<h2>Study objective and method</h2>
To demonstrate

The benefits of adding lyso-GL-3&nbsp;to&nbsp;►

Primary diagnostic for testing for&nbsp;►

Improving detection rate of potential females with FD

Avoiding unnecessary genetic testing

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width: 1120px;">
 <tbody>
 <tr>
 <td>
 First large prospective study</td>
 </tr>
 </tbody>
</table>

11,948&nbsp;females with suspicion of FD
&nbsp;
tested for

Biochemical tests
<ul>
 <li>α-Gal A activity</li>
 <li>Lyso-GL-3 levels</li>
</ul>
&nbsp;
followed by

Genetic confirmatory testing in&nbsp;883&nbsp;females

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td rowspan="7">
 <h3 style="text-align: center;">Groups</h3></td>
 <td style="text-align: center; vertical-align: top;">01.&nbsp;Low α-Gal A activity High lyso-GL-3</td>
 <td style="text-align: center; vertical-align: top;">02.&nbsp;Low α-Gal A activity Normal lyso-GL-3</td>
 <td style="text-align: center; vertical-align: top;">03.&nbsp;Normal α-Gal A activity High lyso-GL-3</td>
 <td style="text-align: center; vertical-align: top;">04.&nbsp;Normal α-Gal A activity Normal lyso-GL-3</td>
 </tr>
 <tr>
 <td colspan="1" style="text-align: center; vertical-align: top;">Classical FD very likely (n=61)</td>
 <td style="text-align: center; vertical-align: top;">Classical FD unlikely (n=184)</td>
 <td style="text-align: center; vertical-align: top;">
 FD very likely (n=256)</td>
 <td style="vertical-align: top;">
 95.8 had normal results (n=11,447*)</td>
 </tr>
 <tr>
 <td colspan="3" rowspan="1" style="text-align: center;">Genetic confirmatory test</td>
 <td style="text-align: center;">No further testing required</td>
 </tr>
 </tbody>
</table>

(184/883) females were identified with one or two&nbsp;GLA&nbsp;variants.

black

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td style="text-align: center;">Distribution of genetically positive samples</td>
 </tr>
 </tbody>
</table>

Better indicator of FD

Elevated lyso-GL-3 levels (39% PPV)

Clearly negative results for both biochemical parameters:
Unlikely to have FD, even in clinically highly suspicious cases

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width: 1120px;">
 <tbody>
 <tr>
 <td style="text-align: center;">Proposed diagnosis decision tree</td>
 </tr>
 </tbody>
</table>

<h3>STEP 2</h3>
Once enzyme deficiency is confirmed, molecular testing is performed to identify GLA genetic variants.

<h3>STEP 2</h3>
Once enzyme activity (deficient or not) together with elevated biomarker is confirmed, molecular testing is performed to identify GLA genetic variants.

*Mutation analysis performed in 389 cases.
α-Gal A: Alpha-galactosidase A; dbFGP: Fabry disease genotype–phenotype database; FD: Fabry disease; Lyso-GL-3: Globotriaosylsphingosine; PPV: Positive predictive value; DBS: Dried blood spotting; GLA: Galactosidase alpha; VUS: Variant of unknown significance.

Reference

BIOCHEMICAL DIAGNOSTIC STRATEGY IN FEMALES SUSPECTED OF FABRY DISEASE

FABRY

RARE-DISEASE

<h2>What molecular pathways are implicated in cGVHD?</h2>
Several pathways have been shown to be key mediators of disease progression in chronic graft-versus-host disease.1

The rho-associated coiled-coil–containing protein kinase (ROCK) molecular pathway plays a key role in immune and fibrotic disease.2,3&nbsp;Additionally, ROCK is downstream of major profibrotic mediators and regulates multiple fibrotic processes, such as myofibroblast activation and profibrotic gene transcription.3 ROCK2, specifically, is involved in both the inflammatory and fibrotic components of cGVHD and has been shown to play an important role in modulating immune homeostasis.2 
 Selective ROCK2 inhibition has been shown to help resolve immune dysregulation by downregulating pro-inflammatory T helper (Th) 17 cells and increasing regulatory T (Treg) cells.2&nbsp;Furthermore, selective ROCK2 inhibition has been shown to downregulate key fibrotic processes, such as TGF-β and LPA, leading to a decrease in fibrosis and collagen deposition.3-5

ROCK

Following HCT, B-cell homeostasis and tolerance mechanisms are disrupted, resulting in reduced memory B-cell formation.6&nbsp;These host-reactive B cells are associated with the development of cGVHD.7 
 BTK is a signaling molecule of the B-cell antigen receptor and cytokine receptor pathways,8&nbsp;which is expressed mainly in B cells and other hematopoietic tissues.9&nbsp;Signaling via BTK results in the activation of pathways necessary for B-cell trafficking, chemotaxis and adhesion.8

