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Tecartus

Tecartus

INTRODUCTION

Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it is a type of B-cell non- Hodgkin’s lymphoma that develops from malignant B cells within the mantle zone, a region of the lymph node. 60–70-year-old men are the most frequent patients among the 200,000 individuals that are diagnosed with MCL each year. The most common first-line treatment is chemotherapy combined with immunotherapy, which can be accompanied by a stem cell transplant and/or an extended course of immunotherapy to prolong cancer remission. As mantle cell lymphoma is an uncommon form of non-Hodgkin’s lymphoma (NHL), accounting for 5% to 7% of all cases of NHL, it is considered a rare disease ². Therefore, Tecartus was considered an orphan medicine in November 2019. It is indicated after two or more unsuccessful treatments, including BTK inhibitors. Patients with mantle cell lymphoma have poor outcomes, particularly if the cancer is not responding to a BTK inhibitor or comes back after therapy with a BTK inhibitor. Tecartus provides a treatment option for these patients¹.

DRUG CHARACTERISTICS

Autologous anti-CD19-transduced CD3+ T-cells make up the active substance of Tecartus. They are activated CD3+ T cells (including CD3+ CD4+ and CD3+ CD8+ cells) obtained from the patient blood, transduced with retroviral vectors expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor, and cultured to be reinfused. These cells can then attack cancer cells that express CD19. It is an advanced therapy englobed in CAR-T treatments, patient-specific, which is given as a single infusion into a vein after a short course of chemotherapy. Immediately before, the patient is treated with paracetamol and antihistamines to reduce the reactions to the infusion

APPROVAL

74 patients are currently involved in the main ongoing study, whose cancer has relapsed after at least two previous treatments including BTK inhibitors. Approximately, 59% of patients had a complete response, a higher percentage than with other treatments. Therefore, the EMA (European Medicines Agency) considered that Tecartus benefits are greater than its risks and they approved its use throughout the EU with a conditional authorization in December 2020¹.

RISK ASSESSMENT

More than half of the patients involved in the pivotal clinical study presented important side effects. Cytokine release syndrome is among them, being the most serious, as it is a potentially life-threatening condition that can cause pain, low blood pressure, shortness of breath, fever, and vomiting. Another severe side effect is encephalopathy, which is a brain disorder that causes headaches, mental confusion, and somnolence. Infections are also
common with this treatment. The risks are still being assessed, and there is still a lack of information about the long-term effects and safety in old patients, women, and with advanced disease. In case of cytokine release syndrome, the hospital must have available tocilizumab and emergency equipment. During at least ten days after treatment, patients should be closely monitored for side effects, and they should be close to a hospital for four weeks¹.

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

Tecartus

Tecartus

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
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KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION

Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapy
product category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in children and
young adults under the age of 25 whose cancer did not respond to previous treatment, has
relapsed two or more times or has relapsed after stem cell transplantation².
 
ALL is a type of cancer of the blood and bone marrow and the most common cancer in children. The term «acute» is derived from the fact that the disease progresses rapidly and creates immature
aberrant lymphocytes³. Kymriah is also approved to treat adults with Diffuse large B-cell lymphoma (DLBCL) whose cancer has recurred or did not respond after two or more prior treatments ². DLBCL is a type of non-Hodgkin lymphoma (NHL), a cancer of the lymphatic system characterized by abnormal proliferation of B lymphocytes⁴ . As both diseases are rare, Kymriah was recognized as an orphan medicine (a medicine used to treat rare diseases) for B-cell ALL and DLBCL in 2014 and 2016 respectively².

DRUG CHARACTERISTICS

Kymriah is made from the patient’s own T cells, which are extracted from the blood and genetically modified in the laboratory to produce a Chimeric Antigen Receptor (CAR). This CAR is specifically designed to bind to CD19 protein², expressed by most B cells. This molecule is required for the survival, differentiation, and activation of B cells in the peripheral immune system⁵. The modified T cells are injected into a vein as a single infusion, following short-term chemotherapy to deplete the patient’s white blood cells. Immediately before infusion, they are administered paracetamol and antihistamines to reduce the risk of infusion reactions ².

