The European Patent Office intends to grant a Patent for Selection Algorithm

May 31, 2022

NextCell Pharma AB ("NextCell" or the"Company") today announces that the European Patent Office (EPO) hasissued an Intention to Grant notice relating to the patent entitled "Allogeneic Composition" (publication number EP3752598). 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.

 "It is reassuring for NextCell that we have received positive notification from the EPO and can protect our most valuable asset," says CEO Mathias Svahn.

ProTrans is NextCell's first drug candidate based on the selection algorithm. It is an allogeneic celltherapy 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 intype-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 withtype-1 diabetes. In addition, clinical trials are ongoing with patients with severe pneumonia due to COVID-19 infection, in Sweden and Canada.

 

This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 31st of May at 08.30 CET.

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

 

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 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).

Download attachmentRead full press release on Cision (external link)
2021-07-30
NextCell Pharma publishes Interim Report 3 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year. Third quarter (2020-03-01 until 2021-05-31) · Operating income amounted to SEK 905 750 (750 512). · Operating result amounted to SEK -6 457 514 (-4 833 332). · Earnings
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth ...
Read moreRead more
2021-06-22
NextCell enters CAR-T joint venture
NextCell Pharma AB (“NextCell”) today announces a joint venture together with their long-term collaborator and contract manufacture organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired ~10 % of shares in the newly started company FamiCordTx through a directed equity issue, raising the capital with 0,5 MEuro in cash. FamiCordTx has exclusively licensed a patent pending CAR-T technology and the tech transfer is completed, and the production of CAR-T cell therapy is awaiting ATMP manufacturing approval before production of CAR-T for clinical trial use can
NextCell Pharma AB (“NextCell”) today announces a joint venture together with their long-term collaborator and contract manufacture organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired ~10 % of shares in the newly started company FamiCordTx through a direc...
Read moreRead more
2021-06-17
Advisory meeting with the European Medicines Agency
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval. The focus was the design of the phase III study ProTrans-3, which NextCell intends to submit an application for later this year.
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval.
Read moreRead more
2021-06-10
COVID-19 patient treated with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by Principal Investigator Associate Professor Josefin Sundh. NextCell's drug candidate, ProTrans, is an immune- balancing cell therapy for the treatment of autoimmune diseases and inflammatory conditions. Patients with severe pneumonia as a result of by SARS-CoV-2 infection are at risk of rapid
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by ...
Read moreRead more
2021-06-08
Article about Gene and Cell Therapy
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both at the Department of Laboratory Medicine, Karolinska Institutet; Karolinska Centre for Cell Therapy, Karolinska University Hospital, Stockholm. The main message of the article is that the development of gene therapy has been rapid, and more and more preparations are reaching patients and in many
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both ...
Read moreRead more
2021-05-28
NextCell presents their latest phase II clinical data at ISCT 2021
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene Therapy virtual conference 2021 (May 26[th]-28[th]). NextCell’s CSO, Dr. Lindsay Davies will attend the meeting and present a poster entitled “Protrans Wharton’s Jelly Mesenchymal Stromal Cells Preserve Beta Cell Function in Newly Diagnosed Type I Diabetes Patients – A Randomised, Double-Blinded,
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene The...
Read moreRead more
2021-05-26
Study start for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheral infusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives. · ProTrans19 + CA, a randomized placebo-controlled phase-II study
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of ne...
Read moreRead more
2021-05-21
Recruitment start for the ProTrans study for treatment of COVID-19
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheralinfusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation and save lifes. The study will be performed at the University Hospital in Örebro in collaboration with the
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory suppo...
Read moreRead more