The Antibody Society’s Post

Regeneron's REGN10597 and Roche's Dual-Binding Antibody (DBA), acquired through Good Therapeutics, depart from the old dogma of IL-2 therapy. Old Dogma of IL-2: The conventional approach differentiated between 'non-alpha IL-2' and wild-type IL-2 or IL-2Rα-biased agonists. The primary reason for using 'non-alpha IL-2' was to avoid activating regulatory T cells. However, studies have shown that Treg activation is generally limited to peripheral tissues, even when using IL-2 with alpha bias. Minimizing the activation of tumor-infiltrating Tregs can mitigate side effects like vascular leak syndrome caused by systemic IL-2 exposure. Innovent Biologics's IBI363 wtIL-2 or IL-2 with alpha bias promotes IL-2 activation via the CD25 receptor. Tumor-infiltrating T cells expressing CD25 and PD-1 are crucial in killing cancer cells within the tumor microenvironment. Therefore, CD25-mediated IL-2 activation through wtIL-2 or IL-2 with alpha bias can enhance the activation of T cells in the tumor microenvironment, potentially boosting antitumor effects. Ref: https://lnkd.in/d7Jpy3cN Regeneron's Patent Insight: "CD122-directed IL-2 molecules are designed to expand NK and CD8+ T preferentially cells over Tregs, primarily in the blood and spleen, but to a much lesser extent in tumors. In contrast, wild-type IL-2 preferentially expands CD8+ T cells within the tumor but not in peripheral tissues." Patent: https://lnkd.in/dbcCBNq2 AACR23: https://lnkd.in/dxsSWxpR Roche's Dual-Binding Antibody Approach: The Dual-Binding Antibody consists of a sensor and an effector. When the sensor domain of the antibody binds to PD-1-expressing cells, it undergoes a conformational change that activates IL-2. This mechanism ensures that IL-2 is specifically activated in the tumor microenvironment, enhancing the antitumor immune response and minimizing systemic side effects. Ref: https://lnkd.in/dgRXn84F

Tirzepatide for Metabolic Dysfunction–Associated Steatohepatitis with Liver Fibrosis..#fattyliver #nash In this phase 2 trial involving participants with MASH and moderate or severe fibrosis, treatment with tirzepatide for 52 weeks was more effective than placebo with respect to resolution of MASH without worsening of fibrosis. Larger and longer trials are needed to further assess the efficacy and safety of tirzepatide for the treatment of MASH. (Funded by Eli Lilly; SYNERGY-NASH ClinicalTrials.gov number, NCT04166773.)

Olatec is at the American Heart Association Scientific Sessions 2024 #AHA24 in Chicago, sharing a scientific poster on our ongoing #Type2Diabetes (T2DM) clinical trial, DAPAN-DIA (NCT06047262). This event provides a forum for breakthroughs in #cardiometabolic science and medicine, breakthroughs that have the potential to transform therapy practices for cardiometabolic conditions, #obesity, and related comorbidities. Our research focuses on an urgent unmet need for T2DM patients at risk for cardiometabolic and other complications. In our completed study in #heartfailure, patients showed improvements in heart function (LVEF) and glycemia (fasting glucose) with dapansutrile (OLT1177®) in T2DM.  Olatec’s ongoing clinical trial in T2DM patients will provide critical data on a new, clinically relevant aspect of T2DM care.  We believe that #dapansutrile (OLT1177®) has the potential to become a new therapeutic option for T2D patient that addresses both inflammation and cardiometabolic health. Join us to view our poster, presented by Antonio Abbate, on Saturday, November 16, from 2:00–3:00 PM in the Science and Technology Hall, South Building, Level 3. For a copy of the poster, please contact us at inquiries@olatec.com. https://lnkd.in/eai-zDWU

Prothena Biosciences Inc. has posted details for a first-in-human study (NCT06699680) to assess the safety and tolerability of PRX019 in healthy adult participants. PRX019 is a potential treatment of neurodegenerative diseases with an undisclosed target. This study is currently recruiting participants. In May 2024, Prothena announced that Bristol Myers Squibb obtained the exclusive global license for PRX019. https://lnkd.in/dMa_jX5N

