Novocure Wins FDA Approval for First Mesothelioma Treatment in 15 Years

BioSpace | May 24, 2019

Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.Novocure, based in the U.K., said the U.S. Food and Drug Administration (FDA) approved NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy as a first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma. This marks the first FDA approval for malignant pleural mesothelioma (MPM) in 15 years, Novocure said in its announcement.

Spotlight

Scott Dylla, Ph.D., Vice President of Research and Development, Chief Scientific Officer, AbbVie Stemcentrx and Tom Hudson, M.D., Vice President of Oncology Discovery and Early Development, AbbVie, discuss 'What is the most exciting field of cancer research right now?'

Spotlight

Scott Dylla, Ph.D., Vice President of Research and Development, Chief Scientific Officer, AbbVie Stemcentrx and Tom Hudson, M.D., Vice President of Oncology Discovery and Early Development, AbbVie, discuss 'What is the most exciting field of cancer research right now?'

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Access Biologicals Completes the First-ever Commercially Available COVID-19 Seroconversion Panel to Confirm SARS-CoV-2 Antibody Assays

PR Newswire | September 07, 2020

Access Biologicals, a market leader in the collection and manufacturing of biologicals products, today announced it has completed the first-ever commercially available COVID-19 seroconversion panel to confirm the presence of anti-SARS-CoV-2 antibodies. Efforts to contain the spread of COVID-19 rely in part on serological tests to identify the presence of anti-SARS-CoV-2 antibodies in people who have had the illness. Until now, however, many of these tests have been developed rapidly and without the independent data to help assess their analytical performance and enable comparisons between different testing methods. With Access Biologicals' seroconversion panel, diagnostic manufacturers, clinical laboratories and researchers will have a reliable benchmark against which they can develop, validate and troubleshoot other COVID-19 serological assays and testing. "An effective, sensitive and specific way to identify and confirm the SARS-CoV-2 infection is urgently needed," said Mike Crowley, Managing Director Access Biologicals. "Our COVID-19 seroconversion panel will help serological assays bridge the gap through precise validation, establishing sensitivity and helping determine the pre-seroconversion window period, which is the time after infection and before seroconversion, when antibodies appear." Collected in a longitudinal series, the Access Biologicals COVID-19 seroconversion panel consists of 14 members (units) of a unique human plasma sample drawn from a single donor during a developing SARS-CoV-2 infection. The panel illustrates the onset and decline of IgM, IgG and Ig total SARS-CoV-2 virus antibody titers over a period of 87 days.

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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. 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.

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CELL AND GENE THERAPY

Specific Biologics Inc. Announces Therapeutic Development Award from the Cystic Fibrosis Foundation

Specific Biologics Inc. | December 08, 2021

Specific Biologics Inc. an early-stage biotechnology company developing novel gene editing technologies, announced that it will receive more than US$527,000 to support the preclinical development of its Dualase™ gene editing platform to target a set of cystic fibrosis -causing nonsense mutations where patients currently have fewer therapeutic options available. "Incredible advancements in the treatment of cystic fibrosis have been made since the identification of genetic mutations in the CFTR gene as the cause of CF Recent developments in gene editing technologies are creating the potential to correct these causative mutations at their source. We are truly grateful for the support of this Cystic Fibrosis Foundation award which will allow us to apply our Dualase™ gene editing technology to several frequent CFTR nonsense mutations." Brent Stead, CEO of Specific Biologics Inc Dualase™ cuts DNA differently than existing gene editors. This feature enables the high frequency insertion of new sequences into precise locations in the human genome. One can think of gene editing like a word processor that can find a specific spelling mistake in billions of letters and replace it with a correction. Similarly, inside a cell, Dualase™ can find a specific spelling mistake in the genome and replace it with the corrected sequence. Specific will deliver its gene editing technology using an inhalable lipid nanoparticle carrier, which will aid in delivering the gene editing machinery inside the cells of the lung. It is believed that if the CFTR nonsense mutations are corrected in enough cells, a gene editing therapeutic could provide a long-lasting benefit for CF patients. The award will help fund preclinical testing in disease relevant models. About Specific Biologics Inc. Specific Biologics Inc. is a venture-backed early-stage biotechnology company on a mission to develop novel gene editing technologies to treat diseases through precision gene editing. Our two-site Dualase™ platform gene editors cut DNA in a way that optimally exploits the cell's naturally occurring DNA repair pathways. This enables two gene editing outcomes, precise DNA deletions to disrupt genes or increased repair to correct genes. Specific also develops lipid nanoparticles to deliver the gene editor to target cells and is developing a pipeline of Dualase™-based therapeutics in areas of high unmet medical need.

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