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)
2025-05-19
Eric Strati Joins NextCell Pharma’s Board of Advisors to Support Commercial Strategy for ProTrans
NextCell Pharma AB ("NextCell") is pleased to announce the appointment of Eric Strati, PharmD, MBA, as a new member of its Board of Advisors, marking a strategic step as the company transitions from a development-focused organization into a pivotal phase aimed at out-licensing and commercializing its leading cell therapy product, ProTrans, for the treatment of type 1 diabetes.
Read moreRead more
2025-05-16
The exercise period for NextCell Pharma’s warrants of series TO2 begins today
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, 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 (“NextCell” or the “Company”) issued a total of 38,711,804 warrants of series TO2 (“Warrants”) within the framework of a rights issue of units during the second quarter of 2025. The exercise period for the Warrants commences today, on May 16, 2025, and continues until May 30, 2025. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company. The subscription price per share subscribed for through the exercise of Warrants has been set at SEK 1.00. Upon full utilization of all Warrants, NextCell will receive approximately SEK 38.7 million before issuance costs. The proceeds from the exercise of Warrants are mainly intended to support the completion of the ProTrans-Young study and continued clinical development, business development, and regulatory preparations for future market approval.
Read moreRead more
2025-05-15
Eight-Year-Old Hugo – Living with Type 1 Diabetes and Participating in the ProTrans Study
NextCell Pharma AB ("NextCell") is featured in the Future Healthcare – Focus on Diabetes supplement of the Swedish national newspaper Svenska Dagbladet, through an article highlighting eight-year-old Hugo Wahlbeck, who is currently enrolled in the ongoing paediatric study with ProTrans – the Company’s leading investigational therapy for the treatment of type 1 diabetes.
Read moreRead more
2025-05-07
Study published in Nature Medicine shows promising results in Alzheimer’s disease – supports the development of ProTrans at NextCell
NextCell Pharma AB (“NextCell” or the “Company”) highlights a recently published clinical trial demonstrating promising results for mesenchymal stromal cells (MSCs) in the treatment of mild Alzheimer’s disease. The results strengthen the scientific foundation for NextCell’s drug candidate ProTrans, which is being developed for autoimmune and inflammatory diseases. NextCell is developing the next generation of MSC therapies with a focus on selection and indication-specific tailoring using its patented platform technology.
Read moreRead more
2025-04-25
NextCell Pharma publishes its Interim Report 2 2024/2025
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period December 1, 2024 – February 28, 2025. 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
2025-04-24
NextCell presents detailed analysis of the administrative report from ProTrans-Young
NextCell Pharma AB’s ("NextCell" or "the Company") CSO, Lindsay Davies, has been interviewed by Flemingsberg Science regarding the analysis of the administrative topline evaluation from the older age cohort of the ProTrans-Young paediatric trial.
Read moreRead more
2025-04-23
NextCell Presents Quarterly Report
NextCell Pharma AB ("NextCell" or the "Company") invites investors, analysts and media to an investor presentation in conjunction with the publication of the Company's second interim report for the 2024/2025 financial year, on Thursday, 25 April 2025.
Read moreRead more
2025-04-15
NextCell CEO Mathias Svahn explains the latest results from ProTrans-YOUNG and his vision for the way forward
NextCell Pharma (“the company” or “NextCell”) has published an interview where the analyst Filip Einarsson from Redeye, who currently covering NextCell, discusses with Mathias questions regarding the latest results from ProTrans-YOUNG and NextCell's participation at the International Diabetes Congress in Bangkok 7-10 April. The interview is now available with English subtitles on NextCell's website https://www.nextcellpharma.com/nyheter#foretagspresentationer
Read moreRead more