SYDNEY and NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) -- EnGeneIC, a pioneer in personalised cancer therapeutics, announces the publication of its clinical trial results in peer reviewed prestigious journal “Clinical Cancer Research”, published by the American Association for Cancer Research. The study, the Carolyn Trial, named in honour of the first pancreatic cancer patient to try the EDV (EnGeneIC Dream Vector) nanocell treatment under a compassionate use program, now shows remarkable outcomes for end-stage Pancreatic Ductal Adenocarcinoma (PDAC) patients receiving targeted EDV nanocells loaded with a super-cytotoxic drug (together an ANDC) as well as an immune-stimulating adjuvant.

The trial results highlight a significant advance in the treatment landscape for PDAC:

Unprecedented Survival Rates. The trial demonstrated a substantial increase in median overall survival for patients, with 88% of participants surpassing at least double the historical survival rates. Notably, the longest-surviving patient had an extended life to an unprecedented 19.7 months and 8 of the 17 evaluable patients achieved more than 6 months survival compared to historical survival of less than 2 months.

Minimal to Negligible Toxicity. In order to overcome drug resistance which is inevitable in PDAC patients who have endured multiple lines of therapy, the EDV – ANDC was packaged with a super-cytotoxic drug as the warhead. Even so, there was minimal to no toxicity, ensuring the patients experienced much better wellbeing throughout the trial than afforded by previous chemotherapy regimes.

Positive Impact on Body Weight. Remarkably, more than 80% of patients receiving the EDV treatment either maintained or experienced weight gain. This stands in stark contrast to the severe body weight loss commonly associated with advanced PDAC, offering hope for improved quality of life alongside treatment efficacy.

Professor Vinod Ganju the Lead investigator for the trial expressed optimism about these findings, stating, “The outcomes observed in the Carolyn Trial signify an early 'proof of principle' of a use of a novel adaptable technology. The treatment was proven to be safe, very well tolerated with relatively long periods of disease control and maintenance of quality of life, in this group of treatment refractory patients with PDAC. I am keen to move this therapeutic approach to earlier lines of therapy where it has potential to deliver greater benefits.”

The publication of the Carolyn Trial comes directly on the heels of EnGeneIC’s announcement last week that a single patient with metastatic PDAC treated in Los Angeles for 12 months has experienced a complete response with no sign of tumour.

Joint-CEO and Director of EnGeneIC, Dr Jennifer MacDiarmid said, “We are very excited about the results of our Carolyn Trial. We also believe that we can significantly enhance patients’ outcomes if we keep them on treatment. Our EDV therapeutic is a first-in-class ANDC and immunotherapy in the one therapeutic. The patient in Los Angeles illustrates how long it takes to rebuild an immune system that has been damaged by frequent toxic chemotherapy, and that for late-stage patients, we may have to consider the cancer as a chronic disease and keep treating until we see a response – in this patient’s case, a complete one.

The publication can be read online at https://aacrjournals.org/clincancerres/article-abstract/doi/10.1158/1078-0432.CCR-23-1821/730179/Phase-I-IIa-trial-in-advanced-pancreatic-ductal?redirectedFrom=fulltext

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 EDV^TM 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 Australia and USA in patients with intractable, low survival cancers, including patients with metastatic pancreatic cancer.