On May 16, 2024 Flamingo Therapeutics ("Flamingo") reported 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 (Press release, Flamingo Therapeutics, MAY 16, 2024, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-first-patient-dosed-in-investigator-initiated-trial-iit-evaluating-danvatirsen-in-phase-1-for-aml-mds-cancers [SID1234643391]). 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.
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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.