Clinical Trials

* On November 3, 2015, Debiopharm International SA presented preliminary results from Phase 1 trials in the development of the IAP inhibitor Debio 1143 at the 27th EORTC-NCI-AACR symposium in Boston. Recommended Dose was achieved in two Phase I studies. Debio 1143 has shown a favorable safety profile in a dose-finding and efficacy Phase I/II trial in combination with chemoradiotherapy in squamous cell carcinoma of the head and neck (Debio 1143-201). The randomized Phase II part of this study will start patient recruitment in November. At the same time, Debiopharm has conducted an indication screening study in combination with carboplatin and paclitaxel in patients with advanced solid malignancies (Debio 1143-103). The recommended dose of Debio 1143 with this combination has been determined with a good tolerability profile. Furthermore, encouraging early signs of efficacy in ovarian cancer patients have been observed (Poster #C2). In addition, new preclinical data illustrating the immunomodulatory function of Debio 1143 will be presented during the conference (Poster #A93). These findings are highly supportive of clinical development in combination with immune checkpoints inhibitors which are currently under development in a wide range of therapeutic indications.

* On November 18, 2014, Debiopharm announced that new data on  Debio 1143 will be presented at the 26th European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) and American Association for Cancer Research (AACR) (EORTC-NCI-AACR) Annual Meeting, November 18 to 21, 2014, to be held in Barcelona. Data featured at the EORTC-NCI-AACR symposium will include the results of the ongoing phase I study of Debio 1143 in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and platinum-refractory epithelial ovarian cancer (EOC). Debio 1143 is an oral, small molecule inhibitor of apoptosis proteins (IAPs) that mimics the activity of the natural second mitochondrial-derived activator of caspases (SMAC). The first signs of activity that have been observed in patients with triple-negative breast cancer and platinum-refractory ovarian cancer will be reported (Abstract number 444).

* On May 28, 2014, Debiopharm announced that new data on Debio 1143 will be presented at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago. Debio 1143 has been assessed in two phase I clinical studies and two phase I/II trials are ongoing in Europe. The abstracts presented at ASCO are:

- Debio 1143 First-in-human, pharmacokinetic (PK) and pharmacodynamics (PD) phase I study of Debio 1143 (AT406) in patients with advanced cancer. Final results. #2532B
- Phase I study of Debio 1143 (AT406) in combination with daunorubicin (D) and cytarabine (C) in patients with poor-risk acute myeloid leukemia (AML). #7029
- A phase I/II randomized study of Debio 1143 combined with concurrent chemo-radiation therapy (CCRT) in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). #TPS6097
- Clinical PK/PD model for Debio 1143, a novel antagonist of IAPs in cancer treatment. #2585

* On June 4, 2013, Debiopharm has announced it treated its first patients in a phase I study of Debio 1143 combined with Carboplatin and Paclitaxel in patients with squamous non-small cell lung cancer (NSCLC), platinum-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer. The aim of this study is to evaluate the safety and tolerability of Debio 1143, a small molecule neutralizing inhibitors of Apoptosis Protein (IAP), in combination with Carboplatin and Paclitaxel, to determine the maximum tolerated dose (MTD) and to establish dosing for further expansion phase.