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leBlog Sign in or Create an account My Account View Cart Blog Homepage About This Blog Get Relevant Allele Products Join Allele Networks Allele awarded NIH grant to develop nanoantibody therapies for treatment of sepsis News Medical Life Sciences: The National Institute of General Medical Sciences of NIH has awarded a Small Business Innovative Research grant to Allele Biotechnology and Pharmaceuticals to develop new single-domain nanoantibody (nAb) therapies for the treatment of sepsis. Sepsis and septic shock are among the leading causes of death in intensive care units (ICUs). The global incidence of sepsis has increased over the years, while the mortality rate, which can reach over 60% for septic shock, has been virtually unchanged for the past three decades due to lack of a cure or effective treatments. Scientists at Allele have focused on how to intervene with so-called cytokine storm,” an intense inflammatory response that occurs early in the pathogenesis of sepsis and causes vascular endothelial barrier dysfunction. Other companies have attempted to develop sepsis therapeutics using conventional monoclonal antibodies targeting similar upstream cytokines. However, monoclonal antibody drugs failed to meaningfully improve the mortality rate of sepsis in clinical trials, because the antibodies did not produce significant enough benefits to patients within the relevant time window. Allele has engineered novel multi-valent and multi-specific nAbs, originally identified from an immunized llama, to combat cytokine storms. These nAbs have superior therapeutic efficacy over conventional antibody drugs in animal models of sepsis because of their unique structural and functional properties. nAbs, also known as VHH domains, are small fragments of antibodies (12-15 Kd) that are very stable and easy to produce. Allele’s research team has found that this class of antibodies possess an outstanding capacity to penetrate to tissues and tumors. Moreover, nAbs can bind epitopes that are difficult for conventional antibodies to access. The first ever approval of a nAb-based drug—caplacizumab, a von Willebrand factor (vWF) target— has been issued to a Belgian company, Ablynx, which has worked almost exclusively on nAbs for 17 years. Ablynx was recently acquired by Sanofi for $4.8 billion. Allele’s involvement in the nAb field began in 2008. The biotech company has received continued NIH funding since 2011 and private investments since 2013. These funds strengthened Allele’s platform, allowing Allele to drastically enhance its capacity of internal research and outside collaboration. Allele now generates high quality nAbs targeting the most devastating diseases including cancers, inflammation, neurological and ophthalmological diseases, and possesses dozens of exciting nAb drug candidates in its pipeline. With the new funding support from NIH, Allele will aggressively move towards clinical stage in finding a much-needed medicine that reduces death from sepsis. Source: http://www.allelebiotech.com/ Tags: Ablynx , biologicals , bivalent , multivalent , nanobody , sepsis Monday, October 15th, 2018 nAb: Camelid Antibodies, Nanobodies, VHH , NIH Budget and You No Comments Allele Receives Tissue Bank License for Manufacturing and Distribution of cGMP-compliant iPSCs Allele Biotechnology & Pharmaceuticals has received a Tissue Bank License from the California Department of Public Health, making it the world’s first establishment to collect tissue for the manufacture and banking of induced pluripotent stem cells (iPSCs) for commercial applications. Allele’s cGMP facility is dedicated to the generation, banking, and differentiation of iPSCs for therapeutic use and drug discovery. All tissues and cells are processed in a state-of-the-art cleanroom to satisfy FDA requirements for Phase III clinical trials and commercial production. The cleanroom’s modular space and adaptable design allow different areas to be dedicated to the manufacture of various iPSC-derived cells. The first tissues were processed in August 2017 when the cGMP manufacturing suite officially opened after a 2-year construction and remodeling effort and nearly a decade of iPSC reprogramming research and optimization. The iPSCs generation process is fully cGMP- and GTP-compliant, beginning with the onsite collection of tissue from donors or clients by a physician. All cGMP manufacturing personnel have undergone extensive training with strict qualification and documentation measures to ensure successful reprogramming of cells in an ISO-5 environment. Once generated, iPSCs are banked and can be distributed or differentiated for transplantation into patients. The entire process is validated and performed under the umbrella of a 21 CFR-compliant quality system . Generation of iPSCs is based on Allele’s proprietary mRNA-only protocol which was designed and optimized expressly for cGMP production. The methods were developed to produce iPSCs that are free from genomic integration of plasmid DNA, viruses, and feeder cells. According to CEO and the lead scientist behind the technology, Dr. Jiwu Wang, The powerful mRNA technology developed by Allele’s researchers made it much easier for cells to enter clinical trials down the road and we expect multiple patent issuances shortly.” The cGMP facility has a dedicated mRNA production area for the manufacture of cGMP-compliant mRNAs . In addition to supporting iPSC reprogramming efforts, cGMP mRNA will support ongoing internal development programs to generate iPSC derived cells. Current efforts are focused on the development of pancreatic beta cells, neurons, oligodendrocytes and their progenitor cells, hepatocytes, muscle cells, and mesenchymal cells. Established in 1999, Allele Biotechnology has a mission to further therapeutic innovation by providing cutting edge technologies and clinical grade solutions to partners working in collaborative and creative ways to support preclinical studies and clinical trials in the stem cell therapy arena. Monday, April 9th, 2018 cGMP , iPSCs and other stem cells No Comments Roundtable on cGMP Stem Cell Manufacturing Allele Biotechnology & Pharmaceuticals is hosting a cGMP Stem Cell Manufacturing Roundtable to discuss ways to accelerate stem cell-based therapies toward clinical development and commercialization. The roundtable will bring together top minds from academic settings, cGMP facilities, and biotech industries in an informal setting to explore partnerships and avenues for developing effective and marketable iPSC-derived therapies. The meeting will be held on April 20th at The Hilton on Torrey Pines and will consist of four sessions covering (1) existing cGMP facilities, (2) manufacturing and quality systems, (3) regulatory concerns, and (4) business strategy. Meeting highlights will be produced to summarize the presentations and discussions. For inquiries, contact info@allelebiotech.com or call 858-587-6645. Wednesday, March 21st, 2018 cGMP , iPSCs and other stem cells , Open Forum , SBIR and Business issues , State of Research , You have the power No Comments Allele-iPSC News Translate: iPS clinical research encounters a problem. Doctors say the problem is not caused by iPSCs” Kobe City Medical Center General Hospital and Riken Research Institute announced and reported to the Japanese government that a patient who had received allogeneic iPSC-derived cells developed an epi retinal membrane”, which they subsequently removed by operation. Dr. Masayo Takahashi at Riken says the problem is caused by the transplantation procedure, but not by iPSCs. This will not affect future clinical research that uses iPSCs.” The laws that govern regenerative medicine in Japan mandates that the deaths and hospitalizations that occur during treatment need to be reported to the government as serious harmful effects”. This is the first such report involving iPSC clinical research. The problem occurred to a man in his 70s, who is at the risk of...