Normunity Doses First Patient In Phase 1 Clinical Trial Of NRM 823, A Novel T Cell Engager Targeting Tumor-Specific Antigens In Solid Tumors

Normunity, a biotechnology company pioneering precision biologics, has announced that the first patient has been dosed in its Phase 1 clinical trial (NCT07182149) evaluating NRM-823, the company’s lead drug candidate. NRM-823 is a first-in-class T cell engager that targets a novel immuno-active, tumor-specific antigen. The Phase 1 study is designed to assess the safety, tolerability, and preliminary efficacy of NRM-823 both as a monotherapy and in combination with immune checkpoint inhibitors in patients with locally advanced or metastatic solid tumors expressing the target antigen.

Rachel Humphrey, MD, Chief Executive Officer of Normunity, described the initiation of this study as a major milestone for the company. “The initiation of this Phase 1 clinical trial represents an important milestone for Normunity, as we bring a potentially transformational cancer therapy forward to patients and transition to a clinical-stage company,” she said. “This study is the initial step utilizing our first in a new class of immuno-smart targets for our T cell engager, NRM-823, and we plan to leverage this target in broader therapeutic modalities beyond T cell engagers. We believe that NRM-823 exemplifies the power of our proprietary discovery platform to uncover new biologic insights specific to both the immune system and tumors, enabling us to translate our science into potential life-changing medicines for cancer patients.”

Preclinical studies of NRM-823 have shown strong anti-tumor activity in both in vitro and in vivo models, with evidence of effective T cell-mediated cytotoxicity in humanized mouse models representing multiple types of cancer. The therapy also demonstrated a favorable pharmacokinetic and safety profile in preclinical studies, with no adverse effects observed in non-human primates at the highest (supratherapeutic) dose tested in the GLP toxicity study.

Commenting on the scientific advancement, Melinda Merchant, MD, PhD, Chief Medical Officer of Normunity, stated, “Normunity’s design and development of NRM-823 allows us to harness the body’s own immune system by activating and redirecting T cells to precisely target tumor cells. Our team is particularly encouraged by the ability of NRM-823 to address a previously unrecognized target that appears to support cancer survival across a range of solid tumor indications. The compelling preclinical efficacy and safety data give us confidence to move into the clinic to evaluate the potential of NRM-823 for patients with advanced or metastatic solid tumors.”

With this milestone, Normunity transitions into a clinical-stage biotechnology company, advancing its mission to develop precision biologics that engage novel immune pathways and deliver meaningful therapeutic breakthroughs for cancer patients.