Aptevo reports frontline AML data for mipletamig, targets Phase 2 talks in early 2027
Aptevo said dose optimization for mipletamig should finish by year end 2026, ahead of a planned Phase 2 regulatory interaction in the first quarter of 2027.
Aptevo Therapeutics Inc. reported financial results for the quarter ended June 30, 2026 in a release dated August 14, 2026. The company's most advanced program, mipletamig, showed updated Phase 1b/2 RAINIER trial data with continued clinical activity in frontline acute myeloid leukemia when combined with venetoclax and azacitidine.1 Among 31 evaluable unfit frontline patients, counting through Cohort 5 plus four frontline patients from a completed dose expansion trial, the company reported a clinical benefit rate of 87% and a remission rate of 81%.1 Aptevo said RAINIER has entered its final dose optimization stage, with plans to complete the Phase 1b trial and select a recommended Phase 2 dose within 2026, ahead of an anticipated Phase 2 regulatory interaction in the first quarter of 2027.1
Additional trial findings cited by the company included that 55% of patients who achieved CR/CRi reached MRD-negative status, 36% of patients with remissions carried the TP53 mutation, and six patients treated to date have proceeded to allogeneic stem cell transplant.1
On leadership, Aptevo named Mary J. Janatpour, Ph.D. as Senior Vice President and Chief Scientific Officer, bringing over 25 years of experience in oncology research and development to the company's clinical and preclinical strategy.1
For its solid tumor program, Aptevo secured a $1.5 million non-dilutive research grant from the Andy Hill Cancer Research Endowment (CARE) Fund to support IND-enabling work for APVO451, a nectin-4-targeted trispecific candidate.1 The company said it is targeting development candidate selection for APVO451 by the end of 2026, with IND-enabling studies planned to begin in the first quarter of 2027.1
Aptevo also disclosed a new radiopharmaceutical effort. The company entered a 50/50 collaboration with Niowave to develop up to three radiopharmaceutical oncology programs.1 Niowave made an at-the-market equity investment in Aptevo at closing, taking an initial 7.9% ownership stake with the potential to build up to 19.99%.1
On finances, Aptevo reported cash and cash equivalents of $9.8 million as of June 30, 20261, and said it raised $0.6 million during the quarter under its Standby Equity Purchase Agreements with Yorkville.1
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