Orano Med’s Post

Alligator Bioscience AB announced positive top-line results from the OPTIMIZE-1 Phase II trial in pancreatic cancer, revealing that mitazalimab combined with mFOLFIRINOX achieved a 40.4% overall response rate (ORR), a median duration of response (DoR) of 12.5 months, and a median overall survival (mOS) of 14.3 months. This compares favorably to the 11.1 months mOS seen with first-line chemotherapies FOLFIRINOX and NALIFIROX. With more than half of the patients still in the study at the primary analysis, the 18-month survival follow-up data was presented at American Society of Clinical Oncology (ASCO) 2024. Get Ahead with Expert Insights and Full Analysis through DelveInsight Business Research LLP's Exclusive ASCO 2024 Coverage: https://lnkd.in/gZDPhuxR #ASCO24 #CancerTreatment #ASCO2024 #LungCancer #NSCLC #mCRPC #PharmaInnovation #MedicalResearch #OncologyAdvancements #ClinicalOncology #Pharmaceuticals #HealthcareConference #CancerResearch #ClinicalPractice #MedicalBreakthroughs #CancerCare #PharmaLeaders

Reminder to come by Plus Therapeutics at the SNMMI 2024 Annual Meeting in Toronto at Booth #1948 Learn about the latest ReSPECT-LM Clinical Trial data for Leptomeningeal Metastases and view our newest poster in the poster hall Two accepted abstracts titled: 1) "Rhenium (186Re) obisbemeda (186RNL) in leptomeningeal metastases (LM) Phase 1/2A Dose Escalation Trial: Update of Initial Safety and Feasibility through Cohorts 1-4" 2) "Radiation Absorbed Dose to Spinal Cord: Therapy of Leptomeningeal Metastasis Using Beta-Emission Radiopharmaceuticals" Posters will be available on https://lnkd.in/eQXB5zz5 after the conference. #SNMMI #BrainCancer #Glioblastoma #BreastCancer #LungCancer #Melanoma #ClinicalTrials 

Medicus Pharma, led by Dr. Raza Bokhari, has submitted an updated Phase 2 clinical protocol to the FDA for a novel treatment targeting basal cell carcinoma. The protocol leverages micro-needle arrays containing doxorubicin, developed by Skinject, Inc., a subsidiary of Medicus Pharma. The submission incorporates enhancements to Chemistry, Manufacturing, and Controls (CMC), stability, and sterility data, addressing previous FDA comments. Notably, it introduces artificial intelligence and confocal microscopy as supplementary endpoints at one clinical site, promising deeper insights into treatment outcomes. 'This updated protocol is well-positioned to receive FDA approval, allowing us to commence participant randomization potentially before the end of this quarter,' stated Dr. Bokhari. The submission underscores Medicus Pharma's commitment to advancing innovative skin cancer treatments through rigorous clinical research and cutting-edge technology. @medicuspharma #skincancer #clinicaltrials #innovation

Kazia Therapeutics Limited is pleased to announced the early conclusion of an important two-part Phase I trial based on positive safety and promising clinical response findings observed to date. This investigator-initiated trial is evaluating the use of paxalisib with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors. Kazia's CEO, John Friend, shared his enthusiasm: “We are now preparing to engage with the Food and Drug Administration to discuss the data and seek guidance on the conduct of a pivotal registration study, with the goal of rapidly progressing paxalisib’s development to potentially provide a more effective treatment option for patients with brain metastases.” Learn more in our press release update here: https://shorturl.at/zAKX0 #paxalisib #brainmetastases #DMGs #DPIG

𝐇𝐄𝐑𝐓𝐇𝐄𝐍𝐀-𝐋𝐮𝐧𝐠𝟎𝟐 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐓𝐫𝐢𝐚𝐥 𝐒𝐡𝐨𝐰𝐬 𝐒𝐢𝐠𝐧𝐢𝐟𝐢𝐜𝐚𝐧𝐭 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐢𝐧 𝐄𝐆𝐅𝐑-𝐌𝐮𝐭𝐚𝐭𝐞𝐝 𝐍𝐒𝐂𝐋𝐂 The HERTHENA-Lung02 Phase 3 trial of patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated NSCLC met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to platinum plus pemetrexed chemotherapy. Overall survival (OS) data remain immature, and the trial will continue. Patritumab deruxtecan, developed by Daiichi Sankyo and Merck, is a potential first-in-class HER3-directed ADC. HERTHENA-Lung02 included patients with EGFR-activating mutations (exon 19 deletion or L858R) who progressed after EGFR TKI therapy. The safety profile was consistent with previous studies, with no new safety signals. Results will be shared with global regulatory authorities and presented at an upcoming medical meeting. #NSCLC #Oncology #EGFRMutations #ClinicalTrials #DaiichiSankyo #Merck #PharmaInnovation

Alligator Bioscience AB announced positive top-line results from the OPTIMIZE-1 Phase II trial in pancreatic cancer, revealing that #mitazalimab combined with #mFOLFIRINOX achieved a 40.4% overall response rate (ORR), a median duration of response (DoR) of 12.5 months, and a median overall survival (mOS) of 14.3 months. This compares favorably to the 11.1 months mOS seen with first-line chemotherapies #FOLFIRINOX and #NALIFIROX. With more than half of the patients still in the study at the primary analysis, the 18-month survival follow-up data was presented at ASCO 2024. Get Ahead with Expert Insights and Full Analysis through DelveInsight Business Research LLP's Exclusive American Society of Clinical Oncology (ASCO) 2024 Coverage: https://lnkd.in/gvjRd-zM #ASCO24 #CancerTreatment #ASCO2024 #LungCancer #NSCLC #mCRPC #PharmaInnovation #MedicalResearch #OncologyAdvancements #ClinicalOncology #Pharmaceuticals #HealthcareConference #CancerResearch #ClinicalPractice #MedicalBreakthroughs #CancerCare #PharmaLeaders

