Lunda Company Xintela Last year, they saw such great potential in their cancer project that they decided to spin off the business into a wholly owned subsidiary. TargintaWhen the page turned to October 2018, an agreement was signed with the American company Catalent who are active in the field of Antibody Drug Conjugates (ADC), which according to IQVIA now accounts for approximately 20 percent of the clinical pipeline of anti-cancer antibodies. Antibody conjugates can be used as targeted therapies where the antibodies are armed with cancer-killing properties to attack only tumors.
The Oncology Project
The collaboration with Catalent aims to jointly finance and develop an ADC therapy against brain tumors glioblastomaWork on the antibody conjugates from Catalent is now in full swing and Xintela is evaluating these in various cell experiments with the goal of identifying the optimal candidate for continued development work.
In the oncology project, Xintela has produced an ADC where a cytotoxic agent has been linked to an antibody that binds to the marker. integrin α10β1 on certain tumor cells. It is the integrin marker that is found on the surface of glioblastoma cells and that sits like a recognition flag on the cells that the company wants to target for treatment. The antibody conjugate can seek out and bind to the tumor cells and deliver the cytotoxic agent to the tumor cell to kill the tumor. Xintela's preclinical results from both cell and animal model studies show that the concept works.
More cancers may become relevant
At the same time, the parties see potential for broader use in more forms of cancer, which is why such an evaluation is taking place in parallel. In the annual report published on Monday, the company's CEO highlights Evy Lundgren-Åkerlund that the research work has been very successful and that a patent application has been submitted for diagnostics and therapy of several aggressive forms of cancer with large underlying market values.
The patent application is an important signal about the level of excellence in the current innovation, and this fact was crowned by the fact that the research results from the glioblastoma study were published on April 25, 2019 in the well-regarded scientific journal cancersOverall, this, according to the company, provides a good negotiating position with potential investors and partners regarding the development of a First-in-Class therapy for glioblastoma and other aggressive tumors.
Stem cell project in Australia nears study start
The stem cell business is also moving forward through both GMP production of the company's stem cell product and the start of the first clinical study with XSTEM-OA, Xintela's product candidate consisting of stem cells selected with the company's marker technology XINMARKThe study design for the clinical trial, which is planned to be conducted in Australia, has been discussed with external clinical advisors and the protocol is nearing completion. The study aims to demonstrate the safety of the company's stem cells and to investigate the effect on articular cartilage in osteoarthritis patients.
Good Manufacturing Practice (GMP)
The work on Xintela's own GMP facility for the production of stem cells, which is a central part of Xintela's path towards clinical studies, is also proceeding as planned, according to the company. The premises and instruments are qualified and in use, the quality assurance system is in place and optimization of methods as well as documentation and work procedures is being completed. After discussions with the Swedish Medical Products Agency, Xintela intends to submit an application for a production permit after the summer.
Discussions are underway with international veterinary companies
Xintela's strategy in the area of stem cell therapy in veterinary medicine is to carry out the development work in collaboration with one or more veterinary companies. The company emphasizes that there is a great interest in stem cell therapy, not least for the treatment of osteoarthritis in dogs. In this area, the company has, according to its own information, received great attention for the internally developed stem cell technology in combination with its GMP production facility and discussions are now underway with international companies with a veterinary focus.
Collaborations and funding
As a final feather in the cap, the company carried out a private placement to the German orthopedic company in October 2018. Bauerfeind AG of approximately SEK 50 million. According to the CEO, the collaboration with Bauerfeind is progressing very positively and ongoing discussions are taking place about new opportunities and areas for deeper collaboration in the future.
Last summer, Xintela signed and CO.DON a letter of intent to jointly develop stem cells for the treatment of articular cartilage damage, including osteoarthritis, in the European and North American markets. The parties entered into discussions on July 9, 2018 regarding a joint venture arrangement in which Xintela will provide its marker and stem cell technology as well as GMP manufacturing capacity. CO.DON, in turn, intends to provide financing and expertise in clinical development and commercialization.
Discussions with CO.DON about a possible collaboration are ongoing until June 30. A collaboration will start at the earliest after the completion of Xintela's clinical phase I/IIa study with the human stem cell product XSTEM-OA for the treatment of osteoarthritis.
The collaboration could theoretically reduce time to market and reduce risks for Xintela, but also enable Xintela to focus entirely on product development and manufacturing of stem cells for clinical trials, while the counterparty adds expertise in clinical development, regulatory issues and marketing.
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