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.

June 13, 2022
Bio International Convention, San Diego, June 13-16
Bio International Convention, San Diego, June 13-16
February 27, 2020

BioStock interview with Xintela's CMO and board member Sven Kili.

August 30, 2018

BioStock was given the opportunity to interview Sven Kili in connection with his visit to Sweden for board and strategy work in Xintela.

February 9, 2017

Dr. Marcus Keep comments on Xintelas glioblastoma project.

January 31, 2017

Xintelas Chairman of the board and strategic advisor Greg Batcheller, tells us more about Xintelas potential and prospects.

January 30, 2017

Dr. Lisa Fortier at Cornell University, New York is interviewed by BioStock about Xintelas positive results in horse study.

December 28, 2016

In the following video interview, Karin explains her role at Xintela and what she considers to be Xintela’s primary strengths.

December 13, 2016

See the interview with Claes Post, member of the board in Xintela. The interview is in swedish with english subtitles.

March 24, 2016

See the interview with Sven Kili, member of the board in Xintela. The interview is in English (introduction is in Swedish).

March 22, 2016

See an interview with Xintela's CEO Evy Lundgren-Åkerlund, after the listing ceremony at Nasdaq First North.

March 15, 2016

Investor presentation from Lund - Jan 27

January 14, 2016

Interview with Xintelas CEO

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) Grundare av Xintela ser notering som viktig milstolpe
March 23, 2016
(Article in Swedish) Xintela covered in Life Science Sweden
February 24, 2016
(Article in Swedish) Rapidus: Xintela på väg till First North
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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