Company Description
Aptevo Therapeutics Inc. (NASDAQ: APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. According to its public disclosures and recent SEC filings, Aptevo concentrates on immune-oncology drug candidates that are designed to engage and modulate the immune system to attack hematologic malignancies and solid tumors. The company’s pipeline is built from two proprietary protein engineering platforms, ADAPTIR and ADAPTIR-FLEX, which support the rational design of precision immune-modulatory drugs.
Aptevo is incorporated in Delaware and, as described in its registration statement on Form S-1, is classified under the pharmaceutical preparation manufacturing industry. Its common stock trades on the Nasdaq Capital Market under the ticker symbol APVO. The company describes itself as clinical-stage, with a portfolio that includes both clinical and preclinical candidates targeting different forms of cancer, particularly acute myeloid leukemia (AML) and multiple solid tumor types.
Core Business and Pipeline
Aptevo’s business centers on discovering and developing bispecific and trispecific antibody-based therapeutics. These drug candidates are engineered to bind to more than one target, enabling complex immune interactions such as redirecting T cells toward tumor cells or providing co-stimulatory signals in the tumor microenvironment.
The company reports two main clinical-stage candidates:
- Mipletamig (CD123 x CD3) – Aptevo’s wholly owned lead proprietary drug candidate. It is a CD123 x CD3 T-cell engager being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia (AML) in patients who are not eligible for intensive chemotherapy. In company communications, mipletamig is described as being administered in combination with standard-of-care venetoclax plus azacitidine. It has received orphan drug designation for AML under the U.S. Orphan Drug Act. Aptevo states that mipletamig is designed to redirect the patient’s immune system to destroy leukemic cells and leukemic stem cells expressing CD123, and that it uses a CRIS-7-derived CD3 binding domain intended to reduce the likelihood and severity of cytokine release syndrome (CRS).
- ALG.APV-527 (4-1BB x 5T4) – A bispecific conditional 4-1BB agonist co-developed with Alligator Bioscience. The molecule is designed to be active only upon simultaneous binding to 4-1BB (a co-stimulatory receptor) and 5T4 (a tumor-associated antigen). Company disclosures state that ALG.APV-527 has been evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4.
Beyond these clinical candidates, Aptevo describes a group of preclinical and earlier-stage assets, many of which are CD3-engaging molecules built around the same CRIS-7-derived CD3 binding domain used in mipletamig. These include:
- APVO442 – A PSMA x CD3 bispecific candidate for prostate cancer, developed on the ADAPTIR-FLEX platform. It is engineered to selectively activate T cells within the PSMA-expressing tumor microenvironment, with design features intended to localize immune activation to the tumor.
- APVO455 – A Nectin-4 x CD3 bispecific T-cell engager described as a preclinical candidate for a range of solid tumors where Nectin-4 is highly expressed, such as bladder, breast, non-small cell lung cancer (NSCLC), and head and neck cancers. The company states that APVO455 is designed to avoid activating T cells in the periphery and to engage them only in the presence of Nectin-4-positive tumor cells.
- APVO451 – A trispecific ADAPTIR-FLEX candidate targeting Nectin-4, CD3, and CD40, intended for hard-to-treat solid tumors. Aptevo reports preclinical data indicating that APVO451 can coordinate T-cell activation and antigen-presenting cell (APC) costimulation within the tumor microenvironment, with immune activation observed only when bound to Nectin-4-positive tumor cells.
- APVO452 – A trispecific candidate targeting PSMA, CD3, and CD40, described as designed for prostate cancer. Company materials characterize APVO452 as bringing together tumor targeting, T-cell activation, and modulation of suppressive immune cells in the tumor microenvironment.
- APVO603 and APVO711 – Preclinical candidates developed using the ADAPTIR platform. Aptevo describes APVO603 as a 4-1BB x OX40 molecule and APVO711 as a checkpoint inhibitor with added functionality, both targeting multiple solid tumor types.
Across these programs, Aptevo emphasizes a consistent design philosophy: using its ADAPTIR and ADAPTIR-FLEX platforms and the CRIS-7-derived CD3 binding domain to create tumor-directed T-cell engagers that aim to balance potent anti-tumor activity with safety and tolerability.
Platform Technologies: ADAPTIR and ADAPTIR-FLEX
Aptevo states that it wholly owns the ADAPTIR and ADAPTIR-FLEX modular protein technology platforms. These platforms are described as enabling the efficient design and creation of monospecific, bispecific, and multi-specific antibody candidates. According to the company’s S-1 and press releases, the platforms are used to:
- Generate antibody-like recombinant protein therapeutics that can engage multiple targets.
- Incorporate the CRIS-7-derived CD3 binding domain in a configuration intended to deliver controlled, tumor-focused T-cell activation.
- Support a modular, platform-based approach to expanding the pipeline across hematologic and solid tumor indications.
Aptevo communications describe the ADAPTIR and ADAPTIR-FLEX platforms as central to its strategy of building a family of CD3-engaging molecules that share a validated design backbone while targeting different tumor antigens and immune pathways.
Clinical Focus Areas
Based on its public statements and filings, Aptevo’s development focus can be summarized in two main areas:
- Frontline AML in patients unfit for intensive chemotherapy – Through mipletamig and the RAINIER trial, Aptevo is targeting newly diagnosed AML patients who cannot tolerate intensive induction chemotherapy. Company disclosures highlight remission rates and safety observations from early cohorts, including the absence of cytokine release syndrome among frontline patients treated to date in reported cohorts.
- Solid tumors with immunosuppressive tumor microenvironments – With candidates such as APVO442, APVO455, APVO451, APVO452, ALG.APV-527, APVO603, and APVO711, Aptevo is pursuing multiple solid tumor indications. The company emphasizes designs that aim to overcome tumor-induced immune suppression by combining tumor targeting, T-cell engagement, and co-stimulatory or checkpoint-modulating signals.
