CG Oncology Announces License and Commercialization Agreement with Kissei Pharmaceutical Co., Ltd. for CG0070 in Japan and Other Asian Countries

BioSpace | March 27, 2020

CG Oncology, Inc. has announced today an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China. CG Oncology has completed an investigational Phase 2 study of CG0070 in the United States in patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC). In addition, CG Oncology is studying the use of CG0070 in combination with immune checkpoint inhibitors in bladder cancer and other solid tumors.

Spotlight

An update on crop biotechnology in Burkina Faso:
Forum international biotechnologie Burkina Faso

Spotlight

An update on crop biotechnology in Burkina Faso:
Forum international biotechnologie Burkina Faso

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ProteoNic Announces Licensing of Technology for Boosting Therapeutic Protein Production to Immunomedics

ProteoNic | October 20, 2020

ProteoNic BV, a leading provider of technology and services in the field of production of biologics, today announced it has licensed its premium 2G UNic™ technology for boosting therapeutic protein production to Immunomedics, Inc. (NASDAQ: IMMU), a biopharmaceutical company developing immuno-therapeutics for the treatment of cancer and other diseases. Under the agreement, Immunomedics gains commercial rights for application of ProteoNic's technology platform to the development of specified proprietary products from mammalian cells. Financial details of the agreement were not disclosed. ProteoNic's protein expression technology improves production levels across a range of host cells, selection systems and protein targets. It increases transcription and translation rates via a combination of novel genetic elements, which together exert a powerful positive effect on recombinant protein production levels without impacting product quality or cell line stability attributes. 2G UNic™ can be readily combined with other protein expression-enhancing technologies to improve their performance.

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INDUSTRIAL IMPACT

BeiGene Announces Launch of Bioisland Innovation Center

BeiGene | December 27, 2021

BeiGene, a global, science-driven biotechnology company focused on developing innovative and affordable medicines, announced the official launch of the BeiGene Bioisland Innovation Center in Guangzhou, China to enable scientists and entrepreneurs to accelerate development of highly differentiated, cutting-edge medical innovations. The BIC is an innovator-centric incubator built on BeiGene’s goal of supporting exploration of new paths to meet patient needs around the world. “Over a decade ago, we started BeiGene’s journey by following the science and have grown to be a global biotechnology company with capabilities across the full value chain. With the BIC, we are supporting entrepreneurs with similar purpose and vision of delivering innovation that will benefit more patients worldwide. We expect the center will also contribute to our innovation pipeline,” John V. Oyler, Co-Founder, Chairman and CEO of BeiGene “Science and innovation are BeiGene’s core strengths. We are committed to supporting entrepreneurs incubate bold, new ideas into impactful programs that will create value for patients and benefit patients globally,” added Xiaodong Wang, M.D., Co-Founder of BeiGene, Chairman of the Company’s Scientific Advisory Committee. “With our scientific research, unique clinical development capabilities, and footprint, BeiGene is well positioned to explore new paths of innovation and support new talents in the booming biotechnology hub of Guangzhou’s Greater Bay Area.” Innovator-Centric Incubator to Accelerate Growth and Possibilities The BIC is located in the Guangdong-Hong Kong-Macau Greater Bay Area, an emerging global biotechnology hub, and will feature a comprehensive research infrastructure and professional management team. The incubator will be equipped with state-of-the-art laboratory infrastructure and comprehensive research capabilities that enable scientists and entrepreneurs to get their ideas off the ground. In addition, scientists and entrepreneurs at the BIC will have potential access to support from BeiGene on full industry value chain integration. The comprehensive, advanced technology platform at the BIC will allow innovators more autonomy in development, and integrated services to position them for growth. “The BIC is focused on cultivating entrepreneurship for new biotech companies with a passion for transformational medicines, diagnostics and medical devices that can help address unmet needs, and advancing breakthrough innovations from early discovery to being accessed by patients all over the world,” said Jonathan Liu, Chief Executive of Bioisland Initiative and Chairman of the Board of BeiGene Biologics Co., Ltd. Dr. H. Fai Poon. CEO of Zhongshan Quacell Biotechnology Co., Ltd., which is part of the innovation center, commented, "We share the same beliefs of the model and concept of the BeiGene Bioisland Innovation Center. This kind of international collaboration not only accelerates technical innovation for small and medium-sized enterprises, but also provides suitable platforms and resources to commercialize these innovations. For Quacell, which also has the 'innovative DNA', to be part of the BIC provides the opportunity to communicate and cooperate with many innovative companies in different fields around the world. We look forward to creating a common path for each other's future research and development. And we believe that this path leads to infinite possibilities to upgrade and even revolutionize the industry." About BeiGene BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of approximately 8,000 colleagues across five continents.

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CELL AND GENE THERAPY

Bone Therapeutics and Link Health sign a non-binding term sheet for the global rights of ALLOB

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. About ALLOB 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.

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