Orphan Medicine Weekly Report . . Claudin 18.2 Targeted Therapy, Gilead TCR Therapy finalist

Last week, the FDA awarded three orphan drug eligibilitys, including Nova Rock Biotherapeutics, a subsidiary of Stone Pharmaceuticals, targeting Claudin 18.2 antibody therapy and Kite Pharma, a subsidiary of Gilead Sciences, who was shortlisted for TCR therapy.
today's article, the Drug Mingkang content team focuses on these two innovative therapies.
: NBL-015 Research and Development: NovaRock Biotherapeutics Treatment: Pancreatic Cancer Introduction: NBL-015 is an all-humanized anti-Cludin technology 18.2 Monoclonal antibodies further optimize the cytotoxic action (ADCC) of antibody-dependent cells, the cytotoxic effect (CDC) of complement dependence, and the phagocytostic effect (ADCP) effect of antibody-mediated by protein engineering modification.
Claudin 18.2 is a highly specific cell surface molecule that is widely expressed in stomach and pancreatic tumors, and the development of therapeutic antibodies against Claudin 18.2 has high anti-cancer potential.
clinical preclinical cell killing experiments, animal pancreatic cancer tumor elimination experiments and toxicity studies show that NBL-015 has the characteristics of low immunogenicity, good safety, strong affinity and high anti-tumor activity.
Drugs: KITE-439 Research and Development Enterprise: Kite Pharma Treatment: HPV-Positive Cervical Cancer Introduction: There is a causal relationship between human papillomavirus (HPV) infection and almost all cervical cancers, and it can also lead to a variety of head and neck cancer and anal genital tumors (anital malignancies).
HPV-16 is the most common type of HPV in these tumors.
current treatment for HPV-related tumors is not only low in remission, but also in patients with short remission periods.
TCR therapy is an individualized immunotherapy that activates the body's own immune system to recognize and kill specific tumors.
it collects the patient's T lymphocytes and then expresses natural lymphocytes on the surface of those cells that target specific tumor antigens.
protein called E7 is expressed in cells of skin cancer tumors caused by HPV.
patients who carry these tumors will not be able to be cured if the cancer returns after receiving standard therapy or become resistant to it.
KITE-439 is a TCR therapy that targets E7 proteins.
by in-body modification of human in-body CD4 plus CD8 plus T cells to allow them to express T cells, can identify HPV-16 E7 protein 11-19 bit amino acids.
early data from phase 1 trials showed that KITE-439 was able to achieve partial tumor remission in some HPV-16-positive cancer patients.
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