APPROVAL

Kymriah’s pivotal study in B-cell ALL involved 92 children and young adults (ages 3–25) whose cancer had recurred or did not respond after previous treatment. About 66% of patients showed a complete remission within three months after treatment. This was better than what was seen with other drugs, such as clofarabine, blinatumomab, or a combination of clofarabine, cyclophosphamide, and etoposide. After 12 months of treatment, the probability of survival was 70%². Patients with B-cell ALL have a poor prognosis (5-year overall survival between 56 and 66%⁶). As improvements with Kymriah were better than with other medicines for this condition, it received a marketing authorization valid throughout Europe and the US for ALL in 2017².

RISK ASSESSMENT

Most patients experience serious side effects, which may include cytokine release
syndrome. It is a potentially life-threatening illness that can cause fever, vomiting, shortness of
breath, pain, and low blood pressure. It may also cause a decrease in platelets, hemoglobin,
neutrophils, and lymphocytes. However, these conditions can be managed with appropriate
measures such as close monitoring for ten days after treatment and staying close to a specialist
clinic for at least four weeks after treatment. Also, in the case of cytokine release syndrome,
another drug (tocilizumab) and emergency equipment can be used².

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

2018;

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
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Carvykti™, the new advanced therapy approved by FDA

Carvykti™, the new advanced therapy approved by FDA

INTRODUCTION

¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment of relapsed or refractory multiple myeloma after four or more prior lines of therapy, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies. The disease is a blood cancer that affects plasma cells, found in the bone marrow. When damaged, these cells quickly spread and give rise to tumors. Although additional treatment options have been developed in recent years, most patients with multiple myeloma face a poor prognosis after disease progression following treatment with these three primary therapy classes².

DRUG CHARACTERISTICS

CARVYKTI™ is a chimeric antigen receptor T-cell (CAR-T) therapy using two single-domain antibodies directed against B- cell maturation antigen (BCMA). It involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that recognizes and eliminates BCMA-expressing cells. Malignant B cells of multiple myeloma are the cells that mainly express BCMA, although mature B cells and plasma cells do it too. When bound with BCMA-expressing cells, the therapy promotes T cell activation, expansion, and elimination of target cells2.

APPROVAL

The approval of the therapy was based on data from the pivotal, open-label, multicenter, Phase 1b/2 CARTITUDE-1 study, which enrolled patients with a median of six prior regimens and whose disease progressed during or after the last treatment. Previous treatment regimens included at least one proteasome inhibitor, one immunomodulator, and one anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the study, 99% were refractory to last-line therapy, and 88% were triple-class refractory, meaning their cancers did not respond, or no longer respond, to any of the three main treatment categories. In the CARTITUDE-1 clinical study, 98% of patients with relapsed or refractory multiple myeloma responded to ciltacabtagene autoleucel monotherapy, and 78% of responders experienced a strict complete response. Responses showed durability over time, resulting in most heavily pretreated patients achieving deep responses at 18 months of follow-up2.

RISK ASSESSMENT

As a personalized medicine, CARVYKTI™ treatment requires extensive training, preparation, and certification to ensure a positive patient experience. It is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI™ REMS program. Safety information for this therapy includes a warning on Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Parkinson’s disease, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and persistent or recurrent cytopenia2.

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

1. FDA grants approval to Janssen’s Carvykti for multiple myeloma treatment.
2. U.S. FDA Approves CARVYKTITM (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma | Johnson & Johnson. Content Lab US. .

Carvykti™, the new advanced therapy approved by FDA

Carvykti™, the new advanced therapy approved by FDA

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
Publicado el

Can a biopsy spread cancer?

Can a biopsy spread cancer?

Ultrasound and magnetic resonance imaging (MRI) are frequent tools to evaluate if an area is a tumor candidate. However, in most cases, the only way to definitively diagnose cancer is to take a biopsy and look at those suspicious cells under a microscope. Sometimes, a biopsy will show that the suspected area contains only benign cells, indicating that treatments, such as surgery, radiation therapy, or chemotherapy are not needed. In other cases, a biopsy can discern how aggressive the cancer is and how advanced (stage and grade) the disease is. Furthermore, it can ease the determination of the type of cancer cells in the tumor. Together, this information can support the decision of the best course of action to treat cancer1.

Doctors remove a small portion of tissue from the suspected tumor or affected area during a biopsy. There are many different techniques for performing biopsies. For example, in a fine-needle aspiration biopsy, a doctor inserts a needle attached to a syringe into the suspicious area to remove a small amount of tissue for diagnosis. Another approach is an excisional biopsy, in which the doctor removes the entire suspicious mass for examination. Many biopsies are performed under imaging guidance, called image-guided biopsies, which use ultrasounds or computed tomography (CT) scans to locate problematic areas and collect samples1. 

