• IND clear­ance enables com­mence­ment of clin­i­cal trial to eval­u­ate NEXI-002 in multiple myeloma patients who have failed >3 pre­vi­ous lines of ther­apy
• FDA action rep­re­sents the Com­pany’s second IND clear­ance in 4Q2019 for its pipe­line of novel cellular ther­apy prod­ucts

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing novel immune-therapeutics based on a pro­pri­e­tary Artificial Immune Modulation (AIM) nanotechnology plat­form, has re­ceived IND clear­ance for the Com­pany’s second cellular ther­apy prod­uct. NEXI-002 is being devel­oped for the treat­ment of multiple myeloma patients that have failed at least three prior lines of ther­apy.

Scott P. Carmer, NexImmune’s Pres­i­dent and CEO, commented, “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. NEXI-002 is a T cell ther­apy that consists of T cell pop­u­la­tions directed against multiple tumor-relevant an­ti­gen targets. In addi­tion, the T cells ex­panded by our pro­pri­e­tary E+E 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.”

The Phase 1/2 trial of NEXI-002 will begin enrolling patients at clin­i­cal sites across the United States. Key sites planning to enroll patients in­clude The Dana Farber Cancer Institute, Memorial Sloan Kettering, MD Anderson, and The Karmanos Cancer Institute. The trial is a multi-center, open-label, single-arm study eval­u­ating the safety, tolerability and initial efficacy of adoptively-transferred patient-derived T-cells as a treat­ment for multiple myeloma patients that have failed >3 pre­vi­ous lines of ther­apy. The trial will eval­u­ate a single dose of NEXI-002, with three patients enrolled in an initial safety cohort, followed by an ex­pan­sion phase which will enroll up to 20 addi­tional patients. All patients will be followed for at least one year.

Paul Richardson, MD, the RJ Corman Pro­fessor of Medicine at Harvard Medical School, Clinical Program Leader and Director of Clinical Research at Dana Farber’s Jerome Lipper Multiple Myeloma Center and the clin­i­cal trial’s lead investigator, stated, “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. 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.”

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. The hallmark char­ac­ter­istic of multiple myeloma is a high level of M protein in the blood. Multiple myeloma typically dis­plays the most activity in bone mar­row, which in­cludes the mar­row in the spine, pelvic bones, ribs, shoulders, and hips.

Though it is rarely curable, multiple myeloma is a man­ageable dis­ease that has seen rapid medical ad­vancement over the past decade. 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 NEXI-002

NEXI-002 is an endogenous (non-genetically engi­neered) cellular ther­apy and in­cludes pop­u­la­tions of primed an­ti­gen specific CD8+ cells directed at five specific multiple myeloma an­ti­gen targets. Gen­er­at­ing T cells against multiple tumor targets minimizes the poten­tial for tumor escape. In addi­tion, NEXI-002 con­tains T cell subtypes that are predominantly memory pheno­types, with the majority being char­ac­ter­ized as stem cell memory and central memory T cells. T cell prod­ucts that con­tain high proportions of memory cells, particularly central memory and stem cell memory, have been asso­ci­ated with potent anti-tumor activity, long-term T cell persistence and durable anti-tumor re­sponse­.

About NexImmune

NexImmune is a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing novel immune-therapeutics based on the pro­pri­e­tary Artificial Immune Modulation (AIM) nanotechnology plat­form. The AIM plat­form enables the ability to ex­pand multi-antigen specific T cells with en­hanced anti-tumor properties without the need for genetic manipulation. NexImmune is using the AIM tech­nology plat­form to de­vel­op a pipe­line of prod­ucts to treat cancer and auto-immune dis­eases.

The AIM plat­form is com­prised of two core components: (1) a syn­thet­ic nanoparticle that functions as an artificial an­ti­gen presenting cell (aAPC) to prime and activate T cells directed at multiple tumor an­ti­gen targets across a broad range of both solid and hema­to­logic malig­nan­cies; and (2) a pro­pri­e­tary T cell enrichment and ex­pan­sion (E&E) process that con­trols ex vivo T cell pro­lif­er­a­tion and subtype dif­fer­en­tiation. In pre­clin­i­cal experiments, the AIM sys­tem has dem­onstrated the ability to en­hance naturally occurring tumor cell recognition, engagement and signaling mech­a­nisms that in­creased the anti-tumor potency, target specific killing and long-term durability of endogenous cytolytic T-cells. Utilizing natural target recognition and killing mech­a­nisms may also reduce the poten­tial for allo­re­ac­tive toxicities observed with genetically engi­neered T cell ther­a­pies. The Com­pany’s aAPCs have also dem­onstrated poten­tial utility as both injectable and cellular thera­peutic agents.

For more in­for­ma­tion visit: www.neximmune.com

Source: NexImmune.