Clinical Trials Arena’s Post

From the clinical data of Mersana Therapeutics' two anti-NaPi2b ADCs (XMT-1536, XMT-1592), we can learn that 'linker stability' can sometimes be more detrimental than beneficial, depending on the target. https://lnkd.in/gMbVi_H5

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today issued a news release highlighting the August 16, 2024 publication of a peer-reviewed manuscript in the Journal of Cardiac Failure describing the "continuing need for a better VKA than warfarin for LVAD patients" that was written by leading LVAD physicians and researchers.   Here is an excerpt from the Journal article referencing tecarfarin:   "To mitigate thrombin generation, maintaining a stable state of thrombin suppression through optimal VKA management (targeted TTR) is crucial. Alternatives like tecarfarin, a novel VKA metabolized by carboxyl esterase rather than the cytochrome P450 system, may offer more stable anticoagulation. In a Phase II study with 66 patients with atrial fibrillation switched from warfarin to tecarfarin, the mean interpolated time in therapeutic range was 71.4% within three weeks, with minimal time spent in extreme INR ranges (<1.5 and >4.0). The FDA has provided an orphan drug indication pathway for study of this agent and a pivotal trial is currently being designed."   We are pleased that these heart failure experts are recognizing that tecarfarin may have the potential to offer more stable and effective anticoagulation and be superior to warfarin. Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is eager to move forward with our planned tecarfarin clinical trial in LVAD patients.   PR Link –https://lnkd.in/g4Qqiv_4  

As early investors in Dyne Therapeutics, we are pleased to share they reported positive updates in their next-generation exon skipping program for Duchenne amenable to skipping exon 51. In their phase 1/2 Trial, Dyne-251 at dose of 10 mg/kg given once a month showed an average 3.2% normal dystrophin expression (7.6% normal dystrophin when adjusted for muscle content) at 6 months. Trends in functional improvements like the NSAA and other tests were observed, but non reached statistical significance at this time. Dyne-251 has fully enrolled cohorts for 20 and 40 mg/kg dosing and is reporting favorable safety profiles, while dystrophin and functional read outs for these higher doses will be coming in the future.    Dyne also reported positive safety, biomarker, functional, and patient reported outcome data in Type 1 Myotonic Dystrophy program (DM1), and anticipates providing updates by the end of the year on their plans for pursuing expedited FDA approvals in both DM1 and Duchenne. #FDA #DMD #DUCHENNE #CUREDUCHENNE #CLINICALTRIALS

Big news in lung cancer treatment! 🎉 Bristol Myers Squibb's Krazati has shown promising results in the Phase III KRYSTAL-12 study. This innovative drug is designed for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbors the KRAS G12C mutation. 🧬The study revealed that Krazati significantly improves progression-free survival (PFS) compared to standard-of-care chemotherapy, specifically in the second-line setting or later. It also demonstrated a better overall response rate, with a safety profile consistent with previous trials. 📊Krazati, originally developed by Mirati, is a game-changer as it locks the mutant KRAS G12C protein in its inactive state, blocking its downstream signaling without affecting healthy cells. 🛡️This advancement is particularly crucial for patients who have undergone at least one prior line of systemic therapy. With Krazati's FDA approval in December 2022 and the positive results from KRYSTAL-12, BMS is now ahead of the game in the KRAS inhibitor space, especially after Amgen's recent setback with Lumakras. 🚀Stay tuned for more updates as BMS plans to share the full analysis at an upcoming medical congress and submit the data to health authorities. #Oncology #LungCancer #Krazati #KRASG12C #NSCLC #BristolMyersSquibb #CancerResearch #ClinicalTrials #PharmaNews #MedicalInnovation"

Nintedanib: A Novel Therapeutic Approach for Idiopathic Pulmonary Fibrosis. Recent studies has shown that Nintedanib has significant efficacy in the treatment of NSCLC (Non-small cell Lung Cancer), Ovarian cancer and IPF (Idiopathic Pulmonary Fibrosis). At Pharmaffiliates, we believe that every new drug molecule is a step towards a healthier world. Together, we can make a difference. Fast-track your research with our trusted & high quality Nintedanib reference standards, pharmaceutical impurities and related compounds. 𝐓𝐨 𝐯𝐢𝐞𝐰 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐥𝐢𝐬𝐭 𝐨𝐟 𝐍𝐢𝐧𝐭𝐞𝐝𝐚𝐧𝐢𝐛 𝐢𝐦𝐩𝐮𝐫𝐢𝐭𝐢𝐞𝐬, 𝐀𝐏𝐈 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 & 𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐜𝐨𝐦𝐩𝐨𝐮𝐧𝐝𝐬 - https://lnkd.in/gBXDmqQR #research #ReferenceStandards #Pharmaffiliates #AnalyticalChemistry #DrugDiscovery #drugresearch #Impurities #contractresearch #cro #cdmo #stableisotopes #intermediates #pharmaceutical #research #researchanddevelopment #analyticalchemistry #drugdevelopment #qualitycontrol #qc #drugdiscovery #pharmacokinetic #CMC #impurityqualification #Pharmacodynamics #drugmanufacturing #healthcareinnovation #pharmamanufacturing #api #activepharmaceuticalingredient #Nintedanib

