The announcement comes after the U.S. Food and Drug Administration cleared NexImmune’s investigational new drug (IND) application for NEXI-002, allowing it to enter clinical testing in relapsed or refractory myeloma patients.
“FDA clearance of our second IND this quarter marks another significant milestone for NexImmune and demonstrates our team’s focus and commitment to bringing novel therapies to patients with significant unmet need,” Scott P. Carmer, NexImmune’s president and CEO, said in a press release.
NEXI-002 is a new therapeutic approach being developed by NexImmune, in which a patient’s own immune cells are primed to detect multiple myeloma cells, without the need for genetic manipulation.
The approach makes use of NexImmune’s Artificial Immune Modulation (AIM) nanotechnology, which uses nanoparticles — microscopic particles — in the lab to mimic natural immune cells, called antigen-presenting cells. These immune cells are key to activating T-cells — those with the ability to fight cancer — and telling them what their targets should be. However, they may become impaired under certain diseases like cancer.
NexImmune nanoparticles work as artificial antigen-presenting cells, directing a patient’s T-cells to five myeloma targets.
Importantly, this technology uses an enrichment and expansion system that guide the expansion of two T-cell populations: active, tumor-killing T-cells that provide immediate responses, and memory T-cells that allow for long-term persistence of the therapy and durable responses to treatment.
In preclinical studies, the AIM nanotechnology has shown promising results, with better anti-tumor responses and long-term persistence of native, tumor-directed T-cells. NexImmune is optimistic about the native T-cell approach, as it avoids potential toxicity often associated with the use of genetically engineered T-cells.
“NEXI-002 is a T cell therapy that consists of T cell populations directed against multiple tumor-relevant antigen targets,” Carmer said. “In addition, the T cells expanded by our proprietary E+E [enrichment and expansion] system consist of T cell subtypes critical to both potent anti-tumor activity and generation of the long-term immunologic memory required for durable responses.”
“Because of this, we are hopeful NEXI-002 will address key limitations observed with other cellular immunotherapies,” he added.
The upcoming open-label Phase 1/2 trial will recruit 23 patients at multiple sites in the United States, including the Dana Farber Cancer Institute in Massachusetts, Memorial Sloan Kettering Cancer Center in New York, MD Anderson in Texas, and the Karmanos Cancer Institute in Michigan.
The first three patients will be included in an initial safety group, aimed at determining the treatment’s safety and tolerability. Pending positive safety results, an additional 20 patients will be included in an extension phase to continue assessing safety and tolerability, as well as preliminary signs of efficacy. All participants will be followed for at least one year.
“Although we have made significant progress in treating patients diagnosed with multiple myeloma, we continue to need novel treatment strategies and, in particular, effective immune therapy. For that reason, a significant unmet need remains for the vast majority of our patients,” said Paul Richardson, MD, a professor at Harvard Medical School and the clinical trial’s lead investigator.
“Novel immune-based therapies like NEXI-002 may represent a promising and practical option for those patients that have either relapsed after, or are refractory to, currently available treatment. We are excited to be a lead site for this trial and look forward to dosing our first patients,” added Richardson, also a clinical program leader and director of clinical research at Dana Farber’s Jerome Lipper Multiple Myeloma Center.