NextCell publishes opinion piece with ISCT

October 11, 2022

NextCell Pharma AB (”NextCell” or ”Company”)published an opinion piece on particulates in cell and gene therapy products with the International Society for Cell and Gene Therapy’s Process Development, Manufacturing and Analytics Committee last week in the journal Cytotherapy.

NextCell Pharma AB is a cell therapy company working in the development and commercialization of the mesenchymal stromal cell therapy product, ProTrans. This product, with its proprietary platform technology, is in clinical development for the treatment of autoimmune conditions, such as type I diabetes and inflammatory conditions such as viral pneumonia.

 

NextCell’s CEO, Mathias Svahn and CSO, Lindsay Davies are active members of the International Society for Cell and Gene Therapy (ISCT), the leading global society for the development and commercialization of advanced therapeutics. Dr Davies is a member of both the ISCT Commercialization Committee and Process Development, Manufacturing and Analytics Committee and an ISCT mentor for early stage professionals entering the cell therapy space. The Process Development, Manufacturing and Analytics working group brings together scientists and cell and gene therapy companies, in all stages of commercial development, to discuss current issues in the advanced therapy arena and lead forward thinking in these novel and evolving areas of clinical development.

 

“It has been great to work with such a diverse and knowledgeable group of scientists and business developers from across the globe to discuss ways of addressing and supporting cell and gene therapy development. The NextCell team is committed to actively participating in advancing knowledge and understanding, promoting regulatory change and thereby ensure wider accessibility of safe cell and gene therapies for patients”, says Dr Davies.

 

Last week Lindsay Davies and the Process Development, Manufacturing and Analytics Committee published an opinion piece in the journal Cytotherapy. The piece entitled, “Particulates are everywhere, but are they harmful in cell and gene therapies?” addresses the potential issue of evaluating particulate matter in cell and gene therapy products, and the need for regulations to differentiate this distinct class of drugs from other, more traditional pharmaceutical products.

 

The published article can be accessed, for free, at https://authors.elsevier.com/a/1fpxZ5DBIBTE%7EZ until November
16, 2022.

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: 08-735 5595
E-mail: info@nextcellpharma.com
Homepage: www.nextcellpharma.com
 
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

 

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 8,5% 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)
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
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 ...
Read moreRead 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.
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 e...
Read moreRead 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
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 th...
Read moreRead more
2020-10-29
Study design and plan for the recently approved COVID-19 study with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The company provides an update prior to the initiation of the study. · ProTrans 19+ will treat COVID-19 patients with NextCell's lead candidate ProTrans. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The com...
Read moreRead more
2020-10-21
ProTrans stem cells approved for clinical trials in COVID-19 patients
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. ProTrans is developed as an immunomodulatory stem cell therapy presently evaluated in clinical trials treating patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in c...
Read moreRead more
2020-10-14
NextCell presents at “Investerarjakten”
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. In September, NextCell published positive data for its Phase II study, ProTrans-2. The patients with type 1 diabetes treated with a dose of the stem cell drug ProTrans had maintained a statistically significantly higher insulin production after 12 months compared with the patients treated with placebo
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. ...
Read moreRead more
2020-09-10
Presentation of the positive results from ProTrans-2
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 September at 16.00. The result from the clinical trial ProTrans-2 said that patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). Today, on Thursday the 10th of
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 Septembe...
Read moreRead more
2020-09-08
ProTrans shows significant effect in Diabetes
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). A total of 15 patients were included in the ProTrans-2 trial. They were randomized to receive either ProTrans (n=10), NextCell’s proprietary stem cell therapy, or placebo (n=5). Treatment was blinded, ensuring that neither patients or their physicians knew whether they had received active
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value...
Read moreRead more