Bio-K | October 22, 2020
Bio-K Plus International Inc. (Bio-K Plus), pioneer in the probiotic sector and leader in the biotech industry, is pleased to announce the launch of its new line of functional beverages, Essential. Focused on offering premium quality probiotics that make a real difference in people's lives around the world, the company is adding the Essential line to its existing Pro and Original lines. In keeping with this tradition of high quality, the Essential line fits perfectly into the active and modern lifestyle of today's consumer, always looking for innovative ways to stay healthy. Bio-K Plus offers a dose of probiotics in the form of fun, delightful and balanced functional beverages. This announcement is the result of more than two years of research and development carried out by Bio-K Plus' experienced team that has developed the best line of functional beverages infused with probiotic bacteria. This project was led by Martin Croteau, Chief Commercial Officer, and was driven by the need to democratize probiotics, making them more accessible for all, and broaden their use to support global health in a more holistic manner.
ILiAD Biotechnologies | January 04, 2022
ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis.
BPZE1 is the most advanced next generation pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht, PhD, at the Institut Pasteur de Lille and French National Institute of Health and Medical research BPZE1 is a live-attenuated intranasal vaccine designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants. Four clinical trials studying BPZE1 in healthy adults have been completed to date, including positive topline results from a 300-participant adult Phase 2b trial demonstrating that BPZE1 induced durable mucosal immunity and reduced nasal colonization — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles. Earlier this month, the Company also announced initiation and enrollment of the first participants in the BPZE1 SUPER Trial (Standing Up to PERtussis) – the fifth clinical BPZE1 study and the first study in school-age children.
Section 506(b) of the FD&C Act provides for the designation of a drug as a Fast Track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” Fast Track provides opportunities for frequent Company interactions with the FDA and the potential for accelerated approval and priority review.
“We are pleased that the FDA is aligned with ILiAD’s position that there is an unmet clinical need for a more effective pertussis vaccine and that the evidence to date supports the potential for BPZE1 to address the major gaps in protection against pertussis. We look forward to continuing to work with the FDA and other global Regulatory Agencies to further clinical development of BPZE1 and to safely and efficiently bring BPZE1 to US and global markets.”
Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin
Pertussis is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months.
BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection and disease. BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly.
About Fast Track Designation
Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of investigational products to treat serious conditions and fill an unmet medical need, with the intent of getting important new products to the population in an expedited manner. Specifically, Fast Track Designation provides the option of licensure via the accelerated approval pathway, which allows licensure based on surrogate endpoints. Additionally, Fast Track designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available. This permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. Priority review is an additional benefit that may potentially be available for BPZE1 as part of the Fast Track designation.
About ILiAD Biotechnologies, LLC
ILiAD Biotechnologies is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.
Seegene | February 01, 2021
South Korea's biotechnology firm Seegene (KQ096530) said Monday it built up the world's first COVID-19 diagnostic variation test, fit for screening COVID-19 and recognizing various mutant variations in a single reaction.
Seegene's new variation test, the 'Allplex™ SARS-CoV-2 Variants I Assay,' can detect and separate virus variations, including those discovered to be more contagious and fatal.
The new variation test identifies COVID-19, yet can likewise recognize major genetic variations that appear to have originated from the UK, South Africa just as different districts including Japan and Brazil.
Besides, it can pre-screen a suspicious new variant, giving understanding on extra variations, likewise a critical component of Seegene technology.
Seegene's new item incorporates in any event ten of its proprietary technologies, including multiplex real-time PCR technique for mTOCE™, which is the forefront technology that solitary Seegene can use. This imaginative technology permits the test to distinguish an objective explicit spot where mutation occurs, empowering exact detection and separation of the Covid just as its transformed versions with a single tube of reagent.