Flamingo Therapeutics and Dynacure have joined forces to form a powerhouse in oncology. The companies have signed a merger agreement to combine their innovative pipelines and expertise to create a cutting-edge oncology company. Flamingo’s leading programs, danvatirsen (in a Phase II trial PEMDA-HN for Head & Neck cancer in combination with pembrolizumab) and FTX-001 (targeting MALAT-1 in cancer, IND ready), will be advanced by the combined company. Additionally, Kurma Partners (France) and PMV (Belgium) have made further investments in Flamingo.
Danvatirsen is revolutionizing the way we treat cancer. This powerful antisense oligonucleotide specifically targets STAT3, a key player in tumor cell growth. In two Phase II clinical studies, Danvatirsen was able to inhibit translation of STAT3 mRNA, leading to reduced tumor cell growth and activated anti-tumor immunity in the tumor micro-environment. This innovative treatment has the potential to revolutionize cancer care as we know it.
Danvatirsen is pushing forward in its Phase 2 clinical development to treat head and neck squamous cell carcinoma and is excited to announce its progress with FTX-001, Flamingo’s most advanced LncRNA program. This program targets MALAT-1, a long non-coding RNA found in the “dark matter” of the human genome, and is nearing readiness for its Phase 1 trial in solid tumors. With its innovative approach, Danvatirsen is poised to make a revolutionary impact on the medical field.
The merger between Flamingo and Dynacure is an exciting strategic opportunity. By combining their expertise in RNA therapeutics and cancer drug development, they have formed a powerful organization that will benefit all stakeholders, including patients, clinicians, and investors. Under the leadership of Stéphane van Rooijen, Chief Executive Officer of Flamingo, the newly formed company is committed to executing a well-defined clinical strategy that will create value for all involved.
We are thrilled to join forces with the Dynacure team and execute an ambitious transition plan that will ensure the long-term success and prosperity of Flamingo. With this merger, we can bolster our clinical execution while leveraging additional resources. Michael Garrett, Chief Operating Officer of Flamingo, emphasizes that this is a major step towards our ambition of becoming a leader in the industry.
Dr. Chris Mirabelli, Chairman of the combined company, is confident in the potential of danvatirsen and their MALAT-1 targeted ASO (FTX-001). He is enthusiastic about the ambitious clinical plan ahead, which is looking to deliver multiple readouts in 2024 and 2025.
Ionis’ Chief Executive Officer, Brett P. Monia, Ph.D., expressed his delight at the union of the two companies which will work together to develop cancer therapies to address unmet needs. He lauded the Flamingo leadership team for their strength and dedication, noting that their oncology drug development experience is essential for creating a successful future for all involved.
Management and Organization
Dynacure and Flamingo are joining forces to form a powerful new biopharmaceutical company that will be led by Stéphane van Rooijen (MD, MBA) as Chief Executive Officer and Michael Garrett as Chief Operating Officer. The company will be headquartered in Leuven, Belgium with offices in Strasbourg, France and Philadelphia, USA. The board of directors of this new combined company will be chaired by Chris Mirabelli, Ph.D., Chairman of Leap Therapeutics, and include Benoit Barteau, Tine Bekaert, Rémi Droller, Jean Franchi, George Gemayel, and Henry Skinner. With its talented leadership and cutting-edge facilities, this new biopharmaceutical company is set to revolutionize the industry.
About PEMDA-HN Phase II Trial in Head & Neck Cancer
Flamingo Therapeutics is taking a bold step forward in the fight against head and neck squamous cell carcinoma (HNSCC) by launching a Phase II clinical trial to assess the effectiveness of a groundbreaking combination of the STAT3 targeting agent danvatirsen and pembrolizumab. The potential of this combination to bring about positive outcomes for patients with HNSCC is an exciting development in the field of oncology.
This upcoming multicenter, open-label, randomized trial will compare the combination of danvatirsen and pembrolizumab to pembrolizumab alone for treatment of recurrent/metastatic HNSCC. Patients with PD-L1 expression in their tumors are eligible for the study, which will be conducted in US study centers. The primary endpoint of the study is to measure overall response rate using RECIST 1.1 as assessed by the investigator. Secondary endpoints will include safety, duration of response, disease control rate, progression free survival and overall survival. All eligible patients will be randomized in a 2:1 ratio to receive either danvatirsen + pembrolizumab or pembrolizumab monotherapy, respectively, and will continue to receive treatment until disease progression or discontinuation. This trial is an exciting opportunity to explore a potential new treatment option for HNSCC.
About Flamingo Therapeutics
Flamingo is revolutionizing oncology with the introduction of its groundbreaking RNA-targeted therapies. Through its collaboration with Ionis Pharmaceuticals, and the support of renowned 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, funds managed by Tekla Capital Management LLC and VIB, Flamingo is on a mission to develop clinical-stage treatments that target undruggable transcription factors and splice variants.