Ming-Hei Tai, PharmD, BCOP’s Post

Refreshing break from the herd mentality… JPM2024: The advantage of using RLT for both diagnostic(imaging)and treatment sets it apart form ADCs and Novartis is showing the way in adopting a new asset - would be interesting to see if rest of Big Pharma players would follow through

#Clinicalfindings 1. Sanofi and Regeneron: #Dupilumab, a monoclonal antibody targeting interleukin-4 and interleukin-13, was tested in a phase 3 trial for children with eosinophilic esophagitis unresponsive to proton-pump inhibitors. The trial found that dupilumab led to histologic remission in significantly more patients than placebo, with the higher-exposure regimen showing notable improvements in histologic, endoscopic, and transcriptomic measures. https://lnkd.in/gKWhrdEf 2. GSK and Novartis: After nearly 10 years of follow-up, adjuvant therapy with #dabrafenib plus trametinib showed better relapse-free and distant metastasis-free survival than placebo in patients with resected #stageIII melanoma with BRAF V600 mutations. Although overall survival favoured the combination therapy, the benefit was not statistically significant, but among patients with BRAF V600E mutations, the risk of death was reduced by 25%. https://lnkd.in/gQ5W3_yM 3. ViiV Healthcare: The study found that switching to #dolutegravir plus #rilpivirine maintained virological suppression in most participants with Lys103Asn mutations at week 48, comparable to those who continued their current antiretroviral therapy. While more adverse events were recorded in the #dolutegravir plus rilpivirine group, the overall frequency of serious adverse events was similar between groups, supporting further investigation in a larger trial. https://lnkd.in/gThwSuax

Retinal neovascular diseases including neovascular age-related macular degeneration (AMD), diabetic macular edema and retinal vein occlusion are the most vision-threatening diseases among the developed world working-age population. Abzyme Therapeutics LLC and its collaborators, Drs. Yoonjee Park of The University of Cincinnati and Barb Rohrer of The Medical University of South Carolina, have been awarded a $1,657,994 Small Business Innovation Research (SBIR) Phase II Grant by the National Eye Institute (NIAID). This project entitled “Multi-specific long-acting antibodies for the treatment of retinal neovascular diseases” is aimed at developing a potent and long-acting camelid-derived multi-specific antibody targeting both VEGF and extracellular MMP inducer (Emmperin/Basigin/CD147) to prevent choroidal neovascularization. #maculardegeneration #abzyme #VEGF #retinaldisease Read more here: https://hubs.ly/Q02nqBnx0

Antibody drug conjugates (ADCs) are fast-growing fields and attract strong interests from antibody professionals. We are highlighting selected ADCs papers published on Antibody Therapeutics (current CiteScoreTracker: 8.3), official journal of the Chinese Antibody Society. The 5th paper was entitled “Mechanisms contributing to ado-trastuzumab emtansine-induced toxicities: a gateway to better understanding of ADC-associated toxicities” contributed by Wenjin Wu from U.S. Food and Drug Administration (FDA). We also highly recommend the special Issue Collection: Antibody-targeted Cytotoxic agents – Immunotoxins and ADCs. This special issue collection includes 14 excellent review and research articles. Special thanks to the two guests, Dr. Antonella Antignani and Dr. David FitzGerald at National Cancer Institute (NCI) of The National Institutes of Health. You may find more ADCs collection through https://lnkd.in/e76efmRZ #ADCs #Antibody #Therapeutics #Immunotoxins