Typically, biopsy samples are preserved in special preservatives and sent to a pathology laboratory for processing3. Then, a pathologist looks at it under a microscope to complete the diagnosis. He is specialized in interpreting laboratory tests and evaluating cells, tissues, and organs to diagnose diseases1. The first step of tissue processing is ensuring that the tests are accurate based on the patient’s characteristics. Depending on the type of assessment required, the following steps may take hours or days. Pathologists identify other factors that affect treatment or recovery. These may include genetic characteristics that can determine treatment options or predict chances of recovery3. When he has finished, the biopsy tissue is stored for a long time. This way, the primary tumor can be checked if cancer recurs or spreads in the future. The pathologist can determine whether the original primary tumor has returned, or if it is a new tumor by looking at the sample again. He can also re-analyze the samples when new treatments based on tumor genetics emerge. Frequently, biopsy samples are used for research to discover new treatments and targeted therapies, only with the patient’s consent3. 

 

Like every medical procedure, biopsies have some risks. For instance, there is a low risk of bleeding, infection, or tumor seeding. The latter is a rare condition in which a needle inserted into a tumor during a biopsy frees and spreads cancer cells. It is frequently known as needle tract or tract seeding because cancer cells grow along the needle tract. Much research has been performed on this topic, concluding that the incidence of needle track seeding is minimal (between 1 and 3 percent). Overall, while needle seeding during a biopsy is not impossible, it is uncommon, and biopsy benefits far outweigh the risks1.

 

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

1. Can a Biopsy Make My Cancer Spread? Cancer.Net. 2021; 

2. Biopsia renal – Mayo Clinic. 

3. Biopsy: 5 Things Every Patient Should Know. Cancer.Net. 2016; 

 

 

Can a biopsy spread cancer?

Can a biopsy spread cancer?

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
Publicado el

Do solar panels increase the risk of developing cancer?

Do solar panels increase the risk of developing cancer?

Are solar panels safe?

Solar panels are placed on the roofs of buildings or in solar farms. Some people wonder whether the technology used to build or operate them carries an increased risk for cancer development. Solar energy is obtained by solar panels and solar farms through photovoltaic technology, which uses cells to absorb the sun’s radiation and convert it to electricity. Afterward, that electricity is stored in batteries or sent to the electrical network1. There are two different types of solar panel technologies: silicon cells and thin-film technology2.

1. COMPOSITION OF SOLAR PANELS

Crystalline silicon cells are the most frequently used domestic solar panels. They are mainly made from rocks, sand2, glass, and aluminum, along with other commonly used plastics and wires. Specifically, the cells of silicon solar panels are made of silicon, which is a natural and common element1. However, they contain small pieces of lead, which can be toxic. Contrarily, thin-film solar panels have a completely different technology from silicon ones. Instead of using silicon, they use various compounds which may be toxic, such as gallium arsenide and cadmium telluride2.

2. DO SOLAR PANELS CAUSE CANCER?

Although some solar panels contain materials that can be toxic, most of the domestic solar panels are made from silicon technology, which is completely safe. The amount of harmful elements is minimal and they are encapsulated by a robust glass and aluminum case to prevent human exposure2. Furthermore, most people do not have direct contact with solar panels, even if they are placed on the roofs of their houses1. In contrast, thin-film technology uses significant quantities of toxic elements, including cadmium and gallium. However, like their silicon counterparts, the elements are completely sealed using an aluminum and glass case2.

3. DOES ELECTROMAGNETIC RADIATION COMING FROM SOLAR PANELS CAUSE CANCER?

Studies of magnetic fields generated by roof-mounted solar panels are scarce, and no definitive conclusions can be drawn. Nevertheless, most research suggests that they are safe because electricity from solar panels and transmission to the electrical network emits extremely weak electromagnetic fields1. Besides, the electricity that the solar panels produce is usually in the form of a direct current, which does not produce electromagnetic fields. Even if some solar panels are carrying AC power, the wires are well coated. Overall, electric magnetic fields produced by solar panels meet industry requirements established for all electrical devices by regulatory bodies, such as the FCC (Federal Communication Commission) in the United States2. In fact, solar panels and solar farms may actually reduce the risk of cancer indirectly, because they are replacing other electricity-generating sources that can contribute to air pollution, which can cause cancer1.