Capital Markets and Nasdaq Listing
Aptevo’s common stock is listed on the Nasdaq Capital Market under the symbol APVO. SEC filings describe several financing arrangements, including at-the-market offerings, registered direct offerings, a Standby Equity Purchase Agreement, and an equity line of credit structure. An 8-K filed on July 1, 2025 notes that Aptevo received confirmation from Nasdaq that it had regained compliance with Nasdaq Listing Rule 5550(b)(1) regarding minimum stockholders’ equity.
In a press release dated January 9, 2026, Aptevo announced a $60 million equity line of credit (ELOC) agreement with Yorkville Advisors Global, LP. The company states that this facility provides access to capital on an incremental basis, at its discretion, with proceeds intended to support ongoing clinical development, advance preclinical programs, and fund general corporate purposes.
Corporate Governance and Stockholder Actions
Aptevo’s definitive proxy statement for its 2025 Annual Meeting of Stockholders outlines various corporate governance matters and stockholder approvals. Proposals approved at the meeting included:
- Election of directors to serve until the 2028 Annual Meeting.
- Ratification of the company’s independent registered public accounting firm.
- Authorization for a reverse stock split within a specified ratio range, later implemented as a 1-for-18 reverse stock split effective in late December 2025, as described in a December 26, 2025 press release.
- Approval of stock issuance under a Standby Equity Purchase Agreement and other equity-related proposals.
- Approval of an amended and restated stock incentive plan and an advisory vote on executive compensation.
An 8-K filed on October 30, 2025 also describes an amendment to the company’s Rights Agreement, extending the definition of the “Final Expiration Date” for certain contingent rights to purchase preferred shares.
Status and Regulatory Filings
Recent 8-K filings show Aptevo reporting quarterly financial results, entering into financing agreements, and announcing clinical and pipeline milestones. The available filings do not include a Form 25 or Form 15-12G, and there are no SEC filings in the provided data indicating bankruptcy, liquidation, or completed merger. Based on these sources, Aptevo continues to operate as a clinical-stage biotechnology company with its shares listed on Nasdaq under APVO.
FAQs about Aptevo Therapeutics Inc. (APVO)
- What does Aptevo Therapeutics do?
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company that develops bispecific and trispecific immunotherapies for cancer. Its programs are designed to engage the immune system, particularly T cells, to recognize and attack cancer cells in hematologic malignancies such as AML and in multiple solid tumor types. - What are Aptevo’s main clinical drug candidates?
According to company disclosures, Aptevo has two clinical candidates: mipletamig, a CD123 x CD3 T-cell engager being evaluated in the RAINIER Phase 1b/2 trial for frontline AML in combination with venetoclax plus azacitidine, and ALG.APV-527, a bispecific conditional 4-1BB agonist targeting 4-1BB and 5T4 for solid tumors. - What is mipletamig and how is it designed to work?
Mipletamig is described as a first-in-class CD123 x CD3 bispecific antibody-like recombinant protein. It is designed to bind CD123 on leukemic cells and CD3 on T cells, bringing them into close proximity to trigger destruction of leukemic cells and leukemic stem cells. The molecule incorporates a CRIS-7-derived CD3 binding domain intended to reduce the likelihood and severity of cytokine release syndrome. - What is the RAINIER trial?
RAINIER is a Phase 1b/2, multi-cohort, open-label study evaluating mipletamig in combination with venetoclax and azacitidine in adults with newly diagnosed AML who are not eligible for intensive induction chemotherapy. The trial includes a dose optimization phase followed by a Phase 2 component. - What is ALG.APV-527?
ALG.APV-527 is a bispecific antibody that targets 4-1BB and 5T4. The company describes it as a conditional 4-1BB agonist designed to reactivate antigen-primed T cells to kill tumor cells, with activity dependent on simultaneous binding to both targets. It has been evaluated in a Phase 1 clinical trial in multiple solid tumor types likely to express 5T4. - What are ADAPTIR and ADAPTIR-FLEX?
ADAPTIR and ADAPTIR-FLEX are Aptevo’s proprietary modular protein technology platforms. The company states that these platforms are used to design and generate mono-, bi-, and multi-specific antibody candidates, including its CD3-engaging portfolio. All current pipeline candidates are reported to have been created using these platforms. - Which preclinical candidates has Aptevo disclosed?
Aptevo has described several preclinical candidates, including APVO442 (PSMA x CD3) for prostate cancer, APVO455 (Nectin-4 x CD3) for multiple solid tumors, APVO451 and APVO452 (trispecific molecules targeting Nectin-4 or PSMA along with CD3 and CD40), and ADAPTIR-based candidates APVO603 (4-1BB x OX40) and APVO711 (a checkpoint inhibitor with added functionality). - Does mipletamig have orphan drug designation?
Yes. Company press releases state that mipletamig has received orphan drug designation for AML under the U.S. Orphan Drug Act. - On which exchange does Aptevo trade and under what symbol?
Aptevo’s common stock is listed on the Nasdaq Capital Market under the ticker symbol APVO, as stated in its press releases and SEC filings. - Has Aptevo undergone a reverse stock split?
Yes. A press release dated December 26, 2025 reports that Aptevo’s board approved and implemented a 1-for-18 reverse stock split of its common stock, with the split becoming effective in late December 2025. The trading symbol APVO remained unchanged. - How does Aptevo describe its mission?
In multiple press releases, Aptevo states that its mission is to improve treatment outcomes and transform the lives of cancer patients through the development of novel bispecific and trispecific immunotherapies.