FAQ & Glossary

This page is intended to answer some questions you may have and also to explain some of the terms found in the text. You can also use this page to navigate to the relevant sections of the website for further information.

Who are Promethera® Biosciences?

1. What does Promethera® Biosciences do?

Promethera® Biosciences is pioneering the development of cutting-edge cell-based therapies for the treatment of liver diseases, thereby restoring liver health. We are driven to create a diverse portfolio of drug candidates, both solo or in collaboration with carefully selected partners, to achieve our vision of treating patients worldwide. Learn more.

2. What is the company’s vision?

We are committed to bring patients life-saving treatment to reduce the need for liver transplantation.

3. What is it like to work at Promethera® Biosciences?

Promethera® is an exciting and diverse company. All our employee’s contributions are valued, and we work closely together to establish pioneering new liver therapies with the potential to save lives. Learn more.

4. What are the company’s values?

We are pioneers leaded by: Excellence Beyond Quality – Persistence – Professional Development – Team Spirit – Trust.

5. Do you have any available job opportunities?

We are always on the hunt for inspiring new colleagues. Learn more.

6. Where is the company located?

The Promethera® Group operates in 4 locations globally:

  • Promethera® Biosciences SA/NV is based in Wallonia, Belgium (headquarters)
  • Promethera® Biosciences LLC is based in Durham, North Carolina, US (organ sourcing and manufacturing)
  • Promethera® Biosciences Japan is based in Tokyo, Japan (Japan operations)
  • Baliopharm AG is a wholly owned subsidiary of Promethera® and is based in Basel, Switzerland (development of antibody-based technology).

7. How is the company managed?

Promethera® Biosciences has an experienced international management team which act according to strategic advice from an expert Board of Directors and medical advice from a distinguished Scientific and Medical Advisory Board. Learn more.

8. How can businesses get involved in Promethera®’s research?

We welcome all types of collaborations and partnerships, both academic and industrial. Our “Partnerships” page has more information about our current collaborations and potential areas of future development. Learn more.

9. Where can I find out about your latest developments?

Promethera® Biosciences regularly publishes press releases and attends conferences across the world. You can also sign up for our newsletter to receive updates via email. Learn more.

10. How can I contact Promethera®?

Simply complete the form on our “Contact Us” page or email info@promethera.com. Learn more.

What is liver disease?

1. What does the liver do?

The liver is central to many crucial bodily processes. It filters the blood from the digestive tract before it enters the rest of the body, and is also responsible for the production, storage and control of many key compounds, such as sugar, hormones, digestive enzymes and blood clotting factors. Learn more.

2. What are the symptoms of liver disease?

Some of the symptoms of liver disease include jaundice (yellowing of skin and eyes), anorexia, fatigue, weight loss, bruising, confusion and impaired organ function. Learn more.

3. How does liver disease start and progress?

The initial stage of liver disease is a buildup of fatty deposits, known as steatosis, which can result in a ballooning of the liver cells and inflammation. Prolonged inflammation causes fibrosis which is essentially scar tissue. Over time, fibrosis leads to cirrhosis which causes increased liver scarring, leading to an impairment in liver function. Untreated liver disease eventually begins to affect the function of other vital organs, including the brain, lungs and kidneys. Learn more.

4. What is fatty liver disease or NAFLD?

Non-Alcoholic Fatty Liver Disease (NAFLD) is caused when lifestyle factors such as an unhealthy diet, lack of exercise or diabetes disrupt the liver’s normal sugar and fat processing functions, leading to a buildup of fat within the liver cells. This can lead to a ballooning of liver cells and inflammation. Learn more.

5. What is NASH?

Non-Alcoholic SteatoHepatitis (NASH) occurs when additional factors, such as insulin resistance, obesity or type II diabetes, cause NAFLD to progress. This results in localized inflammation and fibrosis that carry the risk of cirrhosis or liver cancer, as well as increasing the risk of heart disease. Learn more.

6. What is ACLF?

Acute-on-Chronic Liver Failure (ACLF) occurs when chronic liver disease suddenly results in an abrupt loss of liver function, leading to organ failures and a poor chance of survival. The exact cause of ACLF cannot always be identified, but it is often associated with an infection or excessive alcohol consumption. Learn more.

7. What treatments are currently available for liver disease?

Since early stage liver disease causes few symptoms, usually by the time it is detected the only option for many patients is a liver transplant. This is an operation to transfer healthy liver tissue, either in part or in whole, from a donor to the liver patient. It is far from an ideal approach, since there are many associated complications, along with a shortage of donated livers. Due to the difficulties in detecting and treating liver disease, the best option is prevention by maintaining a healthy lifestyle. Learn more.

8. How do I know if I have liver disease?

Early detection of liver disease is essential for the best chance of successful treatment. However, since early stage liver disease causes few symptoms, it is often only detected during regular checkups. Learn more.

9. Why is liver disease such a problem?

The liver is a vital organ in the human body which is affected by many lifestyle factors, such as obesity and an unhealthy diet which are becoming more common today. When the liver stops working, many crucial bodily functions are affected, and in its later stages, liver disease can cause death. Furthermore, the early stages of liver disease are very difficult to detect, so it is usually only detected later when the disease has already progressed significantly. Learn more.

