NextCell updates on NLS days

September 28, 2022

NextCell Pharma AB ("NextCell" or the"Company") provides a status update today at the Nordic Life Science days in Malmö. NLS days is the Nordic region's largest partnering event in Life Science where NextCell's CEO Mathias Svahn will participate in meetings and give a presentation today at 14:12.

The cell therapy company NextCell Pharma AB has developed a proprietary and patented platform technology to produce mesenchymal stromal cells with properties adapted for allogeneic treatment of specific diseases.

The company's lead drug candidate, ProTrans, is being developed for the treatment of autoimmune diseases and inflammatory conditions. Efficacy and safety have been shown for the treatment of adults with type-1 diabetes (studies ProTrans 1 and 2), and here the aim is to stop the autoimmune course of the disease and thus preserve the endogenous insulin production, which the patient has left at the time of treatment. In addition to the fact that this can contribute to increased quality of life in the patients, it has been reported that remaining endogenous insulin production provides longer estimated life time, as well as reduced late complications.

In October, NextCell is expected to present the 3-year long-term effect of ProTrans from the ProTrans-OBS study.  In November, NextCell is expected to present a 3.5-year long-term effect of ProTrans from the ProTrans-Repeat study.

 

A pediatric diabetes study, ProTrans-Young, is ongoing and led by Professor Per-Ola Carlsson at Uppsala University Hospital. The first group of patients has been treated, and a safety committee's opinion is awaited in November prior to the recommendation to the start of the second part of the study, which could then include new patients in December.

 

A pediatric development plan (Pediatric Investigation Plan, PIP) is required for drug development for the treatment of children. The plan describes the clinical trial program until commercialization and is a requirement for phase 3 studies. NextCell has submitted an application, which will be considered by the European Medicines Agency's expert committee at the end of the year. The application includes ProTrans-3, a pivotal phase III study for both adults and children that, if positive, can give ProTrans marketing approval.

 

NextCell is financially stable, and with the current plan does not require additional capital needs in the coming financial year. An approved pediatric development plan is a prerequisite for applying for a pivotal study involving children and the company may seek some form of partnership before the start of a such a phase III study.

 

NextCell's GMP facility has now been completed and qualification work has begun. The purpose is to bring home the production technology to prepare future technology transfer from NextCell to one or more licensees or buyers of ProTrans. The collaboration with our contract manufacturer continues and together the companies will have production capacity that far exceeds the need for ProTrans clinical trials.

 

In addition to type-1 diabetes studies, COVID-19 studies are conducted where patients with hyperinflammation in the lungs are treated with ProTrans. The recruitment rate has slowed down as a result of the reduced number of patients affected by severe disease. The Swedish study has treated 5 out of 9 patients and the Canadian study 18 out of 48 patients. Dialogues are being conducted on how the studies can be modified to increase the rate of inclusion.

NextCell is the owner of Cellaviva, Scandinavia's largest stem cell bank for family saving of stem cells from umbilical cord blood and umbilical cord tissue. The business has shown good growth during the financial year.

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8-735 5595
E-mail: info@nextcellpharma.com
Webpage: 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 process of establishing its own GMP facility for the production of ProTrans. The GMP facility is expected to be ready for production of small 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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2018-07-31
NextCell Pharma publishes quarterly report three 2017/2018
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its third quarter report 2017/2018 (September 2017 – May 2018). Nine Months (2017-09-01 until 2018-05-31)  · Net sales amounted to SEK 527 545 (318 438). · Operating result amounted to SEK -10 610 012 (-8 477 749).                      · Result per share* amounted to SEK -1,25 (-2,89). · Cash and bank amounted to SEK 5 929 492 (6 558 898). · Solidity amounted to 83.8 (70.4)%. · Net sales amounted to SEK 136 341 (197 846). · Operating result amounted to SEK -3 085 756 (-3 614 243).                        ·
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its third quarter report 2017/2018 (September 2017 – May 2018). Nine Months (2017-09-01 until 2018-05-31)  · Net sales amounted to SEK 527 545 (318 438). · Operating result amounted to SEK -10 610 012 (-8 477 749).                     ...
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Stem cell company NextCell Pharma AB (“NXTCL”) announces that it is preparing to launch a service for saving adipose (fat) tissue derived stem cells during the first half of 2019. The service allows adults to save their own stem cells for future use. The stem cells are collected by liposuction, p...
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2018-07-18
NextCell celebrates its first-year anniversary as a listed company
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The potential market for stem cell therapies is immense and development is at record speed. On July 13, 2017, stem cell company NextCell Pharma AB ("NextCell") was listed on Spotlight Stock Market (formerly AktieTorget). In his own words, CEO Mathias Svahn reflects on the company’s first year as ...
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Publication of scientific article regarding the clinical trial with ProTrans
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2018-07-03
NextCell applies for prediction methodology patent
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The stem cell company NextCell Pharma AB ("NXTCL") has submitted another patent application. This time regarding a method for predicting if a specific patient is susceptible to treatment with the drug candidate ProTrans. Since the beginning of 2017, NXTCL has performed preclinical experiments in ...
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2018-06-29
The Data and Safety Monitoring Board approves the usage of high-dose ProTrans in the ongoing clinical trial
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort. The treatment of all three patients in the medium-dose cohort with ProTrans has been assessed as safe using a one-month follow-up period. Now NXTCL is now able to recruit patients for the last dose cohort, which is the high-dose cohort. The recruitment of the last dose cohort is expected to take one
Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort. The...
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2018-06-28
Extended tissue establishment authorization
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required. NXTCL acquired the tissue establishment authorization in 2014-11-19. The permit is reviewed every other year in connection with inspection. The operations were inspected 2016-01-20 and now by 2018-05-07, again with a positive outcome. Tissue establishment is an establishment where physical or
The stem cell company NextCell Pharma AB ("NXTCL") was inspected on 7th May 2018 by the Health and Care Inspectorate (IVO), which is the supervisor of tissue establishments. NXTCL has today received the inspection report that authorizes the business to continue without any changes being required....
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2018-05-18
Six patients now treated with NextCells ProTrans stem cells
NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candidate ProTrans, is divided into two parts, the first part being a dose-escalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now all patients in the low-dose-cohort and the medium-dose-cohort have been treated. After the 1-month follow-up of the
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