Bone Therapeutics: diversified portfolio of cell and biologic therapies 22nd March 2021
Development of innovative products to address high unmet medical needs in orthopedics and other diseases
Bone Therapeutics is focused on the development of innovative products to address high unmet medical needs in orthopedics and other diseases and has a diversified portfolio of cell and biologic therapies at different stages ranging from preclinical programmes in immunomodulation to mid- to late-stage clinical development for orthopedic conditions.
Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced mesenchymal stromal cells (MSCs) which can be stored at the point of use in the hospital. Currently in preclinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the company’s leading investigational medicinal product, ALLOB, represents a proprietary approach to bone regeneration, converting undifferentiated stromal cells from healthy donors into bone-forming cells. ALLOB is also being evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental conditions.
Knee osteoarthritis treatment
Another of Bone Therapeutics’ developmental products is an off-the-shelf next-generation improved viscosupplement, JTA-004, currently in Phase 3 development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid – a natural component of knee synovial fluid – and a fast-acting analgesic, JTA-004 is intended to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase 2b efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.
Cell therapy process development partnership
In January of this year, Bone Therapeutics and Rigenerand SRL, a biotech company developing and manufacturing medicinal products for cell therapy applications, signed a first agreement for a process development partnership for allogeneic MSC therapies. Bone Therapeutics says advances in process development to scale up these therapies could have major impacts for both their approval and commercial viability.
This first collaboration between Bone Therapeutics and Rigenerand will initially focus on augmented professional bone-forming cells, cells that are differentiated and programmed for a specific task. There is also potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio.
In addition to Rigenerand’s MSC expertise, Bone Therapeutics also selected Rigenerand as a partner for its GMP manufacturing facility. The facility is located in Modena, Italy and has been designed to host a number of types of development processes for ATMPs, including somatic, tissue engineered and gene therapy processes. These multiple areas of Rigenerand capabilities enable critical development of new processes and implementation of the gene modification of existing processes. In addition, Rigenerand has built considerable experience in cGMP manufacturing of MSC-based medicinal products, including those that are genetically modified.
Divestment of manufacturing subsidiary
Last November, Bone Therapeutics’ manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), was acquired by Catalent Pharma Solutions and the SCTS manufacturing infrastructure and production operating teams are now part of Catalent’s Cell & Gene Therapy division. Catalent acquired SCTS for €12 million. Bone Therapeutics and Catalent have therefore entered into associated supply agreements under which the acquired manufacturing entity will continue to service the production of Bone Therapeutics’ allogeneic cell therapy product ALLOB, thereby granting Bone Therapeutics access to Catalent’s global network of clinical and commercial manufacturing facilities. The transaction excludes any IP rights and Bone Therapeutics will retain the know-how and ability to tech transfer ALLOB production.