Xintela's GMP facility is completed and being prepared for production and clinical trials

#Regulatory

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Lund, Sweden, 26th of April 2018 - Xintela AB (publ) today announced that the GMP facility is completed and that the company has moved to offices and laboratories in direct conjunction with the GMP facility. It will now be equipped with instruments and prepared for inspection and approval by the Medical Products Agency for manufacturing licenses for clinical studies. The facility is expected to be ready for production by the end of 2018.

“The transition from our ordinary cell lab to the new GMP-qualified clean room will be smooth since we have already scaled up the methods for producing large amounts of stem cells in the so-called bioreactor," says Xintelas CEO Evy Lundgren-Åkerlund.

With its own GMP facility for manufacturing of stem cells, Xintela gains full control and flexibility over product development and a cost-effective production solution, even in the short term. In addition, Xintela is building a unique competence in GMP production, process development and quality systems that create significant value in the company, both for Xintela's own development, but also as a possible contract manufacturer for other stem cell companies.

“Our decision to produce stem cells in our own GMP facility is getting a lot of attention and increasing the interest of potential collaborating partners," says Evy Lundgren-Åkerlund.

In parallel with preparing GMP-grade production of stem cells, the Xintela team is working on an application to the Medical Products Agency (MPA) to initiate clinical studies on humans and animals. In line with this, Xintela will during the year perform a new study on horses with post-traumatic osteoarthritis to investigate the optimal dose of stem cells and obtain further information on mechanisms of action. These results, together with the results from the previous horse study, will form a critical part of the preclinical documentation that Xintela will present to the MPA.

“We have decided to start with the human clinical study for several reasons. Partly because the requirements for preclinical documentation were found to be similar between human and horse and partly because we can advance the start of a human study by our own GMP production. In addition, we have received great interest from potential partners for the human stem cell project for the treatment of osteoarthritis. If everything works as planned, we expect to be able to start clinical studies on humans in 2019,” says Evy Lundgren-Åkerlund.

Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: 070-329 18 71
Email: evy@xintela.se
Medicon Village
223 81 Lund
www.xintela.se

For investor relations and media questions, please contact:
Mårten Svanberg, Laika Consulting
Tel: 070-362 70 05
Email: marten.svanberg@laika.se
www.laika.se

About Xintela
Xintela develops medical products within regenerative medicine and oncology based on its proprietary marker technology, XINMARK®. Xintela uses the technology to isolate and quality assure stem cells for the treatment of the joint disease osteoarthritis. Studies on horses have shown that the stem cells are safe and that they have a therapeutic effect on the articular cartilage and the underlying bone after an injury. Xintela has recently established its own GMP-facility to produce stem cells for clinical studies. In the oncology program, XINMARK® is used for the development of an antibody-based treatment (Antibody Drug Conjugate, ADC) against specific tumors with first focus on the aggressive brain tumor glioblastoma. Positive preclinical results from cell studies and animal model have shown that the ADC treatment has a targeting and killing effect on specific tumor cells supporting further development of the company’s oncology business. Xintela is listed on Nasdaq First North Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.

Archive

Below you will find the collected information on Xintela’s press releases, newsletters, diary events, films, media coverage and analyses.