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

  1. Can Having Solar Panels or Living Near a Solar Farm Increase Your Cancer Risk? Cancer.Net. 2022;
  2. Do Solar Panels Cause Cancer? (An Analysis & Case Study) – Green Coast. 2019;

Do solar panels increase the risk of developing cancer?

Do solar panels increase the risk of developing cancer?

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
Publicado el

Immune checkpoint inhibitors most common side effects

Immune checkpoint inhibitors most common side effects

WHAT IS IMMUNOTHERAPY?

Immunotherapy is a type of cancer treatment that increases the body’s natural defenses to fight cancer. It improves the immune system’s ability to find and attack cancer cells2 by using substances made either by the body or in a laboratory. This treatment can be used alone or combined with other cancer treatments. There are different kinds of immunotherapies, each working in a different way. Some of them boost the immune system to stop or slow the growth of cancer cells, whereas others destroy cancer cells or stop the cancer from spreading to other parts of the body. The most common immunotherapy types include monoclonal antibodies, tumor-agnostic treatments (such as checkpoint inhibitors), oncolytic viruses, T-cell therapy and cancer vaccines. The tumor-agnostic treatments treat tumors anywhere in the body by focusing on specific genetic changes3. Research is being done to help identify those patients for whom immunotherapy may succeed and those who may have severe side effects4. The type of drug, dose, and treatment schedule depend on many factors, as the type of cancer, size, location, where it has spread, the age, general health, body weight, and how well the patient can cope with side effects3.

WHAT ARE IMMUNE CHECKPOINT INHIBITORS?

Immune checkpoint inhibitors are used to treat many types of cancer, including lung cancer, melanoma, bladder cancer, melanoma, colorectal cancer, kidney cancer 1 and many others. They target the immune checkpoint proteins, which are designed to stop the immune system 4 . For instance, they include PD-1, PD-L1, and CTLA-4 1 . Blocking these proteins activates the immune system in a highly effective way. However, immune checkpoint inhibitors are a new kind of therapy, so the research community is still learning about how it affects people. The over-activation of the immune system can end up attacking healthy and functional parts of the body, causing unpredictable side effects that can be life-threatening if not treated in time 4 . One example of an approved immune checkpoint inhibitor is pembrolizumab, used to treat metastatic tumors that have a specific molecular alteration (microsatellite instability-high) or DNA mismatch repair deficiency. Another example is nivolumab, which has also been approved to treat adults and children with microsatellite instability-high or DNA mismatch repair deficiency in metastatic colorectal cancer that has not been stopped by chemotherapy. Other common immune checkpoint inhibitors are ipilimumab, atezolizumab, avelumab, durvalumab 3 , cemiplimab, and dostarlimab 2

WHY DO IMMUNE CHECKPOINT INHIBITORS CAUSE SIDE EFFECTS?

What are the most common immune checkpoint inhibitors side effects? Any cancer treatment can cause side effects, including immunotherapy 1 , because sometimes the immune system can also attack healthy cells, creating «immune-related adverse events». These side effects can occur at any time during treatment, or sometimes even after stopping immunotherapy, and can range from mild to severe 1 . They will depend on the type of immunotherapy 2 , the type of cancer, its location, general health and other factors, and are different for each person. Therefore, patients should always ask their doctors about the side effects of their personalised treatment 1 .

WHICH ARE THE MOST COMMON SIDE EFFECTS OF IMMUNE CHECKPOINT INHIBITORS?

The most common side effects include gastrointestinal tract problems (diarrhea or colitis as the most frequent, and less commonly, nausea or vomiting) 2 , skin rashes 1 (covering less than 10% of the body) or itching 2 , fatigue, shortness of breath, liver problems 1 , fever, headache, weight loss, difficulty falling or staying asleep, decreased appetite 4 , or problems with the muscles, joints, and bones. Besides, treatment with immune checkpoint inhibitors can cause inflammation of the tissues of the eyes, especially in people who receive a combination of immune checkpoint inhibitors 2 . There are many other possible side effects, including severe ones, but not as frequent as these. Of note, they are common but may not occur in all people or with all types of immunotherapies 4 .


If they occur moderate or severe side effects, the treatment may be paused and the doctor may prescribe corticosteroids or other medications to calm the immune system of the patient. If the side effects are relieved, the doctor may try to start immunotherapy again or adjust the treatment regimen 2

Victoria Menéndez

CoFounder and Chief Scientific Officer

victoria.menendez@geistek.com

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REFERENCES

  1. What People With Cancer Should Know About Immune Checkpoint Inhibitor Side Effects. Cancer.Net. 2021;
  2. Schneider BJ, Naidoo J, Santomasso BD, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J. Clin. Oncol. 2021;39(36):4073–4126.
  3. Understanding Immunotherapy. Cancer.Net. 2013;
  4. What You Need to Know About Immunotherapy Side Effects. Cancer.Net. 2018.

