A few years back, the concept of altering genes to treat disease was considered science fiction. However, it is now a reality. Thanks to technological advancements, numerous other cutting-edge approaches are reshaping how we treat and cure diseases.
Cell therapy is one such approach that involves injecting new cells into a patient’s body to replace or repair damaged tissue to treat a disease. According to the report, a total of 1342 active cell-based therapy clinical trials have been identified and characterised based on cell type, target indication, and trial phase.
Nowadays, various medical organisations use cell therapies that are clinically approved. Based in Gosselies, Belgium, Bone Therapeutics is a biopharmaceutical company focused on innovative cell therapy products to treat bone diseases.
Secured €16M
Recently, the company secured a €16M loan from the European Investment Bank (EIB) to accelerate the clinical development of ALLOB, Bone Therapeutics’ scalable allogeneic cell therapy platform.
Further, EIB will also support and prepare Bone Therapeutics’ lead product, viscosupplement JTA-004, for future regulatory approval and commercialisation.
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 (MSC) from healthy adult donors. It is currently in two Phase I/IIA proof-of-concept trials for the treatment of delayed-union fractures and spinal fusion procedures.
The patient recruitment is expected to complete in the first half of 2022 and the results in the second half.
What is JTA-004?
JTA-004 is Bone Therapeutics’ next generation of intra-articular injectable, which is currently in phase III development for treating osteoarthritic pain in the knee.
JTA-004 consists of a unique patented mix of plasma proteins, hyaluronic acid – a natural component of knee synovial fluid, and a fast-acting analgesic. It intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation.
The Belgian company plans to submit a marketing authorisation application to European regulatory authorities in the first half of 2022. Additionally, the company continues to engage with potential partners to develop and commercialise JTA-004 in Europe, the US, and Asia.
Loan conditions
The EIB will be disbursing the loan in two tranches of €8M each, subject to conditions precedent.
The first €8M will be available upon approval of the issuance of associated warrants by Bone Therapeutics’ General Meetings before the end of August 2021.
The next €8M will be released when specific clinical and commercial milestones have been achieved.
“The loan facility will be in the form of a senior loan, repayable to the EIB in a single payment five years following the disbursement of each of the two tranches. The loan carries a fixed interest of 2 per cent per year paid annually and a 3% capitalized interest,” says the press release.
Diversified cell and biologic therapies portfolio
Founded in 2006, Bone Therapeutics has an extensive portfolio of cell and biological therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions.
“Bone Therapeutics is building towards a very important set of milestones, including moving towards potential regulatory approval and commercialisation of therapy for over 250 million patients, as well as continuing with the clinical development of its allogeneic cell therapy platform ALLOB. In addition, we are building on our success in orthopedics and moving our formidable MSC capabilities to target wider indications. The support of a major European financial institution such as the EIB will be an additional important component to this activity,” says Jean-Luc Vandebroek, Chief Financial Officer, Bone Therapeutics.
“This financing committed by the EIB will allow Bone Therapeutics to further advance the clinical development of its lead product candidates JTA-004 and ALLOB, further accelerating paths to approval and commercialisation,” he adds.
