Rallybio Announces Collaboration to Advance Therapeutic Solutions for Pregnant Individuals at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
- None.
- None.
Insights
The announcement of Rallybio Corporation's collaboration with Johnson & Johnson, alongside a $6.6 million equity investment, is a significant development that merits attention from a financial perspective. This collaboration is poised to enhance Rallybio's financial stability and provide additional capital that can be allocated towards the development of RLYB212, a potential therapeutic for FNAIT. The partnership with a pharmaceutical giant like Johnson & Johnson not only infuses Rallybio with capital but also offers a strategic advantage in terms of market reach and credibility in the biotech industry.
Investors should note the potential for additional payments under the collaboration, which could lead to further financial benefits for Rallybio. The equity investment and subsequent funding can also be seen as a vote of confidence in Rallybio's technology and market potential. From a stock market perspective, such collaborations often lead to positive investor sentiment and can drive Rallybio's stock price upward, assuming that the market perceives this partnership and the development of RLYB212 favorably.
From a medical research standpoint, the collaboration between Rallybio and Johnson & Johnson is a strategic move that could accelerate the development of therapies for FNAIT, a rare but serious condition. RLYB212's unique position as the only reported investigational therapy for non-alloimmunized individuals at risk of FNAIT underscores its potential impact on the market. The Phase 2 dose confirmation study planned for the second half of 2024 will be critical in determining the efficacy and safety of RLYB212, which, if successful, could lead to a new standard of care for FNAIT prevention.
Furthermore, the collaboration's focus on raising awareness and emphasizing the importance of screening could lead to earlier detection and treatment, potentially improving patient outcomes. As such, the medical community and potential stakeholders should closely monitor the progress of this collaboration and the clinical development of RLYB212, as it represents a significant advancement in addressing an unmet medical need.
Understanding the market dynamics for rare disease treatments is essential when evaluating the impact of Rallybio's recent collaboration. The market for FNAIT therapies is niche, yet it holds a high value due to the lack of available treatments. Rallybio's strategic partnership with Johnson & Johnson could enhance its market penetration capabilities and drive the adoption of RLYB212 upon successful development and approval. The investment in awareness initiatives is also a tactful approach to create a receptive market environment for the new therapy.
Moreover, the collaboration's potential to expand treatment options to a broader range of patients—both alloimmunized and non-alloimmunized—could effectively increase the target market size for Rallybio. This inclusive strategy is likely to be well-received by the patient community and healthcare providers, potentially leading to a stronger demand for RLYB212 if it is approved for use.
- Rallybio to Receive Funding for FNAIT Awareness Initiative and Equity Investment from Johnson & Johnson -
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.”
Rallybio is currently conducting a natural history study designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population that is intended to support a future RLYB212 registration study. Pregnant individuals who are already alloimmunized are not eligible for inclusion in Rallybio’s natural history study, nor for potential preventative treatment with Rallybio’s investigational therapeutic, RLYB212.
About FNAIT
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns. FNAIT can arise during pregnancy due to an immune incompatibility between an expectant mother and her fetus in a platelet antigen. When alloimmunization occurs in an expectant mother, the antibodies that develop in the mother can cross the placenta and destroy platelets in the fetus. The destruction of platelets in the fetus can result in severely low platelet counts, or thrombocytopenia, and potentially lead to devastating consequences including miscarriage, stillbirth, death of the newborn, or severe lifelong neurological disability in those babies who survive. There is currently no approved therapy for the prevention or prenatal treatment of FNAIT.
About Rallybio
Rallybio (Nasdaq: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The Company has two clinical stage programs: RLYB212, an anti-HPA-1a antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and RLYB116, an inhibitor of complement component 5 (C5), with the potential to treat several diseases of complement dysregulation, as well as additional programs in preclinical development. Rallybio is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and on currently available information. All statements, other than statements of historical facts contained in this press release are forward-looking statements. 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 timing of initiation of the Phase 2 dose confirmation study for RLYB212, the release of screening numbers of women in the natural history study, and whether the results of the natural history study and the planned Phase 2 dose confirmation study will be sufficient to support design and implementation of a Phase 3 registrational study for RLYB212. 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 studies, and complete such clinical studies 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, our ability to enter into strategic partnerships or other arrangements, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio’s filings with the
____________________
1 FNAIT Collaboration Agreement between Momenta Pharmaceuticals, Inc., a Johnson & Johnson Company, and Rallybio IPA, LLC. |
2 Alloimmunizing: an immune response to foreign antigens upon exposure to genetically different cells or tissues |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240408380440/en/
Investors
Samantha Tracy
Rallybio Corporation
(475) 47-RALLY (Ext. 282)
stracy@rallybio.com
Hannah Deresiewicz
Stern Investor Relations, Inc.
(212) 362-1200
hannah.deresiewicz@sternir.com
Media
Victoria Reynolds
Mission North
(760) 579-2134
rallybio@missionnorth.com
Source: Rallybio Corporation
FAQ
What is Rallybio's ticker symbol?
What is the focus of Rallybio's collaboration with Johnson & Johnson?
What is RLYB212?
When is Rallybio planning to initiate a Phase 2 dose confirmation study for RLYB212?
What is the purpose of Rallybio's natural history study?
