Search Results for “antibody” – Page 18 – media

First Patient Enrolled in the US Phase 2 Combination Therapy of Akeso’s Ligufalimab with Azacitidine for Myelodysplastic Syndrome

Akeso has announced the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). Preliminary studies show that combining AK117 with azacitidine for treating MDS is safe and significantly effective. In response to the urgent need for new therapies among global MDS patients and the evolving market landscape, Akeso has launched an international multicenter Phase II clinical trial. This initiative aims to expedite AK117’s global approval and commercialization process. CD47-targeted drug development for treating MDS shows promising potential. AK117, a next-generation humanized IgG4 anti-CD47 antibody, effectively blocks the CD47-SIRPα interaction to enhance phagocytic activity against tumor cells by phagocytes. Recent data presented at the 65th American Society of Hematology (ASH) Annual Meeting demonstrated that AK117 combined with azacitidine significantly reduces anemia and transfusion requirements ...
- Source: drugdu
- 87
- August 12, 2024
Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, ...
- Source: drugdu
- 99
- August 12, 2024
Hengrui Pharmaceuticals’ Innovative Drug Fronachizumab Approved for Clinical Trials for the Treatment of Moderate to Severe Plaque Psoriasis in Children and Adolescents

Recently, Hengrui Pharmaceuticals’ subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy. Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis ...
- Source: drugdu
- 80
- August 12, 2024
Hengrui Pharmaceuticals’ Innovative Anti-inflammatory Drug SHR-1819 for the Treatment of Prurigo nodularis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary, Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, agreeing to conduct a clinical trial of SHR-1819 Injection for patients with Prutigo nodularis (PN). PN is a chronic, inflammatory skin disease clinically characterized by episodes of intense itching and multiple nodular lesions. The main clinical symptom is intense, recurrent itching accompanied by uncontrollable scratching, which leads to hyperkeratosis of the skin to the point of forming dome-shaped nodules.1 PN leads to the development of psychological disorders in patients who face a significant reduction in quality of life, reduced sleep quality, and anxiety and depression. According to Frost & Sullivan, the number of PN patients in China will be approximately 2 million in 2022 and is expected to reach 2.1 million in 2030. To date, there is no standard diagnosis and treatment program for PN, ...
- Source: drugdu
- 59
- August 12, 2024
Janssen’s psoriasis drug shows promise for childhood diabetes

A new study led by researchers from Cardiff University, King’s College London (KCL), Swansea University and the University of Calgary has revealed that Janssen’s psoriasis drug, Stelara (ustekinumab), shows promise in treating childhood diabetes. Published in Nature Medicine and funded by a Medical Research Council and National Institute for Health and Care Research partnership, the study found that Stelara was more effective in treating the early stages of type 1 diabetes (T1D) in children and adolescents. Accounting for approximately 10% of diabetes cases in the UK, T1D occurs when the pancreas does not produce insulin or makes very little insulin. Since 2009, the immunotherapy Stelara has been used to treat psoriasis, a skin condition characterised by flaky patches of skin that affects around 60 million people globally, as well as other immune conditions, including psoriatic arthritis, severe Crohn’s disease and severe ulcerative colitis. In the study, researchers tested Stelara in ...
- Source: drugdu
- 70
- August 9, 2024
Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
- Source: drugdu
- 91
- August 6, 2024
Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 92
- August 5, 2024
Vir Bio trims staff and pipeline to focus on Sanofi-licensed programmes

Vir Biotechnology has signed a licensing agreement with Sanofi for three clinical-stage masked T-cell engagers (TCE) for cancer treatment. The US-based company has also started strategic restructuring, which includes a workforce reduction of approximately 25% and the discontinuation of its influenza and Covid-19 programmes. Vir will also phase out its T cell-based viral vector platform. The company expects to save approximately $50m each from staff cuts and pipeline reprioritisation, which will be reinvested into the Sanofi-licensed programmes. Vir reported $1.43bn in cash reserves at the end of Q2. The Sanofi-licensed TCE candidates include SAR446309, a dual inhibitor of HER2 and CD3; SAR446329, a dual-masked PSMA and CD3 TCE; and SAR446368, a dual-masked EGFR and CD3 TCE. The TCE candidates were developed using the protease-cleavable masking platform, which Sanofi acquired from Amunix Pharmaceuticals. Both SAR446309 and SAR446329 are being evaluated in Phase I trials in patients with metastatic treatment-resistant HER2-positive tumours ...
- Source: drugdu
- 71
- August 5, 2024
Sanyou Bio Congratulates Eluminex Biosciences and Foreseen Biotechnology on Major Breakthroughs in Innovative Drug Project

SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
- Source: drugdu
- 56
- July 30, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 114
- July 27, 2024

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