IDMC recommends continuation of Ph 3 REGAL Trial of GPS in AML
“I am thrilled by the positive outcome of the interim analysis of our Phase 3 REGAL trial, marking the successful achievement of the most significant milestone for our GPS program to date. The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval for the treatment of AML,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease. We are optimistic about the IDMC’s recommendation to continue the study without modifications, and diligently preparing for the Biologics License Application (BLA). Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission. We look forward to completing the trial with the final analysis to be conducted once 80 events are reached.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000