NEW YORK and SYDNEY: EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, has said that an abstract on the Phase I/IIa clinical trial with EGFR-targeted EDV nanocells in patients with recurrent, metastatic pancreatic cancer has been accepted at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, which will be held from May 29-31, 2020.
Professor Vinod Ganju, the Principal Investigator on the study at Frankston Private Hospital, Melbourne, said, “There have been no significant advances in the treatment of pancreatic cancer and the mortality rate remains very high. The EDV therapeutic is showing a remarkable safety profile and some patients have had prolonged periods of disease control without toxicity. Currently, modifications to dose and schedule are ongoing with the goal of achieving further substaintial improvement in anti-tumour efficacy.”
The abstract, titled, “Interim Data: Phase I/IIa study of EGFR-targeted EDV nanocells carrying cytotoxic drug PNU-159682 (E-EDV-D682) with immunomodulatory adjuvant EDVs carrying α-galactosyl ceramide (EDV-GC) in patients with recurrent, metastatic pancreatic cancer,” provides early data from nine patients in the ongoing open label Phase IIa study, the Carolyn Trial, in patients with treatment-refractory metastatic pancreatic cancer. To date, the EDVs carrying the cytotoxic drug and immune adjuvant have been well tolerated and demonstrated an excellent safety profile. Further, early signs point to durable response in patients in this extremely difficult-to-treat patient population, possibly related to the development of an innate and adaptive immune response as a result of direct cytotoxic effects on drug resistant tumor cells.
Dr. Himanshu Brahmbhatt, Joint-CEO of EnGeneIC, said,”This is the first time a super-cytotoxic drug designed to overcome serious multi-drug resistance in late stage cancers, has been safely delivered in patients. One aspect of the EDV’s unique mechanism of action was recently published in Cancer Cell in March 2020 and the associated cover art depicts the cyto-immunotherapeutic pathway in pictorial form (Cancer Cell, 37: 354-370 (2020).”
EnGeneIC is a clinical stage biopharmaceutical company advancing its proprietary bacterially-derived EDV nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform designed to directly target and effectively kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system’s innate and adaptive anti-tumor response. First- and second-generation EDV nanocells have shown promising results in early clinical studies and EnGeneIC is currently planning to commence further clinical trials in several cancer indications in Australia and USA.