SEATTLE, WA - Aptevo Therapeutics (NASDAQ:APVO), a micro-cap biotechnology firm with a market capitalization of just $4.95 million specializing in novel cancer therapeutics, announced today that all participants in Cohort 1 of the RAINIER Phase 1b trial for acute myeloid leukemia (AML) achieved remission within 30 days. According to InvestingPro data, the company's stock has shown significant volatility, with a beta of 5.01, making these trial results particularly important for investors tracking the company's progress. Of particular note, two patients reached complete remission with minimal residual disease (MRD)-negative status, a key indicator of potential long-term remission and improved survival.
The trial is testing mipletamig, Aptevo's bispecific antibody, in combination with venetoclax and azacitidine, standard treatments for AML. These latest results echo previous trial outcomes, maintaining a 100% remission rate among treated patients. While the company maintains a favorable cash-to-debt position, InvestingPro analysis indicates an overall weak financial health score of 1.3, highlighting the importance of successful clinical outcomes for the company's future. Marvin White, Aptevo's CEO, expressed optimism about mipletamig's consistent efficacy and safety profile, which may revolutionize AML treatment.
Dirk Huebner, MD, Chief Medical (TASE:PMCN) Officer at Aptevo, highlighted that one MRD-negative patient had a TP53 mutation, often associated with poor prognosis and treatment challenges. The promising outcomes for such high-risk patients underscore mipletamig's potential in overcoming significant AML treatment barriers.
The RAINIER study is a multi-center, open-label Phase 1b/2 trial, enrolling adults with newly diagnosed AML who are ineligible for intensive induction chemotherapy. Cohort 2 enrollment has begun, with the trial expected to include up to 39 patients.
Mipletamig is designed to engage the immune system to destroy leukemic cells and has been evaluated in 90 patients across two trials to date. The drug has also received orphan drug designation for AML.
This news is based on a press release statement from Aptevo Therapeutics. The company is advancing its pipeline with a focus on transforming cancer treatment outcomes. Despite a challenging year with a -96.6% year-to-date return, InvestingPro analysis suggests the stock may be undervalued at current levels. However, it's important to note that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected.
In other recent news, Aptevo Therapeutics has executed a 1-for-37 reverse stock split, consolidating every 37 shares of issued and outstanding common stock into one share. This move, approved by the company's Board of Directors, aims to comply with the Nasdaq Capital Market's minimum bid price requirement. The reverse stock split will not alter the par value per share and will proportionately affect the per share exercise price and the number of shares issuable upon the exercise or vesting of all outstanding stock options, restricted stock units, and warrants.
Moreover, Aptevo has made significant strides in collaboration with Alligator Bioscience in their ongoing clinical trials for cancer treatment candidates. Their lead candidate, mipletamig, showed a promising initial efficacy response in a Phase 1b/2 trial, with a 90% reduction in leukemic blasts within a patient 30 days after treatment began. Another clinical candidate, ALG.APV-527, indicated favorable safety and tolerability in a Phase 1 trial, with 56% of evaluable patients achieving stable disease.
In addition to these developments, Aptevo secured shareholder approval for significant corporate actions such as the issuance of a substantial number of Common Stock shares and a potential reverse stock split. The company also raised $2.3 million in a direct offering and set the terms for a $4.6 million public offering. Lastly, Roth/MKM revised Aptevo's stock price target to $8.00, maintaining a Buy rating.
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