Xintela to expand clinical development of stem cell product XSTEM

Lund, Sweden, September 30 2021 - Xintela announces it will expand clinical development of its stem cell product XSTEM to the next chosen indication venous leg ulcers, the most common type of difficult-to-heal (chronic) wounds in humans. A scientific advice meeting with the Swedish Medical Products Agency (MPA) has been successfully completed and preparation of clinical documentation for the clinical study application has been initiated.

Xintela has previously reported excellent wound healing results with XSTEM in a preclinical animal model, which was carried out together with Prof. Folke Sjöberg and his collaborators at The Burn Center, Linköping University Hospital. A clinical study in patients with venous leg ulcers is now planned in collaboration with the Prof. Sjöberg and his team.


"Venous leg ulcers represent a large and attractive market where the medical need is substantial. In addition, time-to-market in this indication is perceived to be fast compared to many other indications", says Xintela's CEO Evy Lundgren-Åkerlund.


In parallel, Xintela is preparing to start the First-in Human study on knee osteoarthritis patients in Australia and XSTEM is currently being manufactured at the company's GMP manufacturing facility in Lund.

"The time is now right for us to extend the stem cell clinical development program. We have extensive preclinical documentation for XSTEM, strongly supporting its use in different indications, including difficult-to-heal wounds, and we have an approval from the MPA to manufacture XSTEM in our own GMP facility. In addition, we have recently expanded and strengthened our clinical development team with a new Director Clinical Development, Camilla Wennersten, a new Chief Medical Officer, Per Norlén, and a newly recruited Senior Clinical Trial Manager who will join us in December", says Xintela's CEO Evy Lundgren-Åkerlund.

Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
Email: [email protected]
Medicon Village
223 81 Lund, Sweden
www.xintela.se

About Xintela
Xintela develops innovative and patent protected cell therapies and targeted cancer therapies based on the marker technology platform XINMARK. The platform is built on specific cell surface proteins (integrins) and more than 25 years of research and development. Xintela uses the marker technology to select and quality assure stem cells (XSTEM) to develop stem cell therapies for diseases that today lack efficient treatment options, including the joint disease osteoarthritis (OA). Xintela has built an in-house GMP-facility for manufacturing of stem cell products and is preparing a First in Human clinical study on patients with knee OA. In the oncology program, Xintela develops antibody-based therapies for treatment of aggressive tumors including glioblastoma and triple-negative breast cancer. Xintela is listed on Nasdaq First North Growth Market Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North Growth Market is Erik Penser Bank AB, +46 8-463 80 00, [email protected]

Xintela erhåller 4,8 miljoner kronor från Vinnova

Lund, Sverige, 18 januari 2022 - Xintela har beviljats 4,8 miljoner kronor från Vinnova inom utlysningen "Nya och förbättrade biologiska läkemedel i sjukvården". Bidraget avser finansiering av en klinisk fas I/IIa studie som ska utvärdera Bolagets stamcellsprodukt XSTEM® för behandling av svårläkta bensår.


Xintela granted 4.8 million SEK from Vinnova

Lund, Sweden, January 18, 2022 - Xintela has been granted SEK 4.8 million from Vinnova within the call "New and improved biological drugs in healthcare". The grant will support a clinical phase I/IIa study to evaluate Xintela's stem cell product XSTEM® for the treatment of patients with difficult-to-heal leg ulcers.


Kommuniké från extra bolagsstämma i Xintela

Idag, den 17 januari 2022, hölls en extra bolagsstämma i Xintela AB (publ). Vid stämman fattades beslut om utdelning av samtliga aktier i Targinta AB enligt nedan.


Kallelse till extra bolagsstämma i Xintela AB (publ)

Aktieägarna i Xintela AB (publ), org.nr 556780-3480, kallas till extra bolagsstämma måndagen den 17 januari 2022 klockan 9.00 i bolagets lokaler på Medicon Village, Scheeletorget 1, i Lund.


Xintela och ScanVet Animal Health A/S tecknar Letter of Intent

Xintela meddelar idag att bolaget har tecknat ett Letter of Intent (avsiktsförklaring) med det danska veterinärmedicinska bolaget ScanVet Animal Health A/S. Parterna avser att ingå ett avtal för att utveckla, marknadsföra och sälja EQSTEM®, Xintelas patentskyddade stamcellsprodukt för hästar, för behandling av ledsjukdomar inklusive artros.


