NextCell Pharma AB
The company is located in Karolinska Institutet Science Park, adjacent to the Karolinska University Hospital. in Huddinge. The region includes a cluster for stem cell research and is a perfect location for advancing stem cell technologies.
NextCell Pharma is a tissue establishment and primary biobank, classified as healthcare provider. Its activities are inspected by the government agency, The Health and Social Care Inspectorate (IVO).
Leo Groenewegen, CFO
BBA, Health Economist, responsible for the financial operations and business development
MD, professor, co-founder and medically responsible for NextCell Pharma AB and Cellaviva.
Lotten Löfberg, Commercial director
MBA, experienced marketer within business to consumer.
Ylva Bäckström, Commercial director
MSc, experienced marketer within business to consumer (parental leave).
Anders Essen-Möller, Business dev. director
MSc, founder of Diamyd Medical AB and Synectics Medical AB
Maria Hägg, QA/RA manager
Ph.D. Background from clinical grade cell production and advanced therapeutic medicinal products (ATMP)
Independent board member with a marketing background in cell therapy and regenerative medicine, CEO at Miris Holding AB.
Professor of molecular genetics. His research has resulted in the identification of several disease genes and to new treatments.
Background as investment manager at Karolinska Development and R&D manager at Pharmacia, Astra and Biotech companies.
Private investor, board member of Copperstone Resources AB and QuiaPEG Pharmaceuticals Holding AB.
Field of operation
NextCell is active in stem cell research, a field that could revolutionize the way diseases are treated in the future.
The company is developing the candidate drug ProTrans™ for the treatment of diabetes and immunosuppression in kidney transplants.
The company intends to conduct a clinical trial with ProTrans™ on diabetes patients, and plans to submit the relevant application in 2017.
Kidney transplants have become standard treatment in complicated renal disorders. NextCell’s aim is for ProTrans™ to be used to help the body accept the transplanted kidney.
NextCell owns the trade name Cellaviva, Sweden’s first family saving stem cell bank – a globally established field of operation.
NextCell’s business concept is to develop and commercialize stem cell products, primarily to treat autoimmune diabetes and as immunosuppressants in kidney transplantation. In addition, auxiliary company Cellaviva offers parents-to-be the opportunity to save their newborn child’s stem cells for any future medical needs the child or family may have.
NextCell’s business model is to develop medicinal products. NextCell is currently in the development phase of its candidate drug ProTrans™, and subject to approval the company intends to apply for a clinical study in the second half of 2017. The drug development will primarily be funded by capitalization, but also partially by various research grants and collaborations. The company’s long-term objective is to sign agreements for the distribution of ProTrans™ with distributors, and thereby secure ongoing sales revenues.
NextCell – history and future
NextCell was founded in 2014 by CEO Dr. Mathias Svahn, board members professor Edvard Smith and Hans-Peter Ekre, and Dr. Lena Degling Wilkingsson. The company was originally called Cellaviva AB and it started Sweden’s first family saving stem cell bank. At the beginning of 2014, Diamyd Medical AB became one of the company’s principal owners, and in late 2014 the company was granted a licence by Sweden’s Health and Social Care Inspectorate (IVO). The service for family saving of umbilical cord blood (hematopoietic stem cells or HSCs) was launched on the market in September 2015. In 2016 a decision was made to expand the operation and also conduct drug development and stem cell research, at which point the company changed name to NextCell Pharma AB. The decision to expand was made when the company, through its Cellaviva activities, found an effective method for harnessing mesenchymal stem cells, and isolating and cultivating them. Mesenchymal stem cells are found in various tissues and are taken from the bone marrow, for instance. The majority of existing studies have been done on stem cells from bone marrow, an approach which involves painful, extensive procedures. There are therefore advantages to using the placenta instead, as NextCell does. Therefore, in late 2016 the company’s auxiliary Cellaviva also launched an option to save the tissue-forming mesenchymal stem cells, which means that at the time of writing, Cellaviva saves both blood stem cells and tissue-forming stem cells.
NextCell plans to apply for clinical trial of its candidate drug ProTrans™ in 2017. While preparing for clinical trials, the company intends to conduct preclinical activities relating to kidney transplantation projects. Initially, the planned clinical study is expected to encompass small groups of diabetes patients with a safety assessment as the primary endpoint. The patients’ ability to produce insulin will be measured before treatment, and compared with the corresponding ability treatment. The change over time will be measured on individual basis. The hope is that the patients treated with ProTrans™ can retain their insulin-producing ability (measured as C-peptide) better than patients in the control group, who are expected to show lower concentrations of C-peptide over time. The initial clinical study has limited opportunity to show efficacy, and the company hopes to extend the study following proven safety, and to include further patients. If the Swedish Medical Products Agency and the principal investigator allow, data from the initial study can be reused in a Phase II study and hopefully bring some statistical significance to the results.
The board of directors deems the market for stem cell treatment of autoimmune diabetes to be extensive. At present there are some 20-40 million people with autoimmune Type 1 diabetes, and around 80,000 are diagnosed every year, many of them children. There is also an equally common, though slower, advancing form of autoimmune diabetes among adults, known as Latent Autoimmune Diabetes in the Adult (LADA). Autoimmune diabetes is increasingly being diagnosed using blood tests, where the occurrence of at least two antibodies against the insulin-producing beta cells indicates the existence of the autoimmune illness. In autoimmune diabetes, the insulin-producing beta cells are attacked by the body’s immune system until the patient can no longer produce enough of its own insulin to keep the blood sugar concentration within normal limits. NextCell’s aim is to treat the diabetic with ProTrans™ in the form of transplanted stem cells, which suppresses the body’s autoimmune reaction to the beta cells, thereby potentially leading to a normal level of blood sugar concentration. The board estimates that the market potential for a drug like ProTrans™ for treating autoimmune diabetes is several billion dollars a year. NextCell today is unaware of any drug that cures the patient of the disease.
Every year some 50,000 kidney transplants are carried out using kidneys from deceased donors. Various complications can arise when transplanting a kidney, one being that the recipient’s body will not accept the new kidney and instead tries to reject it. The risk of rejection is far higher if the kidney is taken from a deceased donor than from a living donor. The board believes that the company’s product, ProTrans™, could potentially be used to protect the transplanted organ and create the conditions for the recipient’s immune system to accept the new kidney. The company therefore believes that the need for immunosuppressive drugs would decrease. Immunosuppressive drugs are used so that the body’s immune system reacts pathologically, i.e. in a non-normal way. Immunosuppressants are used, for instance, in many autoimmune diseases and place a serious burden on the patient’s health. They make the body susceptible to viruses, bacteria and parasitic infections, and the board therefore deems there to be an extensive market potential for ProTrans™ in kidney transplantation. The board estimates this market potential at several billion dollars globally.
Cellaviva is Sweden’s first stem cell bank. Cellaviva has been on the market since September 2015, but has not yet made a market breakthrough. Net sales in 2016 totalled approximately MSEK 0.8.
NextCell Pharma AB has no shareholdings and is not part of a corporate group. The company has one auxiliary company, Cellaviva.