NexImmune, Inc. (NASDAQ: NEXI) is engaged as a clinical-stage biotechnology company, which is focused on developing new, novel immunotherapy treatments that use an individual’s own T-cells to generate an immune response. Shares of the biotech company are rallying 32% through early trading on Friday, July 15, 2022. Over the past three months, NexImmune has seen average daily volume of 201,780 shares. However, volume of 38.93 million shares or dollar volume of around $76.3 million, has already exchanged hands through early trading.
Shares of NexImmune are gaining after the company announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for NEXI-003, the company’s first cellular therapy product candidate to treat solid tumors. NEXI-003 is an autologous antigen-specific T-cell product that is being tested for treatment of human papillomavirus (HPV)-related cancers.
After receiving the IND, NexImmune is beginning to get its plans together to launch Phase 1 clinical trials for NEXI-003, which will take place across multiple clinical sites throughout the United States. The Phase 1 trial is proposed to be a two-part, multicenter, open-label, dose-finding, first-in-human study for the drug product candidate. Between 24 and 36 patients are estimated to be enrolled in the clinical trial, with all patients to be followed for at least one year.
Kristi Jones, NexImmune CEO: “The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our team’s continued focus and commitment to bringing novel therapies to patients with significant unmet need. NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets. The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.”
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