Immune checkpoint inhibitors most common side effects

Immune checkpoint inhibitors most common side effects

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
Publicado el

Acuerdo de Geistek y Nowture para el desarrollo Life Science en España

Acuerdo de Geistek y Nowture para el desarrollo Life Science en España

Geistek x Nowture

Geistek Pharmaceuticals y el fondo de inversión Nowture llegan a un acuerdo para la promoción del ecosistema Life Science en España

Geistek Pharmaceuticals llega a un acuerdo con el fondo de inversión Nowture con el objetivo de colaborar en el desarrollo y promoción del ecosistema biotecnológico y de ciencias de la vida en España.

Con este acuerdo Geistek organizará una vez al mes un foro de inversión con aquellas compañías del sector life science que requieran de financiación y que acudan con proyectos con alto potencial de desarrollo e impacto en la sociedad.

Los ámbitos de inversión cubren desde el descubrimiento de fármacos, hasta el desarrollo de tecnologías biomédicas, biotecnología y biología sintética. Los foros mensuales se organizarán de la siguiente forma:

    • Se debe rellenar el formulario siguiente https://geistek.com/financiation/ para que recibamos toda la información y podamos analizarla desde el punto de vista científico-técnico.
  2.  
    • Se enviarán una vez al mes todos los datos facilitados de todas las compañías candidatas a Nowture. Tras una reunión en la que participarán miembros del equipo de Geistek Pharmaceuticals y Nowture, se procederá a evaluar cuáles son las compañías que presentan un mayor potencial de desarrollo y promoción en el sector.
  3.  
    • Tras esta primera revisión, a las empresas seleccionadas se les dará la posibilidad de ofrecer un Pitch con el equipo promotor de Nowture con el objetivo de resolver dudas, y explicar en mayor profundidad el objetivo de su proyecto.
  4.  
    • Tras estas reuniones, se comunicará a las compañías seleccionadas el dictamen favorable por parte de Nowture, y se comenzarán los trámites pertinentes.

Esta oportunidad que ofrece Nowture para la financiación de proyectos en fase seed y pre–seed supone un avance en España para la generación de un Innnovation Hub dentro del sector biotech que será altamente competitivo con el resto de los países europeos.

Si quieres participar en uno de nuestros foros de inversión, podrás ponerte en contacto con nosotros en el correo electrónico generalinfo@geistek.com, o si no tienes ninguna duda, podrás adjuntar la información solicitada directamente en el enlace https://geistek.com/financiation/. 

Acuerdo de Geistek y Nowture para el desarrollo Life Science en España

Acuerdo de Geistek y Nowture para el desarrollo Life Science en España

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Tecartus

INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it

Diego Fajardo mayo 10, 2022
Uncategorized

KYMRIAH, AN ANTI-CD19 CAR-T THERAPY

INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in

Diego Fajardo abril 19, 2022
Publicado el

Nuevo tratamiento para el Alzheimer

Tratamiento Alzheimer

Nuevo tratamiento para el Alzheimer

Tratamiento Alzheimer

Polémica aprobación por parte de la FDA del primer fármaco para la Enfermedad de Alzheimer en 20 años

El Alzheimer (EA) es una enfermedad neurodegenerativa que causa deficiencias progresivas en la memoria, el lenguaje y el pensamiento, con la eventual pérdida de la capacidad para realizar actividades sociales y funcionales en la vida diaria. En general, la supervivencia promedio es de 4 a 8 años después de su diagnóstico. Existe una necesidad médica urgente e insatisfecha de tratamientos efectivos que retrasen, detengan, reviertan, prevengan o curen la enfermedad.

Aducanumab-avwa (IND 106230) es un anticuerpo monoclonal de inmunoglobulina gamma 1 (IgG1) humana recombinante, fabricado por la compañía Biogen y dirigido a formas agregadas solubles e insolubles de péptido beta amiloide (Aβ). Los depósitos extracelulares de Aβ, denominados placas amiloides, son una de las características patológicas de la EA, junto con los agregados intracelulares de proteína tau hiperfosforilada en forma de ovillos neurofibrilares. Se ha propuesto que la acumulación de Aβ en el cerebro es el principal impulsor del proceso de la enfermedad y precede a la acumulación patológica de proteína tau hiperfosforilada y degeneración neuronal.