Xintela and ScanVet Animal Health A/S sign Letter of Intent

Xintela announces today that the company has signed a Letter of Intent with the Danish animal health company ScanVet Animal Health A/S. The parties intend to enter into an agreement to develop, market and sell EQSTEM®, Xintela's proprietary equine stem cell product, for the treatment of joint diseases including osteoarthritis.


Xintela AB Delårsrapport januari - september 2021

Xintela AB Delårsrapport januari - september 2021


Xintela AB Interim report January - September 2021


Xintela AB Interim report January - September 2021


Xintela erhåller lån om 9 MSEK

Xintela AB meddelar idag att bolaget erhåller ett lån om 9 MSEK


Uppdatering av Xintelas och Targintas status och strategi

Xintela utvecklar stamcellsbaserade behandlingar med fokus på artros och svårläkta bensår samt, genom det helägda dotterbolaget Targinta, riktade antikroppsbaserade behandlingar för aggressiv cancer. Verksamheterna är inriktade på sjukdomar där det medicinska behovet är mycket stort och effektiva behandlingar idag saknas. Ett gediget prekliniskt arbete har lagt grunden för Xintelas och Targintas fortsatta utvecklingsarbete mot kliniska studier och kommersialisering.
En sammanställning över respektive bolags utvecklingsprojekt, projektens status samt strategier och prioriteringar, presenteras nedan.


Update on status and strategy for Xintela and Targinta

Xintela develops stem cell-based treatments with a focus on osteoarthritis and difficult-to-heal leg ulcers and, through its wholly owned subsidiary Targinta, targeted antibody-based treatments for aggressive cancers. We are focused on diseases where there is a high medical need and where effective treatments are lacking today. Solid preclinical R&D has laid the foundation for Xintela's and Targinta's continued progress toward clinical studies and commercialisation.
A summary of each company's development pipeline, the status of each of these projects, and future strategy and priorities, is presented below.


Ny styrelse har utsetts i Targinta AB

Xintela AB meddelar att ny styrelse har utsetts i Targinta AB, ett helägt dotterbolag till Xintela AB. Jeffrey Abbey, Karin Wingstrand och Maarten de Château har valts som nya styrelseledamöter. Gregory Batcheller, styrelseordförande, och Evy Lundgren-Åkerlund är sedan tidigare medlemmar i Targintas styrelse. Gunnar Telhammar avgår som styrelseledamot i Targinta.


New board of directors appointed in Targinta AB

Xintela AB announces the appointment of a new board of directors in Targinta AB, a wholly-owned subsidiary of Xintela. Jeffrey Abbey, Karin Wingstrand and Maarten de Château have been appointed as new board members. Gregory Batcheller, chairman, and Evy Lundgren-Åkerlund are already members of the board of Targinta. Gunnar Telhammar resigns as board member.


Xintela tar EQSTEM, en stamcellsprodukt för hästar, mot marknaden

I en nyligen avslutad studie på hästar visar stamcellsprodukten EQSTEM® signifikant minskad hälta hos hästar med artros till följd av en ledskada, vilket indikerar att produkten kan minska smärtan i leden och förbättra ledens funktion. Xintela tar nu EQSTEM vidare mot marknaden och kommer i dialog med EMA (European Medicines Agency) fastställa vilken kompletterande information som behövs för ett godkännande.


Xintela taking EQSTEM, a stem cell product for horses, towards the market

In a recently completed study in horses, the stem cell product EQSTEM® shows significantly reduced lameness in horses with osteoarthritis (OA) due to joint injury, indicating that this product can reduce joint pain and improve joint function. Xintela is now taking EQSTEM further to the animal health market and will, in dialogue with EMA (European Medicines Agency), determine what additional information is needed for an approval of EQSTEM.


Targinta väljer läkemedelskandidat för trippelnegativ bröstcancer

Det prekliniska onkologibolaget Targinta har valt sin första läkemedelskandidat, TARG10, en terapeutisk antikropp riktad mot målproteinet integrin a10b1. TARG10 har visat kraftfulla effekter både på cancerceller och i prekliniska tumörmodeller, med minskad tumörtillväxt och minskad metastasering i trippelnegativ bröstcancer.


Targinta selects lead drug candidate for triple-negative breast cancer

The preclinical stage oncology biotech company Targinta has selected its first lead drug candidate, TARG10, a therapeutic antibody targeting integrin a10b1. TARG10 has shown strong activity on cancer cells and in preclinical tumor models, with significant inhibitory effects on both growth and metastasis in triple-negative breast cancer models.


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