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).

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2019-09-24
Last patient, last visit completed in the dose escalation part
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the phase I part evaluates safety for three doses. All nine patients have now been followed up for 12 months and have left the study. As previously communicated, all 15 patients in the phase II part of ProTrans-1 have been treated and will be followed for 12 months. The second part is randomized,
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the p...
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2019-09-12
Update on the ongoing clinical trials
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial after 12 months follow-up. The ProTrans-Repeat has included 5 out of 18 patients. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat type-1 diabetes. A single dose of ProTrans is given and the patients own ability to produce insulin is compared
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial afte...
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2019-08-16
NextCell Pharma files another patent application
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the central nervous system. The application was submitted to the Swedish Patent and Registration Agency on August 15 and is formulated to cover the general production of all types of mesenchymal stem cell products derived from multiple donors and cells selected by the selection algorithm. Furthermore, the
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the centr...
Read moreRead more
2019-07-31
Interim report 2018-09-01 - 2019-05-31
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's fiscal year is September 1 - August 31. This English version is a translation of the Swedish version. The Swedish version is at all time to be seen as the leading document. Nine months (2018-09-01 until 2019-05-31) · Operating income amounted to SEK 1 410 055 (527 545). · Operating result
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's f...
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2019-06-20
Final patient treated in the phase II part of the ProTrans-1 trial
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. The final patient has been treated in the randomized, placebo controlled ProTrans-1 phase II part trial. Efficacy and safety data will be collected through regular clinical assessments visits during a 12 month period. Last patient, last will be assessed in July 2020 and thereafter the code will be
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. T...
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2019-06-20
New collaboration and increased digital presence - Cellaviva is gearing for growth
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women which can be downloaded in Appstores under the name Bonzun Pregnant. The app is currently available in 79 countries worldwide under the name Bonzun and in Sweden under the name Min Graviditet. The collaboration has been entered into with the common goal of strengthening the work of sharing knowledge
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women wh...
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2019-06-19
NextCell has treated the first patient in the ProTrans-Repeat trial
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have previously been treated in the ProTrans-1 study's dose escalation phase. This means that the participants receive their second treatment with ProTrans, just over a year after the first. The goal of the ProTrans-Repeat trial is to test whether repeated treatment can increase or maintain the effect of
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have pre...
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2019-06-11
Anders Essen-Möller subscribes to his entire stakes in NextCell Pharmas right issue
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership in NextCell after the investments increases from approximately SEK 3.6 million to 6.0 million. Regarding the ongoing rights issue in NextCell, the principal owner Anders Essen-Möller, also the chairman of the company, has chosen to fully utilize its allotted subscription rights, which means that he
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership ...
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