• Enara’s discovery of DARKFOX delivers on the vision of translating the dark genome into a new class of clinically actionable Dark Antigens and will be highlighted in an oral presentation at SITC 2025
• DARKFOX demonstrates best-in-class target properties: high tumor specificity, homogeneous expression in tumors and high prevalence in significant patient populations including lung, breast and GI cancers
• ENA101, a first-in-class bispecific T cell engager against DARKFOX, has been developed and optimized using Enara’s EnTiCE platform and demonstrates high selectivity, potent cytotoxicity and robust T cell activation supporting a large therapeutic window and strong potential to transform the standard of care
• ENA101 is advancing into IND-enabling studies with clear development path to submission in 2026
• Enara is continuing to invest in EDAPT, its world-leading Dark Antigen discovery platform, with a recent expansion of its discovery capabilities to include Dark Cell Surface Proteins
  
  

Enara Bio, a biopharmaceutical company pioneering the discovery of novel Dark Antigens® and the development of bispecific T cell engagers for solid tumors, will unveil its newly discovered cancer-specific target DARKFOX^TM as the first in a new category of validated Dark Antigens in an oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 annual meeting. SITC 2025 is being held on November 5-9 in National Harbor, MD.

“Our DARKFOX discovery marks a turning point showing that the dark genome harbors a rich source of tumor-specific antigens that can be both prevalent and actionable.” said Kevin Pojasek, Ph.D., Chief Executive Officer of Enara Bio. “Enara was founded on the premise that the next generation of cancer immunotherapies will require novel tumor-specific targets to address the unmet need in patients across a wide variety of solid tumor types. With the discovery of DARKFOX, we have achieved a major breakthrough in validating the first in a completely new class of Dark Antigens, cementing our leadership position in this field.

“Moreover, in ENA101, we have designed an optimized bispecific TCE candidate against DARKFOX using our EnTiCE platform and rapidly confirmed its first-in-class therapeutic potential, and we are now moving decisively to prepare for our first IND submission. As we look to the future, we are exploring multiple ways that Dark Antigens might be targetable including expanding our discovery platform, EDAPT, to identify and validate Dark Cell Surface Proteins, which could enable even more therapeutic modalities.”

DARKFOX is a polypeptide product of an alternative open reading frame (ORF) associated with FOXM1, which is robustly presented at the surface of solid tumor cells. Further, DARKFOX is expressed homogeneously across multiple solid tumor types with minimal expression in normal cells. Importantly, its expression is shared across broad patient populations, including in a majority of patients with squamous cell carcinomas such as Lung, Head & Neck and Esophageal. Taken together, these properties make DARKFOX a compelling new target for cancer immunotherapy that establishes a new precedent for broad applicability of peptide HLA targets.

Based on the breakthrough discovery of DARKFOX, Enara designed ENA101 as its lead bispecific TCE candidate using its EnTiCE® platform, which has been developed to create best-in-class molecules with kinetically optimized properties to maximize patient benefit. Enara’s EnTiCE® toolkit allows for rapid refinement of molecular formats to achieve an optimal immune synapse for any tumor antigen binder. ENA101 is rapidly progressing in IND-enabling studies with the goal of developing a first-in-class bispecific TCE that can provide durable benefit for broad populations of cancer patients.