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Aptevo Therapeutics Inc. (NASDAQ:APVO) is a clinical-stage biotechnology company based in Seattle, Washington, renowned for pioneering oncology and hematology therapeutics. The company leverages its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies to develop novel immunotherapeutic candidates aimed at enhancing cancer treatment outcomes.
Aptevo's robust pipeline includes APVO436, a clinical candidate targeting acute myeloid leukemia (AML), as well as preclinical candidates ALG.APV-527 and APVO603. These candidates utilize the company's versatile technology platforms to generate bispecific and multi-specific antibody candidates that harness the human immune system to target cancer cells.
Recently, Aptevo announced a reverse stock split aimed at regaining compliance with NASDAQ's minimum bid price requirement. The split is part of a strategic plan approved by the shareholders and aims to reduce the number of outstanding shares, thereby increasing the share price.
Among its promising projects, APVO436 has shown significant clinical benefits in combination with venetoclax and azacitidine for frontline AML treatment. The company is preparing to initiate a Phase 1b/2 dose optimization study, further exploring its efficacy. Additionally, ALG.APV-527 is in a Phase 1 trial for multiple solid tumor types, showing early signs of clinical activity and biological effectiveness.
Aptevo's culture of innovation and collaboration has attracted leading minds from pioneering biotech firms, fostering an environment conducive to groundbreaking research and development. The company's latest news highlights ongoing initiatives, such as presenting new data at major conferences and securing strategic partnerships to advance its clinical programs.
Financially, Aptevo remains focused on clinical development and operational efficiency. In recent quarters, the company has reported decreases in research and development expenses due to the transition between phases of its clinical studies. General and administrative expenses have also seen reductions, primarily attributed to lower employee and consulting costs.
Looking ahead, Aptevo continues to advance its pipeline with the aim of transforming cancer treatment paradigms. This commitment is underscored by their participation in major industry conferences and ongoing collaborations with leading CROs and biopharmaceutical firms.
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.
Aptevo Therapeutics has reported encouraging outcomes from its ongoing Phase 1b trial of APVO436, a therapy for patients with relapsed/refractory acute myeloid leukemia (AML). A patient treated with APVO436 as monotherapy has achieved transplant eligibility after a significant reduction in bone marrow blasts. This follows another patient in a combination therapy arm also progressing to transplant. The treatment has demonstrated a favorable safety profile and showed clinical activity in previous dose escalation studies, raising hopes for its role in AML treatment.
Aptevo Therapeutics reported its 2021 financial results, revealing a net loss of $28.5 million or $6.07 per share, up from a loss of $17.8 million in 2020. The company achieved significant progress in its clinical trials, particularly with APVO436 for acute myeloid leukemia, showing a 27.5% clinical activity in 40 patients. Aptevo plans to submit an IND for ALG.APV-527 in late 2022 and reported a 185% increase in royalty revenue to $12.3 million, driven by Pfizer's RUXIENCE. Cash reserves stood at $46.3 million, sufficient for the next 12 months.
Aptevo Therapeutics (NASDAQ: APVO) announced a $10 million non-dilutive milestone payment related to RUXIENCE sales in 2021. The company anticipates additional milestones totaling $22.5 million over the next two years, based on optimistic sales forecasts. The Phase 1b trial for its lead candidate, APVO436, for acute myeloid leukemia (AML) continues to progress, enrolling new sites including MD Anderson Cancer Center. A patient in complete remission is set to advance to transplant, indicating positive clinical outcomes.
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