10. What can I do to avoid liver disease?

Due to the difficulties in detecting and treating liver disease, the best option is to prevent it from occurring by maintaining a healthy lifestyle. Current recommendations include avoiding excessive alcohol intake, eating a healthy balanced diet, exercising regularly and maintaining a healthy body weight. Learn more.

What are regenerative medicine and cell therapy?

1. What is regenerative medicine?

Regenerative medicine refers to a number of techniques in which human cells, tissues or organs are replaced or regenerated in order to reverse birth defects or to repair damage from trauma, disease or age. It is a combination of engineering with developmental biology and involves the application of various materials and cells to contribute to the healing of tissue or to replace missing tissue, either structurally or functionally. Learn more.

2. What is cell therapy?

Cell therapy is a relatively new discipline within the medical sciences. It uses intact, living cells, either human or microbial, to provide various benefits to the patient. One branch of cell therapy aims to achieve the integration of cells at the site of injury, thereby replacing damaged tissue, whereas the other uses cells to release certain therapeutic factors to induce self-healing. Learn more.

3. What are stem cells?

Stem cells are cells that can differentiate to become another cell type and are often used in regenerative cell therapy approaches. They can be extracted from a range of tissue types, including bone marrow, cancerous growths or embryos. Learn more.

4. How can regenerative cell therapy be used to treat liver disease?

The liver is an ideal candidate for regenerative medicine approaches since it has excellent regenerative properties. Promethera® Biosciences is currently developing off-the-shelf therapies with the aim of restoring liver function that are based on liver-derived stem cells, since these are easier to manipulate and store than mature liver cells. Learn more.

What are your solutions for liver disease?

1. Where do your livers come from?

Promethera® Biosciences LLC, based in Durham, North Carolina in the US, has links to most of the US organ procurement organizations from whom we can procure ethically donated livers that are not suitable for transplantation but are otherwise healthy. We use these livers as a cell source for our product development. Learn more.

2. How do you use cell therapy to treat liver disease?

We have two cell therapy products under development for the treatment of liver disease: HepaStem™ and H2Stem®. Both cell types are obtained from donated livers and expanded in the manufacturing laboratory.

3. What is HepaStem™ ?

HepaStem™ is Promethera®’s lead cell therapy product which is in phase 2 clinical trials for both NASH and ACLF. It consists of human allogeneic liver-derived progenitor cells (HALPC) and has the potential to reduce liver inflammation and fibrosis formation. Learn more.

4. What is H2Stem®?

H2Stem® consists of cells derived from donated livers that are likely to have a liver stem cell role. They have been demonstrated in mice to have a high capacity to migrate to and repopulate the liver with mature functional hepatocytes. This product is likely to have potential for tissue repair. Learn more.

5. What are antibodies?

Antibodies are large proteins which play a key role in recognizing foreign compounds or microorganisms and in stimulating an immune response to them. Learn more.

6. How do you use antibodies to treat liver disease?

Promethera®’s antibody therapeutic candidate, Atrosimab, specifically targets TNF-R1, one of the pro-inflammatory tumor necrosis factor receptors. Since TNF-alpha plays a role in fibrosis formation, Atrosimab could be valuable in preventing or treating diseases such as Non-Alcoholic SteatoHepatitis (NASH). Learn more.

7. How do you guarantee the safety of your products?

All our products are manufactured under GMP (good manufacturing practice) conditions and are tested extensively in animal models before progressing to clinical trials in humans. Learn more.

8. Do you have any ongoing clinical trials?

Yes. HepaStem™ is subject to two ongoing phase 2 clinical trials for the treatment of ACLF and NASH. Learn more.

9. Can you provide other organs for research?

The Novabiosis division of Promethera® Biosciences receives other organs that have been generously provided for research and offers them to carefully vetted research entities throughout the US. Novabiosis currently offers a range of primary human cells, organs and tissues. Learn more.

10. How can I become an organ donor?

By choosing to become an organ donor, you have the power to save lives. Please visit www.donatelife.net to find out more information about becoming an organ donor. Learn more.

Dictionary of scientific terms

A

B

C

D

E

F

G

H

I

J

K

L

M

N

O

P

Q

R

S

T

U

V

W

X

Y

Z


A

ACLF

Acute-on-Chronic Liver Failure

ALLOGENEIC

Tissues or cells from different individuals of the same species that are genetically dissimilar and therefore genetically incompatible

ANTIBODY

A protein that recognizes foreign compounds or microorganisms and stimulates an immune response to them

ANTIGEN

A foreign compound or microorganism that stimulates an immune response within the body

APOPTOSIS

A form of programmed cell death which occurs as a normal part of the growth and development of multicellular organisms

ATROSAB

Promethera®’s full-length antibody that is the precursor of Atrosimab which is being developed for the treatment of NASH

ATROSIMAB

Promethera®’s next generation antibody candidate which is being developed for the treatment of NASH

