Core Findings - Telomir Pharmaceuticals has expanded the oncology profile of its investigational compound Telomir-1 to include aggressive human leukemia cells, in addition to its previously reported efficacy in triple-negative breast cancer, pancreatic cancer, and aggressive prostate cancer models [1] Company Overview - Telomir Pharmaceuticals, Inc. is a preclinical-stage biotechnology company focused on developing small-molecule therapies that target the epigenetic and metabolic roots of cancer, aging, and age-related diseases [1]

ROCKVILLE, Md. and SUZHOU, China, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that the Company’s management is scheduled to participate in three upcoming investor conferences in December 2025. Piper Sa ...

Summary of Summit Therapeutics Conference Call Company Overview - **Company**: Summit Therapeutics (NasdaqGM:SMMT) - **Mission**: To significantly impact patients suffering from cancer through innovative therapies, particularly focusing on the development of ivonescimab, a PD-1 VEGF bispecific antibody [3][4] Current Development and Clinical Trials - **Ivonescimab**: Over 3,000 patients dosed in clinical settings, with more than 40,000 patients treated in China where the drug is approved [4] - **Clinical Trials**: 14 phase three clinical trials ongoing, with four global studies sponsored by Summit and 10 additional trials by partners at Kesso in China [4] - **Safety Profile**: Recent HARMONi-6 data indicates improved tolerability of ivonescimab compared to traditional anti-VEGF monoclonal antibodies, particularly in squamous non-small cell lung cancer patients [5][6] Efficacy and Safety Data - **HARMONi-6 Study**: Reported a hazard ratio of 0.60, indicating a 40% improvement in progression-free survival (PFS) over existing standard care [11][12] - **Median PFS**: 11.1 months for ivonescimab compared to 6.8 months for standard treatments [12][13] - **Overall Survival (OS)**: Updated data from Harmony A shows a hazard ratio of 0.74 for OS, indicating a statistically significant benefit [20][23] Future Trials and Milestones - **Harmony 3 Trial**: Focused on squamous and non-squamous populations, with separate analyses planned to ensure robust data [17][19] - **Enrollment Timeline**: Expecting to complete enrollment for the squamous arm in the first half of 2026 and for the non-squamous arm in the second half of 2026 [17][19] - **BLA Submission**: Planned for the current quarter, focusing on the second-line EGFR mutation treatment [32][42] Strategic Collaborations and Expansion - **Colorectal Cancer Trials**: New trials initiated, indicating the potential for ivonescimab beyond lung cancer [36][38] - **Collaboration with Revolution Medicine**: Exploring combinations with RAS inhibitors, expected to begin dosing patients early next year [39] Financial Position - **Funding**: Company has a strong balance sheet with approximately $750 million available after a recent financing round [42][44] Key Takeaways - **Market Position**: Summit Therapeutics is positioned as a leader in the lung cancer treatment space, with a focus on innovative therapies that demonstrate both safety and efficacy [44] - **Investor Watch**: Key milestones include BLA filing, completion of trial enrollments, and pivotal data releases expected in the near term [42][44]

Core Insights - AIM ImmunoTech Inc. reported solid clinical and operational execution in Q3 2025, focusing on advancing Ampligen towards FDA approval for pancreatic cancer treatment [2] - Positive mid-year safety and efficacy data from the DURIPANC clinical trial combining Ampligen with AstraZeneca's Imfinzi were highlighted, with a year-end update expected [2] Financial Highlights - As of September 30, 2025, AIM reported cash, cash equivalents, and marketable investments of $2.4 million [8] - Research and development expenses for Q3 2025 were approximately $607,000, a decrease from $1.4 million in Q3 2024 [8] - General and administrative expenses were approximately $1.8 million for Q3 2025, down from $3.1 million in the same period of 2024 [8] - The net loss from operations for Q3 2025 was approximately $(3.3 million), or $(1.57) per share, compared to $(3.7 million), or $(6.00) per share, for Q3 2024 [8] - The company expects a monthly burn rate of approximately $550,000 while maintaining operational efficiencies [8]

Core Insights - Moleculin Biotech, Inc. has entered into a research agreement with the University of North Carolina at Chapel Hill to conduct preclinical studies on Annamycin for pancreatic cancer treatment [1][2][3] - Annamycin is being evaluated for its ability to enhance tumor delivery compared to existing treatments like Doxil and Free-doxorubicin [2] - The company aims to leverage Annamycin's high affinity for the pancreas and its correlation with poor survival rates in pancreatic cancer patients to expand its clinical applications [3] Company Overview - Moleculin Biotech is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections [1][6] - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with traditional anthracyclines [6][8] - The company is currently conducting a pivotal Phase 2B/3 trial named MIRACLE, evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4][8] Research and Development - The preclinical research at UNC will assess the effectiveness of Annamycin in conjunction with novel agents to improve treatment outcomes for pancreatic cancer [1][2] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML and soft tissue sarcoma lung metastases [3][6] - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, including pancreatic cancer [9]

