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TuHURA Biosciences, Inc. and Kineta, Inc. Stockholders Approve Proposed Merger and All Related Proposals
Prnewswire· 2025-06-23 21:00
TAMPA, Fla. and SEATTLE, June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the C ...
CERo Therapeutics Holdings, Inc. Announces First Patient Completes Dose-Limiting Toxicity Observation Period with No Reported DLTs in Phase 1 Trial of CER-1236
Globenewswire· 2025-06-23 12:15
SOUTH SAN FRANSCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an immunotherapy company developing the next generation of engineered T cell therapeutics targeting TIM4L with phagocytic mechanisms, today announces the completion of the initial evaluation of the first patient in its Phase 1 clinical trial of lead compound CER-1236. Following an evaluation from the trial’s Dose Escalation Safety Committee, preliminary results show that ...
Candel Therapeutics Appoints Charles Schoch as Chief Financial Officer
Globenewswire· 2025-06-23 12:05
Interim CFO elevated to permanent role after demonstrating exceptional financial leadership, guiding the company through major operational and financial milestonesNEEDHAM, Mass., June 23, 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 appointment of Charles Schoch as Chief Financial Officer (CFO). Mr. Schoch, who ...
NKGen Biotech Announces International and U.S. Expansion of Phase 1/2a Troculeucel Alzheimer's Trial with Activation of Clinical Sites in Canada and Florida
Globenewswire· 2025-06-23 12:05
SANTA ANA, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the activation of two additional clinical trial sites for its ongoing Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate Alzheimer’s disease (“AD”) ...
Anixa Biosciences to Host an Investor Webcast on June 26, 2025
Prnewswire· 2025-06-20 11:30
Core Viewpoint - Anixa Biosciences, Inc. is set to host an investor webcast on June 26, 2025, to discuss its business strategy, therapeutic portfolio, market opportunities, and upcoming milestones [1][2]. Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention [4]. - The company is developing an ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor-T cell (CER-T) technology [4]. - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [4]. - The company partners with renowned research institutions to explore emerging technologies for development and commercialization [4]. Webcast Details - The webcast will feature an introductory presentation by Dr. Amit Kumar, Anixa's Chairman and CEO, followed by a Q&A session for investors [2]. - Interested participants must pre-register to listen to the webcast and ask questions during the live event [3].
Aptevo Therapeutics Touts Data From Investigational Drug Trial For Aggressive Blood Cancer
Benzinga· 2025-06-18 15:37
Aptevo Therapeutics Inc APVO stock is surging on Wednesday.As per data from Benzinga Pro, the stock is trading higher with a strong volume of 81.8 million compared to the average volume of 275.3k.What Happened: Aptevo revealed new clinical data from its ongoing Phase 1b/2 RAINIER trial evaluating mipletamig, its first-in-class CD123 x CD3 bispecific antibody, in combination with standard-of-care venetoclax and azacitidine (ven/aza) for newly diagnosed patients with acute myeloid leukemia (AML) who are unfit ...
Elicio Therapeutics to Host Virtual KOL Event on June 25, 2025 to Discuss AMP-Powered ELI-002 for the Treatment of KRAS mutation-driven Pancreatic Cancer
Globenewswire· 2025-06-17 12:00
Core Insights - Elicio Therapeutics is hosting a virtual KOL event on June 25, 2025, to discuss the treatment landscape for mutant-KRAS driven pancreatic ductal adenocarcinoma, highlighting the significant unmet medical need in this area [1][2] Company Overview - Elicio Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, particularly mKRAS-positive pancreatic and colorectal cancers [8] - The company aims to leverage its proprietary AMP technology to create effective off-the-shelf vaccines, enhancing the education and activation of cancer-specific T cells [8][11] Product Pipeline - Elicio's lead product candidate, ELI-002, is an AMP-powered therapeutic vaccine targeting mKRAS-driven cancers, currently in a randomized Phase 2 trial for adjuvant treatment of PDAC [2][9] - ELI-002 has shown promising results in earlier studies, with a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months for the full study population [8] - The company plans to expand ELI-002's application to other mKRAS-positive cancers, including lung cancer [8][10] Technology Platform - Elicio's AMP platform is designed to deliver immunotherapeutics directly to lymph nodes, potentially enhancing immune responses compared to conventional therapies [11][12] - The platform has demonstrated the ability to engage lymph nodes specifically, driving therapeutic immune responses of increased magnitude and durability in preclinical models [11][12]
Moderna (MRNA) Update / Briefing Transcript
2025-06-16 15:00
Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.
Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology
Globenewswire· 2025-06-16 12:30
Teva-engineered TEV-56278 is an anti-PD1-IL2 ATTENUKINE™ therapy in Phase 1 for the treatment of various forms of cancer, including melanomaFosun Pharma-Teva collaboration agreement established with goal of accelerating clinical data generation for TEV-56278Partnership leverages strategic relationships to enable research and development of innovative treatments to advance Teva's Pivot to Growth strategy TEL AVIV, Israel and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYS ...
Regeneron(REGN) - 2025 FY - Earnings Call Transcript
2025-06-13 15:30
Regeneron Pharmaceuticals (REGN) FY 2025 Annual General Meeting June 13, 2025 10:30 AM ET Speaker0 Good morning, and welcome to the twenty twenty five Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message. Speaker1 At Regeneron, we've always pursued bold science to drive our purpose, transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded. Speaker2 We committed to not just treati ...