NexImmune, Inc, based in Gaithersburg, MD, is a clinical-stage biotechnology company developing immunotherapies that employ the body’s own T cells to generate a specific, potent and durable immune response that mimics natural biology. The company’s nanotechnology platform was originally developed at Johns Hopkins University.
The backbone of the company’s approach is its Artificial Immune Modulation, or AIMTM, nanoparticle technology platform. AIM’s purpose is to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. Like natural dendritic cells, AIM nanoparticles employ natural signaling proteins to deliver specific instructions to specific T cells directing a desired immune response. Unlike other cell therapy approaches, this is accomplished without any genetic manipulation of the T cell, thereby creating T cell products designed to maintain natural target identification, engagement and killing mechanisms.
By mimicking natural T cell biology, NexImmune’s T cell product candidates combine the attributes of cellular precision, potency and persistence with reduced potential for undesired toxicities. The company believes this is a significant advantage of the AIM platform and its therapeutic product candidates compared to other T cell therapies.
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The following graphic summarizes the key features of the AIM platform.
NexImmune is evaluating two product candidates in clinical trials, NEXI-001 in patients with AML and NEXI-002 in patients with Multiple myeloma MM. The company is actively dosing patients in both Phase I/II trials and expect to complete enrollment for both trials in 2021, with initial data on most patients in both trials expected by the end of 2021.
As Phase I/II trials, the trials consist of two parts. The first part of the trials, the initial safety evaluation phase, will assess the safety and tolerability of NEXI-001 or NEXI-002 T cells. The second part, the expansion phase, will further define safety and will also evaluate the initial efficacy of each product candidate at the dose and regimen established in the safety evaluation phase. The company is currently in the safety evaluation phase of both trials. Based on analysis of initial data, NexImmune anticipates filing with the FDA to request Breakthrough Therapy Designation and regenerative medicine advanced therapy designation for both NEXI-001 and NEXI-002 product candidates.
Its next adoptive cell therapy product candidate is planned in solid tumors. The company’s has observed (in non-clinical studies) the generation of melanoma-specific T cells from Stage III/IV melanoma patients as well as the activity and persistence of AIM ACT-generated T cells directed against the MART-1 antigen in melanoma tumor-bearing mice. NexImmune has also expanded HPV-specific T cells in vitro to support potential clinical evaluation in a variety of virally-mediated solid tumors.
Another area of development is a next-generation off-the-shelf injectable modality, which the company refer to as AIM INJ. The AIM INJ modality is designed to enable AIM nanoparticles to engage CD8+ T cells directly inside the body without the need for ex vivo expansion and manufacturing, which will (hopefully) result in a greater ease of administration and a less complex and less expensive manufacturing process.
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