NextCell enters CAR-T joint venture

NextCell Pharma AB (“NextCell”) today announces a joint venture together with their long-term collaborator and contract manufacture organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired ~10 % of shares in the newly started company FamiCordTx through a directed equity issue, raising the capital with 0,5 MEuro in cash. FamiCordTx has exclusively licensed a patent pending CAR-T technology and the tech transfer is completed, and the production of CAR-T cell therapy is awaiting ATMP manufacturing approval before production of CAR-T for clinical trial use can be started.

What is CAR-T

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

“During the last four years five different CAR T cell therapies targeting different forms of blood cancer have been approved in the US and Europe. The medicine is composed of live cells, which have the capacity to increase in number to more efficiently destroy the tumor. This is a unique among cancer drugs”, says Doctor C.I. Edvard Smith, CMO & founder & member of the supervisory board NextCell, MD, Ph.D, professor in Molecular Genetics at Karolinska Institutet and chairman of the Swedish Gene and Cell Therapy Society”

What is the market

CAR-T is an extremely competitive area but with great potential. Tisagenlecleucel (Kymriah; Novartis) costs in a range of 300-450 kEUR and the total cost of the treatment often adds upp to almost 1 MEUR. The market is estimated to reach an annual of 1.8 EUR in the next year and is predicted to grow with 20% CAGR. FamiCordTx will focus on a European market with a competitive price.

Why a joint venture

NextCell is a cell therapy company with focus on accessible and highly potent stem cells derived from umbilical cord tissue and blood, comprising mesenchymal and hematopoietic  cells. NextCell’s main asset is the selection algorithm, a platform technology to define and manufacture highly potent mesenchymal st cell-based therapies. The primary drug candidate, ProTrans, is currently clinically evaluated for treatment of type-1 diabtetes and SARS-CoV-2 induced servere pneumonia.

The founders and members of the NextCell management team have vast experience in gene therapy. Professor Smith has a longstanding interest in this field and is heading one of the most experienced research groups at Karolinska Institutet with focus on gene therapy and CEO, Mathias Svahn, defended his doctoral thesis in the same subject.

NextCell have experience in conducting and procure late phase cell therapy clinical trials. The company has attracted internationally recognized ATMP specialists and are collabrorating with top ranked medical universities such as Karolinska Institutet and McGill University. PBKM (FamiCord Group) is the contracted manufacturer of NextCells drug product ProTrans and have vast experience of both production and logistics of cell therapies. PBKM (FamiCord Group) has the infrastructure, know-how, people and most of necessary accreditations and permissions required for manufacturing of clinical grade cell and gene therapies. CAR-T technology is next step in becoming full profile contract development and manufacturing organization (CDMO) .

“NextCell and PBKM have an excellent 5-year track record and we are capable of competing with big pharma, certainly in our own region” conclude Jakub Baran and Mathias Svahn, CEOs at PBKM and NextCell respetivley. “While we currently only work with naïve mesenchymal stromal cells, experience from genetic engineering in the CAR-T space, paves the way for generating engineered stem cells. This will strengthen our future position in the market for mesenchymal cells” adds Mathias Svahn.

How far is FamiCordTx

FamiCordTx has during the last months validated the production of a viral vector in GMP regime to be used for transduction of the patients own (autologous) T-cells. The method to genetically integrate the chimeric immunoreceptor has been validated and the entire manufacturing procedure has already been inspected and audited by the competent authority. The manufacturing license for use in hospital exemption procedure was granted in May 2021 while the manufacturing license for use in clinical trials is expected in coming quarter. Soon after that company will be ready to have “first in human use” at clinical hospital of Warsaw Medical University.

FamiCordTx CAR-T drug product is first anticipated to be evaluated in patients with Diffuse large B-cell lymphoma (DLBCL), pending on ethical committee and medicinal product agency approval in the countries and regions participating.

FamiCordTx plans

Regulatory approval of the ATMP manufacturing method and premises is the first coming milestone. The drug product has been evaluated in preclinical setting and is now ready to start in clinical trials. The plan is to finance the clinical trial program through grants and other forms of external financing. For the purpose of clarification, the structure of a joint venture as a separate legal entity reduces the risk and liability of both PBKM and NextCell in this competitive area.

About PBKM

PBKM (Polski Bank Komórek Macierzystych) spearheads the international FamiCord Group which manages stem cell banks located in Europe. Taking into account the number of newly acquired samples, the Group is by far the largest bank in Europe with around 38% of the market share. At the end of 2020, the Group stored over 400 thousand of umbilical cord blood or tissues and over 540 thousand all biological samples. The main area of PBKM's activity is the collection, processing and long-term storage of stem cells extracted from umbilical cord blood and other postnatal tissues as commissioned by parents (family banking). The purpose of banking is to ensure family safety in the event of a serious illness requiring a transplantation of stem cells to a donor or to members of her/his immediate family. FamiCord Group is present on several European markets. Directly offers services to clients in Poland, Turkey, Spain, Portugal, Hungary, Romania, Switzerland, Italy, Lithuania, Estonia, Luxembourg and Latvia. Almost everywhere is the number 1 on the market. In addition, it provides services for partners who acquire customers in Sweden, Denmark, Serbia and the Balkan countries, Italy and Ukraine. In addition, the Group invests in the development of advanced therapy medicinal products (ATMP) services, which are considered to be one of the most important directions of development in medicine. Since May 2016 PBKM has been listed on the main market of the Warsaw Stock Exchange.

More information at:
https://akcjonariusze.pbkm.pl/
Twitter @PBKM_
FamiCord Media contact: Michał Wierzchowski, cc group, tel. +48 531 613 067, e-mail: michal.wierzchowski@ccgroup.pl

This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 22th of June 2021.

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LinkedIn: https://www.linkedin.com/company/15255207/

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For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Sofia Fredrikson, CFO

Phone: 08-735 5595

E-mail: info@nextcellpharma.com

 

Website:

www.nextcellpharma.com, www.cellaviva.se

www.cellaviva.se

www.cellaviva.dk

About NextCell Pharma AB

NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia's largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.

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