Intravacc's candidate RSV vaccine demonstrates safety in phase I trial

Intravacc | August 18, 2020

Intravacc, a global leader in translational research and development of viral and bacterial vaccines, today announced the publication in the medical journal Vaccine, of a clinical phase I study with its candidate Respiratory Syncytial Virus (RSV) vaccine. The vaccine showed excellent induction of immunogenicity after nasal administration to healthy adult volunteers (18-50 years). In addition, the Live Attenuated Vaccine (LAV), constructed with reverse genetics, appears to be safe and well-tolerated. Intravacc is currently orienting on a suitable partner for further joint clinical development of this vaccine in a large pediatric setting. A pediatric vaccine against RSV would not only prevent morbidity and mortality in infants and young children but could also reduce transmission to the elderly. The RS virus is the most common cold virus in children under the age of five and poses a serious threat to the elderly as well. Many biotech and pharmaceutical companies have been developing an RSV vaccine since the 1960s, but to this day no vaccine emerged out of this. An estimated 120,000 children worldwide still die of the virus every year, especially in developing countries.

Spotlight

Cost containment in the healthcare system has placed clinical laboratories under constant pressure to improve efficiency while addressing patient care and safety concerns. As part of the design process, today’s instrument manufacturers seek to ensure that automation errors do not occur. A cap inspection system is one solution to improve error prevention processes. By inspecting test tubes and caps to collect detailed information such as diameter, cap color, and cap type, instrument manufacturers no longer need to engineer for the worst case scenario.

Spotlight

Cost containment in the healthcare system has placed clinical laboratories under constant pressure to improve efficiency while addressing patient care and safety concerns. As part of the design process, today’s instrument manufacturers seek to ensure that automation errors do not occur. A cap inspection system is one solution to improve error prevention processes. By inspecting test tubes and caps to collect detailed information such as diameter, cap color, and cap type, instrument manufacturers no longer need to engineer for the worst case scenario.

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Stemcyte Submitted its Application for A Biologics License (BLA) For Its Product "HPC-Cord Blood" To The US FDA

Stemcyte | March 23, 2022

On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process. The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorders an appropriate preparative regimen for hematopoietic and immunologic reconstitution. There have been over 40,000 successful umbilical cord blood transplants globally to treat disorders of the hematological and immunological systems and genetic metabolic diseases since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988. StemCyte has donated more than 2,200 cord blood units for transplantation to 1 in every 20 patients with umbilical cord blood transplants globally during the last 20 years. In addition, at least 350 transplant centers around the world, including well-known medical centers such as UCLA Medical Center, Duke University Hospital, Taiwan Chang Gung Memorial Hospital, and National Taiwan University Hospital, consistently meet the quality standards of international accrediting bodies and are recognized and trusted as safe and effective by StemCyte's products.

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Pressure BioSciences Announces the Achievement of a Critical Milestone in Revolutionary Nanoemulsification Technology Development

Pressure BioSciences, Inc. | October 07, 2020

Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide biotechnology, biotherapeutics, and other industries, today announced the achievement of a critical milestone: the lock-in of final design specifications for the commercial production model of its proprietary, next-generation Ultra Shear Technology™ ("UST™")-based nanoemulsification system. Following achievement of this milestone, the Company has begun to build the initial "Alpha" unit of the commercial model. Once built, tested, and approved, the Company will immediately proceed to build an additional 15 ready-for-sale systems, thus enabling PBI to meet its goal of shipping the BaroShear K45 UST System in early (Q1/Q2) 2021. Based on the Company's patented UST platform, the BaroShear K45 is a unique breakthrough nanoemulsification system designed to resolve one of the most substantive problems facing manufacturers of biotherapeutic drugs, nutraceuticals (including hemp-derived CBD products), and other products containing oil-based active ingredients that are at best poorly soluble in water. As with any oil-based product, it is difficult for the water-based biochemistry of humans and other animals to access and absorb the active ingredients hidden within oil drops. Poor water solubility leads to lower absorption and bioavailability of active ingredients, which makes it particularly difficult to design and deliver proper dosing of the desired compound. More recently, growing science around nanoemulsion development has shown that oil-based active ingredients manufactured into high quality nanoemulsions have delivered dramatically increased absorption and bioavailability, resulting in higher quality finished products for the consumer.

