Core Insights - Galecto, Inc. is presenting preclinical data and clinical development plans for GB3226, a novel dual ENL-YEATS and FLT3 inhibitor for acute myeloid leukemia (AML), at the ASH Annual Meeting in December 2025 [1][2] Group 1: Product Overview - GB3226 is a first-in-class, orally bioavailable small-molecule inhibitor targeting ENL-YEATS and FLT3, which is mutated in approximately 30% of adult AML patients [2][4] - The dual inhibition of ENL-YEATS and FLT3 may provide greater therapeutic benefits compared to existing treatments [2] - Preclinical studies show GB3226's potent activity across diverse AML patient-derived samples, leading to rapid tumor regression and significantly prolonged survival in xenograft models [2][4] Group 2: Clinical Development - Two poster presentations will detail the Phase 1 study of GB3226 in patients with relapsed/refractory AML, scheduled for December 6 and December 8, 2025 [3] - The presentations will be held at the Orange County Convention Center in Orlando, Florida, during the ASH Annual Meeting [3] Group 3: Efficacy and Safety - GB3226 demonstrated favorable pharmacokinetics and tolerability in animal studies, with potential additive or synergistic effects when combined with current standard-of-care agents [2][5] - The investigational candidate showed superior efficacy compared to both FLT3 and menin inhibitors in preclinical models [4] Group 4: Company Background - Galecto is a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer and liver diseases, with a pipeline that includes GB3226 and other first-in-class small molecule drug candidates [6]

Core Insights - AB Science SA has provided initial Phase 1 data for the combination of AB8939 with Venetoclax for treating refractory or relapsed acute myeloid leukemia (AML) [1] Group 1: Clinical Data and Efficacy - Early data indicates that AB8939, either as monotherapy or in combination, shows significant activity in high-risk subtypes of AML [2] - The combination of AB8939 and Venetoclax has demonstrated a disease control rate of 100% (3/3) and a partial response rate of 100% (3/3), including one patient achieving complete remission after the first treatment cycle [5][9] - AB8939 has shown activity in MECOM, with long overall survival benefits, and is effective in cell lines resistant to standard treatments [10][8] Group 2: Mechanism of Action - AB8939 operates through a dual mechanism: disrupting microtubules to block leukemia cell proliferation and targeting leukemia stem cells by inhibiting ALDH [10][11] - The combination with Venetoclax is expected to enhance apoptosis in cancer cells, as AB8939 destabilizes microtubules while Venetoclax inhibits the BCL2 pathway, which is crucial for AML resistance [11] Group 3: Market Potential - The addressable market for AB8939 in relapsed/refractory AML is estimated to exceed EUR 2 billion annually [13] - The total incidence of AML cases is approximately 90,200 globally, with significant relapse rates, indicating a persistent unmet medical need [14] Group 4: Next Steps and Development Plans - The next steps include completing Phase 1 in combination therapy and launching an expansion study involving around 15 AML patients eligible for AB8939 + Venetoclax [12] - Discussions with regulatory bodies such as the FDA and EMA are ongoing regarding potential registrational studies for AB8939 [13] Group 5: Intellectual Property - AB8939's intellectual property rights in AML are secured until 2036, with potential extensions until 2044 for specific genetic abnormalities [18]

Core Viewpoint - Omeros Corporation has established the Omeros Oncology Clinical Steering Committee to advance its OncotoX biologics program targeting acute myeloid leukemia (AML), which is a highly fatal form of leukemia accounting for about 80% of acute leukemias in adults and one-third of all blood/bone marrow cancers [1][4]. Group 1: OncotoX Program Development - The OncotoX program consists of proprietary targeted, engineered molecules that deliver a toxic payload directly into cancer cells, effectively killing them [2]. - The steering committee will aid in developing the OncotoX-AML program, designing clinical trials, and interacting with institutional review boards [3]. Group 2: Efficacy and Safety - In vivo and ex vivo studies indicate that OncotoX-AML is highly effective at low doses, providing significant survival benefits compared to existing therapies like AbbVie’s Venclexta and Bristol Myers Squibb’s Vidaza [4]. - OncotoX-AML targets both AML blasts and leukemia stem cells (LSCs), which are often resistant to chemotherapy, thus addressing potential relapse [5]. - Preliminary studies show that OncotoX is well tolerated at doses significantly higher than effective doses without causing neutropenia or major changes in blood chemistry [5]. Group 3: Market Potential and Analyst Insights - Omeros is initiating IND-enabling work for OncotoX-AML, which is crucial given the limited therapeutic options for AML, especially for elderly patients or those with high-risk mutations [6]. - Analyst Jason Kolbert maintains a Buy rating on Omeros with a price target of $36, highlighting the potential of OncotoX-AML to fill gaps in AML treatment [7]. - The company plans to submit a European marketing authorization application for its lead therapy, narsoplimab, in the first half of 2025 [8].