OSE Seeks French Regulatory Approval for Phase 2 Trial of Tedopi in Advanced Pancreatic Cancer

OSE Seeks French Regulatory Approval for Phase 2 Trial of Tedopi in Advanced Pancreatic Cancer

OSE Immunotherapeutics is planning to launch a Phase 2 clinical trial to evaluate the potential of its Tedopi vaccine, alone and in combination with Opdivo (nivolumab), as a maintenance treatment for people with advanced or metastatic pancreatic cancer.

The France-based company submitted its investigational new drug application to the French National Agency for Medicines and Health Products Safety and to the central ethics committee of GERCOR, a leading clinical research association that is sponsoring the trial and includes 300 cancer centers in France.

If the application is accepted, OSE expects to start enrolling patients in the beginning of 2019.

“Our network of clinicians is now mobilizing to start this Phase 2 trial,” Christophe Louvet, MD, PhD, president of GERCOR, said in a press release.

Tedopi (formerly known as OSE-2101) is a cancer vaccine that uses a combination of 10 small proteins optimized to create strong immune responses against five cancer-specific proteins. This is expected to increase the ability of T-cells to identify and eliminate cancer cells.

The approach is thought to work well in combination with immune checkpoint inhibitors, such as Bristol-Myers Squibb’s Opdivo, which block signals from cancer cells that prevent efficient immune surveillance.

OSE’s Phase 2 trial, called TEDOPaM, is intended to evaluate Tedopi alone or in combination with Opdivo as a maintenance therapy for patients who achieved stable disease after receiving standard first-line chemotherapy — FOLFIRINOX, a combination of folinic acid, fluorouracil, irinotecan and oxaliplatin — for four months.

In the trial, Tedopi-based approaches will be compared with standard maintenance chemotherapy — FOLFIRI, a combination of folinic acid, fluorouracil and irinotecan.

“With this new clinical development program evaluating Tedopi in combination with the PD-1 inhibitor nivolumab, a checkpoint inhibitor, in advanced pancreatic cancer, we are broadening our exploration of new pathways in immuno-oncology,” said Alexis Peyroles, CEO of OSE.

The vaccine received orphan drug designation from the U.S. Food and Drug Administration, and was granted personalized medicine status in Europe for the treatment of patients with HLA-A2 positive non-small cell lung cancer.

Tedopi is also being evaluated in the Phase 3 ATALANTE 1 trial (NCT02654587) as a treatment for advanced non-small cell lung cancer patients who failed to respond to prior therapies, including PD-1/PD-L1 immune checkpoint inhibitors. The trial, currently recruiting participants, is taking place across the U.S., Europe, and Israel.