IDEAYA Licenses Biocytogen's Antibody Program for Cancer Treatment, Eyes FDA Submission in 2025
IDEAYA Licenses Biocytogen's Antibody Program for Cancer Treatment, Eyes FDA Submission in 2025
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate.
百奧賽圖-b(臨時代碼)(北京)有限公司(Biocytogen, 香港交易所: 02315),一家專注於新型抗體/adc therapeutics發現的全球生物技術公司,宣佈ideaya生物科學公佈了百奧賽圖的B7H3/PTK7 BsADC項目IDE034的全球獨家許可選擇,並將其提名爲開發候選藥物。
"We are excited that IDEAYA has chosen to exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034, which incorporates our proprietary topoisomerase linker-payload," said Dr. Yuelei Shen, President and CEO of Biocytogen. "This important milestone in our collaboration further validates the capabilities of Biocytogen's RenLite platform, bringing us closer to impactful treatments for patients with solid tumors. We look forward to supporting IDEAYA as they advance this program to clinical stages."
「我們很高興ideaya選擇行使他們對我們B7H3/PTK7 BsADC IDE034的全球獨家許可權,該藥物融入了我們的專有拓撲異構酶連接-有效負荷,」百奧賽圖總裁兼首席執行官沈躍磊博士表示。「我們合作的這一重要里程碑進一步驗證了百奧賽圖的RenLite平台的能力,將我們更接近爲患有實體腫瘤的患者提供有效治療。我們期待支持ideaya推動該項目進入臨床階段。」
Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences, commented, "We are pleased to nominate IDE034 as a development candidate. This promising, potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC has shown significant tumor regression in preclinical models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscore its potential as both a monotherapy and in combination with our PARG inhibitor, IDE161."
ideaya生物科學首席科學官Michael White博士表示:「我們很高興提名IDE034作爲開發候選藥物。這種有前景的,潛在的頭號B7H3/PTK7拓撲異構酶-i-有效負荷雙特異性adc在臨床前模型中顯示出顯著的腫瘤回歸。實體腫瘤中B7H3/PTK7共表達率如肺癌、結直腸癌和頭頸癌的高流行率強調了它可能作爲單藥治療和與我們的PARG抑制劑IDE161聯合使用的潛力。」
IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, to facilitate the initiation of first-in-human trials.
IDEAYA計劃在進行中的臨床前和IND啓動研究完成後,在2025年向美國FDA提交IDE034的新藥審批申請,以促進首次人體試驗的啓動。
Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.
根據百奧賽圖和ideaya之間的許可和許可協議,百奧賽圖將獲得預付款和許可行使費,以及額外的開發和監管里程碑付款、商業里程碑付款和淨銷售的提成,總計40650萬美元,其中包括高達10000萬美元的開發和監管里程碑付款。
Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.
根據Human Protein Atlas數據庫的數據,B7H3/PTK7據報道在多種固體腫瘤類型中呈現共表達,包括大約30%的肺癌、46%的結直腸癌和27%的頭頸部癌症。
譯文內容由第三人軟體翻譯。