GT Biopharma | December 23, 2020
GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology organization focused in on innovative treatments dependent on the Company's restrictive NK cell engager (TriKE™) innovation stage is satisfied to report the introduction of extra interval information results for the Company's lead therapeutic competitor, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).
Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, introduced extra clinical data results with the treatment with HR-MDS persistent #7 of its TriKE™ GTB-3550 during the Q&A meeting following her introduction at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "