Home  >  News
you can get e-magazine links on WhatsApp. Click here
Clinical Trials + Font Resize -

iOnctura expands roginolisib clinical trial programme to NSCLC

Geneva, Switzerland
Wednesday, July 10, 2024, 17:00 Hrs  [IST]

iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, announces expansion of the clinical trial programme for lead pipeline asset, roginolisib. Via clinical collaboration agreements with the ETOP IBCSG Partners Foundation and GSK, roginolisib will be evaluated in combination with dostarlimab in NSCLC.

Roginolisib is an allosteric modulator of PI3Kd, widely recognized as a ‘master switch’ of cancer. Inhibition of PI3Kd unleashes a multi-pronged anti-tumour and immune response to combat the tumour. Roginolisib has demonstrated an unprecedented clinical profile in solid and liquid cancers, with 44 patients treated to date.

Emerging clinical and translational biomarker data supports the hypothesis that combining roginolisib with a programmed death receptor-1 (PD-1) targeting agent, with or without docetaxel, may prevent or reverse drug resistance in NSCLC and may show synergistic anti-tumour immune activity without significant addition of toxicity.

Dostarlimab is a PD-1-blocking antibody approved for certain patients with endometrial cancer, which has also demonstrated clinical activity in combination with chemotherapy in NSCLC. Under the terms of the agreement with iOnctura, GSK will supply dostarlimab for use in a randomized phase II clinical trial in NSCLC patients resistant to first-line checkpoint inhibitor therapy, with or without docetaxel. iOnctura will retain worldwide rights to roginolisib.

The ETOP IBCSG Partners Foundation is a leading organization performing international clinical and translational research in thoracic malignancies and breast cancer. Through the clinical collaboration, iOnctura will be provided access to a network of highly experienced investigators for the phase II study. Professor Solange Peters, MD, PhD, chair of medical oncology and the Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne will be the primary coordinating investigator of the study.

Catherine Pickering, chief executive officer of iOnctura, said: “As iOnctura moves into the next phase of clinical development, we are thrilled to be able to assess the effectiveness of roginolisib in combination with dostarlimab for the treatment of NSCLC. The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development programme with potentially synergistic combinations in NSCLC.”

Solange Peters, Professor and Chair of Medical Oncology & Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne in Lausanne, Switzerland, commented: “On behalf of the ETOP IBCSG Partners Foundation, we are intrigued by the benefit/risk profile of roginolisib. In patients who no longer respond to current therapies, we wish to investigate whether roginolisib in combination with dostarlimab provides a novel treatment option. ETOP IBCSG Partners Foundation is committed to investigate novel treatment options to help our patients.”

Roginolisib is the first allosteric modulator of PI3Kd with a unique chemical structure and binding mode. The PI3K signalling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kd isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Randomized phase II trials are planned to start in late 2024 in UM and other cancers, including non-small cell lung cancer and primary myelofibrosis.

iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways.

The ETOP IBCSG Partners Foundation was established through the merger of the European Thoracic Oncology Platform (ETOP) and the International Breast Cancer Study Group (IBCSG) (ETOP IBCSG Partners Foundation). The foundation, with its legal seat in Bern, Switzerland, has become a leading organization in performing international clinical research in thoracic malignancies and breast cancer.


* Name :     
* Email :    
  Website :  
Copyright © 2024 Saffron Media Pvt. Ltd | twitter