EnGeneIC Limited , a clinical-stage biopharmaceutical company advancing its proprietary EDV(TM) nanocell platform for targeted cyto-immunotherapy in cancer, today announced that the first four patients have been dosed in a Phase 1/2a study using the Company's tumor-targeting, immunogenic EDVs(TM) to deliver a cytotoxic drug payload directly to tumors of patients who have exhausted curative treatment options. The study is enrolling patients with advanced pancreatic cancer and other EGFR-expressing solid tumors in a second cohort, which is currently underway at Frankston Private Hospital in Victoria, Australia, with Professor Vinod Ganju, MBBS, FRACP, as the Principal Investigator.
EnGeneIC's second-generation EDV(TM) nanocells deliver an extremely cytotoxic nemorubicin derivative (D682) directly to solid tumors via EGFR targeting on the tumor cell surface, keeping healthy tissue protected from damage. The novel therapy also includes EDVs(TM) carrying an immune-boosting adjuvant to further augment the anti-tumor immune response stimulated by the bacterially-derived EDVs(TM) and perpetuated by tumor cell destruction.
Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D., joint-CEOs and Directors of EnGeneIC, stated, "We developed our second-generation EDVs(TM) to address multi-drug resistance in patients who have failed multiple lines of chemotherapy and therefore have the highest unmet need. D682 is an extremely potent drug that is far too toxic to be delivered systemically, but has proven safe in patients when encapsulated in our EDVs(TM). We have named the study, the Carolyn Trial, after a close friend who had end-stage pancreatic cancer and was treated in a compassionate use case study. Carolyn was the first patient in the world to receive D682, and we observed highly encouraging results. Not only was survival extended, but quality of life improved considerably for the patient. Moreover, there was significant evidence of tumor regression coincident with a decrease in a key pancreatic cancer blood marker and a robust increase in anti-tumor CD8(+) T cells and other anti-tumor immune cells. We are now executing a more rigorous clinical trial, not only for pancreatic cancer patients, but also for other advanced-stage patients with drug-refractory tumors."
Professor Ganju
