With the start of its sec­ond clin­i­cal trial, NexImmune ex­pands de­vel­op­ment of its unique non-genetically engi­neered T cell immuno­therapies across a range of hema­to­logic malig­nan­cies

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­technol­ogy com­pany devel­op­ing a port­folio of unique non-genetically-engi­neered T cell im­muno­therapies, an­nounced to­day that it has dosed the first patient in its Phase 1/2 clin­i­cal trial for NEXI-002. NEXI-002 is a patient-derived cel­lu­lar prod­uct that con­tains pop­u­la­tions of nat­u­rally-occurring CD8+ T cells directed against sev­er­al mul­ti­ple myeloma (MM)-specific an­ti­gen targets. It is the sec­ond clin­i­cal prod­uct NexImmune has gen­er­ated with its AIM nanoparticle tech­nology.

“While the pri­mary objective in this trial with NEXI-002 is to dem­onstrate safety and tol­er­a­bil­ity, we also hope to see ini­tial signs of im­mun­o­log­i­cal and clin­i­cal ac­­tiv­ity,” said Han Myint, MD, Chief Medical Of­fi­cer at NexImmune. “The AIM tech­nology gives us the unique ability to direct pop­u­la­tions of nat­u­ral T cells against a powerful com­bi­na­tion of cell surface and endogenous anti-tumor targets spe­cif­ic to mul­ti­ple myeloma. We be­lieve this ap­proach has po­ten­tial to address pri­mary tumor escape mech­a­nisms, and provide deep and durable clin­i­cal re­sponses.”

Investigators will en­roll be­tween 22 to 28 patients in the pro­spec­tive, multi-center, open-label, single-arm Phase 1/2 study. The trial’s pri­mary objective is to assess the safety and tol­er­a­bil­ity of a single in­fusion of NEXI-002 T cells in patients with MM who have failed at least three prior lines of ther­apy. Secondary objectives in­clude signals of anti-tumor ac­­tiv­ity, pro­gres­sion-free sur­vival (PFS) and over­all sur­vival (OS). Addi­tional analysis will assess the in vivo persistence, pro­lif­er­a­tion, functionality and T cell re­cep­tor (TCR) repertoire of NEXI-002 T cells as measured in blood and bone mar­row samples. Clinical sites par­tic­i­pat­ing in this trial in­clude Dana Farber Cancer In­sti­tute, Karmanos Cancer In­sti­tute, MD Anderson Cancer Center, City of Hope Comprehensive Cancer Center and Memorial Sloan Kettering Cancer Center.

Despite recent ad­vances in the treat­ment of mul­ti­ple myeloma, there re­mains no cure for the dis­ease. Virally-transduced CAR-T prod­ucts that target the BCMA pro­tein rep­re­sent a new and promising form of ge­net­ic­ally-engi­neered T cell ther­apy for mul­ti­ple myeloma patients who have failed >3 lines of prior ther­apy, but unfortunately, a majority of patients who ini­tially re­spond to these ther­a­pies relapse within one year of treat­ment. Because the T cells in NEXI-002 prod­ucts can attack sev­er­al mul­ti­ple myeloma tumor-specific targets simultaneously and are com­prised of T cell subtypes that can sur­vive for years in patients, they have po­ten­tial to address the lim­i­ta­tions of cur­rent single-target ge­net­ic­ally-engi­neered T cell ther­a­pies.

“With the initiation of NexImmune’s sec­ond clin­i­cal trial, we are bringing our trans­formational tech­nology to another group of patients with a high unmet med­i­cal need,” said Scott Carmer, Chief Exec­u­tive Of­fi­cer at NexImmune. “We be­lieve T cell im­mu­no­ther­a­pies based on the AIM nanoparticle tech­nology rep­re­sent a highly dif­fer­en­ti­ated and clin­i­cally meaningful op­tion for many patients facing life-threatening con­di­tions across the spectrum of can­cer, auto-immune and infectious dis­eases.”

About Multiple Myeloma

According to the Multiple Myeloma Re­search Foundation, mul­ti­ple myeloma is a type of blood can­cer that affects plasma cells. In mul­ti­ple myeloma, malignant plasma cells ac­cu­mu­late in the bone mar­row, crowding out the nor­mal plasma cells that help fight in­fec­tion. These malignant plasma cells then pro­duce an ab­nor­mal anti­body called M pro­tein, which offers no ben­e­fit to the body and may cause tumors, kidney damage, bone destruction, and im­paired im­mune function. Unfortunately, de­spite the in­tro­duc­tion of novel ther­a­pies that offer many mul­ti­ple myeloma patients temporary remission from their can­cer, all patients will ultimately ex­peri­ence dis­ease relapse.

About NexImmune

NexImmune is a clin­i­cal-stage bio­technol­ogy com­pany devel­op­ing unique ap­proaches to T cell im­mu­no­ther­a­pies based on its pro­pri­e­tary Artificial Immune Modulation (AIM) tech­nology. The AIM tech­nology is de­signed to gen­er­ate a targeted T cell-mediated im­mune re­sponse and is ini­tially being devel­oped as a cell ther­apy for the treat­ment of hema­to­logic can­cers. AIM nano-particles (AIM-np) act as syn­thet­ic dendritic cells to de­liver im­mune-specific signals to targeted T cells and can direct the ac­ti­va­tion or sup­pres­sion of cell-mediated im­mu­ni­ty. In can­cer, AIM-expanded T cells have dem­onstrated best-in-class anti-tumor properties as de­ter­mined by in vitro analysis, in­clud­ing the ability to address key mech­a­nisms of tumor escape and relapse through a unique com­bi­na­tion of anti-tumor potency, multi-antigen target-specific kill­ing, and long-term T cell persistence. The mod­u­lar design of the AIM plat­form enables rapid ex­pan­sion across mul­ti­ple thera­peutic areas (such as auto­immune dis­eases and infectious dis­eases), with both cell ther­apy and injectable prod­ucts.

Source: NexImmune.