Skip to content
Medical Health Aged Care

EnGeneIC granted FDA “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic

EnGeneIC 3 mins read

SYDNEY, Australia and NEW YORK, Dec. 07, 2023 (GLOBE NEWSWIRE) -- EnGeneIC, an innovative biopharmaceutical company leading the field of armed antibody therapeutics for oncology, has achieved a significant milestone with the granting of FDA “Fast-Track” designation for its pancreatic cancer therapeutic. This approval underscores the potential of EnGeneIC’s unique approach to revolutionise pancreatic cancer treatment.

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 EDVTM (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.

About EnGeneIC

EnGeneIC is a clinical-stage biopharmaceutical company focused on advancing its proprietary EDV® (EnGeneIC Dream Vector) nanocell technology for oncology and infectious disease applications. The EDVTM nanocell is the foundation of a first-in-class Antibody Nanocell Drug Conjugate (ANDC) platform for delivering a range of therapeutic payloads -- drugs, siRNAs, miRNAs, adjuvants – via antibody-targeting a cancer cell’s surface, with minimal toxicity. For cancer applications, the EDV technology enables delivery of the most potent chemotherapeutic agents, effectively overcoming drug-resistance and killing tumor cells, while simultaneously stimulating the patient’s immune system, allowing a potent anti-tumour response to convert immunologically “cold” tumours into immunoresponsive “hot” tumours. EnGeneIC is now entering Phase IIa clinical trials in Australia and USA in patients with intractable, low survival cancers, including patients with metastatic pancreatic cancer.

EnGeneIC contact:

Dr. Jennifer MacDiarmid
Joint-CEO & Director & EDV technology co-inventor
Email: jmacdiarmid@engeneic.com
Cell phone: +61-407-953-170;

EnGeneIC Pty Ltd,
Level 4, B53, 11 Julius Ave,
North Ryde, Sydney, NSW 2113
Australia.
Website: www.engeneic.com


Primary Logo

More from this category

  • Government Federal, Medical Health Aged Care
  • 16/06/2024
  • 08:00
ASU

Unions move to stop wage theft of disability workers

Unions will on Monday move to stop dodgy NDIS providers stealing $16,000 a year from dedicated disability support workers by paying them below the minimum wage. The ASU, with support from the AWU, UWU and HSU, is applying to the Fair Work Commission to ensure providers pay staff at least the minimum wage for social and community services employees, as they are funded to do. About 10 per cent of providers have been deliberately misclassifying up to 30,000 NDIS workers as home care workers, which has a lower award rate, and pocketing the difference. The difference in the hourly rates…

  • Medical Health Aged Care
  • 15/06/2024
  • 04:30
Dementia Australia

Join us TODAY for Hunter Walk & Jog

What: Dementia Australia’sHunterMemory Walk & Jog. When: Saturday 15 June from 7.30am. Who: More than 750 locals participating on the day. People who have been impacted by dementia, their family, friends and carers. Where: Speers Point Park, Speers Point For more information visit: www.memorywalk.com.au Walk or jog with us. We are in this together. Dementia Australia is the source of trusted information, education and services for the estimated more than 421,000 Australians living with dementia, and the more than 1.6 million people involved in their care. We advocate for positive change and support vital research. We are here to support…

  • Contains:
  • Medical Health Aged Care
  • 14/06/2024
  • 22:07
Takeda Pharmaceutical Company Limited

Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

− Takeda to Receive Exclusive Option to License Global Rights to Olverembatinib in All Territories Outside of Mainland China, Hong Kong, Macau, Taiwan and…

  • Contains:

Media Outreach made fast, easy, simple.

Feature your press release on Medianet's News Hub every time you distribute with Medianet. Pay per release or save with a subscription.