JAK1 and JAK2 are signal mediators of several cytokines and growth factors that are necessary for hematopoiesis and immune function. STATs are recruited to cytokine receptors during JAK signaling, leading to modulation of gene expression.10 In cGVHD pathogenesis, JAK-STAT molecular pathways regulate the development, proliferation and activation of various immune cell types.10

IL-2, a cytokine signaling molecule, is essential for normal Treg cell development, expansion, activity and survival. CD4+&nbsp;Treg cells play a role in immune tolerance and controlling immune responses.&nbsp;Impaired Treg cell function is characteristic of cGVHD and is associated with loss of tolerance and autoimmunity.11

IL-2

Research continues to uncover the role of these pathways.

Learn more about inflammation and fibrosis

What manifestations are caused by the activation of these pathways?

Abbreviations

References

Molecular Pathway

CHRONIC-GRAFT-VERSUS-HOST-DISEASE-CGVHD

TRANSPLANT

<h2>Manufacturing vaccines is a complex journey</h2>
It takes between 6 to 36 months to produce, package and deliver high quality vaccines to those who need them. This includes testing each batch of vaccine at every step of its journey and repeat quality control of batches by different authorities around the world.
Vaccines manufacturing is a biological process where a very high level of expertise is required. We need to continually adapt to satisfy evolving regulatory demands which vary country by country. In addition, the production process is under even greater pressure as demand for certain vaccines grows, such as pediatric combination vaccines and as demand increases from the global public health community to investigate new and emerging threats.

Sanofi Pasteur top priority is to provide vaccines to protect people’s health. We believe in a world in which no one suffers or dies from a vaccine preventable disease. In order to achieve that goal, we have implemented an ongoing investment program in building internal production capabilities.

<h2>Journey of vaccine3</h2>
Vaccine research is long, complex and costly. Its development cycle and production are specific.

Sanofi Pasteur at Glance

INFLUENZA

VACCINES

<div>
 <h2>GENETIC PROFILE</h2>
 ASMD is an autosomal recessive LSD caused by pathogenic variants in the ASM enzyme–encoding gene sphingomyelin phosphodiesterase 1 (SMPD1). 
 Sphingomyelin helps regulate cellular processes, such as cell cycle regulation, cell signaling, and apoptosis. 
 When ASM activity is deficient, sphingomyelin cannot be sufficiently metabolized; it accumulates in lysosomes, particularly in macrophages and hepatocytes. This accumulation damages cells in multiple organs, leading to potentially life-threatening complications. 
 Males and females have an equal chance of being affected4
</div>

Historically known as Niemann-Pick disease type A (NPA) or infantile neurovisceral ASMD
<ul>
 <li>Onset: Early Infancy</li>
 <li>Phenotype: Rapidly progressive with acute multiorgan manifestations and neurodegeneration</li>
 <li>Life Expectancy: 2 to 3 years of age</li>
</ul>

Type A

Historically known as Niemann- Pick disease type A/B (NPA/B) or chronic neurovisceral ASMD
<ul>
 <li>Onset: Infancy to childhood</li>
 <li>Phenotype: Variably progressive with multiorgan manifestations and differing degrees of neurologic involvement</li>
 <li>Life Expectancy: Between early childhood and adulthood</li>
</ul>

Type A/B

Historically known as Niemann- Pick disease type B (NPB) or chronic visceral ASMD
<ul>
 <li>Onset: Infancy to childhood</li>
 <li>Phenotype: Chronic with multiorgan manifestations and no or only minor neurologic involvement</li>
 <li>Life Expectancy: Between childhood and late adulthood</li>
</ul>

Type B

The rarity of ASMD, heterogeneity of its manifestations, and challenging differential diagnosis can result in delayed diagnosis and management of patients.
Early diagnosis of ASMD is critical for appropriate management.

<h3>IMPORTANCE OF EARLY DIAGNOSIS</h3>

A simple enzyme activity test can be performed on a DBS (dried blood spot) to indicate reduced ASM activity.
A positive DBS enzyme assay is highly indicative of ASMD, but an analysis from a whole blood sample and/or genetic testing is required to confirm the diagnosis.5

HOW TO DIAGNOSE

Identifying known disease-causing alleles of ASMD allows for
<ol>
 <li>Individual genetic counseling</li>
 <li>Carrier screening for at-risk individuals</li>
 <li>Family planning</li>
</ol>

ASMD

ACID-SPHINGOMYLENASE-DEFICIENCY-NIEMANN-PICK

<h3>Avoiding influenza may reduce the risk of influenza-related heart attack3:</h3>
META-ANALYSIS: Estimates of interventional efficacy in secondary prevention of myocardial infarction3

<h3>Avoiding influenza can help reduce the risk of severe outcomes4:</h3>
In 124,503 people with type 2 diabetes, from 2003-2010, influenza vaccination was associated with substantial reductions in hospital admission rates.4

aNot significant. 
 AMI=acute myocardial infarction.

