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.
Axion BioSystems | February 03, 2022
Axion BioSystems, a leading life sciences tools company focused on advanced bioelectronic assay technologies, announces the acquisition of UK-based printed electronics manufacturer M-Solv Manufacturing Limited, a subsidiary of M-Solv Ltd. The creation of the new division, called Axion BioSystems Manufacturing, UK, Ltd., cements the six-year partnership between the companies and positions Axion for continued growth and innovation.
“The need to control the supply chain has never been more important. This vertical integration not only ensures that our customers have the products they need to conduct critical biomedical research; it also allows us to advance assay plate technologies more rapidly to meet the increasingly complex scientific demands of our users.”
Tom O’Brien, CEO of Axion BioSystems
Since 2017, M-Solv has supplied Atlanta-based Axion BioSystems with high-resolution proprietary printed electronics circuits, a critical consumable used in Axion’s flagship Maestro Pro multielectrode array benchtop instrument. The Maestro Pro system provides pharmaceutical companies, biotechnology firms, and research scientists with a state-of-the-art cell analysis platform for disease modeling and drug discovery. Integrating M-Solv’s development and manufacturing team represents a key step forward in Axion’s continuous efforts to streamline manufacturing and continue its leadership in this space.
“The M-Solv manufacturing team is proud to have played a role supporting Axion’s growth over the last six years,” said Phil Rumsby, CEO of M-Solv Manufacturing Limited. “Now, as part of the Axion Group, we are looking forward to working together even more closely to grow this part of our business as we develop the next generation of bioelectronic assay consumables. Alongside our biosensor business, we will continue to maintain and grow our strong position in touch-panel devices.”
About Axion BioSystems
Axion BioSystems is a leading life science tools company focused on developing and commercializing label-free, bioelectronic assays used to study the function of live cells in vitro for drug discovery and disease modeling. The team at Axion BioSystems is dedicated to continuing the advancement of bioelectronic assay technology that enables the understanding of biological complexity outside of the body. Axion BioSystems is headquartered in Atlanta, Georgia, USA, and also has an office in Shanghai, China. Axion has more than 90 employees across its current locations.
About M-Solv Manufacturing Limited
M-Solv Manufacturing Limited develops and manufactures unique printed electronics, making industrial-grade capacitive touch panels and biosensors at its foundry in Oxford, UK. Prior to acquisition by Axion, the company was part of the M-Solv Ltd. group of companies. M-Solv Ltd. is a world leader in the supply of advanced laser and inkjet digital production tools with teams based in Taiwan, Hong Kong, and Shenzhen, and is ultimately owned by the Hong Kong-based CN Innovations Group.
CELL AND GENE THERAPY
Kite, Shoreline Biosciences | June 18, 2021
Kite, a Gilead Company, and Shoreline Biosciences, Inc., a biotechnology firm developing intelligently designed allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and Macrophage cellular immunotherapies achieved from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, announced a strategic partnership today to develop novel cell therapies across a variety of indications.
The collaboration will combine Shoreline’s profound experience in iPSC differentiation and genetic reprogramming with Kite’s extensive cell therapy development, commercialization, and manufacturing capabilities to develop new allogeneic candidates for a variety of hematologic malignancies. The collaboration will initially focus on chimeric antigen receptor (CAR) NK targets, with Kite having the option to expand the partnership to include an iPSC CAR Macrophage program for an undisclosed target to be picked after the deal is completed. This agreement comes on the back of Kite’s investment in Shoreline’s recent Series A financing.
“As the pioneer in cell therapy, we are focused on investing in and delivering on the most promising possibilities to improve cell therapy’s therapeutic potential further,” said Mert Aktar, Kite’s Vice President of Corporate Development and Strategy. “We are excited about the potential of Shoreline’s next-generation approach to allogeneic development, as well as how our partnership might accelerate this research across various leukemias and lymphomas.”
“Through this strong partnership, we are thrilled to strengthen our relationship with Kite, which is at the forefront of cancer immunotherapy for more than ten years,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder, Chairman, and CEO. “The combination of Kite’s experience in CAR T-cell therapies with our cutting-edge iPSC platform has the potential to accelerate Shoreline’s timeline to the clinic, expand our pipeline opportunities, and offer transformative cancer treatment options.”
According to the terms of the agreement, Shoreline will get an initial payment and will be eligible for further payments totaling more than $2.3 billion, as well as royalties based on the accomplishment of specific development and commercial milestones.
About Shoreline Biosciences
Shoreline is a biotechnology firm committed to developing intelligently designed allogeneic off-the-shelf, targeted, and standardized cellular immunotherapies for cancer and other severe illnesses. Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell treatment options based on its extensive knowledge of iPSC differentiation methods and genetic reprogramming of disease-relevant pathways.
Kite, a Gilead Company, is a biopharmaceutical company headquartered in Santa Monica, California, with commercial manufacturing facilities in North America and Europe. Kite’s sole focus is on cell therapy to treat and possibly cure cancer. As the pioneer in cell therapy, Kite has more authorized CAR T indications to help more patients than any other company.