La biotecnológica Biogen presentó a la FDA la solicitud de evaluación acelerada de su terapia biológica (BLA, del inglés Biologics License Application) a fecha 7 de julio de 2020, y recibió la aprobación el día 6 de julio de 2021.  Esta decisión ha hecho que la Agencia americana se lleve un aluvión de críticas fundamentadas en la inconsistencia de los resultados de los ensayos clínicos presentados, lo cual ha tenido como consecuencia la dimisión de varios de los consejeros externos de la FDA tras la votación.

Fuente: revisión clínica hecha por la FDA en la que se fundamentó la toma de la decisión

Según informes de evaluadores externos de la FDA, existen discordancias en los resultados de los estudios 301 y 302 que no dejan clara la eficacia del aducanumab en el tratamiento de la EA.

Los consejeros de la FDA afirmaron que el ensayo clínico 301 es un estudio negativo que no contribuye a la evidencia de la eficacia clínica del aducanumab, sin embargo, la FDA argumenta que sus resultados pueden ser complementarios a los del estudio 302, el cual tuvo un fin prematuro.

Ante el hecho de la temprana finalización del ensayo clínico 302 la FDA consideró que los datos, aún así, eran lo suficientemente interpretables y capaces de dar evidencia de la eficacia del medicamento. La Agencia americana calificó a este estudio como “robusto y excepcionalmente persuasivo que otorga la evidencia primaria suficiente como para apoyar a la aprobación del fármaco”.

Con respecto a la concesión de la evaluación acelerada por la Agencia americana se señaló que:

«…EL EFECTO DEPENDIENTE DEL TIEMPO Y DE LA DOSIS  CUMPLEN CON EL ESTÁNDAR DE EVIDENCIA SUSTANCIAL DE EFECTIVIDAD»
«…LA EVIDENCIA QUE RESPALDA EL BENEFICIO CLÍNICO ES FUERTE, PERO ESTÁ ASOCIADA A LA INCERTIDUMBRE RESIDUAL TRANSMITIDA POR LOS RESULTADOS DEL PUNTO FINAL DEL ESTUDIO 301 (Y LA CONTRIBUCIÓN ASOCIADA DE ESOS RESULTADOS A LA TERMINACIÓN PREMATURA DE AMBOS ESTUDIOS)»

En la votación realizada sobre la concesión, de la autorización se obtuvieron un total de 6 votos a favor, 15 votos en contra, y 12 votos en blanco, dividiéndose éstos en preguntas como:

    • ¿El Estudio 302, visto de forma independiente y sin tener en cuenta el Estudio 301, proporcionar pruebas sólidas que respalden la eficacia de aducanumab para la tratamiento de la enfermedad de Alzheimer? Esta pregunta obtuvo un total de un voto a favor, 8 en contra y 2 en blanco.
    • ¿El estudio 103 proporciona evidencia de apoyo de la efectividad de aducanumab para el tratamiento de la enfermedad de Alzheimer? Esta pregunta obtuvo 0 votos a favor, 7 en contra y 4 en blanco.
    • ¿Ha presentado el solicitante pruebas sólidas de un efecto farmacodinámico sobre la fisiopatología de la enfermedad de Alzheimer? En esta pregunta se obtuvieron 5 votos a favor, 0 en contra y 6 en blanco.
    • ¿Considera el estudio 302 como evidencia principal de la eficacia de aducanumab para el tratamiento de la enfermedad de Alzheimer? En esta pregunta se obtuvieron 6 votos a favor, 15 en contra y 12 en blanco.

Fuente: una comparación de aducanumab con otros mAbs muestra que mientras que los últimos mAb se dirigieron en gran medida contra la región del extremo amino de la péptido Aβ y solo reconocieron monómeros, aducanumab se dirigió contra un epítopo conformacional que se encuentra únicamente en los oligómeros del péptido Aβ tóxico.

