Aptevo adds Nectin-4 targeting therapy to CD3 bispecific portfolio

SEATTLE - Aptevo Therapeutics Inc. (NASDAQ:APVO), a micro-cap biotech company with a market capitalization of $3.47 million, has expanded its immuno-oncology pipeline with the addition of APVO455, a preclinical Nectin-4 x CD3 bispecific T-cell engager targeting solid tumors, the company announced Friday. The announcement sparked investor interest, driving a 16.86% stock price gain over the past week, according to InvestingPro data.

APVO455 becomes the third therapy in Aptevo’s CD3-engaging portfolio, joining mipletamig (CD123 x CD3) currently in Phase 1b/2 trials for frontline acute myeloid leukemia, and APVO442 (PSMA x CD3), a preclinical candidate for prostate cancer. Despite its expanding pipeline, InvestingPro analysis reveals concerning financial metrics, including a weak financial health score of 1.4 and negative EBITDA of $23.79 million in the last twelve months.

All three therapies share the same CRIS-7 derived CD3 binding domain, which the company says demonstrates a low cytokine release profile. The solid tumor candidates, APVO455 and APVO442, contain CD3 binding domains specifically optimized for solid tumor targeting.

According to the company, mipletamig has shown promising clinical results with 85% of evaluable frontline patients achieving remission in combination with standard of care across two trials. No cytokine release syndrome was observed in the first two cohorts of the ongoing RAINIER trial.

APVO455 is designed to target bladder, breast, non-small cell lung cancer, and head and neck cancers where Nectin-4 is highly expressed. The therapy aims to activate T-cells only in the presence of Nectin-4 positive tumor cells while avoiding peripheral T-cell activation.

"Compelling mipletamig clinical results, where we have treated more than 100 patients across three trials, give us confidence that CRIS-7 is a critical differentiator," said Marvin White, President and CEO of Aptevo, in the press release statement.

APVO455 represents the sixth overall drug candidate in active development at Aptevo, which focuses on novel bispecific immunotherapies based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies. The company faces significant financial challenges, with a current ratio of 0.67 indicating potential liquidity issues. Discover more detailed financial insights and 13 additional ProTips with InvestingPro.

In other recent news, Aptevo Therapeutics has announced significant developments in its clinical trials and financial activities. The company reported an 85% remission rate for its CD123 x CD3 bispecific antibody mipletamig in frontline acute myeloid leukemia (AML) patients, a result that surpasses competitor studies. This outcome is part of the ongoing Phase 1b/2 RAINIER trial, where no cytokine release syndrome has been observed, highlighting the drug’s favorable safety profile. Additionally, Aptevo has successfully raised approximately $8 million through a registered direct offering, with plans to use the proceeds for further clinical development and general corporate purposes.

In another strategic move, Aptevo enacted a 1-for-20 reverse stock split to maintain compliance with Nasdaq listing standards, which will reduce its outstanding shares significantly. The company also reported a net loss of $6.3 million for the quarter ending March 31, 2025, alongside a cash position of $2.1 million, not accounting for the $4.9 million raised in subsequent months. Meanwhile, Aptevo’s pipeline continues to advance, with mipletamig receiving orphan drug designation for AML and another candidate, ALG.APV-527, in a Phase 1 trial for solid tumors. These updates reflect Aptevo’s ongoing efforts to develop innovative cancer treatments and manage its financial health.

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