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Cantargia reports timelines for nadunolimab clinical trials in leukemia and triple negative breast cancer
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported currently expected timelines for nadunolimab clinical trials. The US FDA has granted MD Andersson Cancer Center the IND for nadunolimab related to the upcoming phase 1b/2a clinical trial of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an estimate for trial initiation during Q4 2024. The first results on safety and short-term efficacy in the ongoing phase 2 clinical trial in triple negative breast cancer (TNBC), in collaboration with GEICAM, is expected during H1 2025.
“The granted IND is an important milestone for the development of nadunolimab in leukemia. The remaining steps, including IRB review, are currently in process before the trial can be initiated” said Göran Forsberg, CEO of Cantargia. “We are also looking forward to completing the Phase 2 study with nadunolimab in triple negative breast cancer and obtaining the results during H1 2025.”
The new phase 1b/2a clinical trial is designed to investigate nadunolimab in up to 20 patients with AML and 20 with MDS. The trial is sponsored by a grant from the US Department of Defense, DOD, to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial. More details on the trial, including estimated timelines will be disclosed once the trial has received full IRB approval, which is expected during Q3 2024, followed by initiation during Q4 2024.
Based on the positive phase 1 clinical data previously presented for nadunolimab combination therapy in TNBC, the randomized, controlled phase 2 clinical trial in approximately 100 patients with TNBC is advancing even though recruitment temporarily slowed down during summer. The first results of the trial, including safety and short-term efficacy, are therefore expected during H1 2025.
Cantargia will present new clinical results using nadunolimab at the upcoming ESMO conference in Barcelona Sep 13-17, 2024. Details on the presentation will be disclosed when abstracts become public Sep 9, 2024.