Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder.

The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview.

“They are very much complementary and not competitive approaches; and both are needed,” said Uden.

As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and Europe in parallel with a Phase II dose confirmation study of RLYB-212, said Uden.

The Phase II trial will be designed as an exposure-response study that will initially treat one sentinel mother with RLYB-212, allowing the biotech to make adjustments and optimise dosage prior to initiating an additional two cohorts of three to four mothers, explained Uden. Exposure response will be the primary endpoint of the Phase II study with safety, tolerability, and alloimmunisation being key secondary endpoints, he added. The Phase II study is set to begin in H2 2024.

RLYB-212, a novel human monoclonal anti-HPA-1a antibody, is designed to prevent the mother’s immune system from generating harmful anti-HPA-1a antibodies that can attack foetal platelets and put the foetus at risk for severe, uncontrolled bleeding. FNAIT is a rare condition that develops when the mother and foetus have different platelet surface antigens. There are currently no approved therapies for the prevention or prenatal treatment of FNAIT.

Aside from FNAIT, J&J has also been exploring nipocalimab’s use in other indications. In February, the pharma company reported positive topline results for the treatment in generalised myasthenia gravis (gMG) and Sjogren’s disease, two rare disease indications. The following week, nipocalimab received FDA breakthrough therapy designation for the treatment of alloimmunised pregnant adults at increased risk of severe haemolytic disease of foetus and newborn (HDFN).

According to GlobalData’s consensus forecast, nipocalimab is projected to generate $200m in global sales in 2029.

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