Olatec Therapeutics’ Post

The exciting news about Kyverna Therapeutics and its treatment for Stiff Person Syndrome continues. The FDA giving KYV-101 RMAT designation, which is a major step forward. Check out this latest article by Melissa Rudy on Fox News Media

We are pleased to announce that FDA has granted clearance of an IND amendment to evaluate ADI-001 in two additional indications, Idiopathic Inflammatory Myopathy (IIM) and Stiff Person Syndrome (SPS)!   This acceptance builds on our recent momentum, expanding our efforts to six #autoimmune indications as we aim to bring our differentiated gamma delta T cell therapy candidates to more patients in need of new treatment options.    In addition to IIM and SPS, ADI-001 is also being studied in systemic #lupus erythematosus (#SLE), lupus nephritis (LN), systemic #sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated #vasculitis (AAV). With its safety profile, robust tissue trafficking and complete B cell depletion in peripheral blood and secondary lymphoid tissue (characteristics important in autoimmune treatment), ADI-001 is uniquely differentiated with the goal to bring durable remissions and provide an immune reset for various autoimmune conditions. We are inspired by the idea of bringing to #patients a potential paradigm shift in the treatment of autoimmune diseases. To learn more about participating in this #clinicaltrial, email clinicaltrials@adicetbio.com.   We also have updated biomarker data being presented in an oral session at #ACRConvergence2024 next month – be sure to tune into that, November 19! #CART #celltherapy #gammadelta #clinicaltrials #autoimmune #autoimmuneclinicaltrials #biotech #biotechinvesting #biotechresearch #allogeneic #offtheshelf

A new #bloodtest for the early detection of #AlzheimersDisease — potentially even before symptoms are present — show that the #diagnostic exhibited high performance metrics, with sensitivity ranging from 99 to 100% and specificity from 95 to 100% across 265 samples. The test from AltPep is called the Soluble Oligomer Binding Assay (SOBA‑AD) and builds on earlier successful results with the assay when it was granted FDA breakthrough device designation two years ago. #AltPep is aiming to test more samples, particularly those with greater racial and ethnic #diversity in the patients. In addition, AltPep is developing a treatment for #Alzheimers and #parkinsonsdisease. #biomarker

Data on LEVEL UP, a Phase 3b/4 head-to-head study comparing upadacitinib to dupilumab for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis, has just been released. Very happy that our clinical trial center CAC - Centro Hospitalar Universitário de Santo António / ICBAS- Instituto de Ciências Biomédicas Abel Salazar contributed to this trial. Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 16 [(19.9% vs 8.9% for upadacitinib and dupilumab respectively, p<0.0001)], with a safety profile consistent with the profile in previous atopic dermatitis studies with no new safety signals identified. All information: https://lnkd.in/dQ_apGqB #atopicdermatitis #LEVELUP #upadacitinib #clinicaltrials

Results from an induction trial and maintenance trial show #Skyrizi (risankizumab) improved endoscopic and histological secondary outcomes characterized by endoscopic improvement, remission, and histological, endoscopic, and mucosal improvements in patients with moderately to severely active #ulcerativecolitis

Ophthopedia Update:Cardiovascular and cerebrovascular adverse events associated with intravitreal anti-vascular endothelial growth factor monoclonal antibodies: a World Health Organization pharmacovigilance study: To analyze cardiovascular and cerebrovascular adverse events (ADRs) after intravitreal anti-vascular endothelial growth factor (VEGF; aflibercept, bevacizumab, brolucizumab, and ranibizumab) treatment. #Ophthalmology #ophthotwitter #eyecare

Scientific prowess is a key factor in developing radical or incremental innovation. We see this on the Science Biotech team. The publication below shows how a simple and yet powerful clinical trial result form the foundation of a project with relevant market potential. A New England Journal of Medicine publication is a coveted start point when it comes to science. If you are wondering about the market potential, the result of this innovative project has already been licensed to a Brazilian partner with upfront payments, major clinical trials sponsorship, and future royalties. Leandro Agati and Eduardo Ramacciotti are cooking many other projects up (incremental and radical innovation) ranging from fertility, women’s health, vaccines, bowel inflammatory diseases, male contraceptives, antidepressants, rhinitis, and cardiovascular diseases. If you are a pharmaceutical company looking to in-license assets to increase your pipeline strength, you should talk to them. They are a part of the Brazil's BEST program that features inovative biotech companies in Brazil with global potential. Dont hesitate to reach out. https://lnkd.in/dHfysR5n

In assigning magnitudes of clinical benefit, the ESMO guidelines consider the OS contributions of the experimental drug and HR values. For cancers with a survival expectancy of less than 12 months, the magnitude of clinical benefit of the experimental drug is highest if both the survival contribution is ≥3 months and the lowest HR boundary is ≤0.65 or its 2-year absolute survival contribution is ≥10%

Lowering the production of apoC-III has been found to decrease fasting triglyceride levels in individuals who lack lipoprotein lipase activity. Read the Viewpoint, published in Med by Cell Press, on the recent phase 3 BALANCE clinical trial examining the impact of olezarsen, a novel antisense oligonucleotide that hinders the expression of apoC-III mRNA, on triglyceride levels and the risk of acute pancreatitis. https://lnkd.in/eyCqA9XF #lipidresearch #triglycerides #pancreatitisprevention #clinicaltrial #BALANCE

𝐕𝐢𝐫𝐢𝐝𝐢𝐚𝐧'𝐬 𝐕𝐞𝐥𝐢𝐠𝐫𝐨𝐭𝐮𝐠 𝐒𝐡𝐨𝐰𝐬 𝐏𝐫𝐨𝐦𝐢𝐬𝐢𝐧𝐠 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐓𝐡𝐲𝐫𝐨𝐢𝐝 𝐄𝐲𝐞 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 Viridian Viridian Therapeutics, Inc. has announced positive topline results from the THRIVE Phase 3 trial of VRDN-001 (veligrotug), an anti-IGF-1R antibody for active thyroid eye disease (TED). TED is an autoimmune condition causing inflammation and damage around the eyes. 🌟 Key Highlights: Topline Results: Veligrotug met primary and secondary endpoints, showing statistically significant improvements (p < 0.0001) in TED symptoms. Rapid Response: 53% of patients achieved a proptosis response after just 1 infusion. Proptosis Reduction: 2.9 mm mean reduction with veligrotug vs. 0.5 mm with placebo (p < 0.0001). Diplopia Improvement: 54% had complete resolution of diplopia vs. 12% with placebo (p < 0.0001). CAS Score: 64% achieved a CAS score of 0 or 1 vs. 18% with placebo (p < 0.0001). ✅ Safety Profile: Veligrotug was well-tolerated with a low rate of serious adverse events. Hearing impairment was observed in 16% of patients (5.5% placebo-adjusted). Viridian is also excited about its subcutaneously administered VRDN-003 and upcoming REVEAL trials. The promising THRIVE results reinforce confidence in the TED treatment landscape. 🔬 Next Steps: Continue monitoring veligrotug’s impact and progress in the TED treatment journey. #ViridianTherapeutics #Veligrotug #ThyroidEyeDisease #ClinicalTrials #Biotech #PharmaInnovation #TED #IGF1R #DrugDevelopment #Healthcare