Rallybio’s New Life-Saving, Plasma-Derived Therapy to Enter Phase 1/2 Study

Rallybio’s newest plasma-derived therapy, RLYB211, will finally enter a Phase 1/2 study.

Last Tuesday, the biopharmaceutical giant based in New Haven, Connecticut, announced that RLYB211 will be advanced for its first-in-human dosing trial in a study of fewer than a hundred participants.

The study will be conducted at the Clinical Research department of Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Branch for Translational Medicine and Pharmacology (TMP) in Frankfurt, Germany, in collaboration with the German Red Cross.

Rallybio is well-known for developing life-saving therapies for patients who suffer from rare disorders. RLYB211 is a plasma-derived hyperimmune globulin developed for the prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), a rare disorder that affects fetuses and newborns.

FNAIT is the result of a mismatch between specific platelet antigens of a mother and her fetus. It can occur during pregnancy, and the most mismatched antigen is the HPA-1 antigen.

Following the mismatch, when the HPA-1 platelets of the fetus enter into the mother’s blood circulation, her immune system identifies them as pathogens. In response, her immune system develops antibodies that attack and destroy those platelets. As a result, FNAIT causes excessive bleeding and severe neurological disability in these fetuses. Frequently, the mother will lose her fetus.

In theory, RLYB211 prevents FNAIT by inducing in the mother what is called Antibody-Mediated Immune Suppression (AMIS). Time will tell whether it will also work in practice.

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