Earlier this week, we shared our first-quarter results and development milestones. In our release, we recapped our successful private funding placement, the ongoing dose escalation in our ABOYA-119 clinical trial clinical trial evaluating ATRN-119 in patients with advanced solid tumors having mutations in defined DDR-related genes, and the recent FDA clearance of our IND for APR-1051, our next-generation inhibitor of WEE1 kinase. Additionally, we shared our timing to initiate the Phase 1 ACESOT-1051 trial for APR-1051. This dose escalation trial will evaluate the safety, tolerability, and preliminary efficacy of this potentially best-in-class and differentiated molecule. Enrollment of the first patient is expected in 2Q 2024 with an update expected in 4Q 2024. As our CEO, Oren Gilad, said, the first quarter of 2024 held several noteworthy achievements across our clinical, regulatory and corporate fronts. Learn more by reading our release here: https://bit.ly/3wC3rpW

We've successfully completed the full recruitment of our Phase 2 trial of SNT-5055, a pan-LOX inhibitor combined with ruxolitinib, aimed at treating the bone marrow cancer myelofibrosis. The trial, which began in December 2023 across 19 sites in the USA, Australia, South Korea, and Taiwan, has now dosed its 15th patient and exceeded the one-month treatment threshold for 12 patients required for FDA safety evaluation. No drug-related dropouts or serious adverse reactions have been observed. Interim results are expected in December 2024, coinciding with the ASH Annual Meeting, potentially paving the way for pivotal FDA discussions in early 2025. The full 12-month data set will be available in Q3 2025. CEO Gary Phillips said: “I’d like to thank the haematology clinics, investigators and the Syntara clinical team for achieving this significant milestone in such a timely fashion. We now look forward to presenting our interim data later in the year and building a solid foundation for the next stage of discussions with the FDA and potential strategic partners. Read the full ASX Announcement here: https://lnkd.in/g7d9fsqP #SNT #Syntara #ClinicalTrials #SNT5055 #Ruxolitinib #Myelofibrosis #BoneMarrowCancer #CancerResearch #FDAEvaluation #Phase2Trial #OncologyResearch #DrugDevelopment

📢 PRESS RELEASE! 📢 Adcendo are very pleased to announce that we have received US FDA IND clearance to commence a Phase I/II Trial of our uPARAP-targeting ADC, ADCE-D01, in patients with metastatic and/or unresectable soft tissue sarcoma (#STS).   The trial, named ADCElerate-01, is a first-in-human Phase I/II trial designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ADCE-D01, a first-in-class antibody-drug conjugate (#ADC). The uPARAP receptor is an endocytic receptor highly overexpressed in mesenchymal cancers including multiple STS subtypes.   This marks yet another highlight here in 2024, which has been a transformative year for the company in terms of growth and development, as we commence our transition into becoming a clinical-stage biotech company.   📰 Learn more about Adcendo and our next steps as we prepare for #clinicaltrial recruitment in the US and EU for testing ADCE-D01 as a monotherapy in patients, in the press release linked in the comments below!   #biotech #oncology #softtissuesarcoma #lifesciences   Read the full press release here: https://lnkd.in/d3ZzYxRx

The Theranojet®ARA is a shielded injection system developed by Lemer Pax for the safe and precise administration of radiopharmaceuticals in theranostic applications. It features advanced radiation protection, ease of use, and secure patient administration. Key Features: 1. Radiation Protection: The system employs lead and lead glass shielding to minimize radiation exposure to medical personnel during preparation, administration, and disposal of radiopharmaceuticals . 2. Ease of Use: With its mobile design, removable drip tray, and contamination tray, the Theranojet®ARA is easy to maneuver and clean . 3. Patient Safety: The configurable pump detects occlusions and air bubbles, preventing extravasation and ensuring safe injection . 4. Successful Implementation: Used effectively at the Beaujon AP-HP Hospital in Paris for Lutetium-177 therapies, the system significantly reduces radiation exposure for healthcare staff . Importance of Minimizing Contamination and Residuals: Injecting a therapeutic radioactive material like Lutetium-177, which has a long half-life, without contamination and minimal residuals is crucial for several reasons: 1. Safety of Medical Personnel: Reducing contamination prevents unnecessary radiation exposure to healthcare workers, which is essential for maintaining their safety and health . 2. Patient Safety: Ensuring no residuals or contamination minimizes the risk of unintended radiation doses to patients, which can lead to complications or ineffective treatment. 3. Environmental Safety: Proper handling and disposal of radioactive materials prevent environmental contamination, protecting the broader community and ecosystem. 4. Therapeutic Efficacy: Accurate dosing without residuals ensures that the patient receives the correct therapeutic dose, optimizing treatment effectiveness for conditions like metastatic neuroendocrine tumors and prostate cancer . The Theranojet®ARA’s design addresses these concerns by providing a safe, efficient, and contamination-free method for administering radiopharmaceuticals, making it a vital tool in modern nuclear medicine.