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ALX Oncology Announces Positive Results from Ongoing Investigator-Sponsored Phase 2 Trial Evaluating Evorpacept in Combination with Standard-of-Care Treatment in Patients with Indolent B-cell Non-Hodgkin Lymphoma, at ASH Annual Meeting
Globenewswire· 2025-12-07 13:00
Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]
Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA
Globenewswire· 2025-12-05 00:00
Core Insights - Ascentage Pharma has received FDA and EMA clearance for a global Phase III study of olverembatinib in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [1][2] - The POLARIS-1 trial aims to accelerate the registration process of olverembatinib in the US and European markets [1] - Initial data from the POLARIS-1 study indicates a 65% minimal residual disease (MRD) negativity rate and molecular MRD-negative complete response (CR) rate after three treatment cycles, showing improved efficacy compared to existing therapies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [6] - The company has a diverse pipeline, including olverembatinib, a third-generation BCR-ABL inhibitor, and lisaftoclax, a Bcl-2 inhibitor [7][8] - Olverembatinib has been approved in China for multiple indications in drug-resistant chronic myeloid leukemia (CML) and is included in the National Reimbursement Drug List (NRDL) [7] Clinical Development - The POLARIS-1 study is a multicenter, randomized controlled trial designed to evaluate the safety and efficacy of olverembatinib in Ph+ ALL patients [2] - The study has also been initiated in China following clearance from the China Center for Drug Evaluation (CDE) [2] - Olverembatinib has received Breakthrough Therapy Designation from the China CDE, highlighting its potential in treating Ph+ ALL [3][4] Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights outside of certain regions [4] - The company collaborates with various leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities [9]
Healthcare stocks are red-hot. Here are 3 picks from a fund manager up 41% this year.
Yahoo Finance· 2025-12-04 18:15
Core Insights - The healthcare sector has outperformed all other sectors, including technology, since the beginning of September, with the State Street Health Care Select Sector SPDR ETF (XLV) rising by 13% during this period [2][5] - The Tema Oncology ETF (CANC) has experienced a significant increase of 28% since September and is up 41% year-to-date [2][5] Company Highlights - Revolution Medicines (RVMD) is the top holding in the Tema Oncology ETF, with a remarkable gain of 127% since August 11, attributed to its strong management and potential breakthrough in pancreatic cancer therapy [3][4] - Roche Holdings (RHHBY) is noted for its portfolio of cancer immunology drugs, trading at an attractive PE ratio of 15, and has a significant pipeline that could enhance its valuation, especially following a positive readout in a breast cancer trial [4][6] - Guardant Health (GH) specializes in diagnostics, particularly a liquid biopsy test for early cancer detection, which is particularly relevant for colorectal cancer, the fastest-growing cancer among young people in the US [6][7]
X @The Wall Street Journal
Healthcare Policy & Research - Policymakers need to ensure the Inflation Reduction Act (IRA) doesn't stifle cumulative research [1] - The research aims to make cancer easier to endure and more affordable to treat [1]
LIXTE Biotechnology Acquires Liora Technologies’ Proprietary Proton Therapy Platform for Cancer Treatment
Globenewswire· 2025-11-25 13:30
Core Insights - LIXTE Biotechnology Holdings, Inc. has acquired Liora Technologies Europe Ltd., marking its entry into the radiotherapy segment of cancer care [1][3] - The acquisition includes Liora's LiGHT System, which offers significant advantages in proton therapy for treating tumors [2][3] - The LiGHT System is expected to set a new standard in cancer treatment, providing high-precision therapy that is scalable and clinically versatile [3] Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, with a lead compound, LB-100, that has shown promise in clinical trials [4][5] - The company aims to enhance existing cancer treatments through its innovative approach in cancer biology, specifically in activation lethality [5] Technology and Development - The LiGHT System, installed at STFC's Daresbury Laboratory, will serve as a center of excellence for proton therapy treatment [2] - The technology is designed to reduce installation costs and treatment sessions while increasing patient capacity at treatment centers [3]
Immuneering to Present at the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-25 13:00
Core Insights - Immuneering Corporation is a clinical-stage oncology company focused on developing innovative cancer treatments to improve patient survival and quality of life [3] Company Presentation - Immuneering will present at the Piper Sandler 37th Annual Healthcare Conference in New York City on December 4, from 11:10 to 11:30 a.m. ET [2] - The presentation will be available via live webcast and archived on the company's Investor Relations website [2] Product Development - Immuneering is developing a new category of cancer medicines called Deep Cyclic Inhibitors, with its lead product candidate, atebimetinib, currently in a Phase 2a trial for advanced solid tumors, including pancreatic cancer [3] - Atebimetinib is designed to be an oral, once-daily medication that enhances durability and tolerability across various cancer indications, particularly those driven by the MAPK pathway [3]
Telomir Pharmaceuticals Announces Telomir-1 Kills Aggressive Human Leukemia Cells
Accessnewswire· 2025-11-21 12:30
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]
Ascentage Pharma to Participate in Three Upcoming Investor Conferences in December 2025
Globenewswire· 2025-11-19 13:00
Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences in December 2025, highlighting its ongoing commitment to engage with the investment community and showcase its advancements in biopharmaceuticals [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Portfolio - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for treating chronic myeloid leukemia (CML) with specific mutations, and is included in the China National Reimbursement Drug List [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies, currently being commercialized in China after receiving NMPA approval for chronic lymphocytic leukemia/small lymphocytic lymphoma [4]. - Ascentage Pharma is conducting multiple global registrational Phase III trials for both Olverembatinib and Lisaftoclax, indicating a strong focus on expanding its clinical footprint [3][4]. Research and Development - The company has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, enhancing its research capabilities [5]. - Collaborations include relationships with prominent research institutions, which support the company's innovative drug development efforts [5].
Summit Therapeutics (NasdaqGM:SMMT) 2025 Conference Transcript
2025-11-18 16:32
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]
AIM ImmunoTech Reports Third Quarter 2025 Financial Results and Highlights Continued Progress Across Pipeline with Strategic Focus on Pancreatic Cancer Clinical Program
Globenewswire· 2025-11-18 13:55
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]