Xintela advances to clinical phase in OA and difficult-to-heal wounds in 2022
There has been no shortage of news in 2021 for Xintela. With positive study results in several indications, as well as a newly recruited CEO to lead the subsidiary Targinta, Xintela is looking ahead to 2022 as they are expected enter clinical phase with two of their development projects. BioStock contacted Xintela’s CEO Evy Lundgren-Åkerlund to find out more about the progress in 2021 and the plans for 2022.
Xintela develops the stem cell treatment XSTEM with focus on treatment of osteoarthritis (OA) and difficult-to-heal leg ulcers, as well as EQSTEM for the treatment of joint diseases in horses. The stem cells are selected and quality assured using the cell marker integrin α10β1, which is found on the surface of mesenchymal stem cells. Using the same marker technology, Xintela’s subsidiary Targinta develops targeted therapeutic antibodies for the treatment of aggressive cancers such as triple negative breast cancer and glioblastoma.
In May 2021, Xintela received permission to produce cell therapy products in its own GMP facility, which initiated the production of XSTEM for clinical studies in patients with osteoarthritis and difficult-to-heal wounds. Since the company has full control and flexibility in the manufacturing, the costs and risk of delays are reduced.
Start of clinical study in osteoarthritis patients in 2022
In 2021, Xintela was able to present preclinical results from an osteoarthritis model that shows that XSTEM directly contributes to repairing damaged cartilage. The candidate thus appears promising as a treatment to slow down cartilage and joint degradation in osteoarthritis patients and regenerate damaged cartilage, i.e., a DMOAD (disease-modifying osteoarthritis drug). There is currently no approved DMOAD on the market, which means that XSTEM has the potential to become a breakthrough treatment for osteoarthritis.
Xintela’s hopes are that XSTEM will demonstrate DMOAD properties in an upcoming clinical phase I/IIa study that will be conducted in collaboration with the Australian CRO GreenLight Clinical, with which Xintela signed an agreement in the spring. The study will be administered by the newly established subsidiary Xindu and is expected to start in early 2022.
Expanded clinical development to difficult-to-heal leg ulcers in 2021
During the spring, Xintela chose to add difficult-to-heal wounds to the clinical development program, after seeing promising results in a preclinical wound model that shows that XSTEM has excellent wound healing capabilities. The company is now planning to start a clinical phase I/IIa study in patients with difficult-to-heal venous leg ulcers in mid-2022, together with Professor Folke Sjöberg and his colleagues at the Burn Centre at Linköping University Hospital.
BioStock has interviewed Professor Folke Sjöberg regarding the preclinical results and the upcoming clinical study in patients with leg ulcers. See the interview here.
Recently, Xintela was granted 4.8 MSEK from Vinnova for the development of XSTEM in difficult-to-heal leg ulcers.
Xintela is taking EQSTEM towards the market
In 2021, Xintela also made progress in the development of the stem cell product EQSTEM for the treatment of horses with osteoarthritis. In October, a study was completed showing that a treatment with EQSTEM leads to significantly reduced lameness in horses with osteoarthritis, indicating that EQSTEM reduces joint pain and improves its function.
The company will, in dialogue with European Medicines Agency (EMA), determine which additional studies are needed for an approval of EQSTEM. Moreover, a Letter of Intent (LOI) has been signed with Danish ScanVet Animal Health to enter into an agreement for the development, marketing and sale of EQSTEM in certain European markets.
Spin-out of Targinta is getting closer
During the year, progress has been made in the spin-out of the subsidiary Targinta, which recently selected its first drug candidate TARG10, a function-blocking antibody for the treatment of triple-negative breast cancer.
Another important step towards the spin-out was when Per Norlén, former CEO of Alligator Bioscience, took over as Targinta’s CEO in September. In addition, the company now has a Board of Directors in place with Gregory Batcheller as Chairman of the Board and Jeffrey Abbey, Karin Wingstrand, Maarten de Château and Evy Lundgren-Åkerlund as board members.
At Xintela’s extraordinary general meeting on 17 January 2022, it was resolved that all shares in Targinta shall be distributed to Xintela’s shareholders, whereby each share in Xintela shall entitle to one share in Targinta. The shares in Targinta are intended to be listed on Nasdaq First North Growth Market.
Xintela’s CEO sums up 2021 and looks forward to 2022
BioStock reached out to Xintela’s CEO Evy Lundgren-Åkerlund to hear her thoughts on the past year and hopes for2022.
2021 has indeed been an eventful year for Xintela with progress on several fronts. If you had to point out the single most significant event in 2021, what would it be and why?
– It is difficult to point to a single event when there is so much that has developed positively for Xintela in the last year, but if I were to select one thing, it is that we received permission from the Medical Products Agency to produce cell therapy products, so-called advanced therapy drugs (ATMPs), in our own GMP facility. This is a major milestone for Xintela, which in addition to building great value in the company makes us very attractive as a development partner by being able to produce our own cell product therapy XSTEM. Only a small proportion of companies globally that develop their own cell therapy products have this advantage, which makes us very competitive.
»It is difficult to point to a single event when there is so much that has developed positively for Xintela in the last year«
What milestones are you looking forward to achieving in 2022?
– The fact that Xintela is taking the step into clinical studies with XSTEM for osteoarthritis and difficult-to-heal leg ulcers, two attractive areas with high medical need and significant markets, are of course very important milestones for the company. Another important milestone is the spin-out of our subsidiary Targinta to become an independent company in the continued development of our new targeted cancer therapies for the treatment of aggressive cancer.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
