Rallybio Announces Publication of Data Highlighting the Ability of HPA-1a-Specific Antibodies to Prevent Alloimmunization in an Authentic Mouse Model of FNAIT
-- Data Demonstrates that HPA-1a Alloimmunization can be Prevented with
FNAIT is a rare, life-threatening bleeding disorder where maternal alloantibodies cross the placenta and lead to depletion of fetal platelets. There are no currently approved therapies for the prevention of FNAIT. In this study, a novel alloantigen-specific mouse model developed by the senior author Dr.
- Both RLYB211 and RLYB212 were equally effective at driving rapid and complete elimination of HPA-1a positive platelets from circulation and preventing the development of HPA-1a alloantibodies.
- HPA-1a negative female mice that were treated prophylactically with anti-HPA-1a antibody prior to exposure to HPA-1a positive platelets gave birth to HPA-1ab pups with significantly improved platelet counts and no bleeding symptoms.
- The threshold effect for rapid and complete elimination of HPA-1a positive platelets is achieved at circulating anti-HPA-1a antibody concentrations estimated to bind as little as ~10% of antigen, consistent with the clinical prophylactic treatment paradigm established for anti-Rhesus D (anti-RhD) to prevent Hemolytic Disease of the Fetus and Newborn (HDFN).
“These preclinical results continue to support that administration of HPA-1a specific antibodies has the potential to effectively prevent HPA-1a alloimmunization in pregnant women who are at risk of developing fetal and neonatal alloimmune thrombocytopenia. We now look forward to discussing data from our Phase 1b proof-of-concept study for RLYB212, our monoclonal candidate, in the first quarter of 2023,” said Róisín Armstrong, Ph.D., Rallybio’s RLYB212 Program Lead.
“It is very gratifying to have this study featured in Blood with an accompanying commentary by leaders in the transfusion medicine community,” added
This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to management. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning the ability of RLYB212 and RLYB211, and the prophylactic administration of HPA-1a-specific antibodies, to clear platelets and prevent alloimmunization in pregnant women, and the anticipated threshold effect for rapid and complete elimination of HPA-1a positive platelets compared to the clinical prophylactic treatment paradigm established for anti-RhD to prevent HDFN. The forward-looking statements in this press release are only predictions and are based largely on management’s current expectations and projections about future events and financial trends that management believes may affect Rallybio’s business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully initiate and conduct our planned clinical trials, including the ongoing and future clinical trials for RLYB212 for the prevention of FNAIT, and complete such clinical trials and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio’s filings with the
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