AUTOIMMUNE DISEASE

A condition which occurs when the immune system begins attacking normal parts of its own body

AWEX

Agence Wallonne à l’Exportation – the Walloon Export and Foreign Investment Agency

B

BAL

Bioartificial liver

BALIOPHARM

A fully-owned subsidiary of Promethera® based in Switzerland that is developing antibody therapy solutions

B CELL

A type of white blood cell that secretes antibodies, also known as B lymphocytes

C

CD19, CD20, CD40

B cell surface proteins known to be involved in blood-borne cancers

CD95

A B cell surface protein that induces cell death

CELL ENGRAFTMENT

The process whereby transplanted stem cells integrate into the desired tissue and become functional

CHEMOTHERAPY

The use of anti-cancer drugs to treat cancer

CRYO-PRESERVATION

A process to enable long-term storage of biological components via freezing, typically to -80°C or -196°C

CIRRHOSIS

Scarring of the liver tissue caused by chronic inflammation and fibrosis

E

EPITOPE

The site of an antigen that is recognized by and binds to an antibody

F

FAB FRAGMENT

The antigen-binding fragment of an antibody

FIBROSIS

The formation of fibrous tissue in an organ, often due to inflammation or damage

G

GMP

Good manufacturing practice – a set of regulatory standards that must be met when manufacturing and selling goods for public consumption

H

HCTS

Hepatic Cell Therapy Support

HEPATIC DECOMPENSATION

A condition which occurs when the liver becomes sufficiently scarred from cirrhosis that its normal function is affected, and symptoms begin to occur

HEPATIC STELLATE CELL

A type of liver cell that plays a role in the liver’s response to damage

HEPATITIS B / C

Two different viruses that can cause liver inflammation

HEPATOBILIARY MARKER

An indicator of biological processes associated with the liver, gallbladder, bile ducts or bile

HEPATOCARCINOMA

The most common type of liver cancer

HEPARESC

Heparesc™ is Promethera®‘s cell technology that is comprised of liver-derived mature hepatocytes (HHLivC) which allows for the treatment of several patients with one donated liver

HEPASTEM

Promethera®‘s cell therapy product comprised of Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC)

HETEROLOGOUS

Derived from a different organism

H2STEM®

H2Stem® is Promethera®’s follow-on hepato-biliary stem cell product currently in pre-clinical development with different features compared to HepaStem™

HEPATOCYTE

The cell type that forms the bulk of the liver which carries out many of the liver’s main functions

HHALPC

Heterologous human adult liver-derived progenitor cells

HHLIVC

Heterologous human liver cells

I

IMMUNOSUPPRESSANTS

A class of drug that reduces the immune response to foreign substances, commonly used to prevent rejection of transplanted organs

INFLAMMATION

Part of the body’s protective response to harmful stimuli such as damage or infection

IN VITRO

A technique in which a biological process is performed outside of the living organism (Latin for “in glass”)

M

MONOCLONAL ANTIBODY

Identical antibodies generated from a single B-cell clone that only recognize one unique binding site on a single antigen

MSC (PROGENITOR) CELLS

Mesenchymal stem cells – stem cells isolated from adult liver tissue

MESENCHYMAL MARKER

An indicator of biological processes associated with liver function

N

NASH

Non-Alcoholic SteatoHepatitis

NAFLD

Non-Alcoholic Fatty Liver Disease

NC

North Carolina

NG2

Neuron-glial antigen 2 which is associated with skin cancer

NK CELL

Natural killer cells are a type of white blood cell that play a major role in the immune response

NOVOTARG

Baliopharm’s CD20/CD95 bispecific antibody that is being developed to induce cell death in cancer

O

ONCOLOGY

The study and treatment of cancer

OPO

Organ procurement organization

P

PARENCHYMA

The functional tissue of an organ

POLYPEPTIDE

A chain of amino acids, the building blocks of proteins

PWTC

Plateforme Wallonne de Thérapie Cellulaire or Walloon Cell Therapy Platform

Q

QC

Quality control

R

R&D

Research and development

RCA

Recoverable cash advance

S

SCFV FRAGMENT

Single chain variable fragment – an antibody fragment that lacks the constant region

STEM CELLS

Cells that can differentiate to become another cell type and are often used in regenerative cell therapy approaches

T

T CELL

Immune cells that destroy infected or cancerous cells

TENASCIN

An extracellular protein commonly found around healing wounds and some tumors

TNF-ALPHA

Tumor necrosis factor alpha plays a major role in inflammation and the immune response

TNF-R1

Tumor necrosis factor receptor 1 is involved in the inflammatory response

TNF-R2

Tumor necrosis factor receptor 2 is involved in the defense against viral and bacterial infections

TRANSPLANTATION

A surgical procedure whereby an organ or tissue is transferred from one individual to a recipient in order to replace a damaged or missing body part

U

UCD

Urea cycle disorder

UCLOUVAIN

Université Catholique de Louvain  

ULB

Université Libre de Bruxelles

X

XENOGRAFT

A surgical procedure whereby an organ or tissue is transferred from an individual of one species to a recipient of a different species