NextCell invests in CAR-T technology

February 8, 2022

NextCell Pharma AB ("NextCell" or the"Company") informs that FamiCordTx, a joint venture cell-gene biopharma company issues new share. The major shareholders, PBKM and NextCell will participate at 50% of their pro rata rights. For NextCell this results in an investment of approximately kEUR 160, whereas its ownership in FamiCordTx will change from 9,43% to 8,45% of the then shares.

FamiCordTx S.A., raised PLN 16 million (approximatly MEUR 3,5) from a pre-IPO issue of shares

•  The proceeds from the issue will be used to fund the Phase 1 clinical trials of CAR T (chimeric antigen receptor T cell) therapy, which is recognised today as the most
  innovative cancer therapy, and the development of new products worldwide

•  FamiCordTx intends to start the clinical trial in the first half of this year

•  The CAR-T therapy offered by FamiCordTx targets the CD19 antigen, which is found for instance on lymphoma and leukaemia cells

•  The plans include an IPO (initial public offer) of FamiCordTx and a stock market début in 2023

•  cc group was the financial consultant for FamiCordTx, engaged in arranging the pre IPO share issue of the company

FamiCordTx, a PBKM Group (FamiCord Group) company, which was established in 2019 to develop and introduce CAR-T therapies. The major shareholders of the company who have provided funds for its development are Polski Bank Komórek Macierzystych S.A. (PBKM) and NextCell Pharma AB – a Swedish biotech company and a long-term business partner of PBKM. The shareholders also include key managers of the company.

‘We are ready to start clinical trials of CAR-T therapy with the use of the medicinal product manufactured at our laboratories. The working name of the product is FCTX CL 19 1. The quality and efficacy of its base version have been confirmed in preclinical studies conducted at sites in the US and at our own research laboratory. It is important to note that the base product has been also used with good results in several patients in China. Our manufacturing procedures were approved by the Główny Inspektorat Farmaceutyczny (Chief Pharmaceutical Inspectorate) last year. We will manufacture the product at special facilities, known as cleanrooms, built by our majority shareholder, PBKM’, says Dr. Tomasz Kolanowski, Member of the Management Board and Scientific Director, FamiCordTx.

‘We raised the funds to conduct the Phase 1 clinical trial from the pre IPO phase of the new share issue. The shares were taken up by several investors including our existing key shareholders. The high interest aroused by the offer demonstrates that investors see the potential of CAR T therapy, which is widely recognized as a breakthrough in blood cancer treatment’, highlights Paweł Martyna, Member of the Management Board and General Director, FamiCordTx.

‘We aim to conduct the Phase I clinical trial this year. At the same time, we will start discussions with the European Medicines Agency (EMA): firstly, we want to obtain Scientific Advice, which is very important for us, and then we will prepare and conduct the multi-centre clinical trials necessary to submit a regulatory application to the EMA. In 2023, we also want to make preparations for the initial public offer (IPO). The proceeds would fund the further technological and clinical development of CAR T therapy and help to get FamiCordTx listed on the stock exchange. The decision on which stock market the shares are to be listed has not yet been made, but we are considering stock exchanges in Germany, Sweden, Spain and the Warsaw Stock Exchange. The strategic objective for FamiCordTx is to receive approval for CAR T therapy in Europe and integrate the therapy into the treatment of patients in 2026. Our medicines will be manufactured in Poland, which will significantly improve the availability of this treatment for Polish cancer patients’, says Dr. Tomasz Ołdak, CEO of FamiCordTx.

FamiCordTx purchased from US-based iCell Gene Therapeutics, Inc. an exclusive licence to use the iCell-developed CAR molecule in Europe, Turkey and Russia. The CAR T therapy developed by FamiCordTx targets the CD19 antigen characteristic of all B-cell tumors.

In 2021, the Główny Inspektorat Farmaceutyczny (Chief Pharmaceutical Inspector) issued a permit for PBKM to manufacture the gene therapy medicinal product FCTX CL 19 1, created on the basis of the licence and FamiCordTx’s proprietary know-how. This therapy represents a breakthrough class of drugs known as CAR T – to be used in treatment of, among others, neoplasms such as B cell leukaemia or B cell lymphomas. The approval for the manufacturing of FCTX CL 19 1 follows more than ten months of development work by FamiCordTx to create a complete platform for manufacturing the CAR-T technology compliant with strict GMP standards. CAR T technology is based on the use of a patient’s own T cells, which are genetically modified in the laboratory so that a scientifically designed and patent-protected protein construct (CAR) appears on their surface. In addition, a transfer vector necessary for the genetic modification of the cells must be prepared and cleaned. So transformed T lymphocytes, already as a CAR T drug, are administered to the patient. The therapy is based on a customised manufacturing process.

‘FamiCordTx is a company that develops new technologies and, after just two years since its formation, is about to enter the clinical phase with its first drug. We are one of the very few such companies in Poland or even in Europe. We believe that we are creating new quality and setting new standards’, says Tomasz Ołdak.

