Pancreatic ductal adenocarcinoma (PDAC) is a notoriously challenging and aggressive form of cancer, usually diagnosed in advanced stages, making curative treatment options limited.

The FDA’s decision to grant “Fast-Track” status reflects the urgency and unmet medical need associated with PDAC. EnGeneIC’s EDV^TM (EnGeneIC Dream Vector) has demonstrated safety and promising anti-tumor efficacy results in the Carolyn Phase I/IIa trial for end-stage PDAC patients in Australia, showcasing its potential to address the challenges posed by metastatic PDAC and to improve patient outcomes.

EnGeneIC’s EDV therapeutic is a first-in-class Antibody Nanocell Drug Conjugate (ANDC) which also promotes a robust anti-tumour immune response. Unlike other ADCs (antibody drug conjugates), the EDV delivers its very large payload of cytotoxic drug 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.

The “Fast-Track” designation expedites the development and review process, allowing EnGeneIC to accelerate the EDV’s development for PDAC patients. The approval also facilitates increased communication and collaboration between and FDA and EnGeneIC, enabling a more streamlined and efficient development process. The company is now poised to leverage the “Fast-Track” to accelerate PDAC clinical development with an approved IND for a randomised and controlled clinical trial at second line in the U.S., expand patient access and bring this ground-breaking technology to market as quickly as possible.

EnGeneIC’s CEO, Dr. Himanshu Brahmbhatt is enthusiastic about the FDA’s “Fast-Track”, stating, “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!”

As EnGeneIC progresses with its development plan, the company anticipates close collaboration with regulatory agencies, clinicians and advocacy groups to ensure a comprehensive and patient-centric approach to bringing its EDV therapeutic to the forefront of advanced PDAC treatment.