According to a well-established clinical-stage oncology company, the FDA has granted Orphan Drug designation to zenocutuzumab (bispecific antibody) for pancreatic cancer treatment on 27, July, 2020.

Zenocutuzumab exhibited strong inhibition of HER2/HER3 heterodimer development and tumor growth in models concealing NRG1 fusions, in preclinical studies. Encouraging early clinical responses in patients with earlier treated pancreatic cancer harboring NRG1 gene fusions was revealed from this drug under study. As per the study results, a substantial tumor shrinkage, with a 44% decrease in tumor diameter at week 8 in 1 patient and a 22% decrease in tumor diameter at week 6 in the other patient with the use of zenocutuzumab.

Presently, the company is registering patients in the global phase 1/2 eNRGy trial to assess the safety and antitumor action of zenocutuzumab monotherapy in NRG1 fusion-positive solid tumors.

The company’s CEO stated, “Zenocutuzumab can most likely play a crucial part in switching the treatment paradigm for NRG1 fusion cancers from conventional chemotherapy to a personalized medicine method.”