Breakthrough multiplication of blood stem cells

April 26, 2023

NextCell Pharma AB (“NextCell” or the “company") announces that the FDA has approved a product of multiplied stem cells from umbilical cord blood. It is a breakthrough that could lead to increased interest in saving stem cells for private use, where Cellaviva is the market leader in Scandinavia. Cellaviva is a part of NextCell with offices in Stockholm and Copenhagen.

On April 17, 2023, the US Food and Drug Administration (FDA) approved the first product with expanded stem cells from umbilical cord blood. In the clinical trial that led to the approval, the number of stem cells was expanded an average of 60 times by cell culture.

"Multiplication or expansion of blood-forming stem cells is a significant achievement. The new method opens the door for the use of even smaller collections of cord blood in clinical practice." says Professor Edvard Smith, Medical Director of NextCell Pharma and Cellaviva.

Stem cells from umbilical cord blood have been used in healthcare for the treatment of over 80 different conditions, such as leukaemias, lymphoma and sickle cell anaemia, for more than 30 years. It has also been shown that in regenerative medicine, treatment with stem cells from umbilical cord blood provides clinical benefits for patients. More than 60,000 patients have already been treated with umbilical cord blood.

In addition to the above-mentioned already approved therapies, over 3,000 research studies are currently underway in various fields around the world to discover the full potential of stem cells. Umbilical cord blood is the source of the youngest, most powerful and most readily available stem cells. They can also be easily collected and stored after birth, to be used later in life. Due to the limited blood volume and number of stem cells isolated from umbilical cord blood; critics have pointed out that an average unit of umbilical cord blood is only sufficient for patients weighing up to 40-50 kg. The FDA's groundbreaking decision to approve expanded, also known as multiplied, umbilical cord blood means that this restriction is no longer a concern.

The product approved by the FDA is manufactured by Gamida under the name Omisirge (also known as omidubicel or NiCord).

Link to FDA press release:
https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell

Link to the scientific article about the study:
https://doi.org/10.1182/blood.2021011719

For more information about NextCell Pharma, 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

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser, info@fnca.se.

About NextCell Pharma AB

NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO)

Download attachment Read full press release on Cision (external link)

2020-12-16

NextCell Pharma publishes prospectus supplement

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND, SINGAPORE OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a supplement to the prospectus regarding the invitation to subscribe for shares in the Company’s resolved rights issue, which was approved by the Swedish

Read more Read more

2020-12-15

ProTrans Observation Study for long term efficacy in diabetes

NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University. The observational study, ProTrans-OBS, is a non-interventional study, i.e. patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of

Read more Read more

2020-12-10

ProTrans demonstrates effect at 2 years after repeated treatments

NextCell Pharma AB ("NextCell") today announces that the ProTrans-Repeat trial met its primary safety endpoint. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans™ (ProTrans). Furthermore, a strong tendency of sustained efficacy was observed in the three patients receiving high dose ProTrans. · Primary safety endpoint met · Tendency of sustained efficacy observed for high dose patients · 2-year preservation of insulin production significantly higher for patients treated with high dose as compared to low dose ProTrans-

Read more Read more

2020-12-03

NextCell Pharma publishes prospectus relating to the rights issue

The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the Rights Issue”), which was resolved by the Board of Directors on 26 November 2020 pursuant to the authorisation from the annual general meeting. The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE

Read more Read more

2020-11-20

The Board of Directors of NextCell Pharma intends on resolving on a fully guaranteed preferential rights issue of approximately SEK 150 million

The Board of Directors of NextCell Pharma AB (“NextCell” or the “Company”) today announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the “Rights Issue”). The Board of Directors’ intent to resolve on the Rights Issue requires that the shareholders at the Annual General Meeting on 24 November 2020 authorizes the Board of Directors to resolve on share issues. In the notice convening the Annual General Meeting, which was published by press release on 23 October 2020, the

Read more Read more

2020-11-16

NextCell supports ProTrans study for children and adolescents

NextCell Pharma AB (“NextCell”) has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTrans™ (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use. NextCell's drug candidate, ProTrans, for the treatment of type 1 diabetes is a mesenchymal stem cell

Read more Read more

2020-11-09

NextCell has formally kicked-off its Eurostars funded project ‘ Bioscale ’

NextCell Pharma AB (“NextCell” or the “Company”) announces today that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell expansion system developed by Scinus Cell Expansion, to further test, develop and validate the involved bioprocesses used in the production of NextCell’s drug candidate ProTrans™ (ProTrans). · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the project is €2.

Read more Read more

2020-10-30

NextCell publishes its Year-End Report

NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2019 - August 31, 2020 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report 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. Twelve months (2019-09-01 until 2020-08-31) ● Operating income amounted to SEK 4 166 123 (1 964 132). ● Operating result amounted to SEK -17 680 697 (-17 997 787). ● Earnings per share* amounted

Read more Read more