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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2019-05-09
ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin. ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat....
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2019-05-08
The Medical Products Agency grants NextCell permission to initiate the ProTrans-Repeat trial
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The goal for this study is to include those patients with type 1 diabetes who participated in the dose escalation part of the ongoing ProTrans-1 study and the study purpose is to demonstrate that ProTrans also has a positive effect when using a repeated treatment approach. ProTrans-Repeat is a Phase IIa
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The g...
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2019-05-08
The NextCell Pharma AB board of directors proposes an Rights Issue of MSEK 24.9 and calls for an extraordinary general meeting
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of intent of approximately 21 per cent and guarantee commitments of approximately 59 per cent, which corresponds to approximately 80 per cent of the total issue volume. The reason for the rights issue is to obtain working capital to expand the clinical trial program with the company's first drug
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of...
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2019-05-08
Discussions on a merger between NextCell AB and Idogen AB are suspended
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The discussions that took place between the boards of NextCell Pharma AB ("NextCell") and Idogen AB ("Idogen") (together "The Companies"), regarding a possible merger, are suspended. Although the discussions have been characterized by pragmatism, but the boards of the companies have concluded tha...
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2019-05-06
Update regarding possible merger between NextCell Pharma AB and Idogen AB
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Discussions between the boards of NextCell Pharma AB (publ) ("NextCell") and Idogen AB (publ) ("Idogen") (together "The companies") regarding a possible merger, are still ongoing. Further information will be published no later than the opening of trading on Wednesday, 08 May 2019. The companies h...
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2019-04-30
Half-year report
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). · Solidity** amounted to 87 (59) %. **Result per share: operating results divided by the average number of shares. Average number of shares for the first half of 2018/2019: 11,486,456 shares (8,505,425). Number of shares in NextCell as per February 28th, 11,486,456 shares (8,505,425). *
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). ...
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2019-04-26
NextCell Pharma AB comments on the trading halt of 25 April 2019
With respect to Spotlight Stock Market’s decision on 25 April 2019 to halt trading in NextCell Pharma AB's share, the stock market has, in accordance with its regulations, ordered the company to comment on the trading halt. Discussions are currently underway between the boards of NextCell Pharma AB and Idogen AB regarding a potential merger. The structure being discussed would entail that NextCell Pharma AB makes a bid for all of the shares in Idogen AB and in turn will offer its own shares as a means of payment. At the time of the press release, the dialogue between the companies has only
With respect to Spotlight Stock Market’s decision on 25 April 2019 to halt trading in NextCell Pharma AB's share, the stock market has, in accordance with its regulations, ordered the company to comment on the trading halt. Discussions are currently underway between the boards of NextCell Pharma ...
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2019-04-05
NextCell's biobank Cellaviva has received permission from IVO to handle stem cells from adipose tissue
NextCell Pharma AB ("NextCell") announces today that its biobank Cellaviva has been granted an extended permit from the Health and Care Inspectorate (IVO), to also handle and store stem cells from adipose tissue. The decision enables the company to launch its new service, stem cell saving for adults. The company has previously been authorized by IVO to operate a tissue establishment using cells from the umbilical-cord and umbilical-cord-blood from newborns and operates a biobank for family saving of these cells. The extended approval state of fat-derived stem cells means for the fat-derived
NextCell Pharma AB ("NextCell") announces today that its biobank Cellaviva has been granted an extended permit from the Health and Care Inspectorate (IVO), to also handle and store stem cells from adipose tissue. The decision enables the company to launch its new service, stem cell saving for adu...
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