<h3>The CDC Advisory Committee on Immunization Practices (ACIP) recommends routine annual influenza vaccination for all eligible persons aged ≥6 months5:</h3>
While the ACIP recommends all persons aged 6 months and older who do not have contraindications receive an influenza vaccine, it is especially important for populations who are at increased risk for severe illness and medical complications. These include, but are not limited to, adults aged 50 years and older and people who have5:
<ul>
 <li>Chronic pulmonary disorders (including asthma)</li>
 <li>Cardiovascular diseases (excluding isolated hypertension)</li>
 <li>Metabolic disorders (including diabetes)</li>
</ul>
<h3>The ACIP recommends being vaccinated against influenza by the end of October each year5:</h3>
Since the timing of the influenza season is unpredictable and vaccine-induced immunity may wane over time, the ACIP suggests the following timing recommendations5:
DON’T VACCINATE TOO EARLY: Early vaccination in July or August for nonpregnant adults should be avoided because it may be associated with decreased vaccine effectiveness before the end of the influenza season, especially for older adults.5
OFFER VACCINATIONS THROUGH FLU SEASON: Vaccination should continue to be offered as long as influenza viruses are circulating.5

Flu and Vaccination

<h2>Nirsevimab is the 1st&nbsp;RSV immunization designed for all infants1 including those born*:</h2>

Healthy or underlying condition

Term or pre-term

During or before RSV season

Nirsevimabis indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season..1
*Beyfortus is contraindicated in infants with hypersensitivity to the active substance or to any of the excipients1

<h2>Health Authorities are Recognizing the Need for RSV Prevention and the High Potential of Nirsevimab</h2>
Nirsevimab is setting a new precedent by achieving accelerated reviews, approvals, and preferential recommendations in many countries as the launch continues

<ul>
 <li>Approved in&nbsp;52&nbsp;countries</li>
 <li>Medical / Scientific Recommendations&nbsp;44</li>
 <li>Recommended by NG in&nbsp;17&nbsp;countries</li>
 <li>Preferential Recommendationa&nbsp;in&nbsp;7&nbsp;countries</li>
</ul>

Countries where nirsevimab is approvedb

NG: National Government a. All infants immunization is the preferential recommendation over maternal immunization b. As of 30 September 2024
Rapid adoptions of All Infants Protection recommendations globally, launched in first countries in 2023, gearing up for 2024

2023:
<ol>
 <li>O’Leary ST, Yonts AB, Gaviria-Agudelo C, Kimberlin DW, Paulsen GC. Summer 2023 ACIP Update: RSV Prevention and Updated Recommendations on Other Vaccines. Pediatrics. 2023; doi: 10.1542/peds.2023-063955</li>
 <li>Nirsévimab, BEYFORTUS 50 et 100 mg, solution injectable en seringue préremplie, Primo-inscription Adopté par la Commission de la transparence le 19 juillet 2023</li>
 <li>Ponencia de Programa y Registro de Vacunaciones</li>
 <li>NIAC recommends RSV immunisation for infants and older adults (imt.ie) eurosurveillance-rsv-luxembourg-2023.pdf (public.lu)</li>
 <li>Recomendación del CAVEI sobre incorporación de un anticuerpo monoclonal para inmunización pasiva contra virus respiratorio sincicial en lactantes en el ProgramaNacional de Inmunizaciones 
 &nbsp;</li>
</ol>
2024:
<ol>
 <li>Epidemiologisches Bulletin 26/2024 (rki.de)</li>
 <li>onsensus statement - recommendation on the prevention of respiratory syncytial virus (RSV) infections with the monoclonal antibody Nirsevimab (Beyfortus®).pdf</li>
 <li>Immunisation-against-RSV-in-the-first-year-of-life-Summary.pdf</li>
 <li>https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-statement-prevention-respiratory-syncytial-virus-disease-infants.html</li>
</ol>
Statement on the prevention of respiratory syncytial virus disease in infants - Canada.ca Valid as of May 17, 2024: The National Advisory Committee on Immunization's statement on the prevention of respiratory syncytial virus disease in infants.

