CELL AND GENE THERAPY
Bone Therapeutics | November 29, 2021
BONE THERAPEUTICS the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd announce the signing of a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics’ allogeneic bone cell therapy. Subject to the fulfillment of customary condition precedents, Bone Therapeutics and Link Health aim to complete the final agreement and to fully execute it by the end of 2021.
This new partnership is separate and independent from the existing license agreement signed on October 5, 2020, for the rights to develop, manufacture and commercialize ALLOB in China for Pregene, and in Hong Kong, Macau, Singapore, Taiwan, Thailand and South Korea for Link Health.
Bone Therapeutics will continue to work closely in partnership with Link Health and Pregene on all development activities. Link Health will be responsible for all future development, including the ongoing ALLOB TF2 Phase IIb trial and costs related to development, process development (scale up) and manufacturing of ALLOB. The deal will have no immediate direct cash impact, other than support of all development costs, since no upfront payment is foreseen, however, Bone Therapeutics will receive commercial milestone payments of up to €60 million in total and tiered royalties on net sales of up to 25%.
“The existing collaboration between Bone Therapeutics, Link Health and Pregene for the development of ALLOB in Asia has progressed swiftly and fully in line with the anticipated schedule. Bone Therapeutics expanding its collaboration with Link Health will allow for the development and potential availability of ALLOB globally for the benefit of patients with high orthopedic unmet medical needs. This deal now enables Bone Therapeutics to concentrate resources and focus more fully on its iMSC platform. We are now utilizing our extensive cell therapy expertise to develop cell and gene therapy products that have strong anti-inflammatory and immunomodulatory properties, for the treatment of acute life-threatening diseases.”
Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics
“Link Health has now broadened its therapeutic portfolio to address orthopedic unmet medical needs, aiming to be a global leader in this area. We have already several assets in clinical trial and next generation drug-material combo will also part of our efforts. For ALLOB, we believe that the evidence that Bone Therapeutics has already generated supports its potential clinical value for patients in various indications including spinal fusion and difficult fractures.” said Yan Song, PhD, Chief Executive Officer of Link Health. “Our extended collaboration with Bone Therapeutics will further support the global development of ALLOB. This will enable us to progress in delivering novel disease modifying solution for unmet medical needs for orthopedic patients worldwide.”
ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. This study will assess and compare against placebo, in association with standard of care stabilization surgery, the potential for ALLOB to accelerate fracture healing after 3-months follow-up and prevent late-stage complications. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union.
ALLOB is Bone Therapeutics’ off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating thousands of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored at the point of care for easy clinical use. The process will therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization. The Company has implemented the optimized production process to produce clinical batches for the ongoing Phase IIb clinical trial in patients with difficult-to-heal tibial fractures.
About Link Health Pharma Co., Ltd
Link Health is a leading Chinese pharmaceutical company based in Guangzhou, Southern China. Link Health has a well-established team with solid track records in Licensing and local development of innovative medicinal products in China and Asia-Pacific. By its fully controlled subsidiary BioBone BV, Link Health has created a pipeline including 8 assets for global development in orthopedics and pain management. Link Health has its own research laboratories and core technology to lead drug-materials combo research and lead in the disease modifying novel therapy for orthopedic complicated diseases. Link Health has full team to execute registration, clinical development, business and marketing in China, in several Asian territories and in Netherlands in the Europe.
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 portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium.
Sartorius Stedim Biotech | December 10, 2020
Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical business, today procured U.S.- based filtration master WaterSep BioSeparations LLC. WaterSep BioSeparations develops, makes and markets empty fiber layer gadgets and pre-cleaned congregations for upstream and downstream biopharmaceutical applications. The exclusive organization situated in Marlborough, Massachusetts, USA, employs around 15 individuals and is required to procure income of approximately 2.5 million U.S. dollars in 2020 at solid development rates and a generous twofold digit EBITDA edge. The gatherings conceded to a price tag of roughly 27 million U.S. dollars in addition to a procure out segment of up to 9 million U.S. dollars, contingent upon the accomplishment of characterized deals revenue growth by 2023.
This official statement contains forward-looking articulations about the future development of the Sartorius Stedim Biotech Group. Forward-looking proclamations are liable to known and obscure dangers, vulnerabilities and different elements that could make real outcomes vary substantially from those communicated or suggested by such explanations. Sartorius Stedim Biotech accepts no risk for refreshing such articulations considering new data or future occasions. This is an interpretation of the first French-language public statement. Sartorius Stedim Biotech will not assume any risk for the accuracy of this translation. The first French official statement is the legally binding version.
GE | June 20, 2022
With most hospitals around the world currently relying on manual “spot-checks” to monitor patient vitals, GE Healthcare unveils Portrait Mobile3, a wireless patient monitoring system that enables continuous monitoring throughout a patient’s stay. The system helps clinicians detect patient deterioration. Early detection of patient deterioration may help reduce length of stay and intensive care unit (ICU) admissions – and improve patient outcomes4. Portrait Mobile includes patient-worn wireless sensors which communicate with a mobile monitor.
Globally, an estimated 65 percent of hospital patients and over 90 percent of post-acute care patients are monitored manually and not continually.5 Many vital sign changes are missed during spot checks which often occur in four-to-six-hour intervals6. A UK national audit of adult in-hospital cardiac arrests showed that more than half (57 percent) occurred on the wards and only five percent in the ICU7 where patients are monitored continuously. Most patients who end up in cardiac arrest or critical care, don’t suddenly deteriorate but rather present with earlier vital signs that show abnormal trends8. Respiratory rate is the highest ranked variable in models predicting clinical deterioration in the hospital9.
With Portrait Mobile, respiration rate, oxygen saturation and pulse rate for general ward and post-surgery patients can be captured wirelessly, continuously. This innovation allows caregivers to identify changes that may signal that cardiorespiratory complications or infectious disease may be developing. It gives clinicians the opportunity to act early and potentially avert serious adverse events.
In an evaluation clinical study conducted at a London hospital in the UK, 90 percent of nurses reported that they feel more reassured about their patient’s condition when continuous monitoring is used versus vital signs spot check measuring, Portrait Mobile provides reliable measurement technology and meaningful alarms in a mobile setting.”
Erno Muuranto, Engineering Director at GE Healthcare in Finland.
For patients, Portrait Mobile’s wireless continuous monitoring helps with the ability to move about the hospital, without being restricted to the bedside. This also allows visitors to interact with the patient without technology getting in the way. Moreover, the solution provides patients and family members peace of mind knowing that monitoring is constant - even when the patient is out of their room. Patient mobility may help improve patient outcomes and reduce length of stay, which may lower costs and elevate patient satisfaction10.
Portrait Mobile is designed to be as reliable as wired technology. Its routable communications architecture enables hospitals to leverage their existing network infrastructure when deploying the system, reducing installation and maintenance costs.
Portrait Mobile was developed in Helsinki, GE Healthcare’s global center of excellence for monitoring solutions where engineers have been developing patient monitoring technology for decades. Today, GE monitors are used in hospitals across the world - from Beijing to London, New York, and more.
About GE Healthcare:
GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.