Danvatirsen

-Trial-in-Progress poster provides overview on PEMDA-HN trial evaluating danvatirsen in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with recurrent/metastatic HNSCC- LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, June 2, 2024 /PRNewswire/ -- Flamingo Therapeutics ("Flamingo") today announced the presentation of a Trial-in-Progress poster at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) taking place in Chicago, Illinois. Flamingo's lead oncology program, danvatirsen, is an oligonucleotide discovered by Ionis that selectively targets STAT3 and has shown clinical activity in HNSCC. 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. The primary endpoint of the study is overall response rate by RECIST 1.1 as assessed by the investigator. The secondary endpoints include safety, duration of response, disease control rate, progression free survival and overall survival. PEMDA-HN is being conducted at study centers in the United States, South Korea and the United Kingdom. ASCO poster details are as follows: Abstract#: TPS6113 Title: "PEMDA-HN, an open-label, phase II, randomized controlled study of danvatirsen plus pembrolizumab compared to pembrolizumab alone in first-line recurrent and/or metastatic head and neck squamous cell carcinoma (RM HNSCC)" Session Title: Poster Session – Head and Neck Cancer Session Date and Time: June 2, 2024, 9:00am CDT Presenting Author: Marshall R. Posner, MD, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai For more information, please visit the ASCO 2024 website. About 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 Abrdn (formerly funds managed by Tekla Capital Management LLC), 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, and 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). A Phase I investigator-initiated trial study has also been initiated evaluating danvatirsen as a monotherapy and in combination with venetoclax in AML/MDS patients. For more information on Flamingo, please visit: PEMDA-HN (head and neck cancer) on clinicaltrials.gov: Danvatirsen monotherapy followed by combination with venetoclax in relapsed/ refractory AML and MDS on clincaltrials.gov: Please engage with us on LinkedIn: . Flamingo Media and Investor Contact: Amy Conrad Juniper Point (858) 366-3243 [email protected] SOURCE Flamingo Therapeutics

-Danvatirsen is now being evaluated in two clinical trials for head and neck and AML/MDS cancers- LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, May 16, 2024 /PRNewswire/ -- Flamingo Therapeutics ("Flamingo") today announced that the first patient has been dosed in an Investigator-initiated Trial (IIT) evaluating the safety and efficacy of danvatirsen in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who have relapsed or are refractory to frontline therapy. The IIT is being conducted by leading researchers at Montifore Einstein Comprehensive Cancer Center (MECCC; New York, USA) and MD Anderson Cancer Center (MDACC; Houston, USA). In the Phase 1 trial, the STAT3 inhibiting oligonucleotide danvatirsen, discovered by Ionis, will be evaluated as a monotherapy and also in combination with venetoclax, an approved frontline treatment in relapsed/refractory MDS and AML. AML and MDS—two related blood diseases that disproportionally impact older adults—are notoriously difficult to treat and associated with high relapse rates. Although new therapies have improved survival, treatment options remain limited, and the prognosis for the 50% of people who experience disease relapse remains poor. STAT3 protein, which danvatirsen is designed to inhibit, has been associated with worse prognosis. "We are excited to dose the first patient and initiate a potentially ground-breaking study to evaluate a novel therapeutic strategy targeting STAT3 with danvatirsen for patients suffering from AML and MDS. This clinical trial builds upon the work that my team has done in the research lab over the past decade, and is a good example of a bench to bedside partnership between academic medical centers and industry," said Aditi Shastri, M.D., Principal Investigator of the IIT, Member of MECCC's Stem Cell & Cancer Biology Research Program and Blood Cancer Institute, and Associate Professor of Oncology, Medicine, and Developmental and Molecular Biology at Albert Einstein College of Medicine. "I look forward to working with the Flamingo team to continue generating promising results in the ongoing clinical trial." The IIT is being funded by a multi-year grant awarded by the US FDA Office of Orphan Products Development (OOPD) to MECCC, with Dr. Aditi Shastri as the principal investigator, and was one of only 10 grants awarded by the FDA OOPD in 2023. MD Anderson Cancer Center (MDACC) is also participating in the trial with Dr.Naval Daver being the principal investigator at the MDACC site. "Drs. Shastri and Daver are recognized among the world's leading experts in AML and MDS and we couldn't be more pleased to collaborate with them, MECCC, and MDACC," said Andrew Denker, MD, PhD, Chief Medical Officer of Flamingo. "We have tremendous momentum right now with danvatirsen, with ongoing clinical programs in head and neck cancer (PEMDA-HN) and in AML/MDS. The IIT announced today is very important to broaden Flamingo's danvatirsen clinical development program, and advance our therapy towards patients who can benefit from novel treatments." The IIT is a Phase I study (NCT05986240) investigating danvatirsen as both a monotherapy and in combination with venetoclax in patients with AML or intermediate/high/very high risk MDS who have relapsed or are refractory to frontline therapy. The sequential dose escalation design seeks to assess safety, efficacy, pharmacokinetics and pharmacodynamics, to inform a recommended phase 2 dose and further investigations. More information on the IIT study can be found here. About 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 Abrdn (formerly funds managed by Tekla Capital Management LLC), 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, and 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). A Phase I investigator initiated trial study has also been initiated evaluating danvatirsen as a monotherapy and in combination with venetoclax in AML/MDS patients. For more information on Flamingo, please visit: PEMDA-HN (head and neck cancer) on clinicaltrials.gov: Danvatirsen monotherapy followed by combination with venetoclax in relapsed/ refractory AML and MDS on clincaltrials.gov: Please engage with us on LinkedIn: . Flamingo Media and Investor Contact: Amy Conrad Juniper Point (858) 366-3243 [email protected] SOURCE Flamingo Therapeutics