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Tedopi®

Tedopi®

Tedopi®, OSE Immunotherapeutics’s most advanced product and therapeutic neo-epitope-based vaccine, is a proprietary combination of nine optimized neo-epitopes, selected and optimized from 5 tumoral antigens to activate specifically T cells, plus one epitope giving universal helper T cell response targeting T cell activation.

Tedopi® is a treatment designed for HLA-A2+ patients, a key receptor of the cytotoxic response.

Tedopi® has been evaluated in a clinical Phase 3 study in patients with non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor failure (trial named Atalante-1).

The positive final results of this study, presented at ESMO 2021 (European Society for Medical Oncology), showed a statistically significant improvement of overall survival, a favorable hazard ratio and a better quality of life in patients with non-small cell lung cancer, with secondary resistance to immune checkpoints.

Tedopi® is also being investigated in other Phase 2 trials:

  • In NSCLC, in combination with Opdivo® (nivolumab), under the sponsorship of the Italian Foundation FoRT
  • In pancreatic cancer, under the sponsorship of cooperative group in oncology GERCOR
  • In ovarian cancer, in combination with Keytruda® (pembrolizumab) under the sponsorship of cooperative group in oncology ARCAGY-GINECO
ABOUT THE TEDOPI® CLINICAL PROGRAM

Tedopi® is being evaluated in three major cancer indications:

  • Non-Small Cell Lung Cancer (NSCLC) after checkpoint inhibitor failure

The Atalante 1 clinical trial of Tedopi® evaluated the benefit of the product in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi® treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

Clinicaltrials.gov: NCT02654587

Positive Phase 3 step-1 results, presented at ESMO 2020*, identified a Population of Interest (PoI) of secondary resistance defined as failure after a minimum of 12 weeks after immune checkpoint inhibitor treatment sequential to platinum-based chemotherapy. This PoI was chosen as the primary population for the final analysis.

Results show statistical improvement in overall survival, favorable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed and better quality of in advanced HLA-A2+ NSCLC patients with secondary resistance to immune checkpoint inhibitors.

*Activity of Tedopi®(OSE-2101) in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (ICI): Step1 results of Phase 3 ATALANTE-1 randomised trial

Press Release of  09/21/2021

Results presented at ESMO 2021

 

  • Phase 2 in NSCLC in combination with Opdivo® (nivolumab) (sponsor FoRT)

This three-arm Phase 2 study evaluates neo-epitope-based vaccine Tedopi® in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, or Tedopi® in combination with chemotherapy versus chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy. The primary endpoint of the study is the 1-year survival rate.

Clinicaltrials.gov: NCT04884282

 

  • Phase 2 in pancreatic cancer (sponsor GERCOR)

The Phase 2 study TEDOPaM aims at comparing Tedopi® in combination with FOLFIRI chemotherapy versus FOLFIRI, in maintenance treatment after treatment with FOLFIRINOX. The primary endpoint of the trial is the one-year survival rate.

Clinicaltrials.gov : NCT03806309

 

  • Phase 2 in ovarian cancer, in combination with Keytruda® (sponsor ARCAGY-GINECO)

The three-arm TEDOVA Phase 2 study evaluates Tedopi® as a maintenance treatment, alone or in combination with the anti-PD-1 Keytruda®, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients, with controlled disease after platinum-based chemotherapy. The primary endpoint of the study is the progression free survival rate.

Clinicaltraisl.gov: NCT04713514