Kidney Awareness Month during March is a particularly meaningful time for us here at Memo Therapeutics, given the many challenges facing Chronic Kidney Disease (#CKD) patients, especially those needing kidney transplantation. With approximately 500,000 people requiring end stage renal disease dialysis support and 100,000 people waiting for kidney transplants in the US alone, early diagnosis and pre-emptive treatment could save thousands of patients’ lives and preserve the quality of life for many others. At Memo Therapeutics, we have used our innovative antibody discovery platform to develop a monoclonal antibody, now in Phase II clinical development, to target BK virus: a major contributor to post-transplantation complications and ultimately graft loss. Read more about our program here:  https://lnkd.in/en6ZhHbV #KidneyAwarenessMonth #KidneyHealth #TransplantsforAll #MemoTherapeutics #MTx #Biotech #AntibodyDiscovery #InfectiousDiseases #DrugDiscovery  

FDA is reviewing the occurrence of secondary cancers in CAR-T therapy recipients. A few points: 1) The incidence of these adverse events is extremely low (19 cases out of the tens of thousands of successfully delivered therapies) 2) It's not clear if these cancers would not have arisen on their own 3) According to the article below, the incidence of these may be higher in KYMRIAH than in any of the marketed products Will be interesting to see how this develops and how it impacts future approvals/IND submissions #cartcelltherapy #cartcells #genetherapy #fdacompliance

https://lnkd.in/gJwk86VQ Key Insights: • Tecentriq® (atezolizumab) in its subcutaneous (SC) formulation features the same monoclonal antibody found in the intravenous (IV) version. This antibody is specifically designed to attach to programmed death ligand-1 (PD-L1), a protein present on both tumor cells and immune cells within tumors. By binding to PD-L1, Tecentriq prevents its interactions with PD-1 and B7.1 receptors. Visit MedicoInsights to explore key insights #HealthcareNews #drugs #StayInformed #MedicalNews #drugapproval #HealthTrends #Insights #HealthIndustry #HealthInnovation #roche #approved #tumors #eu #european #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights

Voyager doses first patient with anti-tau antibody in Alzheimer’s trial: Voyager Therapeutics, Inc. has dosed the first patient in a Phase Ia single-ascending dose study of its investigational anti-tau antibody VY-TAU01 for patients with Alzheimer’s disease.  The trial will be a #randomised, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics of VY-TAU01 in 48 healthy adults. Patients will be randomised to receive intravenously delivered candidate or a placebo. The company plans to initiate a Phase Ib multiple-ascending dose study in 2025, following data from the Phase Ia trial. https://lnkd.in/gcn_vejB #RegulatoryAffairs #Regulations #Regulatorystrategy

Amgen has reported positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) HCP (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD). Uplizna, an antibody therapy already with FDA approval for neuromyelitis optica spectrum disorder, is based on technology licensed from Duke University, developed by the late Duke University School of Medicine Dr. Thomas Tedder and colleagues. MITIGATE was conducted at 80 sites in 22 countries. It is the first placebo-controlled trial providing class 1 evidence for treating IgG4-RD, a chronic, systemic, immune-mediated, fibroinflammatory disease that can affect almost any organ in the body, often involving multiple organs at a time, and can result in irreversible organ damage. The novel, steroid-sparing study design paves the way for a reduced toxicity treatment approach. Based on the MITIGATE primary analysis results, Amgen is planning to file for approval in the U.S. followed by other key markets. https://lnkd.in/enXafGUh #innovation #techtransfer #licensing #immune #IgG4RD #NMOSD #autoimmune #therapeutic

I am thrilled and honored to be part of the team that will be bringing the next generation CAR-T Therapies to NHL/DLBCL patients not only in China but also around the world. This exciting collaboration between J&J and AbelZeta (formerly Cellular Biomedicine Group) is a major step forward in advancing the field of healthcare and improving treatment options for those in need. DLBCL is characterized by the uncontrolled rapid growth of a type of immune cell called lymphocytes. CD20 and CD19 are antigens commonly found on the surface of the cells. As many as half of patients with DLBCL eventually become refractory to first-line treatment and require additional treatment options. C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed or refractory (R/R) DLBCL. A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with R/R DLBCL is underway. C-CAR066 is an optimized novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with R/R DLBCL is anticipated to begin in the second half of 2023.