#United States #Cambridge #oncology #iOnctura #roginolisib

iOnctura Expands Roginolisib Trials to the US

In a groundbreaking move, iOnctura, a clinical-stage precision oncology company, has announced the expansion of its clinical trials for roginolisib into the United States. This development represents a significant step forward in the company's strategy to tackle neglected and difficult-to-treat cancers. The company aims to enhance the available treatment options for patients who are often left with limited choices.

Launch of New Trials

iOnctura's recent announcement highlights that several U.S. trial sites are now officially enrolling patients for the global, randomized Phase II study of roginolisib. This phase focuses specifically on metastatic uveal melanoma, a rare but aggressive form of eye cancer. Notably, the Dana-Farber Cancer Institute has also launched a separate trial to investigate roginolisib's effectiveness in chronic lymphocytic leukemia (CLL), a type of blood cancer, backed by a grant from the Department of Defense.

Catherine Pickering, iOnctura's CEO and co-founder, expressed her enthusiasm for this expansion, stating, "We are proud to begin the next phase of iOnctura's global growth by making roginolisib available to US patients in our clinical studies. The enthusiastic response from US investigators, leading research centers, and patient communities highlights the significant opportunity to impact outcomes for individuals with limited treatment options."

The Promise of Roginolisib

Roginolisib is an orally administered small molecule that functions as an allosteric modulator of PI3Kδ, a pathway commonly altered in various cancer types. The ongoing Phase II randomized OCULE-01 study (NCT06717126) intends to determine if roginolisib can improve overall survival rates in patients with advanced uveal melanoma. The trial commenced in March 2025, and it will involve participants from both the United States and Europe.

Besides uveal melanoma, roginolisib is also under investigation for other malignancies including non-small cell lung cancer (NSCLC) and myelofibrosis. The aim in these studies is to explore the potential of this drug in overcoming resistance to existing treatments.

Support from the Department of Defense

A notable aspect of this expansion is the support from the U.S. Department of Defense, which recently awarded a substantial grant to Dr. Jennifer Brown at the Dana-Farber Cancer Institute to study roginolisib's potential in relapsed/refractory CLL. Dr. Brown, who oversees the CLL Center at the institute, is excited about the possibilities that roginolisib presents. She noted, "We are enthusiastic about the potential of roginolisib in enhancing treatment outcomes for CLL patients who have relapsed after prior Bruton's tyrosine kinase inhibitor therapy. We feel roginolisib offers a promising avenue to improve remission depth and duration in combination with venetoclax and rituximab, whilst minimizing treatment-related side effects."

Preclinical Evidence and Future Directions

Recent preclinical research conducted by scientists such as Sasi and Tarantelli has shown the synergistic effects of roginolisib combined with venetoclax, emphasizing its potential as a powerful treatment strategy for CLL.

iOnctura is committed to changing the narrative for patients suffering from hard-to-treat cancers. The company, headquartered in Amsterdam with subsidiaries in Geneva and Cambridge, Massachusetts, is dedicated to developing first-in-class small molecules designed to extend patient lives and enhance their quality of life. Through its innovative approach and commitment to precision oncology, iOnctura aims to redefine cancer treatment standards, offering hope where little exists.

Conclusion

The expansion of roginolisib trials into the United States underscores the urgent need for effective treatments targeting challenging cancer types. As iOnctura continues its clinical studies, there is hope that this pioneering drug can bring about significant improvements in patient outcomes across various cancer diagnoses.

For more updates on this groundbreaking research and other initiatives, stay tuned to the latest news from iOnctura.