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).
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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
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 have initiated a limited customary, legal, financial and technical/scientific due diligence. At the same time, discussions are taking place between the boards of the Companies. Additionally, the merger if implemented, will take place through an exchange offer from NextCell with consideration in
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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