Cell therapy company Bone Therapeutics has announced it is shifting its R&D activities towards its most advanced clinical asset, the allogenic cell therapy platform, ALLOB.
ALLOB is an off-the-shelf allogenic 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. The platform is designed for orthopaedic indications where it can be used to help injuries such as fractures heal.
The platform is currently being evaluated in a randomised, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. Bone Therapeutics is positioning ALLOB as its lead asset based on data from previous clinical studies which show the platform was well-tolerated in 21 patients who had fractures.1 Bone Therapeutics has stated that whilst topline results of the Phase IIb trial are expected in Q1 of 2023, a delay could occur could due to the pandemic’s effect on patient recruitment.
The company is now seizing all activity of non ALLOB related products. This includes the company’s intra-articular injectable for osteoarthritic knee pain and its pre-clinical iMSCg platform.
The news follows Bone Therapeutics’ fourth quarter update in 2021 and an outlook for 2022 in which the company said that cost and cash management would be a key priority. The company had just raised an additional €3.3 million in December and anticipated that it would have enough cash to carry out its business into at least Q3 of 2022.
Bone Therapeutics is currently looking into a global rights agreement for ALLOB with its Chinese partner Link Health Pharma. The licensing deal would make Link Health responsible for all future costs of development for ALLOB including the ongoing Phase IIb trial. Bone Therapeutics would also receive commercial milestone payments of up to €60 million in royalties on net sales of up to 25%. However, negotiations for that deal are taking longer than expected, the company says.
To ensure R&D activities can continue for ALLOB, a selection of the company’s management team will leave Bone Therapeutics over the coming months. This includes CEO Miguel Forte, CSO Tony Ting, CBO Stefanos Theoharis and CFO Lieve Creten. CEO, Miguel Forte, will remain in function for the transition. In addition, all non-executive members of the Board of Directors have decided to suspend their compensation for the first quarter of 2022 and until further notice.