La FDA ha adjuntado en la carta en la que notificaban a Biogen la concesión de la autorización, un punto adicional que indica que deben realizar un ensayo clínico aleatorizado y controlado con el Gold Standard que ellos consideren siguiendo las siguientes fechas: 

    • Enviar el borrador del protocolo – 10/2021
    • Enviar el protocolo final – 08/2022
    • Haber finalizado el ensayo clínico – 08/2029
    • Enviar el informe final de ensayo – 02/2030

En la carta, la FDA les avisa de que:

«SI LOS ENSAYOS CLÍNICOS POSTERIORES A LA COMERCIALIZACIÓN NO LOGRAN VERIFICAR EL BENEFICIO CLÍNICO O NO SE LLEVAN A CABO CON LA DEBIDA DILIGENCIA, SE PODRÁ RETIRAR ESTA APROBACIÓN»

Desde el otro lado del charco, la Agencia Europea del Medicamento (EMA) ha desaconsejado a los países miembros la autorización del aducanumab. Habrá que esperar a los resultados del ensayo clínico impuesto por la FDA, y a los informes de farmacovigilancia que se vayan emitiendo, para saber si la EMA se retractará, o no, de su decisión sobre la autorización de aducanumab en los países de los Estados miembros de la Unión Europea.

Para cualquier duda relacionada con este post puedes escribirnos aquí.

Nuevo tratamiento para el Alzheimer

Nuevo tratamiento para el Alzheimer

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Ensayos clínicos N-of-1

Ensayos clínicos N-of-1

Geistek Hospital 2

El diseño de ensayos clínicos es un mundo muy complejo que requiere de personal altamente cualificado para poder elegir la mejor estrategia posible. La Medicina Basada en la Evidencia (MBE) se centra en tres pilares fundamentales, que son el juicio clínico, la evidencia científica, y la preferencia del paciente.

Según la MBE, el modelo de máxima evidencia en investigación clínica es el ensayo clínico aleatorizado (ECA), pero tiene algunos problemas. En este tipo de ensayos existe una determinada variabilidad interindividual que no permite conocer cuál es el tratamiento que mejor le puede venir a un paciente determinado. Por ello, surgieron los ensayos conocidos como N-of-1, con el objetivo de conocer cuál será el mejor tratamiento para un paciente, con una patología concreta a tratar.

Los ensayos N-of-1 fueron propuestos por primera vez en 1953 por Hogben y Sim, y consisten en administrar a un mismo paciente diferentes medicamentos y/o placebos, alternando con ciclos de lavado. Este tipo de ensayos están recomendados cuando exista un elevado nivel de incertidumbre en la efectividad comparativa entre dos tratamiento para un cierto paciente. Esta incertidumbre puede venir de diferentes fuentes:

    • No haber realizado un ECA.
    • Existencia de un conflicto entre la evidencia existente.
    • Evidencia cuestionable por el paciente.
    • Heterogeneidad de los efectos del tratamiento (HTE) no predecible con factores pronósticos.

Debido a que en este tipo de ensayos se testarán diferentes terapias y/o placebos en un mismo paciente, se requiere que su patología sea crónica, y estable (o de lenta progresión).

En el año 2015, se realizó un ensayo clínico en hipertensión pulmonar en el que no se sabía si a un paciente le daría mejor respuesta un antagonista del receptor de endotelinas, o un inhibidor de la fosfodiesterasa V. Por ello, el Brigham and Women’s Hospital de Boston realizó un ensayo N-of-1 sobre dicho paciente siguiendo un esquema A-B-C, donde A era el placebo, B era el antagonista del receptor de endotelinas, y C era el inhibidor de la fosfodiesterasa V, teniendo como variable no controlada la variación del volumen de oxígeno.

Diseño de un Ensayo Clínico N-of-1. Building the Case for Novel Clinical Trials in Pulmonary Arterial Hypertension.

Para poder desarrollar este tipo de ensayos, debido al cambio de terapias que se generan en el mismo paciente, es necesario que el efecto se establezca rápidamente, y que el periodo de lavado también sea rápido.

Algunos de los beneficios que conlleva el uso de este tipo de ensayos clínicos consisten en que los pacientes se sienten mucho más cómodos a la hora de recibir el tratamiento porque saben que el clínico elegirá el que más resultados genere en su propio cuerpo. Además, los médicos se desarrollan dentro del ámbito de la generación de datos basados en la MBE, y les motiva a participar en ensayos clínicos posteriores. Por otro lado, los datos generados serán de interés para la práctica clínica habitual, haciendo que el clínico pueda tomar decisiones sobre tratamiento con una mayor seguridad. 

Ensayos clínicos N-of-1

Ensayos clínicos N-of-1

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¿Conoces la vía PRIME de la EMA?