Nirogacestsat: A Discarded Alzheimer’s Drug Becomes the First Approved Gamma-Secretase Inhibitor | https://lnkd.in/gyS4XkrH -2023 Molecule of the Year Nominee (#6/10)- Gamma-secretase is most well-known as a target for Alzheimer’s disease, though such programs have not been successful to date. Nirogacestat is a gamma-secretase inhibitor that Pfizer originally intended to treat Alzheimer’s disease, but has found new life at Pfizer spinout SpringWorks Therapeutics as a treatment as a first-in-class drug for rare and aggressive desmoid tumors (DTs). The molecule was first highlighted as a 2023 Molecule of the Month when it received FDA priority review based on Ph. III data that indicated a reduction in disease progression by 71% in desmoid tumors. In Nov. 2023, nirogacestat received the first FDA approval for a treatment for desmoid tumors after receiving Fast Track, Breakthrough Therapy and Orphan Drug designations, highlighting the importance and urgency for a therapeutic for this particular indication. Continue to the full article to learn how it was discovered, how gamma-secretase inhibition translates to anti-tumor activity, how various confusing assay disconnects were encountered in its discovery and development, and more. Not at one of the 150+ institutions with full Drug Hunter access? Learn how Drug Hunter helps you solve your greatest R&D challenges and request access here: https://lnkd.in/gjZdCZUc

The GW Technology Commercialization Office is delighted to share that The George Washington University Hospital along with UC Irvine and Northwell Health provided Hoth Therapeutics, Inc written approval for First-in-Human (FIH) Phase 2a clinical trial of Topical HT-001 gel. HT-001 is a proprietary gel formulation for topical application developed by Hoth Therapeutics, a patient-focused, clinical-stage biopharmaceutical company. The Phase 2a study will investigate efficacy, safety, and tolerability of application of HT-001 gel, while also focusing on the therapeutic effect of HT-001 in adult subjects and patients for treatment of cutaneous toxicity (skin, scalp, nails) associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI) cancer therapy. Read more: https://lnkd.in/dhj7mYW4 The HT-001 gel is a significant leap towards treating skin disorders induced by EGFRI therapy and has potential to improve patient care. We look forward to the outcomes of the trials and positive impact the gel could have on patients’ lives. #GW #GWTCO #GWHospital #SkinDisorder #CancerTherapy #Healthcare #ClinicalTrails #Pharmaceutical 

🗞️ Last week’s Pharma industry news in Germany and Switzerland 🗞️ Oculis Holding AG presents positive Phase 3 OPTIMIZE-1 trial results for OCS-01 at ASCRS. BioNTech SE presents promising three-year follow-up data for autogene cevumeran. Novartis announces results from the V-INITIATE trial, showing Leqvio significantly reduced LDL-C in ASCVD patients. ADC Therapeutics completes dose escalation in Phase 1b LOTIS-7 trial. Medigene AG secures European patent for its inducible Medigene T cell receptor (iM-TCR) technology. Basilea Pharmaceutica's ZEVTERA® (ceftobiprole medocaril) gains FDA approval for Staphylococcus aureus bloodstream infections, bacterial skin infections, and community-acquired pneumonia in adults and children. Addex Therapeutics and Perceptive Advisors establish Neurosterix, focusing on developing allosteric modulators for neurological disorders. #pharmaceuticalindustry #pharma #Monday_Pharma_News

𝐋𝐢𝐧𝐯𝐨𝐬𝐞𝐥𝐭𝐚𝐦𝐚𝐛 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐬: 𝐄𝐌𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐌𝐲𝐞𝐥𝐨𝐦𝐚 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Regeneron Pharmaceuticals Regeneron ph announces EMA acceptance for linvoseltamab's review to treat relapsed/refractory multiple myeloma. This investigational bispecific antibody aims to activate T cells and enhance cancer-cell killing. Key Points: EMA accepts Marketing Authorization Application for linvoseltamab. Targeting adult patients with relapsed/refractory multiple myeloma after three prior therapies. Supported by Phase 1/2 pivotal trial data (LINKER-MM1) shared in December 2023. FDA Biologics License Application (BLA) also submitted in December 2023. Multiple Myeloma Stats: Second most common blood cancer, with over 176,000 new cases globally each year. Linvoseltamab addresses disease progression in patients who have exhausted other therapies. Clinical Development Program: Phase 3 confirmatory trial (LINKER-MM3) is enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway. #Linvoseltamab #MultipleMyeloma #MedicalInnovation #EMAApproval #CancerResearch #HealthcareAdvancements #ClinicalTrials #Hematology

2024.7.20-2024.7.26 Global Drug Development Progress Weekly Summary: Global Approvals 1. Sun Pharmaceutical's Deuterated Ruxolitinib was approved by the #FDA for the treatment of #severe alopecia areata in adults; 2. CStone Pharmaceuticals' Sugemalimab was approved by the EMA for the treatment of adult patients with metastatic non-small cell lung cancer (#NSCLC) without EGFR sensitive mutations, or ALK, ROS1, RET genomic tumor mutations; 3. AbbVie's Risankizumab was approved by the EMA for expanded indications for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have insufficient response, loss of response, or intolerance to conventional therapies or biologics; 4. Samsung Bioepis' Eculizumab biosimilar (#Samsung Bioepis) was approved by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).