Bioactive Agents Improve Synthetic Bone Substitutes

Technology Networks | October 18, 2019

Synthetic bone substitutes are promising materials for bone defect repair, but their efficacy can be substantially improved by bioactive agents such as growth factors. In a new study, researchers have modified beta-tricalcium phosphate (β-TCP) with increasing quantities of bone morphogenetic protein 2 (BMP-2) derived from E. coli and shown improved bone healing. The study is published in Tissue Engineering, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. Yuelian Liu, PhD, Academic Center for Dentistry Amsterdam, Amsterdam, Netherlands, and colleagues present their work in an article titled "Dose Effects of Slow-Released Bone Morphogenetic Protein-2 Functionalized β-Tricalcium Phosphate in Repairing Critical-Sized Bone Defects". The authors created bone defects in a rat calvarial model and then attempted repair using β-TCP granules coated with a biomimetic calcium phosphate preparation that allows slow release of BMP-2. Bone growth and maturation were studied in comparison with autologous bone grafts using micro-CT scans, histology, and histomorphometry, and toxicity was assessed with blood tests. The E. coli-derived BMP-2 successfully improved bone formation with efficacy comparable to autologous grafts, and higher BMP-2 concentration promoted bone maturation.

Spotlight

The push to prevent skin cancer may have come with unintended consequences impaired brain function because of a deficiency of vitamin D. And although vitamin D is well known for promoting bone health and regulating vital calcium levels hence its addition to milk it does more than that.

Spotlight

The push to prevent skin cancer may have come with unintended consequences impaired brain function because of a deficiency of vitamin D. And although vitamin D is well known for promoting bone health and regulating vital calcium levels hence its addition to milk it does more than that.

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INDUSTRY OUTLOOK

RegeneRx Licensee Acquired by Korean Biopharmaceutical Group

RegeneRx Biopharmaceuticals, Inc. | September 28, 2021

RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration), announced that GtreeBNT, the licensee for several RegeneRx products, is being acquired by HLB Group, a Korean company that includes six biopharmaceutical and financial subsidiaries in Korea and the U.S. GtreeBNT announced that as part of its acquisition the company would issue approximately US$80 million of new stock and convertible bonds to HLB Group to fund ongoing programs. The new capital should speed up the clinical trials currently in progress and allow the company to focus on new drug approval. RGN-259 will remain a priority for the company. HLB's recommended executives are expected to be appointed at the general meeting scheduled for October 29, 2021. Won Yang, the current CEO of GtreeBNT, is expected to remain as the chief research officer and continue to lead the development of new drugs after the acquisition. RegeneRx has scheduled its 2021 Annual Stockholder Meeting for November 10, 2021 and hopes to have additional details on the acquisition and its effect on GtreeBNT's clinical development activities and timing related to RGN-259 and RGN-137, products developed for the treatment of dry eye syndrome, neurotrophic keratitis, and epidermolysis bullosa. The fact that GtreeBNT will receive a significant capital infusion related to the transaction, we believe, should benefit the development of the products we licensed to the company. As soon as practicable after we receive any new information from the new management related to our products we will update our stockholders. - J.J. Finkelstein, president and chief executive. About RegeneRx Biopharmaceuticals, Inc. RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.

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MEDICAL

Genelux and Newsoara Announce Collaboration and License Agreement for Oncolytic Immunotherapies

Genelux Corporation | September 29, 2021

Genelux Corporation, a clinical-stage immunotherapy company, and Newsoara BioPharma Co., Ltd., announced a collaboration and exclusive license for the development and commercialization of Olvi-Vec and other oncolytic viruses. According to the terms of the agreement, Newsoara shall have exclusive rights in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Olvi-Vec for which Genelux currently is planning a U.S. based Phase 3 registration trial in platinum resistant/refractory ovarian cancer. Newsoara also shall have exclusive rights in Greater China to Genelux's proprietary oncolytic virus platform, and the parties will collaborate on the development of novel oncolytic immunotherapeutics. Newsoara, at its cost and expense, will be responsible for development and commercialization and will have the future right to manufacture licensed products in Greater China. The parties also will collaborate on a Phase 2 clinical trial for the intravenous delivery of Olvi-Vec in a new indication using clinical sites in China and the U.S. Newsoara will be responsible for all trial costs. Under terms of the agreement, Genelux will receive up-front and near-term payments totaling $11 million and will be eligible to receive additional per-product payments of up to $160.5 million, contingent on certain development, regulatory and commercial milestones, plus tiered royalties on net sales ranging from mid-single-digit to mid-double-digit percentages. Genelux shall have an exclusive license outside of Greater China to oncolytic virus products derived by Newsoara and will pay Newsoara milestones and royalties on sales of any such products which Genelux elects to develop. We are delighted to be working with Newsoara on developing Olvi-Vec, as well as on our broader collaboration. It is a dynamic organization with a commitment to advancing cutting-edge therapeutics, whose strength in research, development and manufacturing in China is a perfect complement to our focus on the discovery and clinical development of novel virotherapies. Together we look forward to accelerating the development of Olvi-Vec and to strengthening and broadening our pipeline of next-generation oncolytic viral immunotherapies. - Thomas Zindrick, J.D., President and CEO of Genelux. About Olvimulogene Nanivacirepvec (Olvi-Vec) Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit. About Newsoara Newsoara is a clinical-stage biopharmaceutical company with the mission to develop and commercialize life changing medicines for the treatment of patients with cancer, autoimmune, metabolic and other major diseases in China and around the world. With fully integrated drug discovery, CMC and clinical development capabilities, Newsoara has built a robust and broad pipeline for treating major diseases with unmet needs. Newsoara has assembled a world-class management team with extensive experience in novel drug development that is motivated to improve and impact human health worldwide. About Genelux Corporation Genelux is a clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. The core of Genelux's discovery and development efforts revolves around the company's proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.

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CELL AND GENE THERAPY

AbbVie and Caribou Biosciences Announce Collaboration and License Agreement for the Research and Development of CAR-T Cell Therapeutics

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." About AbbVie 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.

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