CELL AND GENE THERAPY
AbbVie | February 11, 2021
AbbVie and Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome altering biotechnology organization, reported today that they have gone into a cooperation and permit arrangement for the innovative work of fanciful antigen receptor (CAR)- T cell therapeutics. Albeit allogeneic, "off-the-shelf" CAR-T cell therapies have indicated early guarantee in some malignancy patients, the requirement for beating the dismissal of allogeneic CAR-T cells by the host immune system stays a vital test to their more extensive turn of events. Utilizing Caribou's CRISPR genome editing platform to engineer CAR-T cells to withstand have resistant assault would empower the advancement of the next-generation of "off-the-shelf" cellular therapies to benefit a broader patient population.
"We are excited to partner with AbbVie on the development of new CAR-T cell therapies. This collaboration validates Caribou's differentiated next-generation CRISPR genome editing technologies that provide best-in-class efficiency and specificity," said Rachel Haurwitz, Ph.D., President and Chief Executive Officer of Caribou. "We believe AbbVie is an ideal partner for Caribou as we expand upon the number of targets and diseases addressable by our technologies. Genome-edited CAR-T cell therapies hold tremendous potential for patients, and this partnership accelerates our ability to address significant unmet medical need."
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
About Caribou Biosciences, Inc.
Caribou is a leading clinical-stage CRISPR genome editing biotechnology company founded by pioneers of CRISPR biology. Outside of this collaboration, Caribou is advancing an internal pipeline of allogeneic cell therapies for oncology. CB-010, Caribou's lead allogeneic CAR-T cell program, targets CD19 and is being evaluated in a Phase 1 clinical trial for patients with relapsed/refractory B cell non-Hodgkin lymphoma. CB-011, Caribou's second allogeneic CAR-T cell therapy, targets BCMA for multiple myeloma, and CB-012, Caribou's third allogeneic CAR-T cell therapy, targets CD371 for acute myeloid leukemia. CB-011 and CB-012 are in preclinical development. Additionally, Caribou is developing iPSC-derived allogeneic natural killer (NK) cell therapies for solid tumors. Through its next-generation CRISPR genome editing technologies, Caribou is implementing multiple strategies to boost CAR-T and NK cell persistence to overcome cell exhaustion and to prevent rapid immune-mediated clearance. These sophisticated edits drive the durability of clinical benefit of these off-the-shelf medicines.
eTheRNA | February 04, 2022
eTheRNA immunotherapies NV ("eTheRNA") is pleased to announce the start of a strategic partnership with Merck KGaA, Darmstadt, Germany with the signing of a Research Agreement. The partnership will investigate the application of eTheRNA's proprietary mRNA design expertise and LNP-delivery platforms to disease areas selected by Merck KGaA, Darmstadt, Germany.
The ongoing pandemic has underlined the capability for mRNA vaccines as a new therapeutic modality. eTheRNA and Merck KGaA, Darmstadt, Germany both recognise the potential for using targeted mRNA therapeutics in an expanded range of diseases. With this collaboration, eTheRNA and Merck KGaA, Darmstadt, Germany will assess the feasibility of using eTheRNA's mRNA and LNP technologies to develop therapeutic vaccination approaches in models of disease. If successful, mRNAs encoding antigens nominated by Merck KGaA, Darmstadt, Germany and directly relevant for human diseases will then be designed and evaluated preclinically.
"We are extremely pleased to sign this partnership agreement with Merck KGaA, Darmstadt, Germany, a leading German science and technology company. As two companies committed to innovation and creating patient focused solutions, we are excited about the many advantages such a partnership can offer to improve patient care and address a significant market need".
Steven Powell, eTheRNA CEO
About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its mRNA chemistry, antigen identification, lipid chemistry and delivery and process engineering platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company's ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding.
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.