Flamingo Therapeutics Announces First Patient Dosed in Phase II PEMDA-HN Study for Head and Neck Squamous Cell Carcinoma (HNSCC)

Excerpt from the Press Release:

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). 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.

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

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.

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