Calidi Biotherapeutics Inc. has received pre-IND regulatory feedback from the FDA on Calidi’s IND-enabling preclinical plans and clinical strategy for CLD-401. The parties agreed on key aspects of the CMC and nonclinical programs, as well as the overall design for the proposed first-in-human study.
A patent from Jiangsu Hengrui Pharmaceuticals Co. Ltd. and Shanghai Hengrui Pharmaceutical Co. Ltd. has divulged new antibody-drug conjugates comprising antibodies covalently linked to N-myristoyltransferase 1 (NMT1) inhibitors for potential use in the treatment of cancer.
Clinical responses to BCMA- or GPRC5D-directed T-cell engagers in relapsed/refractory multiple myeloma (MM) are often limited by disease relapse and antigen escape, underscoring the need for dual-targeting strategies that enhance durability while mitigating cytokine-driven toxicity.
Harnessing an oncolytic signal and redirecting it against the tumor itself could be developed as a selective strategy for certain cancer types, as occurs with ErbB hyperactivity, a form of signaling that drives many carcinomas. Inspired by this idea, scientists at Stanford University have engineered a virus that replicates only in ErbB-hyperactive ovarian cancer cells. This allowed them to precisely kill this specific tumor population, achieving greater efficacy and safety than previous oncolytic viruses.
Researchers from Peking University and Bristar Immunotech Ltd. recently presented the development of a synthetic T-cell receptor and antigen receptor-T (STAR-T) cell therapy targeting leukocyte immunoglobulin-like receptor B4 (LILRB4) for acute myeloid leukemia (AML).
Fortvita Biologics Inc. and Innovent Biologics (Suzhou) Co. Ltd. have jointly reported new antibody-drug conjugates (ADCs) comprising a bispecific antibody or antigen-binding fragments targeting V-set domain-containing T-cell activation inhibitor 1 (VTCN1, B7-H4) and tumor-associated calcium signal transducer 2 (TACSTD2; TROP2) linked to cytotoxic drug. They are described as potentially useful for the treatment of cancer.
Shanghai Ruotuo Biotechnology Co. Ltd. has patented antibody-drug conjugates (ADCs) comprising bispecific antibodies targeting epidermal growth factor receptors (EGFR; ERBB; HER) and receptor tyrosine-protein kinase erbb-3 (ERBB3; HER3) linked to a cytotoxic drug through a linker intended for use in the treatment of cancer.
A team of investigators at Icahn School of Medicine at Mount Sinai and collaborating institutions aimed to isolate the on-target activity of CAR T cells to target tumor cells.
T-Curx GmbH has obtained clinical trial approval from the Swiss agency Swissmedic for the company’s nonviral lead CAR T program, TCX-001. The first-in-human phase I study will open in Switzerland, and a submission to the EMA will seek to expand the trial to sites in Germany. The study will enroll adults with relapsed or refractory acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), including patients not eligible for stem cell transplantation.
Antengene Corp. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for ATG-201 for the treatment of B-cell related autoimmune diseases.