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Engeneic Has Been Granted "Fast-track" Designation by the FDA for Its Novel Armed Nanocell Drug Conjugate (ANDC) Aimed at Treating Pancreatic Cancer

Friday, December 08, 2023

EnGeneIC, an innovative biopharmaceutical company leading the field of armed antibody therapeutics for oncology, has achieved a significant milestone with the FDA granting "Fast-Track" designation for its pancreatic cancer therapeutic. This acknowledgment underscores the potential of EnGeneIC's unique approach to revolutionize pancreatic cancer treatment.

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

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

EnGeneIC's EDV therapeutic is a first-in-class Antibody Nanocell Drug Conjugate (ANDC) that also promotes a robust anti-tumor immune response. Unlike other ADCs (antibody drug conjugates), the EDV delivers its large payload of cytotoxic drugs directly inside the cancer cell. This approach enhances the precision of treatment and eliminates damage to healthy tissues and resultant side effects. The EDV-ANDC is further differentiated from other ADCs since it activates the patient's immune system to contribute to tumor 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 the FDA and EnGeneIC, enabling a more streamlined and efficient development process. The company is now poised to leverage "Fast-Track" to accelerate PDAC clinical development with an approved IND for a randomized and controlled clinical trial at the second line in the U.S., expand patient access, and bring this groundbreaking 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.



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