Repeated treatment with ProTrans is immunologically safe

November 6, 2023

NextCell Pharma AB ("NextCell" or the "Company") today announces that multiple treatments with ProTrans cell therapy does not induce donor specific antibodies in type-1 diabetes patients. A detailed analysis of how the immune system reacts to infusion of ProTrans cells show that treatment can be given to any adult type 1 diabetic, irrespective of pre-existing HLA antibodies.

“This finding is very good news” says Mathias Svahn, CEO for NextCell Pharma. He went on to add, “These data demonstrate not only the safety profile for ProTrans, and its use as an off-the-shelf product, but also that treatment with ProTrans does not limit the patient´s ability to receive blood transfusions or tissue transplants in the future.

NextCell has previously reported the efficacious effect of ProTrans therapy in maintaining insulin production in newly diagnosed type I diabetes patients enrolled in the ProTrans Repeat Study. As part of the long-term follow-up study of these treated patients, the expression of anti-HLA (human leukocyte antigen) antibodies has been investigated.

All cells express HLA molecules on their surface, helping the body to establish what is foreign and self. In the case of blood transfusion or tissue matching for transplantation the donor HLA pattern is matched, where possible, to the HLA pattern of the recipient. This prevents a reaction, or rejection, by the patient upon treatment. One of the major advantages of ProTrans treatment is the lack of need to match donor cells to recipients, allowing for the development of a true off-the-shelf allogeneic therapy suitable for immediate usage.

Analysis of patient samples prior to treatment and post-treatment (1 month post-second infusion) with two doses of ProTrans (equivalent to exposure to ten individual cell donors) demonstrated no anti-HLA antibodies against any donor material.

NextCell will continue their long-term follow-up of these patients for a total of five years. Data to date is very promising with no serious adverse events or safety concerns.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company in Phase 2 trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a Phase 3 trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for COVID-19, in Örebro and in Montreal, Canada. The company is in the process of establishing its own GMP-facility for the production of ProTrans. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use.

 

Download attachmentRead full press release on Cision (external link)
2024-09-03
CSO Lindsay Davies Co-Chairs ISCT Europe 2024 Meeting
NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), a leader in advanced cell therapy and immunotherapy research, is proud to announce that Dr. Lindsay Davies, the company’s Chief Scientific Officer (CSO) and ISCT Europe Regional Secretary, serves as Co-Chair together with Dr. Massimiliano Gnecchi of the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden, from September 4-6.
Read moreRead more
2024-07-25
NextCell publishes its Interim Report 3 2023/2024
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period September 1, 2023 – May 31, 2024. 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.
Read moreRead more
2024-07-03
NextCell carries out a directed issue of units to guarantors in connection with the completed rights issue
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. The Board of Directors of NextCell Pharma AB (publ) (“NextCell” or the “Company”) has today, based on the authorisation from the Annual General Meeting on 30 November 2023, resolved on a directed issue of 894,329 units to guarantors who provided guarantee commitments in the rights issue of units resolved upon by the Board of Directors on 24 April 2024 (the “Right Issue”), in accordance with guarantee agreements entered into (the “Remuneration Issue”). Each (1) unit consists of one (1) newly issued share and one (1) warrant of series TO2. The subscription price in the Remuneration Issue is SEK 1.50 per unit and payment is made by offsetting the guarantors’ claims on the Company.
Read moreRead more
2024-06-17
NextCell’s rights issue oversubscribed
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) (”NextCell” or the “Company”) hereby announces the outcome of the Company’s rights issue of units, consisting of shares and warrants of series TO2, with preferential rights for the Company’s existing shareholders, which was announced through a press release on 24 April 2024 (the “Rights Issue”). The outcome of the Rights Issue shows that 34,747,218 units, corresponding to approximately 91.9 percent of the Rights Issue, were subscribed for with the support of unit rights. In addition, applications for subscription of 22,636,886 units without the support of unit rights have been submitted, corresponding to approximately 59.9 percent of the Rights Issue. Together, subscriptions of units with the support of unit rights and applications for subscription of units without the support of unit rights correspond to approximately 151.7 percent of the Rights Issue. The Rights Issue is therefore oversubscribed and NextCell will from the Rights Issue receive approximately SEK 40.1 million before deduction of issue costs.
Read moreRead more
2024-06-12
The paediatric diabetes study gets the green light to treat the age group 7 – 11 years
NextCell Pharma AB (publ) ("NextCell") announces that the Data Safety Monitoring Board for the ProTrans-Young study has recommended the principal investigator, Professor Per-Ola Carlsson, to continue with treatment of children in the younger age group 7 – 11 years. This decision is based on a review of all available safety data from the 36 children and adolescents who have participated in the study so far. The recruitment of the 30 children aged 7-11 will begin in August 2024.
Read moreRead more
2024-06-11
The Board of Directors and management sign in addition to subscription commitments
NextCell Pharma AB (publ) ("NextCell" or the "Company") carries out a rights issue of units of up to approximately SEK 40.1 million, which is covered to approximately 100 percent by subscription and guarantee commitments. The company's Board of Directors, management and key employees, who have previously entered into subscription commitments of up to a total of approximately SEK 1.5 million, have now announced that they will register their interest in subscribing for units for a total of approximately SEK 3.3 million, corresponding to 8.2 percent of the rights issue.
Read moreRead more
2024-06-10
NextCell publishes supplement to the prospectus regarding the rights issue
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) (”NextCell” or the “Company”) has today published a supplement (the “Supplement”) to the EU Growth prospectus, which was approved and registered by the Swedish Financial Supervisory Authority and published on 30 May 2024 (the “Prospectus”). The Supplement has been prepared due to the fact that the Company on 4 June 2024 announced through a press release that the Company had agreed to a so-called top guarantee of a total of approximately SEK 8.0 million in the ongoing rights issue of units in the Company (the “Rights Issue”).
Read moreRead more
2024-06-05
Cellaviva becomes an independent company under NextCell Pharma
Cellaviva, the stem cell bank operated by NextCell Pharma AB, has announced its transition to an independent company. This strategic move will enable Cellaviva to further focus on its core mission of providing expectant parents with the opportunity to preserve and store valuable stem cells collected from the placenta and umbilical cord. These cells, which would otherwise be discarded post-birth, offer significant potential for future medical treatments and therapies.
Read moreRead more