<h2>All infants protection, using the EtR, the votes under consideration regarding nirsevimab were as follows&nbsp;1,2:</h2>
Infants aged &lt;8 months&nbsp;born during or entering their first RSV season are recommended&nbsp;to receive one dose of nirsevimab.&nbsp;(50 mg for infants &lt;5 kg and 100 mg for infants ≥5 kg)

Children aged 8 through 19 months who are at increased risk of severe RSV disease (per current AAP recommendations for infants recommended to receive palivizumab) and entering their second RSV season are recommended to receive one dose of nirsevimab (200 mg).
EtR; Evidence to Recommendations; RSV: Respiratory syncytial virus; AAP: American Academy of Pediatrics

<h2>Germany STIKO Recommendation on Nirsevimab for RSV Prophylaxis in Infants</h2>

The STIKO recommends RSV prophylaxis with&nbsp;the monoclonal antibody Nirsevimab (Beyfortus) as a single dose for all newborns&nbsp;and infants before or during their first RSV season
&nbsp;
Newborns of any gestational age born during the RSV season should receive Nirsevimab as soon as possible after birth, ideally upon discharge from the maternity facility.
&nbsp;
After examining the available evidence for MI, the STIKO concluded that the current data is insufficient to make a recommendation. Given the small study population and considering the suspension of a similar vaccine’s development due to preterm birth signals during pregnancy, reliable data are essential.

Paediatric population at high risk of developing serious disease from RSV infection, including: (a) preterm infants with &lt;35 weeks gestational age (a single dose should be administered before 12 months of age);

Nirsevimab is recommended&nbsp;in children under 6 months of age born from 1 April 2023 until 31 March 2024.&nbsp;Priority will be given to immunise those born during the season and those born previously will be immunised as early as possible (October).

Nirsevimab International Recommendation

RESPIRATORY-SYNCYTIAL-VIRUS

<h2>Our Heritage</h2>
For over 100 years, Sanofi Pasteur has been committed to extending the life-saving power of vaccination as broadly as possible. Our history is grounded in life science pioneers who discovered how infectious diseases work. They unlocked the public health potential of vaccination and developed efficient mass production methods to ensure the broadest access to vaccines.
Our portfolio of vaccines, ranging from cholera, dengue fever, diphtheria, to&nbsp;haemophilus influenzae&nbsp;type b, polio, pertussis, tetanus, hepatitis A and B, meningococcal meningitis, influenza, to name a few, offer protection against a wide range of infectious diseases to people around the world. We work hand-in-hand with public health partners so our vaccines can help protect as many as half a billion lives annually.

Our team brings their passion to discover and develop vaccines to enhance protection for children, adolescents and adults alike. Our researchers are seeking effective vaccines to extend the benefits of vaccination to a number of infectious diseases, such as respiratory syncytial virus infections which can cause severe lung infections among children, including bronchiolitis and pneumonia.
We are not standing still with our existing vaccines. Our latest generation of 6-in-1 pediatric vaccines helps improve childhood immunization and reduces the number of vaccination visits for infants while improving comfort for children and reducing anxiety for parents1.
With the public health community we are actively involved in addressing funding, access and distribution challenges that inhibit vaccinations in countries with underdeveloped infrastructure. This is what drives us forward and gives us purpose.

Together with our public and private partners, we are all driven by a common goal:

<h3>Your older patients with cardiovascular diseases are at increased risk of a first major cardiovascular event when diagnosed with influenza2:</h3>

Flu and Cardiovascular Disease

In subjects at least 40 years of age or older2,a
an=1227

~10x increased risk of a first heart attack

In subjects 40 years of age or older2,b
bn=762

~8x increased risk of a first stroke

Study limitations: Individual noninfluenza respiratory virus impact and age impact on vascular events were not investigated. During the study period there were changes in microbiological testing practices (eg, PCR was not widely used in 2004). The day after the date of respiratory sampling was used as the start of the risk period.2
<h3>The American Heart Association urges eligible individuals aged 6 months and older to get their annual flu shot3:</h3>
Protecting against influenza can help reduce the risk of cardiovascular events and can help keep your patients out of the hospital.4

<h3>Your patients with chronic respiratory conditions are at increased risk for dangerous complications when diagnosed with influenza2-5</h3>

Flu and Respiratory Disease

<h3>In a study of the correlation between influenza and pneumonia, participants with symptomatic influenza had6:</h3>

3234 children aged 0-14 years old were enrolled in this Nicaraguan study.6,a
&nbsp;
Study limitations:&nbsp;Generalizability to US children may be limited. Given pneumonia is a rare outcome, the categorization by subtype resulted in fewer cases per strata, which may limit statistical power.6

~8x (95% CI: 4.8-14.5) 
 
 increased risk of developing pneumonia within a week following influenza infection

<h3>The American Lung Association urges eligible individuals aged 6 months and older to get their annual flu shot7</h3>
Protecting against influenza can help reduce the risk of pneumonia and can help keep your patients out of the hospital.2,4,8

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