Cancer Immunotherapy

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OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma
Newsfile· 2025-10-10 10:00
OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic OsteosarcomaOctober 10, 2025 6:00 AM EDT | Source: OS Therapies75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001)100% of patients who achieved 12 month event free survival achieved 2 year overall survivalNew York, New ...
OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting
Newsfile· 2025-10-09 11:40
OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur MeetingOctober 09, 2025 7:40 AM EDT | Source: OS TherapiesOverall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care existsRapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of PennsylvaniaNew York, New York--(Newsfile Corp. - October 9, 2025) - OS Therapies In ...
OS Therapies to Participate in Fall 2025 Conferences and Events
Newsfile· 2025-10-07 15:50
OS Therapies to Participate in Fall 2025 Conferences and EventsOctober 07, 2025 11:50 AM EDT | Source: OS TherapiesDaytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and human & canine patients who participated in OST-HER2 clinical trialsNew York, New York--(Newsfile Corp. - October 7, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer ...
Candel Therapeutics to Present at the SITC 2025 Annual Meeting
Globenewswire· 2025-10-03 13:05
NEEDHAM, Mass., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the Company will present insights from its enLIGHTEN™ Discovery Platform, and additional data from the CAN-2409 (aglatimagene besadenovec) program in non-small cell lung cancer (NSCLC), through two accepted poster presentations at the Society for ...
FDA approves Roche's Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
Globenewswire· 2025-10-03 05:05
Core Insights - Roche announced FDA approval for Tecentriq® and Tecentriq Hybreza® in combination with lurbinectedin for maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) [1][3] - This marks the first and only combination therapy approved for first-line maintenance treatment of ES-SCLC, addressing a significant unmet need in a highly aggressive disease [1][3] - The approval is based on the phase III IMforte study, demonstrating a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][2] FDA Approval Details - The FDA approved the combination therapy for adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy [1] - The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include this regimen as a category 2A preferred option for maintenance treatment [1][3] Study Findings - The IMforte study involved 660 patients in the induction phase, with 483 patients randomized for maintenance therapy [2] - Median overall survival for the combination therapy was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] Company Commitment - Roche emphasizes its commitment to improving outcomes in difficult-to-treat cancers through innovative therapies [1][3] - The company has a history of developing treatments for aggressive cancer types, including various formulations of Tecentriq [5]
CytoDyn to Present on Leronlimab Induction of PD-L1 and Immune Checkpoint Inhibitor Responses in Metastatic Triple-Negative Breast Cancer at the AACR Special Conference: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity
Globenewswire· 2025-09-25 12:30
Company to deliver oral and poster presentations for data on leronlimab’s action on PD-L1 expression and patient survival in triple-negative breast cancer VANCOUVER, Washington, Sept. 25, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and colo ...
OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDT
Newsfile· 2025-09-19 11:40
OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDTSeptember 19, 2025 7:40 AM EDT | Source: OS TherapiesNew York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer Therapeut ...
Medicenna to Participate at the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-05 11:00
Core Insights - Medicenna Therapeutics Corp. is a clinical-stage cancer immunotherapy company focused on developing Superkines [1][4] - Dr. Fahar Merchant, President and CEO, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1][2] - The company is developing novel versions of IL-2, IL-4, and IL-13 Superkines, with a focus on enhancing cancer treatment [4] Presentation Details - The presentation is scheduled for September 9, 2025, from 2:30 PM to 3:00 PM (Eastern Standard Time) at the Lotte New York Palace Hotel [2] - A webcast of the presentation will be available for 90 days on Medicenna's investor relations website [2] Company Overview - Medicenna's long-acting IL-2 Superkine, MDNA11, has superior affinity toward CD122 and preferentially stimulates cancer-killing effector T cells and NK cells [4] - The IL-4 Empowered Superkine, bizaxofusp, has been studied in five clinical trials with over 130 patients, including a Phase 2b trial for recurrent GBM [4] - Bizaxofusp has received FastTrack and Orphan Drug status from the FDA and EMA [4] - Medicenna is also developing early-stage BiSKITs™ and T-MASK™ programs aimed at treating immunologically "cold" tumors [4]
Purple Biotech Announces New Data Supporting the Unique Design of CAPTN-3 Tri-Specific Antibody IM1240 in Collaboration with the Icahn School of Medicine at Mount Sinai
Globenewswire· 2025-09-04 11:00
Core Insights - Purple Biotech Ltd. is advancing its tri-specific antibody IM1240, targeting the tumor-associated antigen 5T4, towards first-in-human clinical trials with an IND submission planned for 2026 [1][6] - The collaboration with Dr. Amir Horowitz focuses on evaluating the CAPTN-3 antibody's effects on patient-derived tumor biopsies, particularly in treatment-resistant cancers [2][3] - IM1240 has shown to induce cancer cell apoptosis in resistant head and neck cancer biopsies, demonstrating a unique synergistic effect not observed in related bispecific antibodies [3][4] Company Overview - Purple Biotech is a clinical-stage company developing therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CAPTN-3, CM24, and NT219 [6] - The CAPTN-3 platform utilizes conditionally activated tri-specific antibodies to engage T cells and NK cells, aiming for a strong immune response localized within the tumor microenvironment [6] - IM1240 is the first tri-specific antibody targeting the 5T4 antigen, which is associated with advanced disease and poor clinical outcomes in various solid tumors [6] Research and Development - Dr. Horowitz's research indicates that targeting NKG2A provides a selective checkpoint inhibition strategy, enhancing antitumor activity while minimizing off-target effects [4][5] - Analysis of approximately 26,000 human transcriptomes supports the design of IM1240, showing consistent expression of NKG2A with 5T4 in solid tissues [1][4] - The CAPTN-3 platform's unique design allows for the activation of immune cell subsets with high anti-tumor activity, potentially improving safety and efficacy [4][5]
OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting
Newsfile· 2025-09-02 11:40
Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]