Core Insights - Aptevo Therapeutics has presented preclinical data for its trispecific antibody candidate, APVO451, at the Society for Immunotherapy of Cancer Annual Meeting, highlighting its potential in treating hard-to-treat solid tumors [1][2]. Company Update - APVO451 is designed to address the challenge of immune suppression in solid tumors, such as urothelial, breast, and pancreatic cancers, by utilizing a proprietary CRIS-7-derived CD3 binding domain [2][3]. - The molecule aims to activate the intratumoral immune system, enhancing the ability to target and kill tumor cells effectively [3]. Key Findings from the Presentation - APVO451 demonstrated local activation of T-cells and antigen-presenting cells (APCs) only when bound to the target protein, nectin-4, indicating a favorable safety profile [4]. - The candidate showed dual immune re-activation by stimulating T-cell effector functions and restoring APC function, addressing a common failure point in solid tumor treatments [4]. - In tumor models simulating suppression, APVO451 was more effective in eliminating nectin-4-positive tumor cells compared to standard CD3 T-cell engagers, suggesting its potential to overcome suppressive tumor environments [4]. Next Steps - Aptevo is advancing APVO451 through ongoing preclinical studies to support IND-enabling work and future clinical development targeting nectin-4-expressing solid tumors [5]. About APVO451 - APVO451 is a trispecific ADAPTIR-FLEX therapeutic candidate designed to engage CD3 and CD40, aiming to restore immune engagement in suppressive solid tumors while minimizing off-tumor activation [6]. About Aptevo Therapeutics - Aptevo Therapeutics is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for cancer treatment, with two clinical candidates currently in trials [7].

Core Insights - Aptevo Therapeutics reported that 89% of evaluable frontline AML patients achieved remission in combination therapy across two trials, with a notable 100% remission rate in Cohort 3 of the ongoing RAINIER trial [1][1][1] - The company introduced its first trispecific molecules, APVO451 and APVO452, aimed at overcoming immune suppression in certain solid tumors, utilizing a unique CRIS-7-derived CD3 binding domain [1][1][1] - Aptevo's CD3 T-cell engager portfolio has been expanded to five molecules, indicating growth in its therapeutic offerings [1][1][1] - The company raised $18.7 million in the third quarter and an additional $4.1 million since the quarter ended, extending its cash runway into the fourth quarter of 2026 [1][1][1] Financial Performance - The financial results for the quarter ended September 30, 2025, were reported alongside a business update, highlighting the company's ongoing development in immune-oncology therapeutics [1][1][1]

Core Insights - Aptevo Therapeutics is actively participating in several key financial, industry, scientific, and medical conferences this fall to showcase its ongoing developments and momentum in the biotechnology sector [1] Conference Participation - Aptevo will participate in the 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025, discussing its lead asset mipletamig and its clinical progress in Acute Myeloid Leukemia (AML) [1] - The company will also be present at the Biotechnology Innovation Organization (BIO)-Europe 2025 from November 3-5, 2025, engaging in meetings at the largest biotechnology event in Europe [1] - At the Society of Immunotherapy in Cancer (SITC) 2025, scheduled for November 5-9, 2025, Aptevo's R&D team will present a poster on a novel trispecific targeting approach to address the immunosuppressive tumor microenvironment [1] - The interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for AML will be presented at the American Society of Hematology (ASH) 2025 meeting from December 6-9, 2025 [1]

Core Insights - Aptevo Therapeutics Inc. (APVO) experienced a significant stock increase of 46.10% to $2.06 after reporting breakthrough clinical results for its drug aimed at treating acute myeloid leukemia (AML) [1] Clinical Trial Results - The Phase 1b/2 RAINIER trial showed a perfect remission rate, with all patients in Cohort 3 achieving complete remission using mipletamig in combination with venetoclax and azacitidine [2] - No dose-limiting toxicities or cytokine release syndrome were reported across all cohorts of the trial, indicating a favorable safety profile [2] Market Opportunity and Future Steps - The frontline AML market represents a multi-billion-dollar opportunity, with current standard treatments yielding lower remission rates compared to those observed in the RAINIER trial [3] - 40% of patients in the trial achieved minimal residual disease-negative status, which is a positive indicator for prognosis [3] - Enrollment for Cohort 4 is ongoing at higher dose levels, with a conference presentation anticipated in the fourth quarter [3] Stock Performance Overview - APVO's stock has seen a decline of approximately 31.9% from its one-month peak of $2.07 to a close of $1.41 [4] - Over the past year, the stock has decreased by 98.84%, and it is down 98.36% year-to-date in 2025 [4] - The clinical-stage stock has an annual trading range between $1.32 and $381.10, with a market capitalization of $4.64 million and an average trading volume of 3.98 million shares [4]

Core Insights - Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial for mipletamig, a bispecific antibody targeting CD123 and CD3, in combination with venetoclax and azacitidine for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy [1] - The trial has shown no dose-limiting toxicities or cytokine release syndrome to date, indicating favorable safety and tolerability for mipletamig [1] - The RAINIER trial is progressing efficiently, with Cohort 4 now open for enrollment [1]

Core Viewpoint - Aptevo Therapeutics Inc's stock is experiencing a significant surge due to promising clinical data from its RAINIER trial for mipletamig, a bispecific antibody for treating acute myeloid leukemia (AML) [1][2][6]. Group 1: Clinical Trial Results - The RAINIER trial showed that the mipletamig triplet therapy achieved remissions in 85% of evaluable frontline AML patients, outperforming competitor studies [3]. - Updated results indicate a strong efficacy advantage and a favorable safety profile, with no cases of cytokine release syndrome (CRS) reported in the trial cohorts [4][5]. - The trial is nearing full enrollment for Cohort 3 at the highest dose level evaluated to date [5]. Group 2: Market Impact and Financials - Following the positive trial results, Aptevo's stock price increased by 137.2%, reaching $6.69 [7]. - The company announced a registered direct offering of $8 million, involving 2.465 million shares and pre-funded warrants at an exercise price of $3.25 per share [6].