NextCell investerar i CAR-T behandling

NextCell Pharma AB ("NextCell" eller "Bolaget") informerar om att FamiCordTx, ett samriskbolag inom cell och genterapi, genomför en nyemission. De största aktieägarna PBKM och NextCell kommer att delta till 50% av sin prorata. För NextCell resulterar detta i en investering om cirka 160 kEUR och innebär en förändring från 9,43% till 8,45% av aktierna i FamicordTx.

• FamiCordTx S.A., tog motsvarande 3,5 MEUR i en pre-IPO emission:
• Likviden från emissionen kommer att användas för att finansiera de kliniska fas 1-studierna av CAR T-behandling (chimerisk antigenreceptor T-cell), som idag ansers vara den mest innovativa cancerbehandlingen, och utvecklingen av nya produkter över hela världen
• FamiCordTx avser att starta den kliniska prövningen under första halvåret i år
• Car-T-behandlingen som erbjuds av FamiCordTx riktar sig mot CD19-antigenet, som till exempel finns på lymfom och leukemiceller
• Planerna inkluderar en börsintroduktion av FamiCordTx och en börsdebut 2023
• cc-koncernen var finansiell konsult och engagerad i att arrangera emissionen för FamiCordTx, före börsintroduktionen av bolaget

Forsättning på engelska:

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

Denna information är sådan som NextCell Pharma AB är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning (EU nr 596/2014). Informationen lämnades, genom angiven kontaktpersons försorg, för offentliggörande 2022-02-08 14:30 CET.

‍För ytterligare information om NextCell, vänligen kontakta:

Mathias Svahn, VD
Patrik Fagerholm, Ekonomi- och finansdirektör

Tel: 08-735 5595
E-mail: info@nextcellpharma.com

Hemsidor:
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
‍

Om NextCell Pharma AB

NextCell är ett cellterapibolag i fas II med läkemedelskandidaten ProTrans för behandling av typ 1-diabetes. Fokus är att ta ProTrans till ett marknadsgodkännande via en fas III studie. ProTrans används också i två kliniska Covid-19 studier, i Örebro samt Montreal (Kanada). NextCell arbetar med att färdigställa en egen GMP-facilitet för tillverkning av ProTrans. GMP-faciliteten beräknas vara redo för tillverkning av mindre mängder av ProTrans under 2023. NextCell äger även 10% i FamicordTX ett uppstartsbolag inom CAR-T och onkologi samt 100% av Cellaviva, Skandinaviens största stamcellsbank för familjesparande av stamceller från navelsträngsblod och navelsträngsvävnad med tillstånd från Inspektionen för Vård och Omsorg (IVO).

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