BillionToOne will allow its UNITY fetal antigen test to be used to test patients included in Johnson & Johnson’s (J&J’s) AZALEA phase 3 clinical trial testing the safety and efficacy of nipocalimab, an antineonatal Fc receptor (FcRn)- blocking antibody, in hemolytic disease of the fetus and newborn (HDFN).
UNITY is a noninvasive test used to assess the need for Rh immunoglobulin (RHIG) administration in pregnant Rh-negative patients by detecting the presence of specific antigens capable of triggering antibody production and HDFN in a subsequent pregnancy.
Nipocalimab was recently granted Fast Track designation as a treatment to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant patients.
Earlier this year, BillionToOne published clinical validation data for the UNITY Fetal Antigen Laboratory Developed Test (LDT). The validation study demonstrated the LDT’s accuracy in determining antigen status, achieving more than 99.9% concordance and sensitivity and specificity of more than 99.9% (95% CI: 99-100%). The UNITY Fetal Antigen LDT results were 100% concordant with neonatal antigen genotype/serology for 23 RhD-negative pregnant individuals and 93 antigen evaluations in 30 alloimmunized pregnancies.
The assay will function as a screening tool to determine the eligibility of pregnant individuals participating in the trial across the United States, the European Union and select countries worldwide.
This news comes after J&J announced promising results from the AZALEA phase 2 trial. J&J reported that within two weeks of initiating nipocalimab, patients achieved full FcRn occupancy, together with a substantial decrease in maternal IgG levels and alloantibody titers. Additionally, FcRn occupancy in each patient was lost two to three weeks after the final dose, causing an increase in IgG and alloantibody titers.
The U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) for the UNITY Fetal Antigen CTA in April 2023, thus supporting the launch of the phase 3 AZALEA study of nipocalimab in HDFN in the U.S.
Oguzhan Atay, PhD, CEO of BillionToOne, stated his team is “extremely proud” to play a role in the trial.
“The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification. The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology’s capabilities,” he added.
