Continuation of “Atalante 1” Phase 3 Clinical Trial of Tedopi® in NSCLC Patients Post Checkpoint Inhibitor Failure Following IDMC Recommendation

NANTES, France I June 20, 2019 I OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that, after reviewing global study data, the Independent Data Monitoring Committee (IDMC) saw no safety concerns and recommended the continuation of patient recruitment, without any modifications, of its ongoing international pivotal Phase 3 trial, called Atalante 1, evaluating Tedopi® in HLA-A2 positive non-small cell lung cancer (NSCLC) patients post immune checkpoint inhibitor failure (PD-1/PD-L1).

“This new IDMC review continues to support the development of Tedopi® in NSCLC in patients with unmet medical needs. While checkpoint inhibitors are now considered the standard of care in first- and second-line treatment of advanced NSCLC, many patients still fail to respond or continue to progress on these therapies. Our Phase 3 study with Tedopi® is conducted in a patient population with no currently approved therapeutic option, and the clinical need for patients in immune escape after such treatment is strong,” said Alexis Peyroles, CEO of OSE Immunotherapeutics.

ABOUT  Atalante 1
Atalante 1 is evaluating the benefit of Tedopi® in HLA-A2 positive patients with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment, following failure of a checkpoint inhibitor, compared to docetaxel or pemetrexed chemotherapy treatments in this patient population. The primary endpoint of the trial is overall survival. Next IDMC is planned in  Q1 2020.

ABOUT Tedopi®
Tedopi®, a proprietary combination of 10 neo-epitopes selected and optimized from five tumor associated antigens, has been shown to generate a specific response of cytotoxic T cells versus cancer cells expressing at least one of these tumor associated antigens and an associated T-helper cell response. It is also being studied in a Phase 2 trial in combination with Bristol-Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, in advanced or metastatic pancreatic cancer.

ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neo-epitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is under Phase 1 clinical trial in patients with advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.

SOURCE: OSE Immunotherapeutics

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