The Antibody Society’s Post

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

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

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

Coherus BioSciences has queued a Phase 1 study (NCT06389526) to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors. CHS-1000, a potent monoclonal antibody that binds selectively to human ILT4 (also known as LILRB2), is Fc silent and lacks effector function activity in in vitro assays consistent with the engineered modification of the Fc region of the antibody. The company plans to file an IND in Q2 2024; the Phase 1 study has an estimated start date in October 2024. #mabs https://lnkd.in/ecvMTtCz

New drug watch for mCRPC: MK-5684. First in class oral CYP11A1 inhibitor. (First enzyme in steroid biosynthesis pathway) In the CYPIDES phase 2 study, drug response varied depending on the presence of a tumor mutation in the androgen receptor ligand binding domain. (AR-LBD) Study patients had received at least one prior ARSI (abi, enza, daro, apa) and one prior taxane chemotherapy. 50% or greater PSA response occurred in: - 55.6% of pts with AR-LBD mutation - 16.7% of pts without AR-LBD mutation Encouraging activity in a heavily pretreated population. Phase 3 trial underway: https://lnkd.in/euT44hds (Don’t like control arm of the Phase 3 study. Prefer dealer’s choice of available standard of care agents.) #GU24 Abstract 159: https://lnkd.in/emmagJGu

Eli Lilly and Company has posted details for a Phase 1 study of  LY4052031 in participants with advanced or metastatic urothelial carcinoma or other solid tumors. LY4052031 is a human monoclonal anti-Nectin-4 antibody conjugated to a novel TOPO 1 inhibitor by a cleavable peptide linker at a homogeneous drug antibody ratio (DAR) of 8:1. The study will enroll an estimated 220 patients and has an estimated start date in June 2024. Preclinical characterization of the molecule can be found here: https://lnkd.in/eVyNvSn6 Clinical trial details are here: https://lnkd.in/eshE9UvK

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

Inhibrx, Inc. is advancing their hexavalent OX40 agonist antibody INBRX-106 into a late-stage clinical study. The Phase 2/3 study (NCT06295731) will evaluate the efficacy and safety of INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. The study will enroll an estimated 420 participants and has an estimated start date in May 2024. #mabs https://lnkd.in/ecbW9MHn

Key clinical trial for CIDP Patients to start very soon.

Nammi Therapeutics, Inc. has posted details for a first-in-human Phase 1a/1b study of QXL138AM in participants with locally advanced unresectable and/or metastatic solid tumors and multiple myeloma. QXL138AM is a masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a. The study is enrolling an estimated 100 participants. #immunocytokines #mAbs https://lnkd.in/dgPJjQaF