Phase 1a/1b study will evaluate NRM-823 as monotherapy and in combination with immune checkpoint inhibition in patients with locally-advanced or metastatic refractory solid tumors
NRM-823 is a T cell engager against an immuno-active novel target that is homogeneously and commonly expressed in a broad range of solid tumors
Boston, Mass., and New Haven, Conn. – November 5, 2025 – Normunity, a biotechnology company pioneering precision biologics, today announced that the first patient has been dosed in a Phase 1 clinical trial (NCT07182149) for its lead drug candidate, NRM‑823, a first-in-class T cell engager against a novel immuno-active tumor-specific target. The trial is designed to evaluate the safety, tolerability and initial efficacy of NRM‑823 in increasing dose levels as a monotherapy and in combination with immune checkpoint inhibition in patients with locally-advanced or metastatic refractory solid tumors that express the relevant target.
“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,” said Rachel Humphrey, MD, Chief Executive Officer of Normunity. “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 data with NRM-823 has demonstrated potent anti-tumor activity in vitro and in vivo with T cell-mediated cytotoxicity in humanized mouse models of multiple cancers. NRM-823 has also demonstrated a favorable pharmacokinetic and preclinical safety profile, including no observed adverse events in the GLP toxicity study in non-human primates at the (supratherapeutic) highest dose tested.
“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,” said Melinda Merchant, MD, PhD, Chief Medical Officer of Normunity. “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.”
About Normunity
Normunity is a biotechnology company creating novel anti-cancer therapies focused on untapped biology at the interface of the immune system and the tumor, addressing Immuno-smart targets responsible for tumor-specific immune suppression that are identified with Normunity’s proprietary target discovery platform. The company is using these novel targets to build a pipeline of anti-cancer medicines, including therapeutic antibodies, bispecific antibodies, and payload-carrying biologics. The company’s lead clinical candidate, NRM‑823, is a first-in-class T cell engager that binds a novel, highly tumor-specific target expressed on multiple types of solid tumors but is absent in normal systemic tissues. Normunity is located in Boston, MA, and New Haven, CT. For more information, please visit www.normunity.com and follow us on LinkedIn.
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