Welcome to our dedicated page for Aptevo Therapeutics news (Ticker: APVO), a resource for investors and traders seeking the latest updates and insights on Aptevo Therapeutics stock.
Aptevo Therapeutics Inc. develops clinical-stage immune-oncology therapeutics for cancer using its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies. News about APVO centers on mipletamig, its CD123 x CD3 program for acute myeloid leukemia, including clinical data, safety observations, orphan drug designation for AML, and combination studies with venetoclax and azacitidine.
Company updates also cover pipeline expansion into bispecific, multispecific and trispecific candidates, solid-tumor work such as ALG.APV-527, conference presentations, financing arrangements, operating results, shareholder voting matters, and governance changes tied to Aptevo’s public-company structure.
Aptevo Therapeutics (NASDAQ:APVO) announced the initiation of a Phase 1 trial for ALG.APV-527, aimed at treating solid tumors that express the 5T4 antigen. The dosing of the first patient marks a significant milestone in Apptevo's strategic expansion into solid tumor therapies, complementing its work in hematological cancers. The trial involves multiple cohorts and will assess safety, tolerability, and preliminary efficacy at up to 10 U.S. sites. Preclinical studies suggest a promising safety profile and potential antitumor activity, with preliminary results expected later in 2023.
Aptevo Therapeutics has announced the filing of a provisional patent for APVO711, a bispecific antibody aimed at treating solid tumors like melanoma and lung carcinoma. This innovative candidate, based on their proprietary ADAPTIR platform, engages PD-L1 and CD40 to potentially enhance T cell activation while maintaining a favorable safety profile. Pre-clinical studies are set to begin this year, expanding Aptevo's oncology portfolio to five candidates. CEO Marvin White emphasized the promising efficacy of their existing candidate, APVO436, suggesting APVO711 could yield similar results.
Aptevo Therapeutics announced results from a Phase 1b trial of APVO436, achieving a 100% clinical benefit rate in venetoclax treatment-naive AML patients when combined with venetoclax and azacitidine. Data presented at the ASH Annual Meeting showed APVO436 to be safe and well-tolerated. A Phase 2 trial is planned for 2H23 to further investigate its efficacy in both frontline and relapsed/refractory AML patients. The promising findings highlight the potential of APVO436 to improve treatment outcomes in AML, a disease with significant unmet medical needs.
Aptevo Therapeutics (NASDAQ:APVO) reported its Q3 2022 financial results, highlighting a net loss of $7.6 million ($1.50 per share), up from a loss of $6.9 million in Q3 2021. The company's cash position stood at $22.6 million as of September 30, 2022. Royalty revenue dropped to $0 from $3.1 million YoY due to an amendment to a royalty agreement. Aptevo plans to present new APVO436 Phase 1b trial data focused on Acute Myeloid Leukemia at the upcoming ASH Annual Meeting, while also receiving FDA approval to advance ALG.APV-527 for solid tumors.
Alligator Bioscience and Aptevo Therapeutics announce favorable preclinical data for ALG.APV-527, a second-generation 4-1BB agonistic bispecific antibody. The peer-reviewed publication in Molecular Cancer Therapeutics supports IND clearance from the FDA, allowing progression to clinical trials targeting solid tumors expressing 5T4. The findings suggest a strong safety profile and anti-tumor activity, with potential for improved treatment outcomes. The companies plan to initiate a Phase 1 trial in the US, highlighting their commitment to advancing innovative cancer therapies.
Aptevo Therapeutics announced a poster presentation during the 64th ASH Annual Meeting on December 11, 2022, focusing on its lead candidate APVO436 for treating acute myeloid leukemia.
The presentation will include updated results from a Phase 1 study evaluating the efficacy of this novel bispecific molecule designed for relapsed and refractory cases. The session will be led by Dr. Justin M. Watts from the University of Miami's Sylvester Comprehensive Cancer Center.
Alligator Bioscience and Aptevo Therapeutics announced that the FDA has issued a "may proceed" notification for ALG.APV-527, an investigational drug for treating 5T4-expressing tumors. This allows the initiation of a Phase 1 clinical trial in the U.S. ALG.APV-527 is designed to stimulate antitumor immune responses, aiming to address a significant unmet medical need in solid tumors. This marks a significant milestone for both companies, adding to Aptevo’s therapeutic pipeline alongside APVO436, which is currently in a Phase 1b trial.
Aptevo Therapeutics has released new preliminary data for its clinical trial of APVO436 targeting acute myeloid leukemia (AML). The latest results indicate a 36% remission rate among response-evaluable patients in Cohort 1, which includes combination therapy with standard chemotherapy. Additionally, a patient in Cohort 3 achieved bone marrow complete remission. One patient in the myelodysplastic syndrome (MDS) cohort remains stable after 18 months on treatment. The company remains optimistic about the potential of APVO436 as a therapeutic agent.
Aptevo Therapeutics reported its Q1 2022 financial results, revealing a net loss of $7.7 million or $1.55 per share, slightly higher than the $7.3 million loss reported in Q1 2021. The company earned a $10 million non-dilutive milestone payment from RUXIENCE sales and anticipates $22.5 million in additional milestones over the next two years. Royalty revenue increased by 29% to $3.1 million, while R&D expenses decreased to $4.9 million. Key clinical advancements include two patients achieving transplant eligibility in the APVO436 trial for acute myeloid leukemia.
Preclinical Data Supports APVO442 for Prostate Cancer
Aptevo Therapeutics (NASDAQ:APVO) announced promising preclinical findings for its bispecific candidate APVO442, targeting prostate-specific membrane antigen (PSMA) and CD3. Presented at the AACR Annual Meeting, this candidate aims to enhance tumor-fighting immune responses while reducing side effects, specifically cytokine release syndrome. The company is advancing toward clinical trials, aiming for better treatment options for challenging cases of metastatic castration-resistant prostate cancer.