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

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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.

July 9, 2018
Xintela signs Letter of Intent with CO.DON
June 28, 2018
Xintela receives MUMS-status for the treatment of osteoarthritis in horses
April 26, 2018
Xintela's GMP facility is completed and being prepared for production and clinical trials
April 17, 2018
Xintela develops unique methods in stem cell therapy for the brain and broadens patent portfolio
March 20, 2018
Xintela prepares for a possible spin-out of its oncology business into a separate company
February 22, 2018
Xintela publishes the Year-end Report for 2017-01-01 - 2017-12-31
December 29, 2017
Xintela licenses human antibody technology for cancer therapy
December 19, 2017
Xintela to collaborate with Japanese CellSeed Inc.
November 13, 2017
Xintela raises 17 million SEK in debt and equity
October 17, 2017
Keld Søndergaard has resigned from the company’s Board of Directors, citing personal reasons.
September 11, 2017
Xintela building own GMP-facility for stem cell production
July 17, 2017
Xintela recruits Liselotte Theorell as Director Product Development and Quality Management
June 22, 2017
Xintela participates in multi-million, government funded initiative to form a cell and gene therapy research center
May 22, 2017
Xintela signs Memorandum of Understanding with the leading European cell therapy company, CO.DON
May 9, 2017
Xintela: Keld Sondergaard nominated as new board member
March 21, 2017
Xintela announces today that Thomas Areschoug has been recruited to the business development team......
February 8, 2017
(In Swedish) Xintela: Insynspersoner och huvudägare avser nyttja teckningsoptioner av serie TO1
January 20, 2017
Xintela reports positive preclinical results in cancer project
January 4, 2017
Xintela´s stem cells show positive treatment effects on cartilage damage in horse study
December 22, 2016
Xintela reports positive results from completed horse study
September 12, 2016
Xintela announces that Rickard Mosell has been recruited as Head of Business Development from October 1, 2016.
August 22, 2016
Xintela today announces that it has settled a dispute and will receive 1,500,000 Swedish Crowns in compensation.
June 23, 2016
Xintela announces that Christer Betsholtz has been engaged as a scientific and strategic advisor
June 1, 2016
Xintela strengthens its organisation wih the appointment of Caroline Ehrencrona as Director Clincial Development and Regulatory Affairs
April 25, 2016
Xintela initiates a study on the treatment of cartilage damage in horses in the USA.
March 16, 2016
Xintela's press releases are currently only published in Swedish. Please contact us if you have further questions.
July 17, 2018
Strong first six months for Xintela
March 27, 2018
Large-scale stem cell production paves the way for GMP-certified production
January 5, 2018
Pre-Christmas breakthrough promises an exciting 2018
September 28, 2017
‍Strategic decisions that builds significant value
July 19, 2017
Focusing on Stem Cell Production and Preparations for Clinical Trials
May 16, 2017
On the 21st March 2017, Xintela reported that it was strengthening its Business Development team...
April 5, 2017
A word from the CEO
April 5, 2017
The subscription period for shares supported by warrants has started
December 29, 2016
A Year of Significant Progress
December 14, 2016
Glioblastoma—Xintela's Focus in the Cancer Arena
November 8, 2016
Starting the Autumn with an increased focus on Xintela’s commercial development
October 19, 2016
Since our listing in the Spring, the company has developed in a very positive way and we are on track with the milestones we have set.
August 11, 2016
Confidence in the future with a strong organisation
August 11, 2016
Welcome to Xintela's newsletter
June 18, 2018
18-19 June: Human Biotech & Animal Health Business Partnering Summit, Amsterdam
The first ever conference connecting human biotechs with the animal health industry.
June 13, 2018
13 June: BioStock Live
Xintela will participate on BioStock Live, Stockholm on June 13. For more information, visit www.biostock.se
June 11, 2018
11 June: Småbolagsdagen, Stockholm
On June 11, Xintela will participate on Aktiespararnas Småbolagsdagen. Xintelas presentation will also be livestreamed via the web.
April 9, 2018
9 - 12 April: ICRS Conference, Macau, China
The ICRS Conference will be held between 9 and 12 April. It is arranged every 18 months, and will this year take place in Macau, China
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 16, 2016

Investor presentation from Lund - Jan 27

March 15, 2016

Interview with Xintelas CEO

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
April 12, 2018
Read the full analysis here
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