The Antibody Society的动态

Regeneron has posted details for a first-in-human Phase 1/2 study to assess safety, tolerability, and preliminary anti-tumor activity of REGN7945, an anti-CD38 x anti-CD28 costimulatory bispecific monoclonal antibody, in participants with relapsed/refractory multiple myeloma. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab (anti-BCMA x anti-CD3 bispecific), compared with linvoseltamab alone. Due to start in December 2024, the study will enroll an estimated 186 patients. https://lnkd.in/eRY67jKR

AstraZeneca has posted details for a Phase 1/2 study designed to evaluate if AZD5492, a CD20×TCR×CD8 tri-specific antibody, is safe, tolerable and efficacious in participants with relapsed or refractory B-cell malignancies. The study will enroll an estimated 174 patients and has an estimated start date in late Aug 2024. https://lnkd.in/edUBx24a AZD5492 is an asymmetric, trispecific monoclonal IgG1 antibody that harbors two Fab binding domains to CD20, one VHH binding domain to TCR, one VHH binding domain to CD8 co-receptor. https://lnkd.in/esbvU7xU

Key clinical trial for CIDP Patients to start very soon.

HC Biopharma Inc. has started a first-in-human study of HC006, a therapeutic monoclonal antibody that specifically binds to human C-C motif chemokine receptor 8 (CCR8) and is designed to selectively deplete tumor-infiltrating T regulatory cells with enhanced antibody-dependent cell-mediated cytotoxicity. The study, which started in February, will characterize the safety, tolerability, pharmacokinetics, immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. #mabs https://lnkd.in/d7UgEKSZ

Numab Therapeutics AG has started a first-in-human study of NM32-2668, an anti-ROR1/CD3/anti-HSA T cell engaging, tri-specific antibody with half-life extension. The study will evaluate NM32-2668 for safety and immunogenicity, determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, and explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity?in an estimated 180 patients with advances solid tumors. Details about the molecule are here: https://lnkd.in/ev4XpXBd Clinical trial details are here: https://lnkd.in/eJE4b8fK

AP Biosciences, Inc. has posted details for a Phase 1/2, multi-regional, multi-center, open-label, first-in-human, dose-escalation and dose expansion study to evaluate the effects of AP402 in HER2-positive patients with locally or advanced solid tumors. AP402, developed by AP Biosciences and integrated with the T-cube?Bispecific Antibody Platform, specifically targets the p95HER2 variant, a common HER2 variant that lacks the extracellular domain, making it untargetable by conventional HER2 therapies. The bivalent binding activity of AP402 to both HER2v and CD137 is superior to monovalent binding of other bispecific antibodies. AP402 can efficiently trigger CD137 activation in T cells through HER2v clustering. ?Due to start in December 2024, the study will enroll an estimated 85 patients. #mabs https://lnkd.in/efDY2EW9

Thanks for the coverage, The Antibody Society. APBio's latest T-cell engager, AP402, targets #p95HER2, a truncated form of the notorious #HER2 receptor. Unlike the full-length HER2, p95HER2 lacks almost entire N-terminal extracellular domain, including the trastuzumab binding site, but retains its C-terminal domain. This truncated isoform is present in approximately 30–40% of patients with metastatic, therapy-resistant HER2-positive #BreastCancer. Notably, p95HER2 remains highly active in downstream signaling pathways, a factor associated with poor prognosis in patients expressing high levels of this isoform. Targeting p95HER2 with therapies like AP402 may offers a promising alternative for patients whose HER2-positive breast cancers have relapsed or are refractory to trastuzumab and its related therapies.

Acumen Pharmaceuticals, Inc. has started a Phase 2/3 study of ACU193, a fully humanized IgG2 monoclonal antibody that selectively binds soluble Aβ oligomers, potentially blocking their toxic effects, in Alzheimer's patients. The primary purpose of the study is to evaluate the efficacy of ACU193 infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. #mabs https://lnkd.in/e53JtHd3

?? A Premier Destination for ADC Clinical Trials ?? As antibody-drug conjugates (ADCs) are gaining momentum in oncology research, South Korea has emerged as a key player in conducting cutting-edge clinical trials, including promising ADC therapies like HER3-DXd. Currently, promising positive data has been released in NSCLC. In HERTHENA-Lung02, the following countries participated; USA , Australia, Austria, Belgium, Canada, China, France, Germany, Hong Kong, Italy, Japan, South Korea, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom. ?? With robust infrastructure, experienced clinical research organizations (CROs), and competitive costs that are advantageous for global pharmaceutical companies, South Korea is a smart choice for your research needs. Recent collaborations in ADC clinical trials highlight the country's excellence in this domain. ?? South Korea's unique position in supporting the development of next-generation cancer treatments is unparalleled. Whether you're seeking expertise in early-stage trials or later-stage pivotal studies, South Korea is the ideal partner for your research endeavors. Currently, the other clinical trials for HER3-DXd are recruiting subjects, and South Korea also takes the main role among them. https://lnkd.in/gbZHCYH2 Let's work together to push the boundaries of innovation! #ClinicalTrials #ADC #CancerResearch #GlobalPartnerships #SouthKorea #CNR #CNRResearch

For those tracking antibody-drug conjugates, a new record on clinicaltrials.gov indicates that Hansoh Bio's HS-20089 is an ADC composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. The new Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors. #adcs #mabs https://lnkd.in/e2MzYvCt