NextCell to begin treatment with medium dose in COVID-19

NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans19+SE can commence to enroll patients in the medium dose group. Three patients having received a low dose ProTrans, have been clinically assessed and evaluated by the Data and Safety Monitoring Board, which now allows continuation with medium dose treatment of ProTrans for COVID-19 induced servere pneumonia.

The Data and Safety Monitoring Board (DSMB) has reviewed safety aspects of the study "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", outlined in EudraCT 2020-002078-29.

The meeting was held on Monday, October 25. professor Åke Lernmark, dr Magnus Nisell and associate professor Peter Bergman (chair) constituted the DSMB. Associate professor Josefin Sundh, principal investigator, gave a description of the study and the included patients. The DSMB was given access to complete case report forms, including descriptions of adverse events.

Three patients have been included for the first phase of the study, where 25 million cells were given as a single infusion. All three patients improved during the study period and could be discharged from the hospital. One patient exhibited signs of fatigue, dyspnoea and decreased physical performance for an extended time after discharge. However, this was considered to be a part of the covid-19 disease and not related to the study drug. Overall, the few reported adverse events were mild and most likely not connected to the study drug. Thus, the DSMB allows the enrollment to continue.

ProTrans is developed as an immunomodulatory cell therapeutic and presently evaluated in patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in other autoimmune diseases and inflammatory conditions. The servere stage of COVID-19 is when the immune system becomes hyperactive and attacks organs including the lungs. In this open phase Ib study, a total of three groups, each of three patients, will be treated with different doses of ProTrans.

Principle Investigator for the trial is Professor Josefin Sundh, University Hospital Örebro. The clinical trial protocol is 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 the members professor Edvard Smith (NextCell Pharma) and dr Tomasz Oldak (PBKM).

För further information, please contact:

Mathias Svahn, CEO
Patrik Fagerholm, CFO

Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Home pages:

NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

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).

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.