Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Credit: KGH.

OSE Immunotherapeutics has received approval from French National Agency for Medicines and Health Products Safety (ANSM) and French Central Ethic Committee (CPP) to begin a Phase II trial assessing the combination of tedopi and opdivo (nivolumab) against folfiri for the treatment of advanced / metastatic pancreatic cancer.

Tedopi is developed by OSE and features a combination of ten neo-epitopes selected and optimised from five tumour associated antigens.

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Bristol-Myers Squibb’s opdivo is an immune checkpoint inhibitor, while Folfiri is a combination chemotherapy with folinic acid, fluorouracil and irinotecan.

The trial is known as TEDOPaM and intends to feature three arms.

It is expected to enrol human leukocyte antigen class 1 histocompatibility A-2 (HLA-A2) patients with stable disease following four months of standard chemotherapy with folfiri.

Oncology group Gercor will sponsor the TEDOPaM trial, which will receive parts of its funding from OSE.

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“We hypothesise combining tedopi and opdivo will help stimulate cytotoxic T-cells and potentiate overall anti-tumour effects.”

GERCOR president Christophe Louvet said: “Pancreatic cancer is an indication where we feel that a neoepitope-based therapy in combination with a PD-1 checkpoint inhibitor has great potential.

“We hypothesise combining tedopi and opdivo will help stimulate cytotoxic T-cells and potentiate overall anti-tumour effects.”

Tedopi is currently being evaluated in a separate Phase III trial to treat non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure.

OSE Immunotherapeutics CEO Alexis Peyroles said: “Exploring the potential of tedopi in additional oncology indications has been an important goal for us.

“We are particularly excited to be entering pancreatic cancer, an aggressive disease with a generally poor prognosis, demanding for novel therapeutic approaches and representing significant unmet medical need.

“We hope TEDOPaM will validate that combining tedopi with a PD-1 checkpoint inhibitor has potential as a successful new therapeutic strategy for patients suffering from this devastating form of cancer.”