Pipeline
This is just the beginning
MediSieve has concluded Phase I clinical studies of the Capture System and is making swift progress in its bead programmes. Concluded Phase 1 clinical studies.
Pipeline
Discover our current and upcoming programmes
Application
Enabling Therapy for AAV Gene Therapies
Adeno-associated virus (AAV) vectors are the most established platforms for the targeted delivery of therapeutic genetic material directly into specific tissues in the body, offering cures for diseases such as Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Haemophilia and more. AAV vectors are used in nine gene therapy products currently approved in the United States, six of which are also authorised in Europe. More than 200 AAV-based programmes have entered clinical development across a wide range of genetic diseases. These therapies are designed to address the underlying genetic cause of the disease. Most are intended for a single administration, and sustained clinical benefits have been demonstrated in several indications.
A key limitation of AAV gene therapies is pre-existing immunity to the viral capsid. Natural exposure to wild-type AAV can generate pre-existing neutralising antibodies (NAbs) which block the therapy. NAbs are detectable in 30% to 60% of individuals. When an AAV vector is delivered through the bloodstream, even relatively low NAb titres may reduce vector transduction. Systemically administered AAV therapies therefore require antibody testing before administration, and patients above therapy-specific thresholds are deemed ineligible for treatment.
The problem of AAV NAbs is even more acute when in the context of redosing. While the effects of AAV gene therapies can persist for years, gene expression and therefore clinical benefit can wane over time. However, exposure to AAV capsids during the initial therapy causes very high AAV NAb titres that persist over long periods of time. As of today, because of this problem, no patient can ever be redosed.
MediSieve is developing Magnetic Blood Filtration to reduce circulating anti-AAV antibodies before treatment. The system is designed to selectively capture these antibodies from the bloodstream to bring NAb titres below therapy-specific eligibility thresholds while limiting the non-specific removal of other antibodies and plasma components. This reduction in neutralising antibodies could create a treatment window for patients who are otherwise ineligible to receive life-changing AAV gene therapies.
Working on an AAV programme where pre-existing immunity or redosing presents a challenge?
Application
Enabling Therapy for AAV Gene Therapies
Adeno-associated virus (AAV) vectors are the most established platforms for the targeted delivery of therapeutic genetic material directly into specific tissues in the body, offering cures for diseases such as Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Haemophilia and more. AAV vectors are used in nine gene therapy products currently approved in the United States, six of which are also authorised in Europe. More than 200 AAV-based programmes have entered clinical development across a wide range of genetic diseases. These therapies are designed to address the underlying genetic cause of the disease. Most are intended for a single administration, and sustained clinical benefits have been demonstrated in several indications.
A key limitation of AAV gene therapies is pre-existing immunity to the viral capsid. Natural exposure to wild-type AAV can generate pre-existing neutralising antibodies (NAbs) which block the therapy. NAbs are detectable in 30% to 60% of individuals. When an AAV vector is delivered through the bloodstream, even relatively low NAb titres may reduce vector transduction. Systemically administered AAV therapies therefore require antibody testing before administration, and patients above therapy-specific thresholds are deemed ineligible for treatment.
The problem of AAV NAbs is even more acute when in the context of redosing. While the effects of AAV gene therapies can persist for years, gene expression and therefore clinical benefit can wane over time. However, exposure to AAV capsids during the initial therapy causes very high AAV NAb titres that persist over long periods of time. As of today, because of this problem, no patient can ever be redosed.
MediSieve is developing Magnetic Blood Filtration to reduce circulating anti-AAV antibodies before treatment. The system is designed to selectively capture these antibodies from the bloodstream to bring NAb titres below therapy-specific eligibility thresholds while limiting the non-specific removal of other antibodies and plasma components. This reduction in neutralising antibodies could create a treatment window for patients who are otherwise ineligible to receive life-changing AAV gene therapies.
Working on an AAV programme where pre-existing immunity or redosing presents a challenge?
Application
Enabling Therapy for AAV Gene Therapies
Adeno-associated virus (AAV) vectors are the most established platforms for the targeted delivery of therapeutic genetic material directly into specific tissues in the body, offering cures for diseases such as Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Haemophilia and more. AAV vectors are used in nine gene therapy products currently approved in the United States, six of which are also authorised in Europe. More than 200 AAV-based programmes have entered clinical development across a wide range of genetic diseases. These therapies are designed to address the underlying genetic cause of the disease. Most are intended for a single administration, and sustained clinical benefits have been demonstrated in several indications.
A key limitation of AAV gene therapies is pre-existing immunity to the viral capsid. Natural exposure to wild-type AAV can generate pre-existing neutralising antibodies (NAbs) which block the therapy. NAbs are detectable in 30% to 60% of individuals. When an AAV vector is delivered through the bloodstream, even relatively low NAb titres may reduce vector transduction. Systemically administered AAV therapies therefore require antibody testing before administration, and patients above therapy-specific thresholds are deemed ineligible for treatment.
The problem of AAV NAbs is even more acute when in the context of redosing. While the effects of AAV gene therapies can persist for years, gene expression and therefore clinical benefit can wane over time. However, exposure to AAV capsids during the initial therapy causes very high AAV NAb titres that persist over long periods of time. As of today, because of this problem, no patient can ever be redosed.
MediSieve is developing Magnetic Blood Filtration to reduce circulating anti-AAV antibodies before treatment. The system is designed to selectively capture these antibodies from the bloodstream to bring NAb titres below therapy-specific eligibility thresholds while limiting the non-specific removal of other antibodies and plasma components. This reduction in neutralising antibodies could create a treatment window for patients who are otherwise ineligible to receive life-changing AAV gene therapies.
