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Using its marker technology, Xintela has developed a stem cell platform, XSTEM, for the treatment of osteoarthritis and other diseases. At the end of October, Xintela announced that the European Patent Office (EPO) has issued an ”Intention to grant” for the patent application covering the company’s stem cell product XSTEM. Once the patent is approved, the stem cell product will be protected on the European market for at least another 18 years. BioStock has contacted Evy Lundgren-Åkerlund, CEO of Xintela, to find out more about XSTEM and the patent.

Xintela’s marker technology is already protected by a large number of patents in important markets, such as Europe, USA, Australia, and Japan. The company has an active IP strategy and continuously files new patent applications covering various areas of use, methods, or products that are generated in the company’s R&D pipeline.

Read more about Xintela’s patent applications and already granted patents in BioStock’s latest status report on Xintela.

Preliminary approval for the product patent

On October 29, Xintela announced that their patent application for XSTEM had received a preliminary approval (”Intention to Grant”) from the European Patent Office (EPO). Upon formal approval, Xintela will have patent protection in Europe for XSTEM and the use of the stem cell product against degenerative joint diseases until the year 2038. Evy Lundgren-Åkerlund, CEO of Xintela, expressed her joy at the announcement in a press release:

»This is fantastic news that adds huge value to Xintela’s stem cell business. A product patent that protects the stem cell product XSTEM, combined with our own GMP production facility, secures the development and commercialization of stem cell therapies from our stem cell platform for years to come« – Evy Lundgren-Åkerlund, CEO of Xintela 

XSTEM for the treatment and prevention of joint diseases

The product patent not only protects the product itself; it also protects the use of XSTEM for the prevention and treatment of degenerative joint diseases such as osteoarthritis, bone sclerosis, and degenerative disc disease (DDD) as well as traumatic cartilage and bone injuries.

Xintela’s main focus for XSTEM so far has been osteoarthritis, a joint disease with an immense need for new treatment options. Today, there are no approved disease-modifying osteoarthritis treatments (DMOAD), i.e. treatments that inhibit or reverse the development of osteoarthritis. Xintela’s stem cell product XSTEM-OA has considerable potential to become such a disease-modifying osteoarthritis treatment.

Xintela has their own GMP facility and stem cell production

In recent years, Xintela has built its own GMP facility and production process in order to be able to produce its stem cell product, XSTEM, in an efficient and safe manner. The company plans to submit an application to the Medical Products Agency for a manufacturing permit during Q4 2020. After approval of the GMP facility, production of XSTEM-OA can begin, which in turn enables the start of a clinical phase I/II study which is planned to be carried out in Australia in patients with knee osteoarthritis.

Xintela’s CEO comments on the patent notice

BioStock has contacted Xintela’s CEO Evy Lundgren-Åkerlund to find out more about the preliminary approved product patent.

The European Patent Office has announced an intension to grant the patent for your stem cell product XSTEM. What steps remain before the EPO issues a formal approval and when do you expect such approval? 

Evy Lundgren-Åkerlund, CEO Xintela.

–  An “Intention to grant” decision means that a committee consisting of three reviewers from the EPO considers that all requirements for patentability (novelty, inventive step, experimental support for the patent claims, etc.) have been met.

– The only steps remaining now are formalities, such as paying the official fees to the patent authority and translating the patent claims into German and French. The final approval usually comes one month after the formalities have been completed, which in this case should be around the turn of the year.

What does an approval of the product patent mean for Xintela’s operations and future market initiatives?

–  It is very important for the development and commercialisation of the stem cell product XSTEM for stem cell therapies in several indication areas. In addition, the patent ensures exclusivity for XSTEM in one of the world’s largest markets.

How would you say that the product patent complements Xintela’s current patents?

– Our other patents for XSTEM protect methods for selecting and for quality assuring our stem cells as well as the use of XSTEM for the treatment of degenerative diseases including osteoarthritis. The product patent protects XSTEM as a product for all types of treatments and is thus a very strong protection for future developments and broadening of the stem cell  therapy application area.

»XSTEM has great potential to even treat other joint diseases and traumatic joint injuries. We are currently evaluating different treatment options for XSTEM and how we should prioritise between these.«

In addition to your clinical study of XSTEM for the treatment of osteoarthritis, which is expected to begin in 2021, do you also plan to implement future initiatives in any of the other indications mentioned in your press release (bone sclerosis, degenerative disc disease, traumatic cartilage and bone injuries)?

– Yes absolutely. XSTEM has great potential to even treat other joint diseases and traumatic joint injuries. We are currently evaluating different treatment options for XSTEM and how we should prioritise between these.

In conclusion, what do you think the main advantages of Xintela’s stem cells are compared to stem cells from other cell therapy companies?

–  XSTEM, which consists of integrin α10-selected mesenchymal stem cells, makes our stem cell product unique, and has several advantages – both regulatory and functional. By selecting stem cells from a heterogeneous stem cell preparation that also contains other cells, we get a homogeneous and high-quality stem cell product that is also consistent between donors. This makes XSTEM a safe, effective, and reproducible stem cell product with fantastic clinical and commercial potential.

 

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.

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