LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, Feb. 14, 2024 /PRNewswire/ -- Flamingo Therapeutics ('Flamingo') today announced that the first patient has been dosed in its PEMDA-HN trial evaluating danvatirsen in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

比利时鲁汶、法国斯特拉斯堡和费城，2024年2月14日/PRNewswire/-Flamingo Therapeutics（“Flamingo”）今天宣布，第一名患者已在其PEMDA-HN试验中服用药物，评估danvatirsen联合默克公司的抗PD-1疗法KEYTRUDA®（pembrolizumab）治疗复发/转移性头颈部鳞状细胞癌（HNSCC）患者。

Flamingo's lead oncology program, danvatirsen, is an antisense oligonucleotide discovered by Ionis that selectively targets STAT3 and has shown clinical activity in HNSCC. The global study is planned to be conducted at study centers in the United States, Korea and the United Kingdom..

Flamingo的首席肿瘤学项目danvatirsen是Ionis发现的一种反义寡核苷酸，可选择性靶向STAT3，并在HNSCC中显示出临床活性。这项全球研究计划在美国、韩国和英国的研究中心进行。。

'We are excited to launch this study and evaluate the combination of a STAT3 targeting agent, danvatirsen, with an established checkpoint inhibitor used in first-line therapy for this difficult-to-treat cancer population. Based on the potential synergy of the mechanisms of action, we aim to improve upon the overall response rates of pembrolizumab alone to better serve HNSCC patients,' said Andrew Denker, MD, CMO of Flamingo.

“我们很高兴启动这项研究，并评估STAT3靶向药物danvatirsen与已建立的检查点抑制剂的组合，该抑制剂用于这一难以治疗的癌症人群的一线治疗。Flamingo CMO医学博士安德鲁·登克（AndrewDenker）说，基于这些作用机制的潜在协同作用，我们的目标是提高单独使用pembrolizumab的总体缓解率，以更好地为HNSCC患者服务。

'We are grateful for the contribution of all participants in this study and for the support of our clinical collaborators at each site.'.

“我们感谢本研究所有参与者的贡献以及我们在每个地点的临床合作者的支持。”。

Recurrent/metastatic HNSCC is considered an incurable disease with poor prognosis and limited treatment options. It requires active treatment from the early stages and significantly impacts patients' lives, causing functional disability and a high mortality rate.

复发/转移性HNSCC被认为是一种无法治愈的疾病，预后不良，治疗选择有限。它需要从早期开始积极治疗，并严重影响患者的生活，导致功能障碍和高死亡率。

'Our site is very excited about being the first enrollment on this important head and neck trial.  The data is important to establish the effectiveness of the combination therapy with Danvatirsen and Pembrolizumab.  We are thankful to Flamingo for giving us the opportunity to have this treatment option for our patients here in Kansas City,' added Dr.

“我们的网站很高兴成为这项重要的头颈部试验的第一个参与者。这些数据对于确定Danvatirsen和Pembrolizumab联合治疗的有效性很重要。我们很感谢火烈鸟给了我们机会为堪萨斯城的患者提供这种治疗选择。

Jaswinder Singh, AMR Kansas City Oncology, Kansas City.  .

Jaswinder Singh，堪萨斯城AMR堪萨斯城肿瘤学。。

PEMDA-HN (NCT05814666) is a multicenter, open-label, randomized study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic HNSCC whose tumor expresses PD-L1. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.

PEMDA-HN（NCT05814666）是一项多中心，开放标签，随机研究，评估达瓦蒂森联合pembrolizumab与单独使用pembrolizumab作为肿瘤表达PD-L1的复发/转移性HNSCC患者的一线治疗的疗效和安全性。三分之二的患者将随机接受danvatirsen和pembrolizumab治疗，三分之一的患者将随机接受pembrolizumab治疗。

The primary endpoint of the study is to determine the overall response rate by RECIST 1.1 as assessed by the investigator. The secondary endpoints will include safety, duration of response, disease control rate, progression free survival and overall survival. More information on PEMDA-HN can be found here..

该研究的主要终点是确定研究者评估的RECIST 1.1的总体缓解率。次要终点包括安全性，反应持续时间，疾病控制率，无进展生存期和总生存期。关于PEMDA-HN的更多信息可以在这里找到。。

Dr. Nabil F. Saba, Emory Winship Cancer Institute and Chair of the PEMDA-HN Protocol Steering Committee, added, 'I am enthusiastic about the PEMDA-HN trial. I believe the combination of danvatirsen and pembrolizumab has tremendous promise to treat patients with head and neck cancer. Our center is proud to be participating in this important clinical study.'.

埃默里温希普癌症研究所（Emory Winship Cancer Institute）兼PEMDA-HN方案指导委员会主席纳比尔·萨巴（NabilF.Saba）博士补充说，“我对PEMDA-HN试验很感兴趣。我相信danvatirsen和pembrolizumab的组合在治疗头颈癌患者方面具有巨大的前景。我们中心很自豪能够参与这项重要的临床研究。”。

About Flamingo Therapeutics

关于Flamingo Therapeutics

Flamingo is pioneering RNA-targeted therapies for oncology with a clinical-stage pipeline targeting undruggable transcription factors and long non-coding RNAs. Flamingo has an alliance with Ionis Pharmaceuticals and is supported by well-known biotechnology investors including Andera Partners, Bpifrance Large Venture, Bpifrance through its FABS and Fonds Biothérapies Innovantes et Maladies Rares funds, Eurazeo - Kurma Partners, Perceptive Advisors, PMV, Pontifax, Sphera, Abrdn (formerly funds managed by Tekla Capital Management LLC) and VIB..

Flamingo是针对肿瘤的RNA靶向疗法的先驱，其临床阶段管道靶向不可药用的转录因子和长的非编码RNA。Flamingo与Ionis Pharmaceuticals建立了联盟，并得到了知名生物技术投资者的支持，包括Andera Partners、Bpifrance Large Venture、Bpifrance通过其FABS和Fonds Biothérapies Innovantes et Maladies Rares funds、Eurazeo-Kurma Partners、Perceptive Advisors、PMV、Pontifax、Sphera、Abrdn（以前由Tekla Capital Management LLC管理的基金）和VIB。。

Flamingo has initiated a Phase II trial 'PEMDA-HN' evaluating the STAT3 targeting agent danvatirsen, in combination with pembrolizumab, in patients with head and neck squamous cell carcinoma (HNSCC).

Flamingo启动了一项II期试验“PEMDA-HN”，评估STAT3靶向药物danvatirsen与pembrolizumab联合用于头颈部鳞状细胞癌（HNSCC）患者。

For more information on Flamingo, please visit:https://flamingotx.com

有关火烈鸟的更多信息，请访问：https://flamingotx.com

PEMDA-HN on clinicaltrials.gov:https://clinicaltrials.gov/study/NCT05814666

PEMDA-HN为clinicaltrials.gov：https://clinicaltrials.gov/study/NCT05814666

Please engage with us on LinkedIn:https://www.linkedin.com/company/flamingo-therapeutics.

请在LinkedIn上与我们联系：https://www.linkedin.com/company/flamingo-therapeutics.

Flamingo Media and Investor Contact:

Flamingo Media和投资者联系人：

Amy ConradJuniper Point(858) 366-3243[email protected]

Amy ConradJuniper Point（858）366-3243[受电子邮件保护]

SOURCE Flamingo Therapeutics, Inc.

SOURCE Flamingo Therapeutics公司。