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J&J, Rallybio partner on drug development for rare fetal condition

Dive Brief:

  • Biotechnology company Rallybio is partnering with Johnson & Johnson, announcing a collaboration Wednesday to develop new treatments for a rare disorder known as fetal and neonatal alloimmune thrombocytopenia, or FNAIT.
  • As part of the deal, Rallybio will receive $6.6 million in equity investment from J&J’s venture capital arm. The biotech is currently developing an antibody dubbed RLYB212 to prevent FNAIT and plans to start a Phase 2 trial during the second half of this year.
  • J&J will also provide funding to Rallybio to raise awareness around J&J’s drug nipocalimab, which the pharmaceutical company is testing as a treatment for pregnant individuals that have “alloimmunized,” which describes the development of antibodies that can cross the placenta and destroy platelet cells in the fetus.

Dive Insight:

While rare, FNAIT can be life-threatening, leading to miscarriages, stillbirths or lifelong neurological disabilities of the infant.

Alloimmunization stems from an immune incompatibility between the pregnant person and the fetus in a platelet protein. When allo-antibodies from the mother destroy these blood-clotting cells in the fetus, thrombocytopenia can result.

Currently, there is no preventive treatment. Rallybio’s candidate is a monoclonal antibody aimed at a protein called HPA-1a, which the company thinks could prevent alloimmunization from happening.

J&J’s nipocalimab works differently, targeting another protein known as FcRN. It’s been studied in autoantibody diseases like generalized myasthenia gravis as well as rheumatological conditions like lupus.

J&J is also testing it in alloimmunized pregnant individuals who are at a high risk of a related blood disorder known as hemolytic disease of the fetus and newborn. The pharma disclosed results from a small trial early last year, and a Phase 3 study is now enrolling.

“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,” said CEO of Rallybio Stephen Uden in a statement.

Rallybio is also conducting a natural history study to better understand the disease and how it manifests differently depending on race and ethnicity. Results will inform future testing of RLYB212. As of March, more than 9,000 individuals had been screened, the company said.

Rallybio will also receive an upfront payment of $500,000 from J&J and up to $3.7 million of additional funding to support its natural history study.

“J&J’s support underscores the tremendous unmet need for new therapies that can reduce the risk of FNAIT and our commitment to delivering new options for those who are pregnant,” said Uden in an email to BioPharma Dive.