Xintela building own GMP-facility for stem cell production

#Regulatory

Read as PDF

Lund, Sweden, September 11, 2017 - Xintela AB (publ) announces the company has decided to bring forward the construction of its own facility for production of equine and human stem cell-based ATMPs (Advanced Therapy Medicinal Products) at Medicon Village, Lund. Initially, stem cells will be produced for clinical studies in horses.

After careful evaluation of available options, Xintela has decided to initiate construction of its own facility for the GMP (Good Manufacturing Practice) production of stem cell-based ATMPs. A major reason is that available production units in Sweden cannot produce horse stem cells in parallel with their own production of human stem cells. In addition, Xintela now has the opportunity to build this custom-designed facility in close proximity to its own premises at Medicon Village.

“Compared to engaging an external contract manufacturer, the construction of our own production facility - in addition to increased flexibility and control - reduces costs, even in the short term. The decision means that we will invest time and resources earlier than planned in our own GMP-facility,” says Xintela’s CEO Evy Lundgren-Åkerlund.

With its own production unit, scheduled to be ready by the end of the year, Xintela can produce stem cells for both horses and humans. Before the production of stem cells can be initiated, the equipment, processes and quality systems need to be put in place, validated and inspected and manufacturing permits obtained from the Swedish MPA (Medical Products Agency). Clinical studies on horses will therefore start no earlier than by the end of 2018. However, clinical studies on humans can begin earlier than planned because the processes and quality systems for stem cell production will be developed in parallel for horses and humans.

“We have previously announced the recruitment of Liselotte Theorell, who is responsible for product development and quality management at Xintela. Her extensive experience in building clean rooms for GMP production and establishing processes and quality systems for cell therapy makes me very confident in taking this important step for Xintela,” says Evy Lundgren-Åkerlund.

Liselotte Theorell comments:

“The development of a GMP facility for the production of stem cells is very important when we now take the next steps towards clinical trials in both horses and humans. With our own manufacturing facility, we get full control of the process and can locate the unit near our research facilities in Lund for more efficient transfer of our research and development.”

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 for regenerative medicine and cancer based on its proprietary marker technology, XINMARK®. Xintela uses the technology to select and assure the quality of mesenchymal stem cells for the treatment of cartilage damage and osteoarthritis. In a study on horses, the company has shown that stem cells are safe to use and that they have a positive effect on the articular cartilage and the underlying bone after an injury. XINMARK® is also used for the development of an antibody-based treatment (Antibody Drug Conjugate, ADC) against glioblastoma, the most common and aggressive form of brain tumors in adults. Positive preclinical results from cell studies and animal model have shown that the antibody has a killing effect on glioblastoma cells and thus has confirmed the concept. 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.

This information is such information that Xintela AB (publ) is obligated to publish in compliance with the EU market abuse regulation. The information was provided, through the above contact, for publication on the 11th of September 2017, at 11.00 CET.

Archive

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

August 29, 2018
Xintela has made the decision to spin out its oncology business to a newly formed subsidiary company, Targinta AB.
August 29, 2018
Sven Kili extends his commitment to Xintela as Chief Medical Officer
August 21, 2018
Xintela announces an update on the company's development programs
August 9, 2018
Xintela today announced that the company's international patent application has been published
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
November 12, 2018
12 november: Stora Aktiedagen, Gothenburg
12 november: Stora Aktiedagen, Gothenburg
November 5, 2018
5-7 november: Bio Europe, Copenhagen
5-7 november: Bio Europe, Copenhagen
October 10, 2018
10-12 october: Bio Japan/Regenerative medicine Japan, Yokohama
10-12 october: Bio Japan/Regenerative medicine Japan, Yokohama
October 3, 2018
3-5 october: Cell&Gene on the Mesa, La Jolla
3-5 october: Cell&Gene on the Mesa, La Jolla
September 26, 2018
26 september: Aktiedagen, Malmö
26 september: Aktiedagen, Malmö
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 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
Top