‘From PBKM’s point of view, FamiCordTx is of strategic importance. Firstly, we access a treatment area with a huge growth potential. Secondly, we have several technologies in our pipeline from other areas and at various levels of advancement. We are considering the establishment of other dedicated units to develop them. Thirdly, PBKM is heavily investing in its CDMO capacities, with a focus on manufacturing different ATMPs (including CAR T) and virus vectors. FamiCordTx will be one of PBKM’s clients’, comments Jakub Baran, CEO of PBKM S.A.

Development of the cell and gene therapy market

Chimeric Antigen Receptor (CAR)-T cell technology combines two front-line concepts: cell therapy and genetic engineering. The basic concept is to make use of the unique property of lymphocytes to recognize and destroy cells and equip them with an engineered receptor so that they recognize tumor cells.

CAR T therapy is used to treat, among others, B cell neoplasms, including chronic lymphoblastic leukemia and lymphomas.  Clinical studies in hematology will verify the efficacy of this therapy against, for example, multiple myeloma. CAR T therapies may go beyond hematology and oncology, to cover autoimmune, inflammatory, solid tumors as well as HIV.

The Cell & Gene Therapy (CGT) market is a very competitive area, but has great potential. In the first half of 2021, biotechnological companies engaged in CGT development (including CAR T) raised a total of USD 14 billion from investors – approximately 75% of the funds collected in 2020 (USD 19.9 billion).

The CGT market is estimated to reach an annual value of over EUR 3.4 billion in 2022 and close to EUR 28 billion in 2026.

*Source: Evaluate Pharma, Roland Berger, Regenerative Medicine in 2021: A Year of Firsts & Records, Alliance for Regenerative Medicine

This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 08-02-2022 14:30 CET.

For further information, please contact:

Mathias Svahn, CEO
Patrik Fagerholm, CFO

Tel: +46 8 735 5595

NextCell Pharma AB:
Cellaviva Sverige:
Cellaviva Danmark:


About NextCell Pharma AB

NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 10% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399,

Download attachmentRead full press release on Cision (external link)
Anders Essen-Möller resigns as Chairman of the Board of Directors due to health reasons
NextCell Pharma AB ("NextCell" or the "Company") today announces that its long-time Chairman of the Board, Anders Essen-Möller, after ten years of dedicated leadership, will step down from his role on May 20th, 2024 due to health reasons. Anders has been a central figure in NextCell's journey since 2014 when the Company was founded by Diamyd Medical AB together with board members Hans-Peter Ekre and Edvard Smith, as well as CEO Mathias Svahn and Lena Wikingsson.
Read moreRead more
The Swedish Medical Products Agency approves subgroup analysis in NextCell's ProTrans-Young study
NextCell Pharma AB ("NextCell" or the "Company") today announces that the Swedish Medical Products Agency has approved an application to conduct a subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, treated in the ProTrans-Young study. Principal Investigator Professor Per-Ola Carlsson and his team treated the last patient in the age group in February 2024. The approval for the subgroup analysis by the Swedish Medical Products Agency means that the primary efficacy endpoint readout is available after 12 months. The primary efficacy endpoint is measured as a difference in endogenous insulin production comparing ProTrans and placebo-treated patients one year after treatment. Results from the subgroup analysis are planned to be presented in the second quarter of 2025.
Read moreRead more
NextCell establishes QVance to meet the Nordic’s need for quality analytics
NextCell Pharma AB ("NextCell" or the "Company") today announces that it has formed a subsidiary company specialising in quality control analytics. QVance’s launch is a strategic addition for NextCell as the company grows its presence in the advanced therapy market. QVance will specialise in quality analyses for advanced therapeutic companies, including NextCell, in the growing cell and gene therapy market. QVance will address a large gap in the Nordic region, where there is a significant lack of local providers in this area.
Read moreRead more
NextCell Pharma’s updated growth strategy
NextCell Pharma AB ("NextCell" or the "Company") today announces that the Company has decided to implement strategic changes. The new strategic direction means, amongst other things, that Cellaviva will become a wholly owned subsidiary and that the company's GMP facility will have new sources of revenue. The strategic changes will also result in cost savings as a result of staff reduction.
Read moreRead more
NextCell Pharma presents at Redeye Theme: Regenerative Medicine/Cell Therapy
Today Wednesday on February 14th at 10.30 CET Dr. Mathias Svahn, CEO of NextCell Pharma AB (“NextCell" or the"Company"), will present the latest developments in the company at Redeye.
Read moreRead more
NextCell publishes its Interim Report 1 2023/2024
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2023 – November 30, 2023. The report is available on the company’s website: NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year.  
Read moreRead more
Updates regarding NextCell’s Clinical Trials with ProTrans
NextCell Pharma has several ongoing clinical trials with ProTrans. The largest ongoing study ProTrans Young, which includes 66 patients, is progressing well. All 30 patients in the older age group have been recruited and will be treated with ProTrans. In the long-term follow-up studies ProTrans-Obs and ProTrans-Repeat the first diabetes patients have now completed the studies after five years of follow-up.
Read moreRead more
NextCell Pharma has compiled a Q&A section
NextCell Pharma AB ("NextCell" or the "Company") has compiled questions from the company’s stakeholders in a Q&A section. The questions and answers can be accessed via the link below.
Read moreRead more