Allob (allogeneic osteoblastic cell therapy) / BioSenic - LARVOL DELTA

Percutaneous administration of allogeneic bone-forming cells for the treatment of delayed unions of fractures: a pilot study. (PubMed, Stem Cell Res Ther) - P1/2 | "This pilot study showed that the percutaneous implantation of allogeneic bone-forming cells was technically feasible and well tolerated in patients with delayed unions of long bone fractures. Preliminary efficacy evidence is supporting the further development of this treatment."

Clinical • Journal • Musculoskeletal Diseases • Orthopedics • Pain

[VIRTUAL] Bone Therapeutics (BIO 2021) - "Leveraging its extensive expertise in mesenchymal stromal cells (MSCs), bone physiology and patented manufacturing technology, Bone Therapeutics is developing a commercially ready, allogeneic and off-the-shelf bone cell therapy platform, ALLOB, and a next-generation improved viscosupplement for osteoarthritic pain, JTA-004, which are designed to offer patients and physicians best-in-class treatment options. Currently in Phase II-III clinical development, Bone Therapeutics’ advanced product portfolio targets large orthopaedic conditions with high unmet needs, such as knee osteoarthritis, unhealed fractures and spinal fusion. Building on its allogeneic MSC platform, Bone Therapeutics recently broadens the product portfolio from orthopedics into inflammatory and other conditions."

Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion (clinicaltrials.gov) - P2a; N=38; Completed; Sponsor: Bone Therapeutics S.A; Active, not recruiting ➔ Completed

Clinical • Trial completion

ALLOB-TF2: Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture (clinicaltrials.gov) - P2b; N=178; Recruiting; Sponsor: Bone Therapeutics S.A; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2024 ➔ Mar 2024

Clinical • Enrollment open • Trial completion date • Musculoskeletal Diseases • Orthopedics

ALLOB-TF2: Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture (clinicaltrials.gov) - P2b; N=178; Not yet recruiting; Sponsor: Bone Therapeutics S.A; Initiation date: Jul 2020 ➔ Oct 2020

Clinical • Trial initiation date • Musculoskeletal Diseases • Orthopedics

Bone Therapeutics will consume between 15 and 16 million euros of cash this year [Google translation] (Investir - Les Echos) - "The pivotal phase III clinical trial JTA-004 in osteoarthritis of the knee is ongoing....The recruitment of patients for phase III of the JTA004 study should be finalized before the end of the year and the biotech expects to present its main results in the second half of 2021. In the meantime, net cash consumption in 2020 is expected to reach 15 to 16 million euros this year. The company's funds will therefore not be sufficient to hold out until the announcement of these results."

Financing • P3 data • Osteoarthritis • Pain

Bone Therapeutics to complete recruitment for knee pain trial by year-end (Proactiveinvestors) - "Bone Therapeutics...said it expects patient recruitment for the phase III trial of osteoarthritic knee pain treatment, JTA-004, to be completed by the 2020 year-end. The Euronext-listed biotech added it also expects to start recruitment soon for a phase IIb study of ALLOB for difficult tibial fractures as regulatory approvals are nearly all complete."

Enrollment status • Osteoarthritis • Pain

ALLOB-TF2: Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture (clinicaltrials.gov) - P2b; N=178; Not yet recruiting; Sponsor: Bone Therapeutics S.A

Clinical • New P2b trial • Musculoskeletal Diseases

Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion (clinicaltrials.gov) - P2a; N=6; Terminated; Sponsor: Bone Therapeutics S.A; N=23 ➔ 6; Active, not recruiting ➔ Terminated

Clinical • Enrollment change • Trial termination • Anesthesia

Study to Assess the Efficacy and Safety of ALLOB in Tibial Fracture (clinicaltrialsregister.eu) - P2; N=178; Ongoing; Sponsor: Bone Therapeutics S.A.

Clinical • New P2 trial • Musculoskeletal Diseases • Orthopedics

Bone Therapeutics Provides First Quarter 2020 Business Update (GlobeNewswire, Bone Therapeutics SA) - "Outlook for the remainder of 2020 and COVID-19 impact on 2020-2021 guidance: Following the regulatory approvals, Bone Therapeutics is ready to initiate recruitment in the pivotal JTA-004 phase III clinical study targeting osteoarthritic knee pain and the ALLOB phase IIb study in patients with difficult tibial fractures, in the aforementioned countries....The Chinese Special Administrative Region Hong Kong has been less severely affected by the COVID-19 pandemic and...might be able to resume patient recruitments for the JTA-004 phase III trial before the summer. In Europe, the COVID-19 epidemic seems to have passed its peak...Bone Therapeutics expects to be able to reinitiate clinical trial activities and patient recruitments for the JTA-004 phase III and ALLOB phase IIb studies in the European clinical centers during the summer and second half of 2020."

Enrollment status • Trial status • CNS Disorders • Gene Therapies • Genetic Disorders • Immunology • Inflammation • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Bone Therapeutics provides first quarter 2020 business update (GlobeNewswire) - "Outlook for the remainder of 2020 and COVID-19 impact on 2020-2021 guidance:...In the second half of 2020, the company expects to report results from the 2-year follow-up period of the Phase IIa study with ALLOB in patients undergoing a spinal fusion procedure; In the next few months, Bone Therapeutics plans to initiate the first discussions with the US FDA (Food and Drug Administration) in preparation of the next studies with ALLOB and JTA-004 in the large, important US market."

P2a data • Regulatory • CNS Disorders • Gene Therapies • Genetic Disorders • Immunology • Inflammation • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates (GlobeNewswire, Bone Therapeutics SA) - "Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures. These two studies are the pivotal JTA-004 Phase III clinical study targeting osteoarthritic knee pain and the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities....Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries."

Enrollment status • New trial • Regulatory

Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures (clinicaltrials.gov) - P1/2; N=25; Completed; Sponsor: Bone Therapeutics S.A; Active, not recruiting ➔ Completed

Trial completion