E-EDV-D682/GC / EnGeneIC - LARVOL DELTA

EnGeneIC launches groundbreaking new Australian trial for innovative cancer therapy, with international trial site in Singapore to follow (GlobeNewswire) - "EnGeneIC Pty Ltd...has announced the successful dosing of the first patient in its open-label, multicentre, Phase I/IIa clinical trial at Mater Hospital, Sydney....It will assess the safety and efficacy of EGFR-targeted EDVTM (EnGeneIC Dream Vector) nanocells carrying the super-cytotoxic drug PNU-159682, together with EDVs loaded with an immune-stimulating adjuvant in patients with advanced solid tumours expressing Epidermal Growth Factor Receptor (EGFR)....As part of the expansion of the trial, EnGeneIC will open recruitment at Frankston Hospital, Victoria, this month under the guidance of Principal Investigator, Professor Vinod Ganju before adding further Australian sites. Additionally, the trial will be launched internationally at Curie Oncology in Singapore..."

Trial status • Bladder Cancer • Colorectal Cancer • Mesothelioma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Triple Negative Breast Cancer

Treating #PDAC patients who have exhausted all treatment options with the super-toxic drug E-EDV-D682/GC provided significant #OverallSurvival, minimal side effects and weight stabilization. https://bit.ly/3TfiWwU

EnGeneIC granted FDA “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic (GlobeNewswire) - "EnGeneIC...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....The FDA’s decision to grant 'Fast-Track' status reflects the urgency and unmet medical need associated with PDAC. EnGeneIC’s EDV (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."

Fast track designation • Pancreatic Ductal Adenocarcinoma

EnGeneIC’s breakthrough Armed Nanocell Drug Conjugate (ANDC) treatment shows promising results in Pancreatic cancer patients who have run out of treatment options (GlobeNewswire) - P1/2a | N=25 | "EnGeneIC...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 demonstrated a substantial increase in median overall survival for patients, with 88% of participants surpassing at least double the historical survival rates."

P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Phase I/IIa trial in advanced pancreatic ductal adenocarcinoma treated with cytotoxic drug-packaged, EGFR-targeted nanocells and glycolipid-packaged nanocells (AACR) - "We assessed safety and efficacy of EGFR-targeted, super-cytotoxic drug, PNU-159682-packaged nanocells with α-galactosyl ceramide packaged nanocells (E-EDV-D682/GC) in advanced pancreatic ductal adenocarcinoma (PDAC) patients who had exhausted all treatment options...Of 25 enrolled patients, seven were withdrawn due to rapidly progressive disease and one patient withdrew consent. All 25 patients were assessed for toxicity, 24 patients were assessed for OS which was also assessed for 17 patients completing one treatment cycle...There were no safety concerns, dose reductions, patient withdrawal, or treatment related deaths. Median OS was 4.4 months..."

P1/2 data • Pancreatic Ductal Adenocarcinoma