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)
2021-10-29
NextCell publishes its Year-End Report 2020/2021
NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2020 - August 31, 2021 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. Fourth quarter (2021-06-01 until 2021-08-31) ● Operating income amounted to TSEK 1 381 (842). ● Operating result amounted to TSEK -4 475 (-4 877). ● Earnings per share* amounted to SEK -0,13 (-0,22).
NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2020 - August 31, 2021 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 th...
Read moreRead more
2021-10-26
NextCell to begin treatment with medium dose in COVID-19
NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans19+SE can commence to enroll patients in the medium dose group. Three patients having received a low dose ProTrans, have been clinically assessed and evaluated by the Data and Safety Monitoring Board, which now allows continuation with medium dose treatment of ProTrans for COVID-19 induced servere pneumonia. The Data and Safety Monitoring Board (DSMB) has reviewed safety aspects of the study "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ) Umbilical
NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans19+SE can commence to enroll patients in the medium dose group. Three patients having received a low dose ProTrans, have been clinically assessed and evaluated by the Data and Safety Monitoring Board, which...
Read moreRead more
2021-10-26
NextCell increases market potential and reduces the risk of ProTrans' clinical trial program in type 1 diabetes
NextCell Pharma AB ("NextCell" or the "Company") updates the strategy for the clinical trial program in type 1 diabetes with ProTrans. The aim is to increase potential while reducing the risk. This can be achieved by waiting for preliminary safetydata from the approved ProTrans-Young pediatric trial before submitting the application for ProTrans-3, scheduled for H2 2022. Advantages of the updated strategy for future application for marketing approval are: · Lower age limit for treatment is desirable and could potentially double the intitial market · Increased long term data from
NextCell Pharma AB ("NextCell" or the "Company") updates the strategy for the clinical trial program in type 1 diabetes with ProTrans. The aim is to increase potential while reducing the risk. This can be achieved by waiting for preliminary safetydata from the approved ProTrans-Young pediatric tr...
Read moreRead more
2021-10-06
NextCell invited speaker at the Advanced Therapy Congress in London
Today, NextCell Pharma AB’s CEO, Dr. Mathias Svahn, is presenting clinical data from the ProTrans-1 and ProTrans-2 diabetes studies. Ranked as one of Europe's most important events in the field of advanced therapies, the ExCel event brings together leading players in the pharmaceutical industry to provide information on the latest technologies attracting more than 2,000 visitors. The scope of the summit is to explore, define and tackle the challenges of, and patient access to ATMPs (Advanced Therapy Medicinal Products), as the field moves into an exciting 2022. NextCell has developed an
Today, NextCell Pharma AB’s CEO, Dr. Mathias Svahn, is presenting clinical data from the ProTrans-1 and ProTrans-2 diabetes studies. Ranked as one of Europe's most important events in the field of advanced therapies, the ExCel event brings together leading players in the pharmaceutical industry t...
Read moreRead more
2021-09-09
All patients in the low-dose group treated with ProTrans
NextCell Pharma AB ("NextCell" or the "Company") announces that three patients with Covid-19 have now been treated with ProTrans in the Swedish study ProTrans19+SE conducted at Örebro University Hospital. As a result, all patients in the low-dose cohort are now treated. The full title of the study is: "Treatment of Respiratory Complications Associated with COVID-19 Infection with Wharton's Jelly (WJ) -Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): An Open Phase IB Clinical Trial", (EudraCT 2020-002078-29). NextCell sponsors the study, which will include a total of nine patients
NextCell Pharma AB ("NextCell" or the "Company") announces that three patients with Covid-19 have now been treated with ProTrans in the Swedish study ProTrans19+SE conducted at Örebro University Hospital. As a result, all patients in the low-dose cohort are now treated. The full title of the stu...
Read moreRead more
2021-08-17
NextCell files patent application for treatment of COVID-19 with ProTrans
NextCell Pharma AB ("NextCell" or the "Company”) announces that a patent application has been filed for the treatment of Sars-CoV-2 mediated severe pneumonia with ProTrans. NextCell increases the IP protection for the drug candidate ProTrans for the treatment of autoimmune diseases and inflammatory conditions. The latest patent application has is entitled; "Allogeneic Composition for Treatment off Covid-19". By using the possibility of priority from a previous application, the COVID-19 application has a priori day of August 14, 2020, i.e. dated 1 year back in time. NextCell has filed a
NextCell Pharma AB ("NextCell" or the "Company”) announces that a patent application has been filed for the treatment of Sars-CoV-2 mediated severe pneumonia with ProTrans. NextCell increases the IP protection for the drug candidate ProTrans for the treatment of autoimmune diseases and inflammat...
Read moreRead more
2021-07-30
NextCell Pharma publishes Interim Report 3 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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. Third quarter (2020-03-01 until 2021-05-31) · Operating income amounted to SEK 905 750 (750 512). · Operating result amounted to SEK -6 457 514 (-4 833 332). · Earnings
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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 ...
Read moreRead more
2021-06-22
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
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 direc...
Read moreRead more