Ph 1b/2 “RAINIER” Frontline AML Trial Initiated
“With a strong foundation of positive clinical data demonstrating safety, tolerability, efficacy, and durability, we are thrilled to announce the initiation of our Phase 1b/2 RAINIER study. This trial aims to identify the recommended Phase 2 dose and further evaluate key indicators-such as safety, tolerability, and efficacy-of mipletamig when combined with standard of care venetoclax and azacitidine in frontline AML patients,” stated Marvin White, President and CEO of Aptevo. “Mipletamig has already been administered to 90 patients across two trials, both as a monotherapy and in combination therapy, with results showing an exceptional safety profile and efficacy outcomes more than double those reported in the literature and a 75% complete response rate among frontline patients. We believe the RAINIER trial will not only confirm these earlier outcomes but also establish the recommended Phase 2 dose and further demonstrate mipletamig’s potential to transform AML treatment when used alongside the existing standard of care.”
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