Last update 24 Jun 2024
RLYB-212
Last update 24 Jun 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms RLYB 212, RLYB-212 |
Target |
Mechanism CD61 inhibitors(integrin subunit beta 3 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
Gene Sequence
Sequence Code 2380CDR1-L
Sequence Code 10217CDR2-L
Sequence Code 218946CDR1-H
Sequence Code 9985561VH
Sequence Code 9985568VL
Sequence Code 9985586CDR2-H
Sequence Code 9985597CDR3-H
Sequence Code 9985622CDR3-L
Sequence Code 9985701L
Sequence Code 1117836306H
Related
1
Clinical Trials associated with RLYB-212A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
Start Date01 Sep 2024 |
Sponsor / Collaborator- |
100 Clinical Results associated with RLYB-212
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100 Translational Medicine associated with RLYB-212
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100 Patents (Medical) associated with RLYB-212
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44
News (Medical) associated with RLYB-21217 Jun 2024
– First Reported Large-Scale Analysis of FNAIT Risk Across Broad Population of Diverse Ancestries –
– Topline Results Suggest a Significant Increase in the Number of Pregnancies at Higher Risk for FNAIT Annually and the RLYB212 Addressable Market –
– Rallybio On Track to Initiate RLYB212 Phase 2 Dose Confirmation Study in Pregnant Women at Higher Risk for FNAIT in 2H 2024 –
NEW HAVEN, Conn.--(BUSINESS WIRE)-- Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported topline results from an epidemiological analysis of large genomic datasets evaluating the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in diverse ancestries. Data from this analysis confirmed Caucasian populations as having the greatest proportion of women with the genetic markers for higher FNAIT risk (HPA-1a negative, HLA-DRB3*01:01 positive). Additionally, data from this analysis provides, for the first time, robust evidence quantifying the proportion of women in non-Caucasian ancestries that carry the genetic markers for higher FNAIT risk.
These data indicate that the proportion of pregnant women at higher risk for FNAIT annually has been significantly underestimated. For example, in key geographies of North America and major European countries, it is estimated that more than 30,000 pregnancies each year are at higher risk for FNAIT, representing a 40% increase from prior estimates. Full data from the epidemiological analysis are expected to be presented at a scientific conference in the fourth quarter of 2024.
“This epidemiological analysis leverages the availability of large-scale, diverse genomic datasets, and provides the first clear evidence of the extent to which ancestries beyond the Caucasian population can carry a higher risk for FNAIT,” said Stephen Uden, MD, Chief Executive Officer of Rallybio. “These data indicate that FNAIT risk is more prevalent than previously estimated and highlights the importance of screening. Unlike many other rare diseases, we believe that screening for FNAIT risk could be seamlessly incorporated into standard prenatal care for all mothers. This would ensure all women at higher risk for FNAIT could then be offered prophylactic treatment with RLYB212, if approved.”
Dr. Uden continued, “Based on this new information, we now believe RLYB212 represents a commercial opportunity of greater than $1.6 billion. We thank HealthLumen for their partnership in this endeavor to expand our understanding of FNAIT risk across diverse ancestries.”
Topline results from this analysis demonstrate that the proportion of women at higher risk of alloimmunization and FNAIT was greatest in European Caucasian populations, consistent with published literature. Additionally, the results demonstrate a comparable proportion of women at higher risk in Hispanic White populations, as well as a relatively moderate proportion of women at higher risk in Hispanic Black and Non-Hispanic Black populations. Proportions of women at higher risk in South Asian, East Asian, and Amerindigenous populations were found to be low relative to the European Caucasian populations.
The analysis was conducted by Rallybio in partnership with HealthLumen, a leader in epidemiological modeling of rare genetic diseases. Allele frequencies for HPA-1a were obtained from gnomAD v4, which contains exome and genome sequencing data from approximately 810,000 individuals. Allele frequencies for HLA DRB3*01:01, which is associated with approximately 25-fold higher risk of alloimmunization, were obtained from the US National Marrow Donor Registry (NMDR), which includes data from approximately 2,700,000 individuals.
Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody, to prevent alloimmunization in pregnant women and thereby, eliminate the risk of FNAIT and its potentially devastating consequences in their fetuses and newborns. Rallybio expects to initiate a Phase 2 dose confirmation study of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in the second half of 2024. The Company is also conducting a non-interventional FNAIT natural history study that is designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. As of May 1, 2024, Rallybio had screened approximately 10,000 pregnant women.
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 specific platelet antigen called human platelet antigen 1, or HPA-1.
There are two predominant forms of HPA-1, known as HPA-1a and HPA-1b, which are expressed on the surface of platelets. Individuals who are homozygous for HPA-1b, meaning that they have two copies of the HPA-1b allele and no copies of the HPA-1a allele, are also known as HPA-1a negative. Upon exposure to the HPA-1a antigen, these individuals can develop antibodies to that antigen in a process known as alloimmunization. In HPA-1a-negative expectant mothers bearing a HPA-1a-positive fetus, alloimmunization can occur upon mixing of fetal blood with maternal blood. When alloimmunization occurs in an expectant mother, the anti-HPA-1a 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 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 diversity of ancestries that carry the genetic markers for FNAIT, the increase in the number of pregnancies estimated to be at high risk of FNAIT each year based on the epidemiological analysis and our estimates of the number of pregnancies at higher risk of FNAIT, our ability to identify the number of pregnant women at higher risk of FNAIT based on the results of the analysis, our ability to ensure routine prenatal screening, our estimates of the market opportunity for RLYB212, the timing of initiation of the Phase 2 dose confirmation study for RLYB212, our expectations regarding the usefulness of data from our clinical studies, and the timing of publications relating to FNAIT and 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 trials, including the FNAIT natural history study, and the Phase 2 clinical trial for RLYB212, 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, 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 Quarterly Report on Form 10-Q for the period ended March 31, 2024, 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.
Phase 2Clinical Result
09 May 2024
- On Track to Initiate RLYB212 Phase 2 Dose Confirmation Trial in Pregnant Women at Higher Risk of FNAIT in 2H 2024 -
- $94.2 Million in Cash, Cash Equivalents, and Marketable Securities as of March 31, 2024; Provides Runway into Mid-2026 -
NEW HAVEN, Conn.--(BUSINESS WIRE)-- Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported first quarter financial results for the period ended March 31, 2024 and provided an update on recent company developments.
“This year is off to a strong start as we continue to progress towards the initiation of our Phase 2 dose confirmation trial for RLYB212 in pregnant women at higher risk of FNAIT, which is on track for the second half of 2024," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Last month, we were particularly pleased to announce our collaboration with Johnson & Johnson, marking a significant step forward in our mission to eliminate FNAIT and its devastating consequences. Together with Johnson & Johnson, we look forward to further driving awareness of FNAIT, emphasizing the importance of screening for FNAIT risk, and advancing our complementary therapeutic approaches, which aim to ensure all pregnant women at risk of FNAIT have a potential treatment option regardless of their alloimmunization status."
Dr. Uden continued, "In the near-term, we look forward to sharing initial data from an epidemiologic analysis investigating the genetic markers of FNAIT risk in a racially and ethnically diverse population beyond the Caucasian population, where FNAIT risk has been better established in published literature. This analysis will more accurately inform the number of pregnant women at higher risk for FNAIT annually. We expect that these data combined with data from our ongoing FNAIT natural history study will further emphasize the need for a preventative therapeutic and identify a market opportunity for RLYB212 that is larger than our current estimates."
Recent Business Highlights and Upcoming Milestones:
Corporate Updates
In April 2024, Rallybio announced a collaboration with Momenta Pharmaceuticals, Inc., a Johnson & Johnson Company, to advance complementary therapeutic solutions for pregnant women at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Rallybio received an equity investment of $6.6 million from Johnson & Johnson Innovation – JJDC, Inc.
