ISA Pharmaceuticals Commences Patient Treatment in Third Phase 2 Clinical Trial with the Combination of ISA101b and Libtayo® (cemiplimab)
ISA Pharmaceuticals Commences Patient Treatment in Third Phase 2 Clinical Trial with the Combination of ISA101b and Libtayo® (cemiplimab)
OEGSTGEEST, Netherlands, Sept. 8, 2021 /PRNewswire/ -- ISA Pharmaceuticals B.V., a clinical stage biotech company, announces the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo® (cemiplimab) in advanced HPV16 positive oropharyngeal cancer. This new study is the third with active recruitment under ISA Pharmaceuticals' strategic immuno-oncology collaboration with Regeneron.
OEGSTGEEST， 荷蘭， 2021 年 9 月 8 日 /PRNewswire/ — 臨床階段生物技術公司ISA Pharmicals B.V. 宣佈在一項關鍵臨床試驗中開始給患者給藥，該試驗正在研究 isa101b 和 Libtayo®（cemiplimab）聯合治療晚期 HPV16 陽性口咽癌。這項新研究是ISA Pharmicals與Regeneron戰略免疫腫瘤學合作下的第三項積極招募的研究。
The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.
這個 口咽癌 2 期研究（NCT04398524）將包括86名復發/轉移性 HPV16 陽性口咽癌患者，這些患者在先前的抗PD-1治療中取得了進展，這種癌症的醫療需求未得到滿足。主要療效結果參數是總體反應率（ORR），該研究預計將在2023年下半年公佈最高數據。
The other studies testing the combination of ISA101b and Libtayo are:
其他測試 isa101b 和 Libtayo 組合的研究有：
A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.
宮頸癌 2 期研究(NCT04646005) 正在由 Regeneron 進行。它將招收103名在一線化療後出現疾病進展的復發/轉移性 HPV16 陽性宮頸癌成年患者。這項研究的主要終點將是ORR。
A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for this study are expected in the second half of 2022.
一項針對一線和二線 HPV16 陽性頭頸癌的隨機、安慰劑對照 2 期研究（NCT03669718），這將包括194名同樣以ORR爲主要終點的患者。ISA Pharmicals進行這項研究。這項研究的最終結果預計將在2022年下半年公佈。
ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA's proprietary Synthetic Long Peptide (SLP®) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.
isa101b 免疫療法靶向 HPV16 陽性癌症。它誘導對 HPV16 病毒的強大和特異性免疫反應，並（重新）對受感染和/或癌細胞和組織建立強大而有針對性的 T 細胞免疫反應。isa101b 正在使用 ISA 專有的合成長肽 (SLP®) 技術。Libtayo是一種抗PD-1抗體，由Regeneron和賽諾菲共同開發。
Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."
Gerben Moolhuizen，ISA Pharmicals首席執行官表示：“我們很高興地宣佈，在這項新研究中，第一位患者已經接受了治療。它凸顯了我們與Regeneron的富有成效的合作，兩家公司都積極參與了運營工作。這項額外試驗有可能縮短獲批 HPV16 陽性癌症適應症的途徑。”
Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe1 and 46,000 new cases and 9,000 deaths in the US2.
頭頸癌和宮頸癌可能嚴重並危及生命，通常在年輕至中年成年人中被診斷出來，一旦這些癌症發展到晚期，總存活率就會很低。HPV16 是頭頸癌的主要原因，新增病例超過 25,000 例，死亡 11,000 人 歐洲1 在美國有46,000例新發病例和9,000例死亡2。
More information on the clinical trials can be found here.
有關臨床試驗的更多信息可以在這裏找到。
1 Adapted from https://gco.iarc.fr/today/data/factsheets/cancers/3-Oropharynx-fact-sheet.pdf
1改編自 https://gco.iarc.fr/today/data/factsheets/cancers/3-Oropharynx-fact-sheet.pdf
2 Adapted from https://www.cancer.org/cancer/oral-cavity-and-oropharyngeal-cancer/about/key-statistics.html
2改編自 https://www.cancer.org/cancer/oral-cavity-and-oropharyngeal-cancer/about/key-statistics.html
About ISA Pharmaceuticals
關於 ISA 製藥
ISA Pharmaceuticals is an immunotherapy company developing treatments for various cancers and infectious diseases. ISA Pharma has best-in-class technology to stimulate and activate the human immune system, specifically T cells, to fight diseased or infected cells. Its lead asset ISA101b is in late-stage clinical trials for human papillomavirus type 16 (HPV16)-induced cancer in a collaboration with US pharmaceutical company Regeneron. Other assets are in preclinical stage development and include immunotherapies to treat patients that suffer from chronic hepatitis B infections, cancers that over-express PRAME, cancers caused by other HPV types than HPV16, or SARS-CoV2 infections. For more information, please visit www.isa-pharma.com.
ISA Pharmacels是一家免疫療法公司，開發各種癌症和傳染病的治療方法。ISA Pharma 擁有一流的技術，可以刺激和激活人類免疫系統，特別是 T 細胞，以對抗患病或受感染的細胞。其主要資產isa101b正與美國製藥公司Regeneron合作，對人類乳頭瘤病毒（HPV16）誘發的癌症進行後期臨床試驗。其他資產處於臨床前開發階段，包括用於治療慢性乙型肝炎感染、PRAME 過度表達的癌症、由 HPV16 以外的其他 HPV 類型引起的癌症或 SARS-CoV2 感染的患者的免疫療法。欲瞭解更多信息，請訪問 www.isa-pharma.com。
SOURCE ISA Pharmaceuticals
來源 ISA Pharm
譯文內容由第三人軟體翻譯。