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Investing.com -- Aptevo Therapeutics (NASDAQ:APVO) stock soared 330% after the company reported compelling clinical activity for its mipletamig treatment in frontline acute myeloid leukemia (AML) patients.
The clinical-stage biotechnology company announced an 85% remission rate in evaluable frontline AML patients treated with mipletamig in combination with standard-of-care venetoclax and azacitidine. This significantly exceeds results from competitor studies, including the Viale A trial that evaluated venetoclax and azacitidine as a doublet therapy.
Aptevo’s treatment demonstrated a strong safety profile with no cytokine release syndrome (CRS) observed in the first two cohorts of the ongoing Phase 1b/2 RAINIER trial. The company is now nearing full enrollment for Cohort 3, which will evaluate the highest dose level to date in combination therapy.
"These results deepen our conviction in mipletamig’s ability to elevate treatment outcomes for frontline AML patients who are not candidates for intensive chemotherapy," said Marvin White, President and CEO of Aptevo. "This outstanding remission rate, combined with a compelling safety profile-no CRS reported in the first two cohorts, reinforces mipletamig’s potential to meaningfully enhance the venetoclax/azacitidine backbone."
The company highlighted that one patient was able to receive a transplant after treatment, a rare outcome for previously ineligible unfit patients. Another patient achieved complete remission with no minimal residual disease despite having the TP53 genetic biomarker, which is typically associated with resistance to chemotherapy.
Aptevo attributes mipletamig’s success to its unique CD3 engineering strategy using the CRIS-7 binding domain, which the company says mitigates cytokine-related toxicity while preserving anti-cancer activity.
AML is an aggressive blood cancer with limited treatment options for older or medically unfit patients, who typically face poor outcomes.
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