Positive feedback on the paediatric plan of the EMA

January 18, 2023

NextCell Pharma AB ("NextCell") has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency’s (EMA) pediatric committee (PDCO).

As previously announced, NextCell submitted a proposal in Q4 outlining how ProTrans should be developed for the treatment of children with type-1 diabetes. The agency has returned with comments and recommendations that aiming to ensure that children younger than 7 years old can also receive treatment in the future.

"The PDCO has been very helpful with the development plan and the proposed changes strengthen our proposal.  We will of course implement these before the PIP is finally submitted for approval", says Mathias Svahn, CEO.

A PIP is a development plan aimed at ensuring that all necessary safety and efficacy data are obtained through clinical studies in children, prior to application for authorisation of a medicine for pediatric usage. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP.

Only small changes have been requested by EMA, aimed at allowing even younger age groups to be treated after a possible market approval than what is treated in the ongoing pediatric study, ie children younger than 7 years. The changes do not affect the study design of the planned phase 3 study.

In addition to clinical trials, the plan also includes preclinical studies of biodistribution and toxicology. NextCell is currently reviewing the recommendations by the PDCO and amending the proposal prior to submitting for approval.

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

NextCellis 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-19studies, 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).
Download attachmentRead full press release on Cision (external link)
2022-04-01
Cellaviva delivers stem cells to treat serious blood disease
NextCell Pharma AB ("NextCell" or the ”Company”) announces that the stem cell bank Cellaviva has released umbilical cord blood stem cells to Rigshospitalet, Denmark's leading hospital.
Read moreRead more
2022-02-22
The Canadian ProTrans in COVID-19 single center trial is expanded to a multicenter trial
NextCell Pharma AB (“NextCell”) today announces that the clinical trial ProTrans19+CA expanded to include an additional site: the Jewish General Hospital in Montreal, Canada.  The hospital is one of the largest in Canada and is affiliated with the trial Sponsor, the Research Institute of McGill University Health Center. Patient enrolment increased due to the omicron variant, which we envisage will be further enhanced by patient reqruitment at both sites, the Royal Victoria and Jewish General Hospital. The coronavirus pandemic has transformed over time and omicron has shown to be more
NextCell Pharma AB (“NextCell”) today announces that the clinical trial ProTrans19+CA expanded to include an additional site: the Jewish General Hospital in Montreal, Canada.  The hospital is one of the largest in Canada and is affiliated with the trial Sponsor, the Research Institute of McGill U...
Read moreRead more
2022-02-21
Pediatric diabetes study with ProTrans in progress
NextCell Pharma AB ("NextCell") has previously announced a clinical trial with ProTrans™ to treat children and adolescents with type 1 diabetes. The study recently started with screening of patients. Before treatment, patients are followed for about a month and the first adolescents will soon undergo treatment. The first part of the study is a safety part (phase Ib) where all patients are treated at Akademiska university hospital. 3 patients aged 12-18 years receive treatment first and there after 3 patients aged 7-11 years. The data will then be reviewed by the Data Safety Monitoring Board,
NextCell Pharma AB ("NextCell") has previously announced a clinical trial with ProTrans™ to treat children and adolescents with type 1 diabetes. The study recently started with screening of patients. Before treatment, patients are followed for about a month and the first adolescents will soon und...
Read moreRead more
2022-02-18
NextCell Pharma presents at Redeye Theme: Regenerative Medicine/Cell Therapy
On February 23rd at 10.40 CET Dr. Mathias Svahn, CEO of NextCell Pharma AB (“NextCell" or the"Company"), will present the latest developments in the company at Redeye. The presentation is live broadcasted and can be followed at https://www.redeye.se/events/825130/redeye-theme-regenerative-medicine-cell-therapy where the replay and the presentations will be available afterwards.
On February 23rd at 10.40 CET Dr. Mathias Svahn, CEO of NextCell Pharma AB (“NextCell" or the"Company"), will present the latest developments in the company at Redeye. The presentation is live broadcasted and can be followed at https://www.redeye.se/events/825130/redeye-theme-regenerative-medici...
Read moreRead more
2022-02-08
NextCell invests in CAR-T technology
NextCell Pharma AB ("NextCell" or the"Company") informs that FamiCordTx, a joint venture cell-gene biopharma company issues new share. The major shareholders, PBKM and NextCell will participate at 50% of their pro rata rights. For NextCell this results in an investment of approximately kEUR 160, whereas its ownership in FamiCordTx will change from 9,43% to 8,45% of the then shares. FamiCordTx S.A., raised PLN 16 million (approximatly MEUR 3,5) from a pre-IPO issue of shares •  The proceeds from the issue will be used to fund the Phase 1 clinical trials of CAR T (chimeric antigen receptor
NextCell Pharma AB ("NextCell" or the"Company") informs that FamiCordTx, a joint venture cell-gene biopharma company issues new share. The major shareholders, PBKM and NextCell will participate at 50% of their pro rata rights. For NextCell this results in an investment of approximately kEUR 160, ...
Read moreRead more
2022-01-27
NextCell Pharma publishes Interim Report 1 2021/2022
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2021 - November 30, 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. First quarter (2021-09-01 until 2021-11-30) ● Operating income amounted to TSEK 1 347 (1 148). ● Operating result amounted to TSEK -6 472 (-5 473). ● Earnings per share* amounted to
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2021 - November 30, 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
2022-01-25
NextCell invited speaker at the prestigious Advanced Therapy Week in USA
NextCell Pharma AB ("NextCell" or the"Company") has been invited to give a presentation about the company journey within the cell therapy arena. Starting as a Karolinska Institute spin-out to phase II clinical trials listed on Nasdaq. The Miami-based meeting is the largest event in the Cell & Gene Therapy arena and brings together a range of key opinion leaders in the advanced therapies field with an expected 1650 participants. The wider theme for the meeting is to advocate for the application of advanced therapies in healthcare, by innovation & investment, manufacturing, logistics and
NextCell Pharma AB ("NextCell" or the"Company") has been invited to give a presentation about the company journey within the cell therapy arena. Starting as a Karolinska Institute spin-out to phase II clinical trials listed on Nasdaq. The Miami-based meeting is the largest event in the Cell & Ge...
Read moreRead more
2021-12-13
NextCell collaborates with T.A.D.1 and T1D app
NextCell Pharma AB ("NextCell" or the"Company") has entered into a collaboration agreement with T.A.D.1, a non-profit association whose purpose is to increase knowledge in society about type 1 diabetes and run projects to support everyone living with and around T1D.  Together, we want to spread hope for type 1 diabetes and make NextCell's clinical trials visible. Every year, more than 900 children are diagnosed with type 1 diabetes and at least as many are diagnosed in adulthood. The disease has a huge impact on life and something that needs to be dealt with daily, for the rest of your life.
NextCell Pharma AB ("NextCell" or the"Company") has entered into a collaboration agreement with T.A.D.1, a non-profit association whose purpose is to increase knowledge in society about type 1 diabetes and run projects to support everyone living with and around T1D.  Together, we want to spread h...
Read moreRead more