- Rallybio to Receive Funding for FNAIT
Awareness Initiative and Equity Investment from Johnson &
Johnson -
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.”
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 New Haven, Connecticut. For more information,
please visit www.rallybio.com and follow us on LinkedIn and
Twitter.
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 U.S.
Securities and Exchange Commission (SEC), including Rallybio’s
Annual Report on Form 10-K for the period ended December 31, 2023,
and subsequent filings with the SEC. The events and circumstances
reflected in our forward-looking statements may not be achieved or
occur and actual future results, levels of activity, performance
and events and circumstances could differ materially from those
projected in the forward-looking statements. Except as required by
applicable law, we are not obligated to publicly update or revise
any forward-looking statements contained in this press release,
whether as a result of any new information, future events, changed
circumstances or otherwise.
____________________
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
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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
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