ProTrans cell therapy to be granted patent protection beyond Europe

August 25, 2022

NextCell Pharma AB ("NextCell" or the "Company") today announces that the Japan Patent Office (JPO) has issued a notice of allowance relating to the patent entitled "Allogeneic Composition" (publication number JP2020543858A). The patent describes the method of manufacturing the drug candidate ProTrans, where the selection algorithm is key for selecting optimal cells and donors.  Patent protection is valid until 2039.

The selection algorithm consists of a method for selecting cells with a suitable immunomodulatory effect that are assessed by a panel of different analyses. The algorithm makes an overall assessment of several functional analyses to identify optimal donors and cells for the manufacture of cell therapies. NextCell's accurate and advanced selection method has a scalable capability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in consistently high-quality cells and hence a strong safety profile with few side effects.

 

"Japan is leading the cell therapy and stem cells field, thus protection in this region is important." says CEO Mathias Svahn.

 

ProTrans is NextCell's first drug candidate based on the selection algorithm. It is an allogeneic cell therapy which means that donated cells, not the patient's own, are used.  The cells are extracted from donated umbilical cord tissue and the cells are then multiplied to generate large amounts of cells.

 

Clinical trials in type-1 diabetes have shown promising results for ProTrans to stop the course of the disease for 1 year in adult patients, potentially longer. Ongoing trials are now evaluating efficacy in adolescents and children newly diagnosed with type-1 diabetes. In addition, clinical trials are ongoing with patients with severe pneumonia due to COVID-19 infection, in Sweden and Canada.

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, 08-528 00 399, info@fnca.se.

About NextCell Pharma AB

NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 10% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).
Download attachmentRead full press release on Cision (external link)
2021-04-14
Pediatric diabetes study with stem cells approved
NextCell Pharma AB ("NextCell") announces today that Uppsala University Hospital and the principal investigator, Professor Per-Ola Carlsson, have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial with ProTrans™ to treat children and adolescents with type-1 diabetes. The study is a phase I / II study with a total of 66 patients. The first six patients treated will be evaluated for safety. The first six patients, three adolescents (12-18 years) and three children (7-11 years), will be treated and assessed for safety.
NextCell Pharma AB ("NextCell") announces today that Uppsala University Hospital and the principal investigator, Professor Per-Ola Carlsson, have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial with ProTrans™ to trea...
Read moreRead more
2021-03-31
NextCell welcomes Consensus Sverige Selectas as a shareholder
The Board of Directors of NextCell Pharma AB (”NextCell or the ”Company”) has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on a directed issue of 666,666 new shares (the “Share Issue”) to Consensus Sverige Select (”Consensus”). The subscription price in the share issue amounts to SEK 15 per new share and the Company receives approximately SEK 10 million in issue proceeds. The Board of Directors of NextCell has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on the Share
The Board of Directors of NextCell Pharma AB (”NextCell or the ”Company”) has today, based on the authorization granted by the Annual General Meeting held on 24 November 2020, resolved on a directed issue of 666,666 new shares (the “Share Issue”) to Consensus Sverige Select (”Consensus”). The sub...
Read moreRead more
2021-03-02
The stem cell company NextCell invests in own production facility
The stem cell company NextCell Pharma AB (“NextCell” or “the Company”) announces today that they have entered into an agreement with the property manager Hemsö and the clean room supplier QleanAir, to build a full-scale production facility. This new production facility will be directly connected to the Company's existing office and clean room in the Novum building, next to Karolinska University Hospital in Huddinge. The construction will take place later this spring and the premises are expected to be completed during the third quarter of 2021. The significant upcomming medical need for
The stem cell company NextCell Pharma AB (“NextCell” or “the Company”) announces today that they have entered into an agreement with the property manager Hemsö and the clean room supplier QleanAir, to build a full-scale production facility. This new production facility will be directly connected ...
Read moreRead more
2021-02-02
Canadian Trial for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) today announces that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled “Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans™): a Randomized Phase II Controlled Clinical Trial”. The sponsor for this trial is the Research Institute of the McGill University Health Centre. The trial will enrol 48 patients with severe pneumonia associated with confirmed COVID-19 (SARS-CoV-2) infection,
NextCell Pharma AB (“NextCell”) today announces that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled “Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton’s Jelly (WJ)-Umbilical Cord (UC) Me...
Read moreRead more
2021-01-29
NextCell Pharma publishes Interim Report 1 2020/2021
NextCell Pharma AB (publ) (NXTCL) publishes its Interim Report 1 for the period September 1, 2020 - November 30, 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. First quarter (2020-09-01 until 2020-11-30) · Operating income amounted to SEK 1 148 187 (1 222 087) · Operating result amounted to SEK -17 680 697 (-17 997 787).. · Earnings per share
NextCell Pharma AB (publ) (NXTCL) publishes its Interim Report 1 for the period September 1, 2020 - November 30, 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...
Read moreRead more
2020-12-23
NextCell Pharma’s rights issue was oversubscribed
NextCell Pharma AB ("NextCell" or the ”Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the “Rights Issue”). The Rights Issue was oversubscribed. Thus, no guarantees have been utilized. 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
NextCell Pharma AB ("NextCell" or the ”Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the “Rights Issue”). The Rights Issue was oversubscribed. Thus, no guarantees have been utilized. ...
Read moreRead more
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
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 UNLAWFU...
Read moreRead 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
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-...
Read moreRead more