Delta-Fly Pharma Inc.: Update for Development Status of DFP-17729

We are excited to share our latest development status.

We are pleased to announce that as a result of consultation with the PMDA on December 3rd, 2024, the Phase II/III clinical trial of DFP-17729 in combination with TS-1 versus TS-1 alone in patients with pancreatic cancer after third-line treatment was approved.

In a Phase I/II study of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer, no significant difference was observed against the control treatment (TS-1 or gemcitabine), but stratified analysis showed that when patients in the third-line or later treatment were treated for more than 6 weeks, DFP-17729 in combination with TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months) and a significant correlation was also observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, as key proof of concept. We had presented these results at the ESMO Gastrointestinal Cancers Congress 2024 and the 55 Annual Meeting of the Japan Pancreas Society, where much attention was paid to the presentation.

DFP-17729 is a novel approach to neutralize the acidic cancer microenvironment, and several patents on related inventions have been granted in major countries around the world, and its potential of efficacy has been published in peer-reviewed journals.

We will first identify DFP-17729 as a treatment for refractory pancreatic cancer, for which effective treatment is not yet available, and then seek to expand the indication to other types of cancer through partnership with major global pharmaceutical companies.

Please take notice of our own innovative approach for miserable cancer patients and contact us.

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