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TuHURA Biosciences Completes Acquisition of Kineta
Prnewswire· 2025-06-30 12:50
Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]
Allarity Therapeutics Receives Australian Patent Acceptance Notice for Stenoparib DRP® Companion Diagnostic
Globenewswire· 2025-06-30 12:00
Core Viewpoint - Allarity Therapeutics has received formal acceptance of its patent application for the Drug Response Predictor (DRP) companion diagnostic specific to stenoparib from IP Australia, marking a significant step in its global strategy for intellectual property protection and commercialization of its proprietary technology [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment using its proprietary DRP technology [1][6]. - The company is headquartered in the U.S. and has a research facility in Denmark, aiming to address significant unmet medical needs in cancer treatment [6]. Patent and Intellectual Property - The accepted patent covers 40 claims and is a crucial part of Allarity's strategy to protect its DRP platform internationally, with the patent expected to be granted within 20 working days if unopposed [2][3]. - Allarity has previously secured a European patent for the stenoparib DRP and holds 18 granted patents for drug-specific DRPs, including eight in the U.S. [3]. Drug and Technology Details - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications in various cancer types, particularly ovarian cancer [4]. - The DRP technology is designed to select patients likely to benefit from specific drugs based on gene expression signatures, enhancing therapeutic benefit rates [5]. Future Prospects - The acceptance of the Australian patent is seen as a vital achievement in securing international IP protection while advancing stenoparib through Phase 2 trials towards U.S. regulatory approval [3].
Why Iovance Biotherapeutics Stock Dove by Almost 15% This Week
The Motley Fool· 2025-06-27 22:57
Core Viewpoint - The departure of top-level management at Iovance Therapeutics has raised investor concerns, leading to a nearly 15% decline in the company's stock value during the week [1]. Management Changes - CFO Jean-Marc Bellemin resigned from his position, effective July 10, following a regulatory filing on June 13 [2][4]. - The resignation is occurring during a challenging period for the company, which is facing legal issues and a commercial setback for its flagship drug, Amtagvi [4]. Legal and Commercial Challenges - Iovance is currently under investigation by multiple law firms, which suggests that the company's legal troubles may be contributing to its management instability [2][4]. - The company has experienced a significant reduction in its product-revenue guidance for the year, despite some top-line growth attributed to Amtagvi, a melanoma drug [5]. Investment Outlook - While Iovance is facing significant challenges, Amtagvi still holds potential, indicating that the company may be worth monitoring for investors willing to take on higher risks [6].
Atossa Therapeutics(ATOS) - 2024 Q4 - Earnings Call Presentation
2025-06-27 12:11
Year-end 2024 Business Update NASDAQ: ATOS www.atossatherapeutics.com Disclaimer • This presentation may contain certain forward-looking statements related to or Atossa Therapeutics, Inc. (the "Company") that involve risks and uncertainties. • Actual results and events may differ significantly from results and events discussed in forward-looking statements. • Factors that might cause or contribute to such differences include, but are not limited to, those discussed in "Risk Factors" in the Company's Annual ...
Anixa Biosciences (ANIX) Update / Briefing Transcript
2025-06-26 19:00
Anixa Biosciences (ANIX) Update Summary Company Overview - Anixa Biosciences was reinvented in 2017 as a biotechnology company focusing on cancer therapies, with a robust pipeline of products currently in clinical trials [5][6] - The company has established partnerships with leading organizations such as the Cleveland Clinic and Moffitt Cancer Center, and receives funding from the U.S. Department of Defense and the National Cancer Institute [6][7] Financial Position - Anixa maintains a strong balance sheet with over two years of cash on hand, allowing for significant clinical milestones without frequent capital raises [8][12] - The company has a clean capital structure with 32 million shares of common stock and no warrants or preferred stock [10][11] Clinical Programs CAR T Therapy for Ovarian Cancer - The CAR T therapy targets terminally ill ovarian cancer patients and is currently in clinical trials at Moffitt Cancer Center [17][19] - The therapy utilizes a unique target, the follicle stimulating hormone receptor (FSHR), which is only found on ovarian cells and tumor blood vessels, allowing for a dual mechanism of action [29][31] - Early results show promising outcomes, with some patients living significantly longer than expected [39][41] - The FDA has approved the possibility of administering a second dose to patients showing initial responses, which is a rare approval for CAR T therapies [41][80] Breast Cancer Vaccine - The breast cancer vaccine aims to treat and prevent breast cancer, particularly targeting triple-negative breast cancer [42][43] - The vaccine is based on the alpha lactalbumin protein, which is produced during lactation and is found in many breast cancer cells [43][44] - Initial Phase I trials have shown strong immune responses and safety, with plans for a Phase II trial to compare the vaccine's effectiveness against standard care [51][55] - The vaccine has the potential to change the paradigm of cancer prevention, aiming for primary prevention in women without a history of cancer [59][60] Market Opportunities - Anixa is addressing large markets, including breast and ovarian cancer, with plans to expand into lung, prostate, and colon cancer [7][20][61] - The company anticipates significant market opportunities if their therapies prove successful, particularly in the context of the breast cancer vaccine [58][61] Strategic Partnerships and Funding - Discussions with potential pharmaceutical partners for both the CAR T therapy and breast cancer vaccine are ongoing, with hopes for fruitful collaborations in the near future [68] - The U.S. Department of Defense has funded the breast cancer vaccine study, recognizing its potential to change cancer treatment landscapes [70][71] Key Milestones and Future Outlook - Upcoming milestones include comprehensive clinical data presentations at the San Antonio Breast Cancer Conference and ongoing updates on patient outcomes for the CAR T therapy [64][66] - The company is optimistic about the potential for partnerships and funding based on the promising early results from their clinical trials [68][86]
BeiGene (BGNE) Update / Briefing Transcript
2025-06-26 13:30
BeiGene (BGNE) Update / Briefing June 26, 2025 08:30 AM ET Speaker0 Hello, everyone. Welcome to b one medicine's twenty twenty five investor research and development day. My name is Liza Heaps. I'm senior director of investor relations at b one. We are very excited to host our investor event today, both in person in New York City and online for our global attendees. Thank you all very much for joining us. This is truly an exciting time at b one, and we are thrilled to walk you through recent progress to dat ...
BeiGene (BGNE) Earnings Call Presentation
2025-06-26 12:16
BeOne's Innovative Pipeline Progress Investor R&D Day JUNE 26, 2025 Forward-looking Statements Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, constitute forward looking statements. Examples of such forward-looking statements include statements regarding the projected size of the oncology market and related sectors; BeOne's research, discovery, pre-clinical and early-stage clinica ...
Cellectar Biosciences and U.S.-based Nusano Enter Into Multi-Isotope Supply Agreement
Globenewswire· 2025-06-26 12:05
Core Insights - Cellectar Biosciences has signed a multi-year supply agreement with Nusano for iodine-125 and actinium-225, essential for its clinical studies and future commercial needs [1][2] - This partnership is crucial for advancing Cellectar's targeted radiotherapy programs, including CLR-125 for triple-negative breast cancer and CLR-225 for pancreatic cancer [2][5] - Nusano's next-generation production facility in Utah will produce these isotopes, addressing supply chain challenges and enabling innovation in cancer treatment [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4] - The company's product pipeline includes iopofosine I-131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [5][6] - Cellectar has received multiple designations from the FDA for its products, including Breakthrough Therapy Designation and Orphan Drug Designation [6] Industry Context - Nusano aims to stabilize the supply of medical radioisotopes, which are critically undersupplied in the market, and to support innovation across multiple industries [3] - The partnership between Cellectar and Nusano highlights the growing importance of reliable access to high-quality radioisotopes for advancing cancer therapies [2][3]
Positive Preliminary Cohort B Results from the AGITG-led ASCEND Trial to be Presented at ESMO GI Evaluating Lisata’s Certepetide in Combination with Standard-of-Care Chemotherapy in Metastatic Pancreatic Cancer
Globenewswire· 2025-06-26 12:00
ASCEND comprises two dosing regimens of certepetide evaluated in two separate study arms enrolled sequentially Positive signal in progression-free survival and objective response rate observed in certepetide-treated group compared to placebo-treated group Cohort B data corroborate Cohort A data indicating certepetide has a treatment effect and an attractive safety profile Full study data from both cohorts expected later this year BARCELONA, Spain, June 26, 2025 (GLOBE NEWSWIRE) -- The Australasian Gastro-In ...
Provectus Biopharmaceuticals Announces Publication of Moffitt Cancer Center Research on PV-10 for Head and Neck Cancer
Globenewswire· 2025-06-26 12:00
KNOXVILLE, Tenn., June 26, 2025 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced the publication of preclinical research by Christine Chung, MD and her team (the “Chung Lab”) at Moffitt Cancer Center in Tampa, Florida (“Moffitt”), evaluating intratumoral PV-10 in models of head and neck squamous cell carcinoma (“HNSCC”). The study, published in Molecular Cancer Therapeutics, highlights novel mechanistic findings that could support future cli ...