MEDICAL

PhageNova Bio, Inc. Announces Publication Describing New Method for Safe and Effective Pulmonary Delivery of Therapeutics

PhageNova Bio, Inc. | December 14, 2020

PhageNova Bio, Inc. ("PhageNova") is pleased to declare the distribution of information created through a sponsored research agreement with Rutgers, The State University of New Jersey. The Med (a Cell Press distribution) article, entitled Targeted Phage Display-Based Pulmonary Vaccination in Mice and Non-human Primates, portrays another technique for protected and effective pulmonary delivery of therapeutics, including an aerosol vaccination strategy which is being developed to address the current SARS-CoV-2 pandemic.

"Our targeted method of pulmonary delivery is the initial step towards the development of aerosol phage-based vaccines for human applications against multiple diseases," says Renata Pasqualini, PhD, co-senior study author, Founder and Chief Scientific Officer of PhageNova, and Chief of the Division of Cancer Biology, Department of Radiation Oncology at Rutgers Cancer Institute and Rutgers New Jersey Medical School. "Other advantages of phage particles are that they are highly stable under harsh environmental conditions, and their large-scale production is extremely cost-effective compared with other vaccine strategies because they don't need to be refrigerated, which is a particularly important requirement for the developing world."

Spotlight

Dr Chris Taylorson tells us about the Molecular Biosciences at UCL.The term biotechnology refers to any technology, process or practice that modifies or harnesses any living organism or system to be useful to any human purpose. The word defines itself: bio means life and technology is defined as the application, or harnessing of science for a specific purpose.

Spotlight

Dr Chris Taylorson tells us about the Molecular Biosciences at UCL.The term biotechnology refers to any technology, process or practice that modifies or harnesses any living organism or system to be useful to any human purpose. The word defines itself: bio means life and technology is defined as the application, or harnessing of science for a specific purpose.

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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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RESEARCH

Evelo Biosciences Presents Data on EDP1815 Mechanism of Action and Supporting Ongoing Clinical Development for Inflammatory Diseases

Evelo Biosciences, Inc. | January 18, 2022

Evelo Biosciences, Inc. a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii. “The data presented today build on the substantial evidence accumulated through our clinical and preclinical work, deepening our understanding of the mechanism by which EDP1815 drives its clinical effects. They explain how an oral, gut-restricted SINTAX medicine can interact with the immune system in the gut, leading to systemic inflammation resolution without immunosuppression or concerning side-effects. We are particularly pleased to share these results with the clinical community as we progress EDP1815 into later stages of development for the treatment of psoriasis and atopic dermatitis, two inflammatory diseases that affect millions of people worldwide.” Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo Preclinical data from the studies presented at the Winter Clinical Dermatology Congress confirm that EDP1815 modulates systemic inflammation through its initial interaction with innate immune receptors, including TLR2, leading to downstream changes in circulating immune-cell phenotypes. In addition, the data demonstrate that preclinical effects in Th17 models translate into signs of clinical benefit in psoriasis, and that preclinical effects in Th2 models translate into signs of clinical benefit in atopic dermatitis, supporting further clinical development of EDP1815 in these indications. A Phase 2 study of EDP1815 in patients with mild to moderate psoriasis is ongoing, and a Phase 2 study of EDP1815 in patients with mild, moderate, and severe atopic dermatitis is expected to initiate dosing in the first quarter of 2022. About EDP1815 EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from multiple independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation. About Evelo Biosciences Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act on the small intestinal axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases.

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CELL AND GENE THERAPY

Taysha Gene Therapies Announces New Additions to Leadership Team to Deepen Manufacturing and Communications Capabilities

Taysha | December 30, 2020

Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-driven gene therapy organization focused in on creating and commercializing AAV-based quality treatments for the treatment of monogenic infections of the focal sensory system in both uncommon and huge patient populaces, today reported new increases to its authority group with the arrangements of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations. Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy organization zeroed in on creating and commercializing AAV-based qgene therapies for the treatment of monogenic infections of the focal sensory system in both uncommon and huge patient populaces, today declared new increases to its authority group with the arrangements of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations.

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