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ASP Isotopes and Isotopia Announce Supply Agreement for Gadolinium-160 to Accelerate Terbium-161 Production for Advanced Cancer Therapies
Prnewswire· 2025-06-02 13:00
PETACH TIKVA, Israel, June 2, 2025 /PRNewswire/ -- ASP Isotopes Inc. (NASDAQ: ASPI) and Isotopia Molecular Imaging Ltd. have entered into a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), a critical precursor isotope for producing Terbium-161 (Tb-161), an emerging medical isotope with significant potential in targeted radiotherapeutics. This partnership addresses longstanding supply challenges for Gd-160, enabling Isotopia to advance Tb-161-based therapies for prostate cancer, neuroend ...
BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPV-Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) at the 1.8 mg/kg Q2W dosing regimen
GlobeNewswire News Room· 2025-06-02 12:00
45% overall response rate (ORR) and a 100% disease control rate (DCR) in HPV+ OPSCC patients treated with a median of 3 prior lines of therapy Marked unmet need exists in 2L+ HPV+ OPSCC patients; standard of care agents (methotrexate, docetaxel, or cetuximab) report an ORR of 3.4% Plan to finalize Phase 3 trial design in 2L+ HPV+ OPSCC with the U.S. Food and Drug Administration (FDA) SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB) (the “Company”), a global clinical-stage biotechno ...
Bio-Path (BPTH) Update / Briefing Transcript
2025-05-29 13:30
Bio-Path Holdings Conference Call Summary Company Overview - **Company**: Bio-Path Holdings (BPTH) - **Industry**: Biotechnology, focusing on DNA-powered medicine and therapeutics for oncology and obesity Key Points and Arguments 1. **Company Mission and Technology**: Bio-Path aims to usher in a new era of DNA-powered medicine, focusing on developing drug products from their platform technology and licensing them for commercialization [4][5] 2. **Investment Opportunity**: The company presents a strong investment opportunity due to the potential for high returns from licensing drug candidates, which can occur earlier than waiting for drug approvals [5] 3. **Pipeline Highlights**: - **Solid Tumor Treatment**: Potential for rapid clinical development [6] - **Relapsed AML Treatment**: Targeting patients with survival expectations of less than three months, with potential for Fast Track approval [6] - **Type 2 Diabetes and Obesity Treatment**: High return potential [6] 4. **DNAbilize Technology**: A patented method for producing antisense DNA therapeutics that overcomes traditional delivery challenges, allowing for high payload delivery without toxicity [7][8][9] 5. **Intellectual Property**: The company holds a robust patent portfolio with seven issued patents in the US and 61 in foreign jurisdictions, protecting their technology across 26 countries [10] 6. **Clinical Trials**: - **Prexigebersen**: Advancing in a Phase 2 trial for AML, with promising results from patients demonstrating treatment durability [11][12][13] - **BP1002**: Targeting Bcl-2 protein in refractory relapsed AML patients, with a focus on overcoming resistance mechanisms [14][15] - **BP1003**: Targeting STAT3 protein, with plans for an IND application to the FDA [19][20] - **BP1001 A**: A treatment for obesity and related metabolic diseases, with preclinical models showing promise in enhancing insulin sensitivity [21][22] 7. **Patient Outcomes**: Positive responses reported in clinical trials, including a patient with a 15% reduction in tumor size after treatment with BP1001 A [23][24] 8. **Market Resilience**: Despite recent market turbulence, the biotech sector remains innovative and presents growth opportunities [25] Additional Important Content - **Regulatory Pathway**: The company is preparing to file IND applications for BP1001 A in 2025 to initiate Phase 1 clinical trials [22] - **Patient Population**: The focus on vulnerable patient populations, particularly those with limited treatment options, highlights the company's commitment to addressing unmet medical needs [18][24] - **Future Outlook**: Bio-Path is well-positioned for continued success with a promising pipeline and expected meaningful news flow throughout the year [25]
Alzamend Neuro Announces Dosing of First Patient in its Phase II Clinical Trial of AL001 “Lithium in Brain” Study Taking Place at Massachusetts General Hospital
Globenewswire· 2025-05-29 12:00
