A few years ago, the concept of modifying genes to treat disease was considered science fiction. However, this is now a reality. Thanks to advancements in technology, many other cutting-edge approaches are reshaping the way we treat and cure disease.
Cell therapy is one such approach that involves injecting new cells into a patient’s body to replace or repair damaged tissue in order to treat disease. According to the report, a total of 1342 clinical trials of active cell therapy were identified and characterized based on cell type, target indication and trial phase.
Recently, the winners of the Future Hamburg Award 2021 were announced.
Nowadays, various medical organizations use cell therapies which are clinically approved. Based in Gosselies, Belgium, Bone Therapeutics is a biopharmaceutical company specializing in innovative cell therapy products to treat bone diseases.
â¬ 16 million secured
Recently, the company secured a â¬ 16 million loan from the European Investment Bank (EIB) to accelerate the clinical development of ALLOB, Bone Therapeutics’ scalable allogeneic cell therapy platform.
In addition, the EIB will also support and prepare Bone Therapeutics’ flagship product, viscosupplement JTA-004, for future regulatory and commercial approval.
What is ALLOB?
ALLOB is an allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from ex vivo cultured bone marrow mesenchymal stromal cells (MSCs) from healthy adult donors. It is currently the subject of two Phase I / IIA proof-of-concept trials for the treatment of delayed union fractures and spinal fusion procedures.
Patient recruitment is expected to be completed in the first half of 2022 and results in the second half.
What is JTA-004?
JTA-004 is the next generation of intra-articular injectable products from Bone Therapeutics, currently in Phase III development for the treatment of osteoarthritis knee pain.
JTA-004 consists of a unique patented blend of plasma proteins, hyaluronic acid – a natural component of knee synovial fluid, and a fast-acting pain reliever. It aims to provide additional lubrication and protection to the cartilage of the arthritis joint and to relieve osteoarthritis pain and inflammation.
The Belgian company plans to submit a marketing authorization application to European regulatory authorities during the first half of 2022. In addition, the company continues to engage with potential partners to develop and commercialize JTA-004 in Europe, the United States and Asia.
The EIB will disburse the loan in two installments of â¬ 8 million each, subject to conditions precedent.
The first â¬ 8 million will be available upon approval of the issuance of the associated warrants by the General Meetings of Bone Therapeutics before the end of August 2021.
The next 8 M â¬ will be released when specific clinical and commercial milestones have been reached.
âThe loan facility will take the form of a senior loan, repayable to the EIB in a single payment five years after the disbursement of each of the two tranches. The loan bears a fixed interest of 2% per annum paid annually and a capitalized interest of 3%, âthe press release said.
Diversified portfolio of cell and biological therapies
Founded in 2006, Bone Therapeutics has a broad portfolio of cell and biologic therapies at various stages ranging from preclinical immunomodulation programs to mid to late stage clinical development for orthopedic conditions.
âBone Therapeutics is advancing on a series of very important milestones, including progress towards potential regulatory approval and commercialization of a treatment for over 250 million patients, as well as further clinical development of its cell therapy platform allogeneic ALLOB. In addition, we are building on our success in orthopedics and shifting our formidable MSC capabilities to target broader indications. The support of a large European financial institution such as the EIB will be an important additional part of this activity, âsaid Jean-Luc Vandebroek, CFO of Bone Therapeutics.
“This funding from the EIB will allow Bone Therapeutics to advance the clinical development of its flagship product candidates JTA-004 and ALLOB, further accelerating the approval and commercialization pathways,” he adds.