May 20, 2025
May 21, 2025
Biostock, The Global Forum 2025
May 15, 2025
May 16, 2025
13th Oswestry/Keele Cartilage Symposium, Keele (UK)
Apr 15, 2025
Apr 17, 2025
Cell & Gene meeting on the med, Rome (Italy)
Dec 12, 2024
Dec 14, 2024
4th Regenerative Medicine Orthopedic Summit, Miami
Nov 4, 2024
Nov 6, 2024
BIO-Europe, Stockholm, Sweden
Sep 25, 2024
Sep 27, 2024
7th ICRS Summit, Catania
Sep 18, 2024
Sep 20, 2024
EORS 2024, Aalborg
Sep 4, 2024
Sep 6, 2024
ISCT Europe 2024, Gothenburg
Jul 10, 2024
Jul 13, 2024
ISSCR 2024, Hamburg
Jun 3, 2024
Jun 6, 2024
BIO International Convention, San Diego
May 8, 2024
May 10, 2024
21st ESSKA Congress, Milan
Nov 30, 2023
Dec 2, 2023
3rd Regenerative Orthopaedic Summit by the Regenerative Medicine Orthopaedic Society (RMOS), Istanbul
Nov 21, 2023
Nov 23, 2023
43rd Orthopaedic World Congres by the International Society of Orthopaedic Surgery and Traumatology (SICOT), Cairo
Oct 10, 2023
Oct 12, 2023
2023 Cell & Gene Meeting on the Mesa, Carlsbad, October 10-12
Sep 9, 2023
Sep 12, 2023
- 17th world congress by the International Cartilage Regeneration & Joint Preservation Society (ICRS), Sitges/Barcelona
Jun 5, 2023
Jun 8, 2023
BIO International Convention, Boston
May 31, 2023
Jun 3, 2023
23rd European Congress of Rheumatology, by European Alliance of Associations for Rheumatology (EULAR), Milan
May 11, 2023
May 13, 2023
2nd Regenerative Orthopaedic Summit, Naples
May 12, 2023
May 13, 2023
10. Berliner Knorpelsymposium, Berlin
Apr 27, 2023
Apr 29, 2023
ICRS Focus Meeting on Allografts and synthetics on the frontstage, Nice
Apr 12, 2023
Apr 14, 2023
Cell & Gene Meeting on the Med 2023 Barcelona
Mar 17, 2023
Mar 20, 2023
OARSI world congress on osteoarthritis, Denver
Mar 16, 2023
BioStock Investor Meeting (broadcast online)
Mar 1, 2023
Mar 2, 2023
European Life Sciences CEO Forum (ELSF 2023) in Zürich, March 1-2, 2023
Feb 22, 2023
Redeye Theme: Regenerative Medicine / Cell Therapy, February 22, 2023
Jan 9, 2023
JPM Annual Healthcare Meeting 2023, San Francisco, January 9-12
Dec 1, 2022
1st Regenerative Orthopaedic Summit, Athens, December 1-3, 2022
Nov 29, 2022
BioStock Life Science Summit, Lund, November 29-30 2022
Nov 14, 2022
Investival Showcase, London, November 14, 2022
Nov 2, 2022
BioEurope (Digitalt), November 2-4, 2022
Oct 11, 2022
2022 Cell & Gene Meeting on the Mesa, Carlsbad, October 11-13
Oct 6, 2022
ICRS Focus Meeting, Bologna, October 6-7
Sep 28, 2022
Nordic Life Science Days, Malmö, September 28-29, 2022
Aug 30, 2022
2nd Integrin-Targeted Drug Development Summit, Boston, August 30 - September 1
Jun 13, 2022
Småbolagsdagarna, Stockholm, June 13-15
Jun 13, 2022
Bio International Convention, San Diego, June 13-16
June 1, 2023

CEO Evy Lundgren-Åkerlund presents the company at ProHearings Capital Market Day in Stockholm on June 1, 2023.

June 1, 2022

Watch the video interview with CEO Evy Lundgren-Åkerlund (in Swedish).

January 22, 2024
BioStock: Targinta’s CEO “Strong interest in ADCs in 2023”
June 1, 2023
DIs #InvestTalks - Xintela develops new generation stem cell products
May 30, 2023
BioStock: Xintela highlights the unique properties of XSTEM
May 2, 2023
BioStock: Xintela initiates last dose level in knee osteoarthritis study
March 22, 2023
BioStock: Targinta positions itself in the ADC field
July 6, 2022
BioStock: Xintela in clinical development
June 1, 2022
BioStock Studio: Xintela's CEO comments on the upcoming share issue
April 12, 2022
BioStock: Xintela's CEO on the potential in difficult-to-heal wounds
March 4, 2022
BioStock: Xintela presents plans for 2022 in its Q4 report
January 27, 2022
BioStock Studio: Targinta provides business update prior to spin-off
January 19, 2022
BioStock: Xintela advances to clinical phase in osteoarthritis and difficult-to-heal wounds 2022
October 12, 2021
BioStock: Professor Folke Sjöberg about XSTEM for treatment of venous leg ulcers.
November 9, 2020
BioStock: Xintela’s CEO comments on the positive patent notice
June 22, 2017
Xintela covered in GEN regarding its participation in multi-million, government funded initiative to form a...
March 2, 2017
Xintela covered in Horsetalk.co.nz regarding that its stem cells are safe for use in horses
March 23, 2016
(Article in Swedish) Xintela tar behandling av ledskador och cancer till First North.
March 23, 2016
(Article in Swedish) Xintela covered in Life Science Sweden
March 23, 2016
(Article in Swedish) Grundare av Xintela ser notering som viktig milstolpe
February 24, 2016
(Article in Swedish) Rapidus: Xintela på väg till First North
June 4, 2025
Västra Hamnen Corporate Finance has published an analysis of Xintela.
May 12, 2025
Västra Hamnen Corporate Finance has published an analysis of Xintela.
May 12, 2025
Västra Hamnen Corporate Finance has published an analysis of Xintela.
May 2, 2025
Västra Hamnen Corporate Finance has published an analysis of Xintela.
November 29, 2024
Västra Hamnen Corporate Finance has published a research update for Q3 2024.
September 5, 2024
Västra Hamnen Corporate Finance has published a research update for Q2 2024
May 29, 2024
Västra Hamnen Corporate Finance has published a research update Q1 2024
March 13, 2024
Västra Hamnen Corporate Finance has published a research update for Q4 2023.
December 1, 2023
Västra Hamnen Corporate Finance has published an initial analysis of Xintela.
December 10, 2021
Edison Group has published a research update on Xintela.
July 14, 2021
Xintela, backed by its integrin biomarker technology platform XINMARK, is a potential disrupter
November 9, 2020
A status report of the Xintela has been published by Biostock
April 12, 2018
Read the full analysis here
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