Mantell Associates’ Post

🗞️ 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

Redx Pharma PLC (AIM:REDX) said it has kicked off a phase I clinical trial for RXC008, a 'first-in-class' ROCK inhibitor treatment targeting fibrostenotic Crohn's disease. This study aims to assess the safety and pharmacokinetic profile of the drug - in other words, its activity in the body over some time, including the processes by which RXC008 is absorbed, distributed in the body, localised in the tissues, and excreted. It will be assessed in healthy volunteers with the results from the study expected by the end of this year. Chief executive Lisa Anson told investors: "We are delighted to confirm that the first participant has been dosed in the RXC008 phase I clinical study. "RXC008 is a potential first-in-class treatment for patients with fibrostenotic Crohn's disease, a debilitating condition where successive surgeries are the only treatment option available today. More at #Proactive #ProactiveInvestors #AIM #REDX #Crohnsdisease #treatment http://ow.ly/SBp8105k03L

AFM24 Plus Atezolizumab Gets FDA Fast Track for EGFR NSCLC https://lnkd.in/gCcNyPMg #Affimed #immunooncology #NSCLC #investigational #growth #EGFR #atezolizumab #FDA #development #EGFR THE CORPORATE MAGAZINE

Today, we announced that the U.S. Food and Drug Administration has cleared our Investigational New Drug (IND) application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T cell engaging bispecific antibody. The IND supports the initiation of a Phase 1 dose escalation and expansion #clinicaltrial of CTIM-76 in patients with CLDN6-positive #gynecologic and #testicular #cancers. Context anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial in mid-2024. https://lnkd.in/g9FkTBNP

The landscape of NSCLC treatment is evolving rapidly, and personalized medicine is at the forefront. Our latest blog post dives into a massive dataset of 80,000+ ALK, 35,000+ ROS1, 11,000+ EGFR, and more FISH results, shedding light on the prevalence of key mutations and the potential for more precise treatment plans. For pharmaceutical companies seeking to target clinicians and patients effectively, this data is a game-changer. Learn how these insights can revolutionize NSCLC care: https://bit.ly/3SkGEGT #NSCLC #PersonalizedMedicine #RealWorldData #PrognosHealth

Phase 3 EVOKE-01 Study in Metastatic NSCLC Falls Short of Primary Endpoint: Researchers from Gilead remain confident for positive results as they continue the phase 3 EVOKE-03 study in 1L metastatic PD-L1-high NSCLC. #finance #pharmacy #lifesciences

GZ17-6.02 Effective in Killing Multiple Myeloma Cells, Other Benefits When Combined With Bortezomib: The combination of GZ17-6.02 and bortezomib reduced of HDAC, and as a result ATG13 phosphorylation was enhanced, BAK levels increased, and BCL-XL levels were reduced. #finance #pharmacy #lifesciences

In one of the most highly anticipated clinical trial readouts this year, an RNA silencing treatment developed by Alnylam Pharmaceuticals reduced the risk of death, heart-related hospital visits and hospitalizations by 28% compared to placebo in patients with a heart muscle disease. The results, announced Monday, pave the way for Alnylam’s therapy vutrisiran to become the first RNA silencing therapy on the market for ATTR amyloidosis with cardiomyopathy, a condition in which misfolded proteins build up in the heart and can result in heart failure. If approved, Alnylam could enter a multibillion-dollar market currently dominated by Pfizer. https://lnkd.in/dVGzZDYS

Impact of Emerging Therapies on Outcomes for EGFR-Mutated NSCLC: Alan Chin, PharmD, BCOP, examines the PALOMA-3 trial's influence on the treatment of EGFR-mutated metastatic NSCLC and explores the evolving role of antibody-drug conjugates (ADCs) in the therapeutic landscape of EGFR-mutated NSCLC. #finance #pharmacy #lifesciences

Sibeprenlimab’s Phase III trial results are in. This investigational therapy targets APRIL (A PRoliferation-Inducing Ligand) to reduce high quantities of protein accumulation in the kidney, a key marker of kidney damage. Discover more at https://buff.ly/3BSn6nM by Soumya Shashikumar. #KidneyDisease #ChronicKidneyDisease #ClinicalTrials #DrugDevelopment #IgANephropathy