On June 1, 2020 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported 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) (Free ASCO Whitepaper) Virtual Scientific Program, which will be held from May 29-31, 2020 (Press release, EnGeneIC, JUN 1, 2020, View Source [SID1234560742]).

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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.

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."

Dr. Himanshu Brahmbhatt, Joint-CEO of EnGeneIC, stated, "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)."

Details of abstract can be found at the ASCO (Free ASCO Whitepaper) Meeting Library.

Abstract Number: 4632
Title: "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"

Session: Gastrointestional Cancer, Gastroesophageal, Pancreatic, and Hepatobillary

Trial: View Source