Bone Therapeutics appoints Scientific Advisory Board for iMSC cell and gene therapy platform development

Gosselies, Belgium, 12 October 2021, 7:00 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has appointed key experts to a Scientific Advisory Board (SAB).

Bone Therapeutics has appointed the members of this SAB specifically to provide additional expert guidance on the development of Bone Therapeutics’ novel, next generation induced pluripotent stem cell-derived mesenchymal stromal cell (iMSC) platform. This iMSC platform will be used to develop cell and gene therapy products that have strong anti-inflammatory and immunomodulatory properties, for the treatment of acute life-threatening unmet medical diseases.

Bone Therapeutics has appointed its SAB with world-recognized scientists and clinicians in the cell and gene therapy field. Each SAB member has been selected having demonstrated leadership roles in the clinical development of engineered cell and gene therapy for specific acute unmet medical conditions. These specific conditions include graft vs host disease, acute respiratory distress syndrome, sepsis, and trauma, as well as orthopedic conditions including osteoarthritis.

“Bone Therapeutics is developing a next generation iMSC platform that has the potential to develop transformative cell and gene therapies for patients suffering from a range of life-threatening unmet medical diseases. Given the therapeutic potential of this platform and to deliver this platform to an operational state as quickly as possible, Bone Therapeutics has brought together a group of world-leading experts to support its development,” said Tony Ting, PhD, Chief Scientific Officer, Bone Therapeutics. “These thought leaders have been selected to bring a wealth of specific experience in the clinical development of cell and gene therapies. The input from this SAB will be critical as Bone Therapeutics develops its next-generation iMSC products for acute inflammatory diseases.”

“Given the therapeutic potential of the iMSC platform that Bone Therapeutics is developing, the invitation to chair and help form this scientific advisory board was too tempting to decline,” said Massimo Dominici, MD, chair, Bone Therapeutics’ Scientific Advisory Board. “The blend in expertise of this scientific advisory board will be able to provide key advice and consultancy to Bone Therapeutics and will make key contributions to ensure the development of the iMSC platform to reach patients of acute life-threatening unmet medical diseases as quickly as possible.”

The Bone Therapeutics Scientific Advisory Board are as follows:

Massimo Dominici, MD, (Chair) - Full Professor of Medical Oncology and Director of the Division of Medical Oncology and of the Program of Cellular Therapy and Immuno-oncology at the University Hospital of Modena and Reggio Emilia (Italy). Also a member of the World Health Organization (WHO) Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations serving the INN Expert Group. Since 2016, the Director of the Residency School in Medical Oncology, since 2005, head of the Laboratory of Cellular Therapies at the University Hospital of Modena and Reggio Emilia (Italy). Scientific founder of the university start-up Rigenerand since 2009. Co-founder and coordinator of the Mirandola Science & Technology Park. Co-founder of the Forum of Italian Researcher on MSC (FIRST), board member of JACIE, WBMT and scientific advisor for the Italian Minister of Health. President of ISCT 2014-2016, Emeritus Member of ISCT and now Member of the ISCT Strategic Advisory Council. From June 2014 until May 2020 Chair of the ISCT Presidential taskforce on unproven cell and gene therapies.

Frank Barry, PhD, Professor of Cellular Therapy at the Regenerative Medicine Institute (REMEDI), National University of Ireland Galway and Visiting Scientist at the Schroeder Arthritis Institute in Toronto. He has made key contributions to the fields of tissue engineering and regenerative medicine by developing innovative and successful cellular therapies for tissue repair, joint injury and arthritic disease. By undertaking a large body of basic and translational research, he has contributed to the industry’s current understanding of the phenotypic attributes of mesenchymal stromal cells that make them attractive candidates for advanced therapeutics. He has also contributed to the development of methods for automated, efficient and scalable cell expansion for GMP application and has been a leader in the development of clinical protocols for patient testing. He is the Coordinator of the ADIPOA2 clinical trial to test the efficacy of stromal cell delivery as a treatment for osteoarthritis. Frank Barry has received the Marshall Urist Award for excellence in tissue regeneration research from the Orthopaedic Research Society. Recently elected as a Member of the Royal Irish Academy.

Robert Deans, PhD, CSO at Synthego, a genome engineering company automating a new era of cell and gene therapeutics. Previously CTO at BlueRock Therapeutics, creating iPSC based allogeneic cell therapeutics by harnessing pluripotent stem cell biology and gene editing tools and founding CSO at Rubius Therapeutics, developing a platform of novel enucleated cell therapeutics based on genetic engineering and expansion of hematopoietic progenitors to mature red cells. Dr. Deans has more than 30 years of experience in adult stem cell therapeutics which includes HSC gene therapy and commercialization of progenitor cell therapeutics from bone marrow.

  

Richard Maziarz, MD, has been involved in clinical investigation and translational research, for over 30 years, beginning with research and clinical training at the Dana-Farber Cancer Institute and the Brigham & Women’s Hospital and continuing in 1991 when he moved to Oregon Health & Science University (OHSU) to develop a transplantation immunology program and served as the medical director of the adult OHSU stem cell transplant program since 1994. His research involved the immunology of transplantation or its complications, particularly in studying the immunopathophysiology of GVHD. He has served as principal investigator or co-investigator on over 100 clinical trials including multiple initiatives sponsored by numerous national transplant organizations including SWOG, CIBMTR, ISCT, NMDP and BMT CTN. Within the BMT CTN, he serves on the Steering committee, chaired the Regimen Related Toxicity Committee, was a member of the GVHD Committee and served as the principal investigator for the BMT CTN on the first multicenter, stem cell transplant trial for patients with advanced chronic lymphocytic leukemia (BMT CTN 0804).

Patricia Rocco, MD, PhD, Full Professor at the Federal University of Rio de Janeiro, and heads the Laboratory of Pulmonary Investigation. Elected Member of the National Academy of Medicine in Brazil and Brazilian Academy of Science. Past Vice-President of ISCT for the South and Central America regions. Authored and co-authored more than 380 peer-reviewed publications and 120 book chapters. She is the President of the Brazilian Society of Physiology (2021-2022). Her research activities focus mainly on the development of new therapies for lung diseases.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell and gene 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 pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics’ scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

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. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at

For further information, please contact:

Bone Therapeutics SA

Miguel Forte, MD, PhD, Chief Executive Officer

Lieve Creten, Chief Financial Officer ad interim

Tel: +32 (0)71 12 10 00

For Belgian Media and Investor Enquiries:

Bepublic

Catherine Haquenne

Tel: +32 (0)497 75 63 56

International Media Enquiries:

Image Box Communications

Neil Hunter / Michelle Boxall

Tel: +44 (0)20 8943 4685

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For French Media and Investor Enquiries:

NewCap Investor Relations & Financial Communications

Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé

Tel: +33 (0)1 44 71 94 94

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