SYDNEY, Australia and NEW YORK, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Pancreatic ductal adenocarcinoma (PDAC), which accounts for >90% of pancreatic tumors, is one of the most lethal malignancies and currently the third ranked cause of cancer-related deaths in the United States and Australia. Moreover, unlike other cancers where advances in the development of new therapies have changed the treatment landscape, such advances have eluded PDAC and there have been no increases in survival rate for decades.
EnGeneIC, an Australian/USA biotechnology company, has developed a proprietary targeted nanocell-based therapeutic focused on treatment of low survival solid-tumors, including PDAC. The nanocell (designated EDVTM; EnGeneIC Dream Vector) is best described as an Antibody-Nanocell-Drug-Conjugate (ANDC) which also stimulates a powerful anti-tumour immune response. On the strength of the safety and increases in overall survival in EnGeneIC’s recently completed Phase I/IIa Australian trial, the Carolyn Trial, for end-stage PDAC patients, the US food and Drug Administration (FDA), has accepted an Investigational New Drug application (IND) for an EDV-PDAC trial in the US but at 2nd line and randomised against physician’s choice of approved drug.
At the same time, oncologists at a Los Angeles cancer centre reviewed the encouraging data and teamed up with EnGeneIC to apply for a Single Patient IND under the “right to try” legislation in order to treat their patient with metastatic PDAC who had failed all approved therapies and experimental treatments.
The patient commenced on the EDV treatment in late April 2022 and to date has received more than 80 repeat doses of the EDVs.
Amazingly, after 15 months of EDV therapy, the patient’s cancer has disappeared and this has been achieved with minimal side effects. In fact, the patient’s quality of life improved so much that she was allowed EDV-treatment breaks for holidays in Paris and Hawaii.
This is believed to be the first instance of a PDAC patient with advanced metastatic disease who, having exhausted all treatment options, went on to achieve a complete remission from an experimental therapy.
When asked how the EDV could achieve such a dramatic result, Dr. Himanshu Brahmbhatt, Joint CEO of EnGeneIC said, “Once patients have run out of treatment options and their disease has spread throughout the body, the cancer is invariably resistant to any conventional drug you throw at it. However, the EDV has a unique mode of action in that it can carry a super-cytotoxic drug, too toxic to be given systemically, directly to the tumour to overcome drug resistance and kill tumour cells. Concurrently, EDVs stimulate a plethora of different types of immune cells, training them to recognise and eliminate tumour cells.” He continued, “We are impressed with the treating oncologists since they kept their patient on treatment, understanding that it takes time to gear up an anti-tumour immune response when the patient has been battered by repeated rounds of different chemo”.
EnGeneIC’s Australian PDAC trial has been accepted for publication in a leading clinical journal, and the remarkable story of the L.A. PDAC patient is being written up for submission to a peer-reviewed medical journal.
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 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 ant-tumour response. EnGeneIC is now entering Phase IIa clinical trials in patients with intractable 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
