iOnctura Expands Roginolisib Clinical Trials to NSCLC

iOnctura, a biopharmaceutical company in clinical stages, is expanding its trial program for its lead compound, roginolisib, through collaborations with ETOP IBCSG Partners Foundation and GSK. The new study will focus on combining roginolisib with dostarlimab, and potentially docetaxel, to treat non-small-cell lung cancer (NSCLC) patients who have developed resistance to first-line checkpoint inhibitor therapy.

Roginolisib functions as an allosteric modulator of PI3Kδ, a critical pathway in cancer biology. By inhibiting PI3Kδ, roginolisib initiates a strong anti-tumor response and bolsters the immune system's ability to fight cancer. So far, 44 patients have been treated with roginolisib, showing positive results across various cancer types, both solid and liquid.

Recent clinical and biomarker data suggest that combining roginolisib with PD-1 targeting agents like dostarlimab, with or without the addition of docetaxel, could overcome or reverse resistance in NSCLC treatments. This combination is believed to provide a synergistic anti-tumor immune response without significantly increasing toxicity.

Dostarlimab is a PD-1-blocking antibody already approved for certain endometrial cancer patients and has shown clinical effectiveness in combination with chemotherapy for NSCLC. According to the agreement with iOnctura, GSK will supply dostarlimab for a randomized Phase II trial involving NSCLC patients who are resistant to initial checkpoint inhibitor treatments. iOnctura will maintain global rights to roginolisib.

The ETOP IBCSG Partners Foundation, known for its extensive research in thoracic malignancies and breast cancer, will support iOnctura's study. This collaboration grants iOnctura access to a network of experienced researchers and clinicians. The primary investigator for the study will be Professor Solange Peters from the University Hospital of Lausanne.

Catherine Pickering, CEO of iOnctura, expressed enthusiasm about advancing to the next phase of clinical development. She highlighted that the promising data on uveal melanoma and preclinical findings support the strategy to investigate roginolisib in combination with dostarlimab for NSCLC.

Professor Solange Peters, representing the ETOP IBCSG Partners Foundation, emphasized the importance of exploring new treatment options for patients who no longer respond to current therapies. She expressed optimism about the potential benefits of the novel combination treatment being tested.

iOnctura is committed to developing new and effective treatments for challenging cancers. In addition to roginolisib, which targets the PI3Kδ pathway, the company is also advancing cambritaxestat, an autotaxin inhibitor. Both compounds are in mid-stage clinical development. iOnctura operates from Amsterdam and Geneva, with support from several institutional investors, including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners, and Schroders Capital.

Roginolisib stands out as the first allosteric modulator of PI3Kδ, uniquely designed to target this pathway crucial in many cancers. It has shown a favorable safety profile and significant clinical activity in treating uveal melanoma, a rare eye cancer. Plans are underway to start Phase II trials in late 2024 for various cancers, including NSCLC and primary myelofibrosis.

The ETOP IBCSG Partners Foundation, formed from the merger of the European Thoracic Oncology Platform and the International Breast Cancer Study Group, leads numerous clinical trials and research projects internationally. Based in Bern, Switzerland, the foundation focuses on advancing treatments for thoracic and breast cancers.