¿Conoces la vía PRIME de la EMA?

ema, european medicines agency logo

¿Qué es la vía PRIME?

La vía PRIME fue propuesta por la Agencia Europea del Medicamento (EMA) en marzo de 2016 con el objetivo de acelerar la llegada al mercado de aquellos medicamentos que podrían tratar enfermedades raras, o simplemente aquellas que no encuentran un tratamiento eficaz en la terapéutica actual. Está vía está especialmente orientada a los grupos académicos y las PYMES, que por norma general, no tienen un amplio conocimiento regulatorio. Gracias a PRIME, la EMA se encargará de proveer a estas instituciones de asesoramiento tanto científico, como regulatorio, previo inicio del ensayo clínico. 

A través de esta vía, los ensayos pueden recibir sesiones de consultoría para optimizar los resultados potencialmente generados, además de poder acceder al procedimiento de evaluación acelerada cuando se vaya a solicitar la autorización de comercialización. 

Este procedimiento reducirá los tiempos de evaluación desde los 210 días, hasta los 150 y se deberá solicitar con una antelación de al menos 2, o 3 meses, antes de presentar la solicitud de autorización de comercialización.

Para solicitar la evaluación acelerada, los investigadores deben justificar si el medicamento que pretenden lanzar al mercado es de gran interés para la salud pública y, en particular, desde el punto de vista de la innovación terapéutica. En caso de que la EMA valore que la información aportada es convincente, procederá a comprobar las certificaciones GMP y GCP del laboratorio, y las inspecciones rutinarias de ambas que hayan tenido. 

Los motivos por los que la evaluación acelerada pueda ser desestimada serán: 

    • Si existen objeciones mayores durante la evaluación, que no se resuelven a tiempo (tan solo se dispondrá de un mes para contestar). 
    • Cuando la compañía solicita una extensión del tiempo para contestar.
    • En caso de que se necesite llevar a cabo una inspección de GMP, o GCP.
    • Tras una “oral explanation”, la percepción es negativa. 

Según el informe presentado por la EMA en julio de 2021, las áreas que más aceptabilidad tienen dentro del programa PRIME son la hematología (62,96% aceptados), las vacunas (54,55% aceptados) y la psiquiatría (50% aceptados), mientras que los números más elevados de solicitudes son del área de la oncología (27 aceptados de 109), la neurología (8 aceptados de 44) y las enfermedades infecciosas (6 aceptados de 27).

En el informe publicado por la EMA el 14 de octubre de 2021 figura que aplicaron al programa PRIME un total de 375 compañías, de las cuales 96 recibieron un dictamen favorable. De estas 96, el 40,63% eran PYMES, y el 59,38% otros tipos de compañías entre las que no se incluyen grupos académicos.

Las terapias aceptadas durante 2021 por PRIME fueron:

    1. Pabinafusp alfa (JR-141), para el tratamiento de la mucopolisacaridosis tipo II.
    2. TAK-994, para el tratamiento de la narcolepsia con cataplexia. 
    3. MB-107, para el tratamiento de la inmunodeficiencia combinada severa ligada al cromosoma X (XSCID) en niños.
    4. CTI-1601, para el tratamiento de la ataxia de Friedreich.
    5. CTX001, para el tratamiento de la beta talasemia.
    6. Apitegromab, para el tratamiento de la atrofia muscular espinal.
    7. Obecabtagene, para el tratamiento de la leucemia linfoblástica aguda refractaria.
    8. PF-06863135, para el tratamiento del mieloma múltiple.
    9. RP-L201, para el tratamiento del síndrome de adhesión leucocitaria.
    10. ARU-1801, para el tratamiento de la anemia falciforme.
    11. Talquetamab, para el tratamiento de los pacientes con mieloma múltiple refractario que han recibido al menos 3 líneas terapéuticas previas.
    12. Teclistamab, para el tratamiento de los pacientes con mieloma múltiple refractario que han recibido al menos 3 líneas terapéuticas previas.

Si quieres conocer cómo aplicar a la vía PRIME, no dudes en ponerte en contacto con nosotros y te guiaremos durante todo el procedimiento, además de asesorarte sobre si el estudio cumple, o no, los criterios de elegibilidad impuestos por la EMA.

Tienes alguna duda más no dudes en preguntarnos. Haz clic aquí y pregúntanos.

¿Conoces la vía PRIME de la EMA?

¿Conoces la vía PRIME de la EMA?

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