GenScript Receives FDA Emergency Use Authorization for cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript | November 10, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2. The conventional method for measuring neutralizing antibodies requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass™ kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard research or clinical diagnostic laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows results from both tests are strongly correlated.

Spotlight

The Human Genome Project set out to sequence the DNA of every human chromosome, thereby promising to advance knowledge of human biology and improve medicine. This project was huge in scale, as it sought to determine the order of all 3 billion nucleotides in the human genome. To reach this lofty goal, scientists developed a number of sequencing techniques that emphasized speed without too much loss of accuracy.

Spotlight

The Human Genome Project set out to sequence the DNA of every human chromosome, thereby promising to advance knowledge of human biology and improve medicine. This project was huge in scale, as it sought to determine the order of all 3 billion nucleotides in the human genome. To reach this lofty goal, scientists developed a number of sequencing techniques that emphasized speed without too much loss of accuracy.

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Lilly, Vir Biotechnology and GSK Collaborates to Evaluate a Combination of two COVID-19 Therapies in Low-risk Patients

Lilly | January 28, 2021

Eli Lilly and Company, Vir Biotechnology, Inc. also, GlaxoSmithKline plc declares a collaboration effort to assess a mix of two COVID-19 therapies in low-risk patients with mild to direct COVID-19. Lilly has extended its progressing BLAZE-4 trial to assess the organization of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (otherwise called GSK4182136) 500mg, two killing antibodies that quandary to various epitopes of the SARS-CoV-2 spike protein. This unique collaboration effort denotes the first occasion when that monoclonal antibodies from discrete organizations will be united to explore expected results. Bamlanivimab is a neutralizing antibody coordinated against the spike protein of SARS-CoV-2 designed to obstruct viral connection and entry into human cells, in this manner killing the infection. Bamlanivimab emerged out of the collaboration among Lilly and AbCellera to make antibody therapies for the avoidance and treatment of COVID-19. Bamlanivimab is approved for emergency use for the treatment of mild to direct COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. "Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."

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Alligator Bioscience Announces IND Approval for CD40 Targeting Antibody Mitazalimab

Alligator Bioscience | December 07, 2020

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MEDTECH

FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1

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 About Pertussis 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. About BPZE1 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. 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