RLYB212

RLYB212

Stage
Phase 2
Indication
Prevention of HPA-1a alloimmunization in pregnant women at higher risk of HPA-1a alloimmunization and Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Approach
Monoclonal anti-HPA-1a antibody
Mode of Administration
Subcutaneous injection

Fetal and Neonatal Alloimmune Thrombocytopenia

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns. FNAIT can arise during pregnancy due to an immune incompatibility between a pregnant woman and her fetus in a specific platelet antigen called human platelet antigen 1, or HPA-1. 

There are two predominant forms of HPA-1, known as HPA-1a and HPA-1b, which are expressed on the surface of platelets. Individuals who are homozygous for HPA-1b, meaning that they have two copies of the HPA-1b allele and no copies of the HPA-1a allele, are also known as HPA-1a negative. Upon exposure to the HPA-1a antigen, these individuals can develop antibodies to that antigen in a process known as alloimmunization. In HPA-1a-negative pregnant women bearing a HPA-1a-positive fetus, alloimmunization can occur upon mixing of fetal blood with maternal blood. When alloimmunization occurs in a pregnant woman, the anti-HPA-1a antibodies that develop in the woman can cross the placenta and destroy platelets in the fetus. The destruction of platelets in the fetus can result in severely low platelet counts, or thrombocytopenia, and potentially lead to devastating consequences including miscarriage, stillbirth, death of the newborn, or severe lifelong neurological disability in those babies who survive. There is currently no approved therapy for the prevention or prenatal treatment of FNAIT. 

RLYB212

RLYB212 is designed to rapidly eliminate HPA-1a positive fetal platelets from an pregnant woman’s circulation, thereby preventing maternal HPA-1a alloimmunization. Prevention of maternal alloimmunization eliminates the risk of FNAIT in the fetus. 

Journal Publications

Scientific Presentations