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CELL AND GENE THERAPY

2seventy bio Announces Expanded Collaboration Agreement With Novo Nordisk to Continue Development of in vivo Gene Editing Approach

2seventy bio, Inc | January 07, 2022

2seventy bio, Inc. announced that it has entered into an option and license agreement with Novo Nordisk for joint research and development of an in vivo gene editing treatment for hemophilia A. This agreement builds upon a successful existing multi-year research collaboration between the two companies. Under the terms of this agreement, Novo Nordisk will have the option to license 2seventy bio’s proprietary mRNA-based megaTAL™ technology for the development of a new treatment approach for hemophilia A patients with the goal of offering a sustained therapeutic effect. “This collaboration aims to develop the first direct in vivo application of our megaTAL technology. We are excited to explore this technology with Novo Nordisk, with the goal of developing a new potential therapeutic approach for patients with hemophilia A. Moreover, we view this work as further validation and a natural extension of our technology platform. Based on what we continue to learn, this technology may play a potential role in expanding our gene editing platform toward future in vivo and ex vivo applications that can enhance our oncology pipeline. We are also excited to announce a partnership between 2seventy bio and Genevant Sciences for the use of Genevant’s lipid nanoparticle platform in our collaboration with Novo Nordisk.” Philip Gregory, D. Phil., chief scientific officer, 2seventy bio The collaboration agreement with Novo Nordisk builds upon the original research collaboration signed between bluebird bio and Novo Nordisk in 2019, focused on identifying a development gene therapy candidate for people with hemophilia A. The collaboration utilizes 2seventy bio’s megaTAL technology that has the potential to provide a highly specific and efficient way to silence, edit, or insert genetic components. Hemophilia A is a genetic bleeding disorder resulting from defective Factor VIII. “We are excited to continue our partnership with 2seventy bio to jointly develop a next-generation in vivo genome editing treatment, with the ultimate ambition of offering people with hemophilia A lifetime free of factor replacement therapy,” said Karin Conde-Knape, senior vice president, Global Drug Discovery, Novo Nordisk. “This partnership reflects Novo Nordisk’s commitment to utilizing novel technology platforms to advance truly disease-modifying therapies for people with serious chronic diseases.” Under the terms of the agreement, Novo Nordisk will obtain the option to exclusively license 2seventy bio’s in vivo mRNA platform and gene editing technology for use in the treatment of patients with hemophilia A. 2seventy bio will receive an upfront payment of $5 million and is eligible for near-term milestone and option exercise payments of up to $35 million, in addition to development, regulatory, and commercial milestones, as well as a royalty on net sales. Novo Nordisk will be responsible for funding all research and development activities. Related to this collaboration, 2seventy bio has also entered into an agreement with Genevant Sciences for access to Genevant’s industry-leading LNP technology platform for use in 2seventy bio’s collaboration with Novo Nordisk for the treatment of patients with hemophilia A. 2seventy bio plans to use the Genevant LNP platform for efficient delivery of megaTAL mRNA to hepatocyte cells within the liver. “We are very pleased that 2seventy bio has entrusted Genevant and our LNP platform with delivery for its important gene editing program in hemophilia A,” said Pete Lutwyche, Ph.D., president and chief executive officer, Genevant Sciences Corporation. “Our scientists have been at the forefront of the LNP field for more than 20 years, and we are excited for our innovative technology to be used for this important application with great unmet need.” Under the terms of the agreement between 2seventy bio and Genevant, 2seventy bio obtained rights to license Genevant’s LNP technology for use with megaTAL mRNA products in the treatment of patients with hemophilia A. Genevant is eligible for upfront and near-term option exercise payments totaling $10 million, as well as development and commercialization milestones, and royalties in the mid-single digits on future product sales. About megaTALs MegaTALs are single-chain enzymes that combine the natural DNA recognition and cleavage processes of Homing Endonucleases with the modular DNA binding properties of transcription activator-like effectors. This protein fusion architecture allows the generation of highly specific and active nucleases in a compact format compatible with all current viral and non-viral cell delivery methods. About Novo Nordisk A/S Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 47,000 people in 80 countries and markets its products in around 170 countries. About Genevant Sciences Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, the industry’s most robust and expansive lipid nanoparticle patent estate, and decades of experience and expertise in nucleic acid drug delivery and development. The Company’s scientists have pioneered LNP delivery of nucleic acids for over 20 years, and the Company’s LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved RNAi-LNP (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. About 2seventy bio Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour — to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering new therapies and leveraging platform technologies that truly disrupt the cancer treatment landscape.

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