Rallybio Announces Collaboration to Advance Therapeutic Solutions for Pregnant Individuals at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a collaboration with Johnson & Johnson¹ to support the development of complementary therapeutic approaches aimed at reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). In addition, Rallybio received an equity investment of $6.6 million from Johnson & Johnson Innovation – JJDC, Inc.

Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody designed to prevent pregnant individuals from alloimmunizing², thereby eliminating the risk of FNAIT and its potentially devastating consequences in their fetuses and newborns. Rallybio is on track to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of 2024.

Under this collaboration, Johnson & Johnson will provide funding for Rallybio to raise awareness of Johnson & Johnson’s FNAIT clinical program in connection with Rallybio’s ongoing FNAIT natural history study. Rallybio is also eligible to receive additional payments under the collaboration.

RLYB212 is the only investigational therapy currently reported to be in clinical development to address the needs of pregnant individuals at risk of FNAIT who have not alloimmunized². Johnson & Johnson is conducting a Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn, in pregnant individuals who are already alloimmunized. As these individuals have the alloantibodies that can cause FNAIT, preventative treatment with RLYB212 would not be appropriate.

“We are thrilled to be working with Johnson & Johnson on our mission to eliminate FNAIT,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “Our complementary approaches, if successful, would ensure that pregnant individuals at risk of developing FNAIT have a potential treatment option – regardless of their alloimmunization status. Together, we can more effectively and expeditiously drive awareness of FNAIT, emphasize the importance of screening pregnant individuals for their risk of developing FNAIT, and advance our complementary therapeutic approaches.”