Core Insights - Theriva Biologics has made significant progress in its oncology pipeline, particularly with VCN-01 for metastatic pancreatic ductal adenocarcinoma (PDAC) and VCN-12, a next-generation oncolytic virus [2][3] Financial Overview - As of September 30, 2025, cash and cash equivalents were $7.5 million, which increased to $15.5 million following recent capital raises, extending the cash runway into Q1 2027 [8] - General and administrative expenses decreased by 18% to $1.9 million for Q3 2025 compared to $2.3 million in Q3 2024, primarily due to reduced compensation costs [5] - Research and development expenses decreased by 7% to $2.6 million for Q3 2025 from approximately $2.7 million in Q3 2024, attributed to lower clinical trial expenses [6] Clinical Development - Expanded data from the VIRAGE Phase 2b trial showed that VCN-01 combined with standard-of-care chemotherapy improved overall survival (OS) and progression-free survival (PFS) in metastatic PDAC patients [3][12] - The company is pursuing regulatory interactions with the European Medicines Agency and the US FDA for a proposed Phase 3 study of VCN-01 plus gemcitabine/nab-paclitaxel as first-line treatment for metastatic PDAC [2] - VCN-12 demonstrated increased cell killing in preclinical studies compared to VCN-01 and showed a similar toxicity profile in animal studies [9] Pipeline and Future Plans - The company is designing a potential Phase 2/3 clinical trial for retinoblastoma, with discussions with regulators anticipated in the first half of 2026 [2] - Ongoing preclinical studies for VCN-12 are expected to confirm its efficacy and safety profile [9]

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Core Insights - Ascentage Pharma Group International has announced that results from two clinical studies of its drug, lisaftoclax (APG-2575), will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, marking the fourth consecutive year for such presentations [1][2][4] Clinical Study Results - Lisaftoclax is an orally available Bcl-2 inhibitor showing efficacy in hematologic malignancies and solid tumors, currently approved in China for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received prior systemic therapy [2][18] - At ASH 2025, an oral report will present results from a registrational Phase II study of lisaftoclax monotherapy in patients with relapsed/refractory CLL/SLL, while a poster will feature data on its combination with azacitidine in newly diagnosed or prior venetoclax-exposed myeloid malignancies [2][11] Efficacy and Safety Data - In the Phase II study, among 72 evaluable patients with R/R CLL/SLL, the objective response rate (ORR) was 62.5%, with a median progression-free survival (mPFS) of 23.89 months [8][10] - The treatment demonstrated a manageable safety profile, with frequent grade ≥3 treatment-related adverse events primarily being hematologic toxicities, and no treatment-related deaths reported [9][10] Additional Presentations - The ASH Annual Meeting will also feature presentations on other investigational drug candidates from Ascentage Pharma, including olverembatinib and APG-5918, showcasing the company's robust capabilities in clinical development [4][5][19]

Core Insights - Ascentage Pharma's novel drug, olverembatinib, has been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year for this recognition, highlighting its significance in the hematology community [1][4] - The company will present data from multiple clinical studies, including the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) [2][6] - Ascentage Pharma is actively advancing its clinical development programs to provide more treatment options for patients [4][18] Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [19] - The company has a robust pipeline that includes olverembatinib, the first third-generation BCR-ABL inhibitor approved in China, and other investigational drug candidates like lisaftoclax and APG-5918 [20][22] Clinical Study Highlights - The POLARIS-1 study aims to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive ALL, with a primary endpoint of minimal residual disease negativity rate [7][9] - In the study, olverembatinib demonstrated a 64.2% MRD-negative complete response rate by the end of induction therapy, indicating its potential effectiveness [9] - Safety results showed that olverembatinib combined with chemotherapy was well tolerated, with common grade ≥3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [8] Additional Clinical Findings - In a registrational Phase II trial, olverembatinib showed a significant therapeutic advantage over the best available therapy in patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP), with a median event-free survival of 21.22 months compared to 2.86 months for the control group [14] - The study also reported high complete hematologic response rates (85% for olverembatinib vs. 34.8% for BAT) and complete cytogenetic response rates (37.5% vs. 18.9%) [14] Future Directions - Ascentage Pharma is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and SDH-deficient gastrointestinal stromal tumors (GIST) [20] - The company aims to continue accelerating its clinical development programs to expand treatment options for patients [4][18]

Core Insights - SELLAS Life Sciences Group, Inc. is advancing its late-stage clinical biopharmaceutical development, particularly focusing on SLS009 for relapsed or refractory acute myeloid leukemia (r/r AML) [1][2] - The Phase 2 study of SLS009 will be presented at the upcoming ASH Annual Meeting, highlighting its potential in combination with azacitidine and venetoclax [1][3] - The company emphasizes the growing evidence supporting SLS009's efficacy across hematologic malignancies, with preclinical data demonstrating its cytotoxic effects on AML cell lines [2][4] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company dedicated to developing novel therapies for various cancer indications, with a lead product candidate, GPS, targeting the WT1 protein [4] - SLS009, a CDK9 inhibitor, is positioned as a potentially first-in-class treatment with reduced toxicity and increased potency compared to existing CDK9 inhibitors [4] - The company aims to address significant unmet needs in treating difficult-to-manage cancers, particularly in patients with unfavorable prognostic factors like ASXL1 mutations [4]