FDA grants fast-track designation for EnGeneIC's pancreatic cancer candidate

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The US FDA has granted fast-track designation for EnGeneIC's pancreatic cancer therapeutic.

The Australian company said the designation reflects the potential of its EnGeneIC EDV (EnGeneIC Dream Vector) for the treatment of pancreatic ductal adenocarcinoma (PDAC).

PDAC is a challenging and aggressive form of cancer, usually diagnosed in advanced stages, meaning curative treatment options are limited.

EnGeneIC’s EDV therapeutic is a first-in-class Antibody Nanocell Drug Conjugate (ANDC) promoting a robust anti-tumour immune response.

The company said that, unlike other antibody-drug conjugates, the EDV delivers its substantial payload of cytotoxic drugs directly inside the cancer cell.

"This approach not only enhances the precision of treatment but also eliminates damage to healthy tissues and resultant side effects. The EDV-ANDC is further differentiated from other ADCs since it wakes up the patient’s own immune system to do the heavy lifting of tumour shrinkage and elimination," it said.

EnGeneIC’CEO Dr Himanshu Brahmbhatt said, “This approval is a testament to the potential impact of our EDV-based ANDC in addressing the urgent needs of patients with metastatic PDAC. We are committed to expeditiously advancing our clinical program for PDAC patients and others with low survival cancers. These are the patients who need it most!”