In February 2024, Rallybio announced a prioritization of its portfolio and a 45% workforce reduction to focus the Company’s resources on its two Phase 2 ready assets, RLYB212, a novel human monoclonal anti-HPA-1a antibody in development for the prevention of FNAIT, and RLYB116, a once-weekly, low volume subcutaneously injected inhibitor of complement component 5 (C5) in development for patients with complement-mediated diseases.
RLYB212 Program
Rallybio is on track to initiate a Phase 2 trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in the second half of 2024. The primary objectives of this trial are to assess the pharmacokinetics and safety of subcutaneously administered RLYB212 in pregnant women. Secondary objectives include assessments of pregnancy and neonatal outcomes, and the occurrence of emergent HPA-1a alloimmunization. Administration of RLYB212 will be initiated by Gestational Week 16 and continue every 4 weeks through parturition.
Screening in the Company's FNAIT natural history study is ongoing. This study is designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. As of May 1, 2024, Rallybio has screened approximately 10,000 pregnant women. The FNAIT natural history study is designed to run in parallel with the Phase 2 study and to continue through to initiation of the planned Phase 3 trial to enable seamless transition of participating sites into the registration trial.
To better understand the frequency of HPA-1a-negative, HLA-DRB3*01:01-positive status in a broad and diverse population, Rallybio partnered with HealthLumen, a leader in epidemiological modeling of rare genetic diseases, to conduct an epidemiologic analysis utilizing information from large genomic datasets. Rallybio expects data from this analysis to be disclosed in mid-2024.
Several presentations and publications are expected in the second half of 2024, including additional data from the Phase 1b proof-of-concept study and an integrated summary of clinical and nonclinical data supporting the RLYB212 Phase 2 dose.
RLYB116 Program
RLYB116 manufacturing work continues and is on track to complete in the second half of 2024. Furthermore, additional biomarker development work is underway to further evaluate results of the Phase 1 multiple ascending dose (MAD) study, which was completed in the fourth quarter of 2023. Rallybio expects to provide an update on this analysis and future development plans for RLYB116 in the second half of 2024.
Preclinical Programs
Rallybio continues to believe that its preclinical programs have the potential to address significant existing unmet needs for patients and caregivers and bring meaningful value to stakeholders. Given Rallybio's focus of current capital and resources on its clinical-stage assets, primarily RLYB212, the Company is seeking alternative options to further advance its preclinical programs, including partnerships and other forms of non-dilutive financing.
RLYB332: In the first quarter of 2024, Rallybio completed nonclinical studies that demonstrated favorable tolerability, dose-dependent pharmacokinetics, and sustained pharmacodynamic effects with RLYB332, a long-acting version of the RLYB331 anti-Matriptase-2 antibody. These findings support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload. Presentation of this data is expected in the second half of 2024.
RLYB114, EyePoint Collaboration: EyePoint has demonstrated feasibility for sustained delivery of Rallybio’s inhibitor of C5 using EyePoint’s proprietary intraocular drug delivery technology, and optimization work is ongoing.
First Quarter 2024 Financial Results
Research & Development (R&D) Expenses: R&D expenses were $12.9 million for the first quarter of 2024, compared to $11.2 million for the same period in 2023. The increase in R&D expense was primarily due to an increase in payroll and personnel-related costs, largely related to severance costs incurred in connection with the workforce reduction, effective March 6, 2024. The increase was partially offset by a decrease in costs related to the development of RLYB212.
General & Administrative (G&A) Expenses: G&A expenses were $6.9 million for the first quarter of 2024, compared to $7.2 million for the same period in 2023. The decrease in G&A expense was primarily related to decreases in other general and administrative related expenses and director and officer insurance premiums. This decrease was partially offset by an increase in payroll and personnel-related costs, primarily related to severance costs incurred in connection with the workforce reduction, effective March 6, 2024.
Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $19.0 million, or $0.47 per common share, for the first quarter of 2024. This compares to a net loss of $17.3 million, or $0.43 per common share, for the first quarter of 2023.
Cash Position: As of March 31, 2024, cash, cash equivalents, and marketable securities were $94.2 million.
