NEW YORK – Everest Medicines said on Sunday that the US Food and Drug Administration cleared an investigational new drug application (IND) seeking permission to begin studying its mRNA vaccine EVM14 in patients with cancer, including non-small cell lung and head and neck tumors.
EVM14 comprises mRNA that encodes five tumor-associated antigens. After the mRNA, which is encapsulated in a lipid nanoparticle delivery system, is delivered via an injection, it is taken up by antigen-presenting cells and translated into the target antigens. Once these antigens are presented to T cells, they trigger an immune response, and the T cells are then able to recognize and kill cancer cells expressing the target antigens.
"With FDA IND approval, EVM14 has become Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development," Everest CEO Rogers Yongqing Luo said in a statement, highlighting that EVM14, the clinical-stage personalized cancer vaccine EVM16, and the in vivo CAR T programs serve as the "foundational elements" of the firm's innovation strategy in oncology and autoimmune diseases.
Luo added that the Shanghai-based firm plans to submit an IND application for EVM14 to China's National Medical Products Administration, as well.
In preclinical studies, EVM14 demonstrated increased immune activation and anti-tumor activity along with the ability to induce immune memory and prevent tumor recurrence. The preclinical studies in mice also suggested that combining EVM14 with an anti-PD1 antibody or anti-CTLA4 antibody could significantly increase anti-tumor activity.
EVM14 is Everest's second mRNA therapeutic cancer vaccine to enter clinical development. Earlier this month, researchers began treating patients with the personalized cancer vaccine EVM16 in an investigator-initiated trial in China. In that study, researchers are testing EVM16 as a monotherapy and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors, and they are using Everest's neoantigen prediction algorithm, EVER-NEO-1, to determine the neoantigen targets included in the personalized vaccine, based on each patient's specific tumor mutations.