Publication date: 19/12/2019
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address highly unmet medical needs in orthopaedics and bone diseases, today announces the appointment of Dr. Miguel Forte as Chief Executive Officer, effective 1 January 2020. Dr. Forte succeeds Thomas Lienard who leaves the Company in common agreement with the Board of Directors. Thomas will remain available to the Company for six months to support the succession during the transition period.
Dr. Forte has significant experience in regenerative medicine and in the cell therapy industry, most recently as Chief Executive Officer of Zelluna Immunotherapy, a biopharma company focusing on developing transformative T cell receptors (TCR) based cellular immunotherapies for the treatment of cancers. He is currently also serving as Chief Commercialization Officer and Chair of the Commercialization Committee of the International Society of Cellular Therapy (ISCT).
Dr. Forte held in the past a senior position at the European Medicines Agency (EMA), was Vice-President Global Medical Affairs Inflammation at UCB, Chief Medical Officer (CMO) at TxCell, a cellular therapy company, where he played a key role in TxCell’s 2014 IPO, and served as Chief Medical Officer of Bone Therapeutics in 2017. In this last position, Dr. Forte was responsible for the Company’s clinical development strategy and advancing its products towards the market. He played a key role in increasing the visibility of the Company throughout the medical community.
With over 20 years professional activity in Clinical, Academic and Pharmaceutical Industry environments with deep experience in the management of operational and strategic functions across Research & Development, Manufacturing, Medical and General Management, Dr. Forte is a recognised leader in the regenerative medicine field who has gained broad expertise in medical and regulatory affairs and commercialisation, leading early and late stage clinical trials to market authorization and the launch of new biologic products for various indications.
Dr. Forte graduated in Medicine from the University of Lisbon, specializing in infectious diseases. He then obtained a PhD in Immunology at the University of Birmingham. He is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK and Associate Professor in Health Sciences and Pharmacy at the University of Lisbon.
Jean Stéphenne, Chairman of Bone Therapeutics, commented: "We are delighted to welcome Miguel as the new Chief Executive Officer of the Company. His knowledge of Company’s products and experience in product development will be particularly appreciated as Bone Therapeutics has entered a phase of late-stage clinical and regulatory development for its cutting-edge technology ALLOB and for JTA-004 for different applications. I trust Miguel's broad and deep experience will bring the Company successfully into the next phase. We would also like to thank Thomas for his leadership, contribution and dedication over the past years. His impact in maximising the potential of Bone Therapeutics' pipeline of innovative products has been invaluable. We wish him all the best in his future projects."
Thomas Lienard, commented: "Bone Therapeutics has made a major evolution during the last few years and the teams have performed great work to prepare the Company for the upcoming launch of the JTA-004 Phase III and ALLOB Phase IIb studies. I believe bringing Miguel on board is a great opportunity for Bone Therapeutics as his vast expertise in cell therapy will be key to lead the Company through the next stages of its development. I wish the Company the best for the future."
Commenting on his appointment, Dr. Miguel Forte said: "I am very excited to be joining again Bone Therapeutics and to be appointed as Chief Executive Officer. The Company has an advanced clinical pipeline with promising and innovative bone cell therapy products as well as JTA-004. I look forward to working with the Bone Therapeutics team in order to bring the Company's key products to the next level of clinical and regulatory development for the benefit of patients."
Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy and an innovative biological product in later-stage clinical development across a number of disease areas, which target markets with large unmet medical needs and limited innovation.
Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is expected to enter Phase III development for the treatment of pain in knee osteoarthritis further to reported positive Phase IIb efficacy results in patients with knee osteoarthritis, showing a statistically significant improvement in pain relief compared to a leading viscosupplement. The Phase III program with JTA-004 in patients with knee osteoarthritis shall start in Q1 2020 and the Company is currently submitting the related clinical trial application (CTA) with the regulatory authorities in Europe.
Bone Therapeutics’ other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, cutting-edge manufacturing process. Further to recently reported strong Phase IIa efficacy and safety results for ALLOB, the Company plans to submit a CTA with the regulatory authorities before year-end to initiate a Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.
The Company’s lead product candidate in the ALLOB product pipeline is a regenerative cell therapy that is expected to enter Phase IIb clinical development for the treatment of difficult-to-heal fractures. The ALLOB platform technology has many other applications and will continue to be evaluated in other applications like spinal fusion, maxilofacial, dental and osteotomy.
Bone Therapeutics’ cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. Further information is available at www.bonetherapeutics.com.