Atossa Therapeutics Modifies Breast Cancer Trial with Increased (Z)-endoxifen Dose Atossa Therapeutics has adjusted its ongoing clinical trial by augmenting the dose of (Z)-endoxifen and blending it with Eli Lilly's abemaciclib to target ER+/HER2- breast cancer. This alteration is based on favorable results from the Phase II EVANGELINE study, demonstrating a significant reduction in the cellular proliferation marker Ki-67 and the size of tumors. The updated trial will encompass about 80 participants across two cohorts, covering both pre- and post-menopausal women. Notably, premenopausal women in the second cohort will also undergo ovarian function suppression to facilitate direct outcome comparisons. Atossa's CEO, Steven Quay, expressed enthusiasm concerning the protocol update and the backing from Eli Lilly, highlighting the positive safety profile and optimal drug concentrations achieved with the increased (Z)-endoxifen dosage. # Thank you Elena Barbosa for your submission!
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🚀 FDA Clears Ariceum’s 225Ac-Satoreotide for Phase I/II Cancer Trials! 🩺 Exciting news in the fight against cancer! The FDA has granted Ariceum Therapeutics the green light to launch Phase I/II trials for their innovative radiolabelled peptide, 225Ac-SSO110 (satoreotide). 🔍 This groundbreaking study, known as the SANTANA-225 trial, will focus on treating small cell lung cancer (SCLC) and Merkel Cell Carcinoma (MCC). It marks a significant milestone as the first human trials for Actinium-225-labelled somatostatin receptor 2 (SSTR2) antagonists. 🗓️ Set to enroll patients in Q1 2025, this trial aims to evaluate safety and preliminary efficacy in individuals undergoing first-line maintenance therapy with checkpoint inhibitors. Ariceum’s Chief Medical Officer, Germo Gericke, expressed optimism about this innovative approach: “225Ac-SSO110 offers an optimal combination of a long half-life α particle emitter and robust tumour retention. We’re hopeful about its impact on hard-to-treat cancers.” This advancement positions Ariceum at the forefront of targeted systemic radiopharmaceuticals. 👉 Click on the link to learn more about this pivotal development! #CancerResearch #ClinicalTrials #FDA #FDAApproval #InnovationInMedicine #Pharma #Radiopharmaceuticals #MarketAccess #MarketAccessToday
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📰 One of the top news stories of the day, with ASCO24 underway: 📅 Moderna's cancer vaccine, mRNA-4157, + Merck's Keytruda, showing clinical effects after three years, achieving the primary endpoint in their latest PIIb trial, being evaluated in resected, high-risk melanoma. 💪 The combo demonstrated a significant and durable improvement in recurrence-free survival and reduced the risk of recurrence or death by 49% compared to Keytruda alone. Additionally, for distant metastasis-free survival, the risk of developing distant metastasis or death was reduced by 62% compared to Keytruda alone. #Merck #Moderna #2024ASCO #Oncology #Pharma #Healthcare
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Triple Negative Breast Cancer Clinical Trials, Treatment Drugs, Pipeline Insights, and Companies 2024: DelveInsight’s, “Triple Negative Breast Cancer Pipeline Insight 2024” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Triple Negative Breast Cancer pipeline landscape. It covers the Triple Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also … Continue reading → #PharmaceuticalsBiotech
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🚨 Gilead Sciences is withdrawing its cancer drug, Trodelvy, from bladder cancer treatment after disappointing results in a key trial. The TROPiCS-04 study showed the drug didn’t improve survival rates in patients with metastatic urothelial cancer. This move affects only the bladder cancer indication; Trodelvy remains approved for other cancer treatments, including advanced breast cancer. Stay tuned for updates on Gilead’s efforts in oncology. 💊🔬 #PharmaNews #CancerResearch #DrugDevelopment #GileadSciences Read the full story here ⬇️
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BiVictriX Therapeutics plc (AIM:BVX, OTC:BVTXF) has reported positive initial results from preclinical testing of its lead solid tumour treatment, BVX002, targeting ovarian cancer. BVX002 is a bispecific antibody-drug conjugate (Bi-Cygni ADC), a targeted cancer treatment that combines two antibodies to specifically attack cancer cells while carrying a powerful drug to kill them. This approach helps focus treatment on cancer cells, reducing damage to healthy cells and lowering side effects. In a mouse model, the drug showed tumour growth reductions between 78.3% and over 100%. Shrinkage of up to 63.1% was observed at mid and high doses. The drug was administered weekly over four doses and was well tolerated even at the highest levels, with no major side effects. More at #Proactive #ProactiveInvestors http://ow.ly/frjA105I699
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The firm said it has received positive feedback from the FDA on the design of a Phase III trial of ELI-002 in KRAS-mutant pancreatic cancer.
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Oncolytic Virus Cancer Therapy Pipeline 2024: Therapies, MOA Insights, and Key Clinical Trial Updates by DelveInsight | CG Oncology, Targovax, Transgene, Istari Oncology, Targovax, Oncolytics Biotech: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Oncolytic Virus Cancer Therapy pipeline constitutes 120+ key companies continuously working towards developing 125+ Oncolytic Virus Cancer Therapy treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech
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It's hard to believe that it's been a decade since Keytruda first received approval from the FDA, given that it now treats 20 different types of cancer and is one of the highest selling drugs of all time. It is also consistently used in ongoing combination trials. Interesting article from BioPharmaDive below commenting on its successes as well its limitations in present day cancer treatment. #keytruda #biotech #biotechinvesting #oncology https://lnkd.in/epbtnPFz
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HER2-Negative Breast Cancer Pipeline Insights, Treatment Drugs, Emerging Therapies and Companies 2024: DelveInsight’s, “HER2-Negative Breast Cancer Pipeline Insight 2024” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in HER2-Negative Breast Cancer pipeline landscape. It covers the HER2-Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics … Continue reading → #PharmaceuticalsBiotech
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Important oncology news of the week: BioNTech ($BNTX) announced positive topline Phase II Results for its mRNA vaccine BNT111 in advanced melanoma - Good to have more positive cancer vaccine data but the level of improvement over Libtayo alone will remain doubtful until the data is shown. Another risk factor is the comparison to historical controls, hence Phase III will still carry some risk. https://lnkd.in/e3KqPdeH Merck & Co ($MRK) secured its 40th! indication for Keytruda (pembrolizumab) + chemotherapy following FDA approval for the treatment of advanced or recurrent endometrial carcinoma. The approval was based on results from the Phase III KEYNOTE-868 study. https://lnkd.in/eqPKksYq Adaptimmune’s ($ADAP) Tecelra (afamitresgene autoleucel) becomes the first approved TCR therapy for solid tumors. This FDA approval was pending for quite some time and is now finally available for patients with previously treated synovial sarcoma whose tumor expresses the MAGE-A4 antigen. The approval was based on a 43% ORR from the Phase II SPEARHEAD-1 trial.https://tinyurl.com/ajp72w4h
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