Core Viewpoint - Alzamend Neuro, Inc. has initiated its first Phase II clinical study of AL001, a novel lithium-delivery system aimed at treating Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, with the first patient dosed in the trial [1][4]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6]. - The company's pipeline includes two therapeutic candidates: AL001, which utilizes patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine targeting Alzheimer's [6]. Product Details - AL001 is designed to enhance lithium delivery to the brain while minimizing systemic side effects and the need for therapeutic drug monitoring (TDM) [3][5]. - Previous studies indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, potentially leading to safer treatment options [2][5]. - The formulation aims to reduce the risks associated with traditional lithium therapies, such as kidney and thyroid side effects, by favorably distributing lithium in the brain [3][5]. Clinical Study Insights - The Phase II study will assess AL001's effectiveness in healthy subjects, serving as a baseline for future studies in patients with Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [2][4]. - Topline data from the study is expected to be announced before the end of 2025 [4][9]. - Head-to-head studies comparing AL001 with marketed lithium carbonate products will be conducted to evaluate pharmacokinetics in healthy subjects [9].
Werewolf Therapeutics to Participate in the Upcoming Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
WATERTOWN, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today announced that Daniel J. Hicklin, Ph.D., President and Chief Executive Officer and Randi Isaacs, M.D., Chief Medical Officer, both of Werewolf Therapeutics, will participate in a fireside chat at ...
Spyre Therapeutics to Participate in Upcoming June Investor Conferences
Prnewswire· 2025-05-28 12:30
Live audio webcasts and replays of these events will be available on the Spyre investor events website at https://ir.spyre.com/events-and-presentations. WALTHAM, Mass., May 28, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company advancing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations for the treatment of Inflammatory Bowel Disease ("IBD") and other immune-mediated diseases, today announ ...
Wave Life Sciences Announces Appointment of Dr. Christopher Wright as Chief Medical Officer
Globenewswire· 2025-05-28 12:00
Dr. Wright brings deep experience across a wide breadth of therapeutic areas and modalities and will guide clinical development of Wave's robust RNA medicines pipeline CAMBRIDGE, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced the appointment of Christopher Wright, MD, PhD, as Chief Medical Officer. Dr. Wright will join Wave's executive te ...
TransCode Therapeutics Appoints Dr. Phillip D. Zamore to Science Advisory Board
Prnewswire· 2025-05-28 12:00
"We are honored to welcome Dr. Zamore to our Science Advisory Board," said Dr. Zdravka Medarova, Chief Scientific Officer and co-founder of TransCode Therapeutics. "His deep expertise in RNA biology and his track record of translating scientific discoveries into therapeutic innovations will be invaluable as we advance our pipeline of RNA-targeted cancer therapies." RNA pioneer and biotechnology innovator joins TransCode Therapeutics Science Advisory Board to advance RNA oncology Dr. Zamore co-founded Alnyla ...
Entrada Therapeutics Receives Authorization in the European Union to Initiate ELEVATE-45-201, a Phase 1/2 Multiple Ascending Dose Clinical Study of ENTR-601-45 in Patients Living with Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping
GlobeNewswire· 2025-05-28 11:00
About ENTR-601-45 ENTR-601-45, a proprietary Endosomal Escape Vehicle (EEV™)-conjugated phosphorodiamidate morpholino oligomer (PMO), is the second product candidate within Entrada's Duchenne muscular dystrophy franchise from its growing pipeline of EEV-therapeutics. Each EEV-PMO therapeutic candidate has an oligonucleotide sequence designed and optimized for the specific subpopulation of interest. ENTR-601-45 is designed to address the underlying cause of Duchenne due to mutated or missing exons in the DMD ...
InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum
Globenewswire· 2025-05-28 05:30
JENA, Germany, May 28, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. This recommendation was based on data analysis of the first 30 patients enrolled in the study, wi ...