Phanes Therapeutics Announces First Patient Dosed in Clinical Study of PT886 in Combination With KEYTRUDA (Pembrolizumab)
Phanes Therapeutics Announces First Patient Dosed in Clinical Study of PT886 in Combination With KEYTRUDA (Pembrolizumab)
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., SAN DIEGO, Oct. 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the first patient has been dosed in the clinical study of PT886 in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The dosing was conducted in a cohort of gastric and gastroesophageal junction cancers.
舊金山，2024年10月8日 / PRNewswire / - 默沙東旗下的臨床階段生物技術公司Phanes Therapeutics, Inc.(Phanes)今天宣佈，對Merck的抗PD-1療法KEYTRUDA（pembrolizumab）與PT886聯合治療的臨床研究中，首位患者已經接受了劑量給藥。這次給藥是在胃癌和胃食管結合部癌症隊列中進行的。
As previously announced, Phanes is conducting this study under a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada). PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. PT886 is currently being evaluated as monotherapy and in combination with pembrolizumab, or with chemotherapy, either alone or in combination with pembrolizumab.
正如之前宣佈的，Phanes正在根據與默沙東（在美國和加拿大以外地區稱爲MSD）的臨床試驗合作協議進行這項研究。 PT886是一種類IgG的新型異二特異性抗體，靶向claudin 18.2和CD47。2022年，它獲得了FDA對胰腺癌治療的孤兒藥品認定（ODD），今年早些時候針對轉移性claudin 18.2陽性胰腺腺癌患者治療也榮獲了快速通道認定。目前，PT886正在評估作爲單藥療法以及與pembrolizumab或化療聯合使用，或者與pembrolizumab聯合使用。
The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655).
PT886（NCT05482893）的多中心I / II期臨床試驗，即TWINPEAk研究，目前正在評估PT886在局部晚期或轉移性胃癌，胃食管結合部癌和胰腺癌患者中的安全性，耐受性，藥物代謝動力學，藥效學以及初步療效。PT886的I期臨床試驗也正在中國進行（CTR20241655）。
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
KEYTRUDA是美國默沙東公司的子公司Merck Sharp＆Dohme LLC的註冊商標。
ABOUT PHANES THERAPEUTICS
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Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA.
Phanes Therapeutics, Inc.是一家專注於腫瘤領域創新藥物研發的臨床階段生物技術公司。目前，它正在進行三項I期臨床試驗，包括具有最佳單克隆抗體（mAb）計劃的晨星研究的PT199，帶有PT886的TWINPEAk研究以及具有PT217的SKYBRIDGE研究。PT886和PT217都是第一類別的雙特異抗體，並已被FDA授予了孤兒藥品認定以及快速通道認定。
The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody, SPECpair and ATACCbody to develop novel biologics that address high unmet medical needs in cancer.
該公司利用其專有技術平台PACbody、SPECpair和ATACCbody構建了強大的產品線，開發了解決癌症等高未滿足醫療需求的新型生物製品。
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SOURCE Phanes Therapeutics, Inc.
資訊來源：Phanes Therapeutics, Inc.