Working on an AAV programme where pre-existing immunity or redosing presents a challenge?
Application
Direct Therapy for IL-6 Driven Hyperinflammation
Hyperinflammation or dysregulated immune responses result from an imbalance between pro-inflammatory cytokines, such as IL-6, and anti-inflammatory cytokines, like IL-10. These conditions commonly occur in hospitalised patients, especially those in intensive care units (ICUs). Elevated levels of IL-6 in the bloodstream have been strongly associated with disease progression and outcomes, including prognosis and mortality rates. IL-6's role is particularly prominent in various conditions such as Acute Respiratory Distress Syndrome (ARDS), Acute Pancreatitis, Sepsis, Acute Kidney Injury, Cytokine Release Syndrome, Burn and Trauma, Cardiac Surgery, Pneumonia, and COVID-19.
Standard treatment approaches for these conditions typically involve organ support (such as dialysis and ventilation), fluid management, and appropriate administration of antibiotics. Numerous studies have revealed a correlation between high IL-6 levels upon admission and acute inflammation, as well as a poor prognosis for patients.
MediSieve's product offers a unique selling point by providing the ability to modulate the IL-6 cascade through the physical removal of soluble IL-6 from the blood. This innovative technology holds several key benefits:
1. Improved patient outcomes: By intervening and reducing the severity of hyperinflammatory conditions, this novel approach has the potential to alleviate patient suffering and lower mortality rates.
2. Reduced hospital stay: By mitigating the intensity and severity of hyperinflammatory conditions, the average time spent in ICUs and hospitals can be significantly decreased. This allows patients to be discharged earlier, freeing up vital healthcare resources.
3. Lower treatment costs: Reducing the duration of hospital stays, particularly in ICUs, can lead to substantial cost savings for healthcare systems. By reducing resource utilisation and optimising patient care, the financial burden on both patients and healthcare providers can be reduced.
Application
Direct Therapy for IL-6 Driven Hyperinflammation
Hyperinflammation or dysregulated immune responses result from an imbalance between pro-inflammatory cytokines, such as IL-6, and anti-inflammatory cytokines, like IL-10. These conditions commonly occur in hospitalised patients, especially those in intensive care units (ICUs). Elevated levels of IL-6 in the bloodstream have been strongly associated with disease progression and outcomes, including prognosis and mortality rates. IL-6's role is particularly prominent in various conditions such as Acute Respiratory Distress Syndrome (ARDS), Acute Pancreatitis, Sepsis, Acute Kidney Injury, Cytokine Release Syndrome, Burn and Trauma, Cardiac Surgery, Pneumonia, and COVID-19.
Standard treatment approaches for these conditions typically involve organ support (such as dialysis and ventilation), fluid management, and appropriate administration of antibiotics. Numerous studies have revealed a correlation between high IL-6 levels upon admission and acute inflammation, as well as a poor prognosis for patients.
MediSieve's product offers a unique selling point by providing the ability to modulate the IL-6 cascade through the physical removal of soluble IL-6 from the blood. This innovative technology holds several key benefits:
1. Improved patient outcomes: By intervening and reducing the severity of hyperinflammatory conditions, this novel approach has the potential to alleviate patient suffering and lower mortality rates.
2. Reduced hospital stay: By mitigating the intensity and severity of hyperinflammatory conditions, the average time spent in ICUs and hospitals can be significantly decreased. This allows patients to be discharged earlier, freeing up vital healthcare resources.
3. Lower treatment costs: Reducing the duration of hospital stays, particularly in ICUs, can lead to substantial cost savings for healthcare systems. By reducing resource utilisation and optimising patient care, the financial burden on both patients and healthcare providers can be reduced.
Application
Direct Therapy for IL-6 Driven Hyperinflammation
Hyperinflammation or dysregulated immune responses result from an imbalance between pro-inflammatory cytokines, such as IL-6, and anti-inflammatory cytokines, like IL-10. These conditions commonly occur in hospitalised patients, especially those in intensive care units (ICUs). Elevated levels of IL-6 in the bloodstream have been strongly associated with disease progression and outcomes, including prognosis and mortality rates. IL-6's role is particularly prominent in various conditions such as Acute Respiratory Distress Syndrome (ARDS), Acute Pancreatitis, Sepsis, Acute Kidney Injury, Cytokine Release Syndrome, Burn and Trauma, Cardiac Surgery, Pneumonia, and COVID-19.
Standard treatment approaches for these conditions typically involve organ support (such as dialysis and ventilation), fluid management, and appropriate administration of antibiotics. Numerous studies have revealed a correlation between high IL-6 levels upon admission and acute inflammation, as well as a poor prognosis for patients.
MediSieve's product offers a unique selling point by providing the ability to modulate the IL-6 cascade through the physical removal of soluble IL-6 from the blood. This innovative technology holds several key benefits:
1. Improved patient outcomes: By intervening and reducing the severity of hyperinflammatory conditions, this novel approach has the potential to alleviate patient suffering and lower mortality rates.
2. Reduced hospital stay: By mitigating the intensity and severity of hyperinflammatory conditions, the average time spent in ICUs and hospitals can be significantly decreased. This allows patients to be discharged earlier, freeing up vital healthcare resources.
3. Lower treatment costs: Reducing the duration of hospital stays, particularly in ICUs, can lead to substantial cost savings for healthcare systems. By reducing resource utilisation and optimising patient care, the financial burden on both patients and healthcare providers can be reduced.
