Treatment start of severe pneumonia with high dose of ProTrans

July 5, 2023

NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans 19+SE (also called Protrans V) can start recruiting patients in the high dose group, which is the last dose group. Three patients treated with medium dose of ProTrans have been clinically evaluated and the data has been reviewed by the Data Safety Monitoring Board, which now allows continued treatment with high-dose ProTrans for severe pneumonia caused by COVID-19, Influenza, Human Metapneumovirus and RSV.

The Data and Safety Monitoring Board has analyzed the safety aspects of the clinical trial: "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ) Umbilical Cord (UC) Mesenchymal Stromal Cells {ProTrans®): open Phase IB Clinical Trial", described in EudraCT 2020-002078-29.

The meeting was held on Monday 3 of July 2023. The members of the Board are Professor Åke Lernmark, Doctor Magnus Nisell and Professor Peter Bergman (Chairman). The Data and Safety Monitoring Board had access to full data collection forms including adverse events.

ProTrans is being developed as an immunomodulatory cell therapy currently being evaluated for the treatment of patients with type 1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in other autoimmune diseases and inflammatory conditions. When the condition of COVID-19 patients worsens, it is because the immune system becomes hyperactive and attacks organs, including the lungs. In this open-label phase Ib study, a total of three groups, consisting of three patients each will be treated with different doses of ProTrans. Now 6 out of 9 patients have undergone treatment and only 3 patients in the high dose group remain.

Early this year, the Swedish Medical Products Agency approved the study, which initially only treated patients with severe pneumonia caused by SARS-CoV-2 infection, to also include patients with the same symptoms caused by influenza A, respiratory syncytial (RS) and human metapneumo (HMP) virus. The treatment is designed for patients who are hospitalized and who are at high risk of needing to be put on a ventilator. ProTrans is given intravenously to reduce hyperinflammation in the lungs. The goal of the treatment is to shorten the hospital stay, rehabilitation time and to save lives.

The principal investigator of the study is Associate Professor Josefin Sundh, Örebro University Hospital. The protocol was written by Professor Dominique Farge, St. Louis Hospital in France, and Dr. Lindsay Davies, CSO NextCell Pharma. The steering committe consists of chairman Professor Farge and members Professor Edvard Smith (NextCell) and Dr Tomasz Oldak (PBKM).

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma

For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se

Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser, info@fnca.se.

About NextCell Pharma AB
NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of 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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2019-10-01

All patients in ProTrans-Repeat are now treated

NextCell Pharma AB ("NextCell") announces that another significant milestone has been reached when the last patient, as part of the ProTrans-Repeat active treatment group, today has received their treatment. This implies that all treatments, related to the two ongoing ProTrans studies, have been completed. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat diabetes type-1. ProTrans-Repeat, which was initiated in May 2019, is a continuation trial of ProTrans-1 dose escalation part with the aim of maximizing data collection on repeated

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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,

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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

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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

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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

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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

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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

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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

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