On October 20, 2022 OSE Immunotherapeutics reported an update on Tedopi, an immunotherapy activating tumor specific T-cells, developed in advanced or metastatic non-small cell lung cancer (NSCLC), ovarian cancer and pancreatic cancer (Press release, OSE Immunotherapeutics, OCT 20, 2022, View Source [SID1234646958]). Authorizations for compassionate use* of Tedopi in NSCLC have recently been granted by Health Agencies in Europe. Regulatory meetings are planned to validate the confirmatory Phase 3 clinical trial in NSCLC.

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Compelling Phase 3 Clinical Data
Tedopi is the first cancer vaccine to show clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) post-immune checkpoint inhibitors (ICI) failure in advanced or metastatic NSCLC:

– Significant overall survival (primary endpoint) (p=0.017, HR=0.59) with 44.4% overall survival (OS) rate at 1 year with Tedopi versus 27.5% for chemotherapy and a meaningful gain of median OS of 3.6 months (ESMO 2021);
– Improved post-progression survival benefit in the Tedopi arm (7.7 months versus 4.6 months, p=0.004, HR=0.46) (ESMO 2021);
– Significant delayed median time to worsening ECOG** performance status with a difference of 5.3 months (p<0.01, HR=0.43) (ASCO 2022);
– Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy, p<0.05) (ESMO 2021);
– Significant better Quality of Life (Global health status: p=0.045; Role Functioning: p=0.025) (ASCO 2022) and positive Net Treatment Benefit (p=0.032) with Tedopi compared to chemotherapy (ESMO 2022).

These positive clinical results in a clearly-defined target population for this first Phase 3 trial are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi differs from ICI releasing the break of immune response.

Compassionate Use Authorizations in Europe – Regulatory Meeting with FDA Planned
The significant medical need for new therapeutic options in NSCLC patients post-ICI failure associated with promising efficacy, safety and quality of life data resulted in authorizations for compassionate use** of Tedopi from Health Agencies in Europe – in France, Italy and Spain – in third line post-chemotherapy and immunotherapy. The medical need in this targeted population with high mortality previously led to an orphan drug designation by the FDA, while Tedopi was recognized as a precision medicine in Europe for the treatment of HLA-A2 positive NSCLC patients.

OSE Immunotherapeutics is preparing a confirmatory Phase 3 pivotal trial to support the regulatory registration of Tedopi as a new standard of care in advanced or metastatic NSCLC in secondary resistance post-ICI failure***. The Company has filed a formal request for a "Type C meeting" with the US Food and Drug Administration (FDA) to validate the new study protocol in NSCLC metastatic patients in second line after ICI-failure. OSE Immunotherapeutics has already received a "Scientific advice" from the European Medicines Agency (EMA) on this targeted population.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "Despite progress made with immune checkpoint inhibitor-based therapies, today only a minority of NSCLC patients achieve longterm survival post-chemotherapy and immunotherapy. No treatment has yet shown efficacy and safety results in randomized controlled studies post-ICI failure. Tedopi is the first treatment option to address this high unmet medical need in advanced or metastatic NSCLC. Considering HLA-A2-positive patients represent about 45% of all NSCLC patients, given the large use of anti-PD(L)1 and based on ICI failure data, the targeted population for Tedopi in second line could be estimated up to 100,000 patients per year in 7 major markets across the US, Europe, China and Japan.

The strong medical need in the identified targeted population underlined by recent compassionate use authorization along with the clinically meaningful study results confirm that Tedopi can be positioned as a potential new standard of care in advanced or metastatic NSCLC in secondary resistance post-ICI failure.

OSE Immunotherapeutics is committed to make this innovative therapeutic option available to improve lives of patients who clearly need access to much improved treatment options.

Given the potential of Tedopi, OSE Immunotherapeutics has further strengthened the global intellectual property for Tedopi until 2038. This has been achieved through the grant of patents in 2022 for Europe, the US, China and Japan. These patents protect the innovative emulsion manufacturing process validated for the ready-to-use peptides combination.

On-going Combination Studies – A Further Source of Clinical Value
Tedopi is currently being evaluated in phase 2 combination trials in three indications:
– NSCLC: Tedopi plus docetaxel or Tedopi plus nivolumab or docetaxel alone, in second-line treatment in metastatic NSCLC, progressing after first-line chemo-immunotherapy (CombiTED study: NCT04884282, 105 patients planned, sponsor: FoRT);
– Pancreatic cancer: Tedopi plus FOLFIRI vs FOLFIRI as maintenance treatment in patients with advanced or metastatic pancreatic adenocarcinoma with no progression after 8 cycles of FOLFIRINOX (TEDOPaM study: NCT03806309, 106 patients planned, sponsor: GERCOR);
– Ovarian cancer: Tedopi alone or in combination with pembrolizumab vs best supportive care as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients (TEDOVA study: NCT04713514, 180 patients planned, sponsor: ARCAGY-GINECO).