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 - Morgan Stanley reports that Ascentage Pharma (06855) has seen a year-to-date stock price increase of approximately 83%, aligning with the strong performance of the Hang Seng Healthcare Index, which has risen about 78% [1] Group 1: Stock Performance and Target Price - Morgan Stanley has updated its model for Ascentage Pharma following discussions at the recent Sino-US Biotechnology Forum, considering the latest developments in the company's product pipeline [1] - The target price for Ascentage Pharma has been significantly raised by 79% from the previous HKD 52 to HKD 93, while maintaining an "Overweight" rating [1] Group 2: Key Assets and Sales Forecast - The firm remains optimistic about the company's key assets, "olverembatinib" and "lisaftoclax," which are expected to drive strong product sales this year [1] - There is an improved outlook for the overseas potential of "lisaftoclax," particularly in light of the failure of "venetoclax" to demonstrate overall survival benefits in myelodysplastic syndromes (MDS), along with the drug's market approval scope in China exceeding expectations [1]

Core Viewpoint - AB Science has received regulatory approval from several European countries to initiate the third stage of its Phase I/II study combining AB8939 with venetoclax for treating acute myeloid leukemia (AML), indicating potential advancements in treatment options for patients with relapsed/refractory AML [1][4]. Group 1: Study Details - The third stage of the study has been approved in France, Germany, Spain, and Greece, focusing on determining the maximum tolerated dose (MTD) of AB8939 [2]. - The first two stages of the Phase I study involved 28 and 13 patients, respectively, establishing the MTD of AB8939 at 21.3 mg/m² after both 3 and 14 consecutive days of treatment [3]. - The current stage will evaluate the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML [3][6]. Group 2: Treatment Rationale - The combination of AB8939 and venetoclax is expected to have low hematologic toxicity, potentially making it less toxic than the current standard treatment of azacitidine plus venetoclax [5]. - Both compounds target different mechanisms in cancer cells, which may lead to additive or synergistic effects in efficacy [5][9]. - AB8939 destabilizes microtubules, preventing cancer cell division, while venetoclax inhibits BCL2, promoting apoptosis in cancer cells, thus addressing resistance mechanisms [7][13]. Group 3: Market Potential - The estimated market potential for AML treatments exceeds €2 billion annually, with significant addressable markets in the United States, Europe, and Asia-Pacific [11][12]. - The total incidence of AML in the United States, Europe, and Asia-Pacific is approximately 79,100 cases, with a significant portion being poor responders to standard therapies [12][15]. Group 4: Intellectual Property and Regulatory Status - AB8939 is protected by patents until 2026, with potential extensions and additional protections for specific uses in AML, extending to 2044 for certain chromosomal abnormalities [16][18]. - The drug has received orphan drug designation from both the EMA and FDA, granting it marketing exclusivity for 10 years in Europe and 7 years in the US [19].

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].