There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise.
Colorectal cancer remains a prevalent and deadly form of cancer. A significant challenge to treating colorectal tumors is the creation of a suppressive tumor immune microenvironment that leads to tumor progression and resistance to immunotherapy.
Interleukin-18 (IL-18) is a pro-inflammatory cytokine that plays a crucial role in promoting antitumor immunity by activating T and natural killer (NK) cells. However, the therapeutic use of wild-type IL-18 has faced limitations due to its susceptibility to neutralization by IL-18 binding protein (IL-18BP), short in vivo half-life and unfavorable physicochemical properties.
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
Lung cancer is the most frequent cause of cancer-related death in both men and women worldwide. Current treatments can fail because of variable responses in different types of patients, drug resistance, poor tumor penetration and systemic toxicity, prompting the continuing search for better therapeutics.
Genome Therapeutics Ltd. has synthesized compounds and their immunoconjugates comprising an antibody covalently linked to a cytotoxic drug through a linker reported to be useful for the treatment of cancer.
Aussie researchers have used CRISPR gene editing tools to “armor” chimeric antigen receptor (CAR) T cells to activate additional cancer-fighting proteins at the tumor site, enabling them to target cancer cells in solid tumors.
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies, primarily due to its dense, desmoplastic and immunosuppressive tumor microenvironment (TME) that hinders the efficacy of immune checkpoint inhibitors such as anti-programmed cell death 1 (PD-1).
Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.
Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.
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