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
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

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, info@fnca.se.

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