Nanoparticle cancer therapy company EnGeneIC Ltd. receives FDA approval

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Story highlights

  • Nanomedicine company receives FDA approval
  • The company are developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutic
  • The comapny now plans to proceed with a Phase I study

(Nanotech Magazine)- Nanomedicine company EnGeneIC Ltd. has announced that the  U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for using (EGFR)-EDVs loaded with doxorubicin (dox) in patients with recurrent glioma.

Phase 1 Trials

The company now plans to proceed with a Phase I study designed to evaluate its proprietary (EGFR)-EDV-dox for treating advanced glioma in patients who have exhausted all treatment options, with enrollment of patients expected by the end of the year. The primary objective of the Phase I study is to assess the safety of (EGFR)-EDV-dox in this patient population. EnGeneIC will also assess the anti-tumor response according to Response Assessment in Neuro-Oncology (RANO) criteria and overall survival (OS) of patients, as well as measure certain parameters of the adaptive immune response following administration with (EGFR)-EDV-dox.

According to the Joint-CEO of EnGeneIC, Dr. Himanshu Brahmbhatt, “While we have shown our EDVs to be extremely well tolerated in first-in-man trials and have some recent exciting results in patients with mesothelioma, the FDA’s acceptance of our three-component therapeutic, being a drug-loaded nanocell carrying a targeting antibody, is an extremely important step in our overall strategy of proving our cyto-immunotherapy platform has potential in intractable cancers like recurrent glioma. It also validates our tailored medicine approach to develop a pipeline of novel EDV-based therapeutics with different payloads for different cancers, allowing us to kill cancer cells as well as stimulate the immune system to effect dramatic improvements in overall survival.”

Nanoparticle cancer therapy

The company’s bacterially-derived EDV™ nanocells are a  nanoparticle drug, siRNA, or miRNA delivery system designed to directly target and effectively kill tumor cells with minimal toxicity, while at the same time stimulate the immune system’s natural anti-tumor response. Intravenously injected EDV™ nanocells exit the leaky vascular system only within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody. Once attached, the nanocell is able to enter the tumor cell and deliver intracellularly a drug, siRNA, or miRNA payload. In parallel, the bacterial cell wall of the nanocells stimulates key components of the immune system, which are then activated to seek out and destroy cancer cells.

 

 

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