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Nanotech Pancreatic Cancer Immunotherapy Gains FDA Fast Track

T-cells and cancer cells

Killer T-cells surround a cancer cell (NICHD, Flickr)

8 Dec. 2023. The developer of an experimental immunotherapy delivering nanoscale payloads to treat pancreatic cancer says the treatment received fast-track status from the Food and Drug Administration. The biotechnology company EnGeneIC in Sydney, Australia is developer of cancer therapies delivered directly to tumor cells, guided by synthetic antibodies that it says avoid toxicity to healthy tissue.

The EnGeneIC technology packages cancer-killing treatments, either conventional chemotherapies or synthetic interfering RNA, as glycolipid or carbohydrate/natural oil particles about 400 nanometers across; one nanometer equals one billionth of a meter. The company says its EnGeneIC dream vectors or EDVs can concentrate up to one million molecules of the cancer-killing drugs, much higher concentrations than given systemically to patients, making them more potent in destroying tumors. EnGeneIC says at 400 nanometers, EDVs  are too large to pass through blood vessel linings in healthy tissue, but will escape through in leaky blood vessels in microenvironments, the supportive mass of cells and blood vessels surrounding tumors.

The company says its EDVs are guided to tumors by synthetic antibodies designed to target epidermal growth factor receptor proteins, overexpressed on cell surfaces in the vast majority of solid tumors. Once on the cell surface, says EnGeneIC, the nanoscale therapy payloads are ingested through the cell membrane, then broken-down inside the cell, releasing their cancer-killing contents, thus minimizing toxicity elsewhere. In addition, says the company, the presence of EDVs creates a microenvironment more receptive to immune responses, with a preclinical study showing a greater production of dendritic, macrophage, natural killer, and tumor-specific T-cells that can prolong remission times.

EnGeneIC is testing its EDVs in a clinical trial among patients with advanced pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer that begins in the lining of the ducts carrying enzymes from the pancreas. Pancreatic cancer in many cases is difficult to diagnose in its early stages, making treatments more problematic once detected in later stages. The early- and mid-stage trial is enrolling up to 40 patients in Australia with advanced pancreatic ductal adenocarcinoma or PDAC expressing epidermal growth factor receptor proteins. The study team is looking for safety indicators, such as adverse effects from the treatments to determine safe dose levels, as well as anti-cancer activity, immune responses, and survival times. The trial has no control or comparison group.

Six months vs. two months average survival time

Initial results of the trial, published last month in the journal Clinical Cancer Research, report on 25 enrolled patients, of which seven patients dropped out due to the rapid advance of their disease, and one withdrew consent. The study team reports that before the withdrawal of these participants, 19 of the 25 reported mild to moderate adverse effects, which were resolved within hours, but showed no other safety-related concerns. Patients also exhibited minimal to no toxicities from the treatments.

Moreover, eight of the 17 patients completing the trial survived more than six months, compared to historical average survival times of two months. In addition, say the authors, 80 percent of patients receiving EDV treatments maintained their body weights or gained weight, compared to the severe weight loss seen in most pancreatic cancer patients.

FDA awards fast-track status to experimental drugs for serious unmet medical conditions exhibiting superior effectiveness, fewer adverse effects, reduced toxicities, or meeting key public health priorities. Treatments with fast-track status gain more frequent meetings and written communications with FDA staff, and are eligible for expedited or rolling (stage-by-stage) reviews.

In an EnGeneIC statement released through Globe Newswire, the company says fast-track status from FDA will help expedite clinical trials of EDVs for pancreatic cancer patients in the U.S. Co-founder and CEO Himanshu Brahmbhatt notes, “We are committed to expeditiously advancing our clinical program for PDAC patients and others with low survival cancers. These are the patients who need it most.”

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