Exciting Breakthrough in Pressure Ulcer Treatment! 🌟 We are thrilled to share the results of the R.I.S.E. U.P. Study, a groundbreaking clinical trial evaluating the effectiveness of the EmoLED medical device in treating stage II and III pressure ulcers. This study is the first randomized clinical trial demonstrating the power of Photobiomodulation with Blue Light! ✅ The results? A 76% greater reduction in PUSH scores for patients treated with EmoLED compared to conventional therapy. ✅ 97.2% of patients treated with EmoLED showed significant wound improvement, compared to only 56.1% in the control group https://lnkd.in/gEdUdF3n

Byondis has queued a first-in-human study of BYON4413, a novel antibody-drug conjugate that binds with high affinity to CD123. BYON4413 comprises a humanized IgG1 antibody directed at CD123 that is site-specifically conjugated to Byondis' proprietary duocarmazine linker-drug (LD) technology, ByonZine® and ByonShieLD®. This LD, when cleaved upon internalization and lysosomal routing, releases a potent duocarmycin payload that alkylates DNA, generating damage that results in replication stress and cell death. Due to start in May 2024, the study will enroll an estimated 100 participants. https://lnkd.in/eqggdgus

Heartbeats Highlights: *A DUE trial* Fixed-Dose Macitentan/Tadalafil Combo Gets FDA Approval for PAH FDA approved macitentan/tadalafil (Opsynvi) today (03/25/2024) as the first single-tablet combination therapy targeting multiple pathways for pulmonary arterial hypertension (PAH). A study of 187 people in WHO functional class II or III that showed that dual macitentan/tadalafil reduced pulmonary vascular resistance nearly 30% more than macitentan and tadalafil monotherapy by week 16. #Cardiovascular #interventionalCardiology #cardiacImaging #heartfailure

Looking forward to traveling to NYC together with Jonas Zeller for the annual Parkinson's Disease Therapeutics Conference 2024, organised by The Michael J. Fox Foundation for Parkinson's Research. #PDTC2024 We'll be able to exchange with an excellent audience on the many challenges in drug development for this condition and how we approached it with Talineuren (liposomal GM1 ganglioside) in an entirely new way. Lipids - as we put them to use in medicine - are largely unexplored by pharma in terms of therapeutics. Especially when it comes to the human #brain and #CNS, this is particularly nutty, as lipids make up approximately 70% of the dry weight of brains. So, what are the chances that lipids harbor great therapeutic potential in treating chronically degenerative conditions that are rather triggered by aging (metabolism!) instead of something else? Happy to share our latest clinical data from 22 patients treated during the phase 1/2a NEON study ( https://lnkd.in/gbs3wse2 ) See you there! 🤓

🌐 Latest Alzheimer's Disease Drug Development in Clinical Trials 🌐 The 2024 Alzheimer's Disease Drug Development Pipeline report highlights significant progress and challenges in the field. Authored by Dr. Jeffrey Cummings and published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, the report notes 164 active trials and 127 unique treatments. Bases on this review paper, it shows key findings include:76% of the treatments are disease-modifying, aiming to slow memory decline. 34% are biological therapies administered intravenously.12% are cognitive enhancers.13% target behavioral symptoms like agitation.31% are repurposed drugs initially developed for other diseases. For a detailed read, you can access the full report here or learn more from the following link. https://lnkd.in/g9KESpYN In addition, I have highlighted the current ongoing studies that are recruiting subjects. Over 20 trials are actively running and enrolling subjects. https://lnkd.in/gWSPq8JH #ClinicalTrials #CRO #Alzheimer #CNRRrsearch #씨엔알리서치 #임상시험 #알츠하이머

Key End Points in Clinical Trials: Panelists discuss how clinical trials in multiple myeloma can be improved to better reflect real-world scenarios and patient outcomes, emphasizing the importance of end points such as progression-free survival, overall survival, and quality of life measures, while also considering ways to increase trial inclusivity and applicability to diverse patient populations. #finance #pharmacy #lifesciences