以治療的疾病。C4T的降解劑藥物旨在利用人體的天然蛋白質回收系統快速降解致病蛋白,從而有可能克服耐藥性、不可藥物靶標和改善患者預後。欲了解更多信息,請訪問。

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.

前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》所指的C4 Therapeutics, Inc.的 「前瞻性陳述」。這些前瞻性陳述可能包括但不限於關於我們爲患者開發潛在療法的能力、治療方法的設計和潛在療效、我們實現里程碑和從合作伙伴貝塔製藥那裏獲得潛在特許權使用費的能力,以及我們爲未來運營提供資金的能力的明示或暗示陳述。本新聞稿中的任何前瞻性陳述均基於管理層當前對未來事件的預期和信念,並存在許多風險和不確定性,這些風險和不確定性可能導致實際業績與此類前瞻性陳述中列出或暗示的業績存在重大不利差異。這些風險和不確定性包括但不限於:與臨床前和臨床研究的啓動、時機、進展和進行以及候選產品的其他開發要求相關的不確定性;我們的任何一種或多種候選產品的開發成本更高或可能無法成功開發和商業化的風險;以及在可接受的條件或要求的時間向我們提供足夠資金來資助我們未來運營的風險。有關這些風險和不確定性以及其他重要因素的討論,其中任何一個都可能導致我們的實際業績與前瞻性陳述中包含的有所不同,請參閱C4 Therapeutics向美國證券交易委員會提交的最新10-k表年度報告和/或10-Q表季度報告中題爲 「風險因素」 的章節。本新聞稿中的所有信息均截至發佈之日,除非法律要求,否則C4 Therapeutics沒有義務更新這些信息。

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

聯繫人:
投資者:
考特尼·索爾伯格
投資者關係高級經理
CSolberg@c4therapeutics.com

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

媒體:
洛蘭·斯普林
企業傳播與患者宣傳高級董事
LSpreen@c4therapeutics.com


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