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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2018-10-31
Publication of year-end report
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).                   · Result per share amounted to SEK -0,61 (-0,64). · Cash and bank amounted to SEK 3 115 876 (16 600 937). · Solidity amounted to 59 (88) %. · Net sales amounted to SEK 127 868 (198 765). · Operating result amounted to SEK -3 422 282 (-4 757 996).
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).      ...
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2018-10-25
The Safety Committee recommends proceeding with part 2 of the stem cell trial in type 1 diabetes
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes aged 18-40 years old who had the disease for a maximum of 2 years and who have some own insulin production are candidates to be included in the study. The second part of the ProTrans trial is a Phase-II study with the aim to further evaluate the efficacy and safety of ProTrans. The efficacy of the
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes age...
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2018-10-01
NXTCL’s Cellaviva brand is expanding into Denmark
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates that its entrance into Denmark will allow for a doubling of annual sales for Cellaviva. The establishment fits within the existing budget and does not affect NXTCL's capital requirements. Cellaviva has now decided to expand its operations to Denmark as of 1st October 2018. The company holds all the
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates th...
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2018-09-20
Redeemed warrants are now registered with the Swedish Companies Registration Office
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which means that the number of shares in NXTCL after registration amounts to 11 226 356. The share capital amounts to SEK 2 301 402.98. Conversion of interim shares to shares is expected to take place on 28th September 2018. Different agents may take a different amount of time to convert, which means that
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which ...
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2018-09-17
NXTCL is allocated approximately SEK 12.9 million through redemption of warrants
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. NXTCL is therefore allocated approx. SEK 13.6 million before issue costs, which are estimated to amount to approx. SEK 0.7 million. CEO Mathias Svahn comments "I would like to thank all of those who have shown - and continue to show - their interest and trust in the stem cell company NXTCL. We
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. ...
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2018-09-11
NextCell to present status of ongoing clinical trial at the Nordic Life Science Days
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later this week. NXTCL's clinical trial is divided into two parts, the first part is a three-step dose escalation phase with three patients in each cohort, a total of nine patients. The second part of the trial is randomized, double-blind and placebo-controlled, with ten patients receiving ProTrans and five
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later t...
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2018-09-11
Last day of trading in series TO 1 warrants
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are available on the following websites: NXTCL (www.nextcellpharma.com (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/TLO3KWR6/www.nextcellpharma.com)); Sedermera Fondkommission (www.sedermera.se (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are a...
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2018-09-05
Reminder to exercise your series TO 1 warrants
The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs. The subscription of series TO 1 warrants to be
The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrant...
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