2022 was an eventful and successful year for Xintela. The company entered into clinical development for the treatment of knee osteoarthritis and difficult-to-heal venous leg ulcers and thus has two ongoing clinical phase I/IIa studies with XSTEM. In addition, further development of EQSTEM for the treatment of joint diseases in horses is planned. In parallel with the stem cell projects, a phase 0 study is being prepared in the subsidiary Targinta. Xintela’s CEO Evy Lundgren-Åkerlund tells us more about the plans for 2023 in an interview with BioStock.
Xintela develops stem cell therapies and targeted cancer therapy based on the company’s cell surface marker integrin a10b1 which is found on mesenchymal stem cells and aggressive cancer cells.
The company’s stem cell products are produced in its GMP-approved manufacturing facility. Xintela has also secured greater production capacity for commercialization and broadening of the business through a collaboration with NorthX Biologics.
Osteoarthritis study in Australia is progressing
Since 2022, a clinical phase I/IIa study with XSTEM is being conducted in Australia in patients with knee osteoarthritis. The purpose of the study is primarily to evaluate the safety, but also preliminary efficacy. The study includes three different dose groups, with eight patients in each group. The dosing of the first patient group has been completed and concluded as safe and the company is now at the end of the second dose level. They also have the opportunity to expand the study with another 30 patients.
Xintela plan to have safety readouts from all three dose levels and early efficacy signals in 2023, which is expected to generate interest from potential partners.
Recruitment of patients with difficult-to-heal leg ulcers
In parallel, patients are being recruited to the phase I/IIa study with XSTEM in patients with difficult-to-heal leg ulcers, which is a huge medical problem that causes great suffering for the patients and large healthcare costs. The study is being conducted at Linköping University Hospital and will include 12 patients with difficult-to-heal venous leg ulcers.
XSTEM or placebo is placed on the wound and then a first safety and efficacy readout is conducted after just 10 weeks. This indicates that Xintela will present results from the study in 2023.
The primary goal of the study is to show that the treatment is safe and that XSTEM has a positive effect on wound healing. The company has previously shown good wound healing capacity of XSTEM in a preclinical wound model – see BioStock’s interview with Professor Folke Sjöberg regarding this.
Accelerating the development of EQSTEM
Xintela is also developing the equine stem cell product EQSTEM for the treatment of joint diseases in horses. Preclinical results show that the treatment significantly reduces lameness in horses and has a disease-modifying effect on the cartilage, which supports continued development towards the market. However, the equine development program has been running at low speed in 2022 as the company’s full focus has been on clinical studies with XSTEM.
Xintela plans to accelerate the development of EQSTEM and has recently hired a project leader, to drive the veterinary program forward. The company also has an ongoing dialogue with ScanVet Animal Health for the development and commercialization of EQSTEM.
Targinta plans for phase 0 microdosing studies
Xintela’s subsidiary Targinta also took important steps in 2022 in the development of the company’s targeted antibodies for the treatment of aggressive cancer. The preclinical development has resulted in two drug candidates; TARG10 which is a function-blocking antibody that inhibits metastasis and TARG9 which is a so-called antibody-drug conjugate (ADC) that kills the cancer cells.
The company has decided to conduct phase 0 clinical trials, where a very low dose of the antibody is given to cancer patients to show that it can target the tumor. In this way, the target molecule and treatment concept can be validated, which would reduce development risk and increase attractiveness among potential partners and licensees. The goal is to enter into partnerships or outlicense the candidates after completing phase 0 studies in about two years.
Thomas Eldered – new board member
In connection with Xintela’s capital raise in 2022, the reputable investor Flerie Invest came in as a major shareholder in the company. Today, they hold 40.7 per cent of the shares and votes in Xintela and Thomas Eldered is a member of the company’s board of directors. BioStock had a chat with Eldered regarding his role on the board and the progress of Xintela’s projects – watch the interview here.
Interview with CEO Evy Lundgren-Åkerlund
For the development projects to proceed as planned, financing is an essential part. Xintela is now evaluating various financing options to optimize the way forward for both Xintela and Targinta. BioStock contacted Xintela’s CEO Evy Lundgren-Åkerlund to find out more about the strategy going forward.
First of all, what was the most important milestone for Xintela in 2022?
– The most important milestone was of course the start of the clinical studies with XSTEM. It is the result of our development of the unique stem cell product XSTEM and our own GMP manufacturing of XSTEM. We are now a clinical-phase company and have taken a major step towards partnership and commercialization.
»We are now a clinical-phase company and have taken a major step towards partnership and commercialization«
In addition to the clinical studies with XSTEM, you now also seem to be able to accelerate the development of the veterinary product EQSTEM. What do the development plans look like?
– We have had dialogues with regulatory experts in the development of veterinary products and have gained a good idea of additional development activities we need to do. Although we have not had the possibility to spend time and resources on clinical studies in horses in 2022, due to a focus on clinical studies in humans, we have continued to evaluate the mechanism of action of EQSTEM in a horse model for osteoarthritis in collaboration with the University of Copenhagen. The results, form a strong basis for future clinical studies in horses. We have also recently employed a project leader, Camilla Andersen, Doctor of Veterinary Medicine for the veterinary program.
If we instead focus on Targinta – when do you expect to be able to initiate phase 0 studies with the two drug candidates?
– We plan to produce the antibodies in 2023 and then conduct toxicological studies and clinical studies in 2024. It is an exciting and innovative development plan that we have for Targinta with the goal of validating our unique target molecule in cancer patients and our antibody treatment concept.
»It is an exciting and innovative development plan that we have for Targinta with the goal of validating our unique target molecule in cancer patients«
What is the strategy for the separation of Targinta from Xintela?
– Given that the market climate continues to be unfavorable for a spin-off and listing of Targinta, we continue to have the companies under the same roof and wait with the separation. We do not rule out that a spin-off will eventually take place.
How will you finance Xintela’s and Targinta’s activities during the year?
– We continue to evaluate the best financing solutions for both Xintela and Targinta that can either be implemented jointly or separately. With Flerie Invest as a long-term major shareholder with interest in both Xintela and Targinta, we feel that we have good support in the financing activities going forward.
»We have a very exciting year ahead of us with several read-outs from our clinical studies with XSTEM. In our osteoarthritis study, we will have safety data from all three dose levels and also early efficacy data«
Finally, what milestones are you looking forward to achieving in 2023?
– We have a very exciting year ahead of us with several read-outs from our clinical studies with XSTEM. In our osteoarthritis study, we will have safety data from all three dose levels and also early efficacy data. In the study on difficult-to-heal venous leg ulcers, the recruitment of patients is ongoing and we expect to have both safety data and efficacy data in 2023. As for the oncology projects, the goal is that we will have the antibodies TARG9 and TARG10 produced by the end of 2023 and that we are prepared to start the phase 0 studies. In addition, we have a number of interesting business development activities ongoing that can also lead to positive results during the year.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.