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SEATTLE - Aptevo Therapeutics (NASDAQ:APVO), currently trading near its 52-week low at $2.82, announced Wednesday that its CD123 x CD3 bispecific antibody mipletamig, combined with standard-of-care venetoclax and azacitidine, achieved an 85% remission rate in evaluable frontline acute myeloid leukemia (AML) patients who are unfit for intensive chemotherapy. According to InvestingPro analysis, the company’s stock appears undervalued despite recent market challenges, with 15+ exclusive ProTips available for subscribers.
The data comes from the company’s ongoing Phase 1b/2 RAINIER trial. According to the press release statement, the triplet therapy’s remission rate exceeds results from competitor studies, including the Viale A trial that evaluated venetoclax and azacitidine as a doublet therapy.
No cytokine release syndrome was observed in the first two cohorts, and no dose-limiting toxicities were reported among evaluable patients. Cohort 3 is nearing full enrollment at the highest dose level evaluated to date in combination therapy.
The company noted that three patients with poor prognosis based on genetic biomarkers achieved complete remission. One patient was able to receive a transplant, which the company described as a rare occurrence in the unfit AML patient population.
"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.
Mipletamig has received orphan drug designation for AML according to the Orphan Drug Act. The RAINIER trial consists of 28-day treatment cycles across multiple sequential cohorts for adults aged 18 or older with newly diagnosed AML who are not eligible for intensive induction chemotherapy.
The trial is being conducted in two parts: a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study.
In other recent news, Aptevo Therapeutics Inc. has announced promising clinical trial results for mipletamig, a treatment for acute myeloid leukemia (AML), showing a 90% remission rate in frontline AML patients. The trials have reported no cases of cytokine release syndrome, highlighting a favorable safety profile. Additionally, Aptevo has enacted a reverse stock split at a 1-for-20 ratio to maintain compliance with Nasdaq listing standards. This move, effective on May 23, 2025, was approved by shareholders and the board, reducing the number of outstanding shares from approximately 13.5 million to about 0.7 million.
Aptevo has also initiated a common stock offering, filing a prospectus supplement with the SEC for shares valued up to $3,167,548. This offering is part of an At The Market Agreement with Roth Capital Partners, allowing sales at market prices. Furthermore, Aptevo has entered agreements for a registered direct offering of common stock, aiming to raise approximately $2 million to support its clinical development projects. The company reported a net loss of $6.3 million for the quarter ending March 31, 2025, with a cash position of $2.1 million, supplemented by additional funds raised in April and May 2025. These developments reflect Aptevo’s ongoing efforts to advance its cancer treatment pipeline and strengthen its financial standing.
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