Our Approach

Our Product Candidates

Flamingo is a clinical-stage oncology company that leverages the breadth and depth of our team’s expertise in RNA therapeutics and cancer drug development. Flamingo has a promising pipeline focused on “undruggable” targets, with a lead therapeutic (danvatirsen, STAT3 inhibiting anti-sense oligonucleotide (ASO)) in Phase 2 development and a second therapeutic (FLM-7523, MALAT1 inhibiting ASO) ready for the clinic.

Our Pipeline

Flamingo’s focus is on the development of RNA-targeted therapies for difficult to treat cancers.

Patients are at the center of what we do.

Our Clinical Trial – PEMDA-HN

More information on
PEMDA-HN can be
found here.

PEMDA-HN Now Enrolling

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 has a PD-L1 expression. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone. 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.

Publications

Danvatirsen
ASO-mediated STAT3 knockdown relieves immunosuppression and sensitizes tumors to immunotherapies

Veronica Finisguerra, Marie-Aline Neveu, Joppe Lochten, Dido Van de Velde, Natalie De Geest, Marie Wallays, Marijke Pellens, Michel Janicot, Andrew Denker, Tiziana Girardi

A Phase 1 Study Investigating the Safety and Efficacy of Danvatirsen As Monotherapy Followed By Combination with Venetoclax in Patients with Relapsed/Refractory MDS and AML

Aditi Shastri, Mendel Goldfinger, Ioannis Mantzaris, Guillermo Garcia-Manero, Tapan Kadia, Jing Ning, Balda Tirone, Rikin Gandhi, Steven Kornblau, Guillermo Montalban Bravo, Farhad Ravandi, Naveen Pemmaraju, Anne Munoz, Michelle Golez, Lianchun Xiao, Kith Pradhan, Karen Fehn, Lamisha Shah, Hui Zhang, Samarpana, Chakraborty, Eric Feldman, Nicholas Short, Jayatsu Senapati, Dennis Cooper, Alex Sica, Noah Kornblum, Lauren Schwartz, Nishi Shah, Susan MacIntyre, Ulrich Steidl, Amit Verma, Kira Gritsman, Andrew Denker, Marina Konopleva, Naval Daver

PEMDA-HN, an Open-Label, Phase II, Randomized Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)

N.F. Saba, H. Youssoufian, E. Cohen, J. Singh, L. Makris, M. Perdomini, S. MacIntyre, A.E. Denker

AZD9150, a next-generation antisense oligonucleotide inhibitor of STAT3 with early evidence of clinical activity in lymphoma and lung cancer

Hong D, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MV, Mohseni M, Lawson D, Reimer C, Blakey DC, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR.

Sci Transl Med. 2015 Nov 18;7(314):314ra185. doi: 10.1126/scitranslmed.aac5272.

STAT3 Antisense Oligonucleotide Remodels the Suppressive Tumor Microenvironment to Enhance Immune Activation in Combination with Anti-PD-L1.

Proia TA, Singh M, Woessner R, Carnevalli L, Bommakanti G, Magiera L, Srinivasan S, Grosskurth S, Collins M, Womack C, Griffin M, Ye M, Cantin S, Russell D, Xie M, Hughes A, Deng N, Mele DA, Fawell S, Barry S, Reimer C, Barrett JC, McCoon P.

Clin Cancer Res. 2020 Dec 1;26(23):6335-6349. doi: 10.1158/1078-0432.CCR-20-1066. Epub 2020 Sep 17.

STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial.

Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS.

J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5.

MALAT-1 & LncRNA
Preclinical development of FTX-001: First-in-class inhibitor of the long non-coding RNA MALAT1

Marie-Aline Neveu1, Alexey Revenko, Tae-Won Kim, Xiaolin Luo, Youngsoo Kim, Joanna Schmidt, A. Robert MacLeod & Andrew E. Denker

 Flamingo Therapeutics, Leuven, Belgium; Ionis Pharmaceuticals, Carlsbad, CA. USA, Flamingo Therapeutics, Lower Merion, USA

Differentiation of mammary tumors and reduction in metastasis upon Malat1 lncRNA loss.

Arun G, Diermeier S, Akerman M, Chang KC, Wilkinson JE, Hearn S, Kim Y, MacLeod AR, Krainer AR, Norton L, Brogi E, Egeblad M, Spector DL.

Genes Dev. 2016 Jan 1;30(1):34-51. doi: 10.1101/gad.270959.115. Epub 2015 Dec 23.
PMID: 26701265 Free PMC article.

The noncoding RNA MALAT1 is a critical regulator of the metastasis phenotype of lung cancer cells.

Gutschner T, Hämmerle M, Eissmann M, Hsu J, Kim Y, Hung G, Revenko A, Arun G, Stentrup M, Gross M, Zörnig M, MacLeod AR, Spector DL, Diederichs S.

Cancer Res. 2013 Feb 1;73(3):1180-9. doi: 10.1158/0008-5472.CAN-12-2850.

MALAT1 Long Non-Coding RNA: Functional Implications.

Arun G, Aggarwal D, Spector DL.

Noncoding RNA. 2020 Jun 3;6(2):22. doi: 10.3390/ncrna6020022.

Abstract 1541: LncRNA MALAT1 as a potential therapeutic target in triple negative breast cancer.

Oluwatoyosi Adewunmi, Jeffrey Rosen.

Cancer Res 15 June 2022; 82 (12_Supplement): 1541. https://doi.org/10.1158/1538-7445.AM2022-1541