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Chimerix to Speak Today at The White House Cancer Moonshot Forum

Chimerix to Speak Today at The White House Cancer Moonshot Forum

Chimerix今日將在白宮癌症登月論壇上發言
Chimerix ·  01/13 05:00

Chief Scientific Officer, Joshua E. Allen, Ph.D. to Highlight Cancer Moonshot's Impact on Brain Cancer and Rare Pediatric Disease Drug Development

首席科學官喬舒亞·E·艾倫博士將強調癌症登月計劃對腦癌和罕見兒童疾病藥物開發的影響

DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, announced today that Dr. Joshua E. Allen, Chief Scientific Officer at Chimerix, will speak at the Biden Cancer Moonshot Mission Report 2024 – And Beyond. Dr. Allen's remarks will cover the program's impact on advancing therapies for brain and rare pediatric cancers, including H3 K27M-mutant diffuse glioma.

美國北卡羅來納州杜赫姆,2025年1月13日(全球新聞稿)-- Chimerix(納斯達克:CMRX),一家致力於開發能夠顯著改善和延長面臨致命疾病的患者生命藥物的生物製藥公司,今天宣佈,Chimerix首席科學官喬舒亞·E·艾倫博士將在2024年拜登癌症登月計劃任務報告和之後的活動中發言。艾倫博士的發言將涵蓋該計劃對推進腦癌和罕見兒童癌症療法的影響,包括H3 K2700萬.mutant瀰漫性膠質瘤。

"The Biden Cancer Moonshot has significantly improved the approach to cancer diagnosis and treatment with, among other achievements, programs to improve health equity in clinical trials as well as broadening patient navigation services for pediatric cancer," said Mike Andriole, Chief Executive Officer of Chimerix. "The invitation to speak today is an opportunity to share more about the impact of Biden Cancer Moonshot on cooperative efforts to accelerate promising research in pediatric brain cancer drug development and chart new courses for the future."

"拜登癌症登月計劃通過改善臨牀試驗中的健康公平性以及擴展兒童癌症患者導航服務等一系列成就,顯著改善了癌症診斷和治療的方法," Chimerix首席執行官邁克·安德里歐爾表示。"今天的發言邀請是一個機會,分享拜登癌症登月計劃對加速兒童腦癌藥物開發的合作努力的影響,以及爲未來開闢新的方向。"

"The Biden Cancer Moonshot has provided a critical platform to advance innovation for pediatric and rare cancers where progress has been limited for decades. I am honored to speak today about the tireless collaborative efforts of researchers, physicians, regulators, and patient advocates to improve outcomes for the most challenging forms of brain cancer. The accelerated development of dordaviprone highlights the importance of this forum. The Biden Cancer Moonshot has provided a critical forum for action to occur with the urgency that cancer patients and their families deserve," said Dr. Allen.

"拜登癌症登月計劃爲推進那些幾十年來進展有限的兒童和罕見癌症的創新提供了一個關鍵的平台。我今天很榮幸能談論研究人員、醫生、監管機構和患者倡導者在改善最具挑戰性的腦癌的結果方面不懈合作的努力。多達白給叢藥的加速開發突顯了這個論壇的重要性。拜登癌症登月計劃提供了一個關鍵的行動論壇,能夠以癌症患者及其家庭應得的緊迫性進行行動," 艾倫博士說道。

In December Chimerix submitted a New Drug Application (NDA) for dordaviprone to the U.S. FDA, seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma. The company also requested Priority Review, which, if granted, could result in a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has received Rare Pediatric Disease Designation and has applied for a Rare Pediatric Disease Priority Review Voucher as part of the NDA process.

去年12月,Chimerix向美國FDA提交了一項新的藥物申請(NDA),尋求對複發性H3 K2700萬.mutant瀰漫性膠質瘤的加速批准。該公司還請求優先審查,若獲批准,可能導致處方藥用戶費法案(PDUFA)行動日期在2025年第三季度。多達白給叢藥已獲得罕見兒童疾病資格,並在NDA過程中申請了罕見兒童疾病優先審查券。

About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company's most advanced clinical-stage development program, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data.

關於Chimerix
Chimerix是一家生物製藥公司,致力於開發能顯著改善和延長面臨致命疾病的患者生命的藥物。公司的最先進臨牀階段開發項目dordaviprone正在爲H3 K2700萬突變膠質瘤開發。公司正在進行ONC206的第一階段劑量遞增研究,以評估安全性和藥代動力學數據。

About Dordaviprone
Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).

關於Dordaviprone
Dordaviprone (ONC201)是一種新型的首創小分子imipridone,能夠選擇性靶向線粒體蛋白酶ClpP和多巴胺受體D2 (DRD2)。

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things: the possible regulatory path forward for dordaviprone, including the potential to seek accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; timing and consequences of an NDA submission to FDA; FDA's acceptance for filings; the initial potential PDUFA timing. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks related to the ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; uncertainty on the response of regulators to including additional supportive data to be submitted in the NDA filing, including RANO 2.0 assessments, and uncertainty with respect to the initial potential PDUFA timing; risks related to the clinical development of our clinical candidates; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

前瞻性聲明
本新聞稿包含1995年《私人證券訴訟改革法案》意義上的前瞻性陳述,這些陳述受風險和不確定性的影響,可能導致實際結果與預測結果存在重大差異。前瞻性陳述包括與以下事項相關的內容:dordaviprone的可能監管前景,包括尋求加速批准的潛力、優先審查、稀有兒童疾病優先審查憑證和市場授權批准;向FDA提交新藥申請的時間和後果;FDA對申請的接受;初步潛在的PDUFA時間。可能導致實際結果與前瞻性陳述中所示的結果存在重大差異的因素和風險包括:與獲得和維持加速批准、優先審查、稀有兒童疾病優先審查憑證以及市場授權批准的能力相關的風險;對於提交申請時是否可以增加額外支持數據,尤其是RANO 2.0評估,監管機構的反饋存在不確定性,以及與初步潛在的PDUFA時間的相關不確定性;與我們的臨牀候選人臨牀開發相關的風險;以及在公司向證券交易委員會提交的文件中列出的其他風險。這些前瞻性陳述代表了公司在本發佈日期的判斷。然而,公司聲明不對更新這些前瞻性陳述有任何意圖或義務。

INVESTOR CONTACT:
Will O'Connor
Stern Investor Relations
212-362-1200

投資者聯繫方式:
威爾·奧康納
斯特恩投資者關係
212-362-1200

MEDIA CONTACT:
Dana Davis
Steelwire
dana@steelwire.co

媒體聯繫方式:
達納·戴維斯
鋼絲
dana@steelwire.co


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Source: Chimerix, Inc.

來源:Chimerix, Inc.

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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