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 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, 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, whether the manufacturing work for RLYB116 will be timely completed or successful, the timing of the availability of data from our clinical studies, our expectations regarding the usefulness of data from our clinical studies, our expectations regarding driving awareness of FNAIT through the Johnson & Johnson collaboration, our ability to more accurately identify the number of pregnant women at higher risk of FNAIT based on the results of the genomic analysis, our estimates of the market opportunity for RLYB212, the timing of publications relating to FNAIT and RLYB212, the timing of completion of the RLYB116 biomarker work, the timing of achieving milestones in 2024 for our preclinical programs, the likelihood that Rallybio will be successful in developing RLYB212, RLYB116, or any of our other product candidates, our ability to successfully identify and implement alternative and acceptable options to further advance our programs, our estimates of our capital requirements and the sufficiency thereof, and our cash runway. 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 FNAIT natural history study, and the Phase 2 clinical trial for RLYB212, 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, 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.
Financial Tables
RALLYBIO CORPORATION
SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
FOR THE THREE MONTHS ENDED MARCH 31,
(in thousands, except share and per share amounts)
2024
2023
Operating expenses:
Research and development
$
12,936
$
11,202
General and administrative
6,851
7,172
Total operating expenses
19,787
18,374
Loss from operations
(19,787
)
(18,374
)
Other income:
Interest income
1,276
1,546
Other income
167
73
Total other income, net
1,443
1,619
Loss before equity in losses of joint venture
(18,344
)
(16,755
)
Loss on investment in joint venture
685
563
Net loss
$
(19,029
)
$
(17,318
)
Net loss per common share, basic and diluted
$
(0.47
)
$
(0.43
)
Weighted-average common shares outstanding, basic and diluted
40,773,615
40,248,893
Other comprehensive (loss) gain:
Net unrealized (loss) gain on marketable securities
(86
)
153
Other comprehensive (loss) gain
(86
)
153
Comprehensive loss
$
(19,115
)
$
(17,165
)
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
MARCH 31,
2024
DECEMBER 31,
2023
Cash, cash equivalents and marketable securities
$
94,175
$
109,929
Total assets
99,359
115,620
Total liabilities
10,202
9,436
Total stockholders' equity
89,157
106,184
Phase 1Phase 2Financial StatementPROTACs
07 May 2024
NEW HAVEN, Conn.--(BUSINESS WIRE)-- 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 that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Tuesday, May 14, 2024 at 11:30 a.m. ET in New York, NY.
A live webcast of the fireside chat will be accessible through the Events and Presentations section of Rallybio’s website at . An archived replay of the webcast will be available for 30 days following the presentation.
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 and follow us on LinkedIn and Twitter.
View source version on businesswire.com:
Contacts
Investors
Samantha Tracy
Rallybio Corporation
(475) 47-RALLY (Ext. 282)
investors@rallybio.com
Kevin Lui
Stern Investor Relations, Inc.
(212) 698-8691
kevin.lui@sternir.com
Media
Victoria Reynolds
Mission North
(760) 579-2134
rallybio@missionnorth.com
Source: Rallybio Corporation
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100 Deals associated with RLYB-212
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Alloimmune thrombocytopenia | Phase 1 | US | 30 Jan 2022 | |
| Fetal and neonatal alloimmune thrombocytopenia | Phase 1 | US | 06 Jan 2022 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Biospace Manual  | Phase 1 | 8 | pihiguajpa(sdkrpgcqqb) = RLYB212 was observed to be generally well-tolerated with no reports of injection site reactions or serious adverse events. qqagfbyitf (uqxmawszmw ) | Positive | 28 Nov 2023 | ||
placebo | |||||||
Not Applicable | - | aespnwtsdd(zscujalegx) = aaioqrznrt aywfeqwpmv (qcumvofonw ) View more | - | 24 Jun 2023 | |||
aespnwtsdd(zscujalegx) = snlfbzmnje aywfeqwpmv (qcumvofonw ) View more | |||||||
Corporate Publications Manual | Phase 1 | - | vitxsvhgfe(ginzshwadb) = ahsmmrnlko qmhybhifsn (fnbbhionuq ) | Positive | 28 Sep 2022 | ||
Placebo | - |
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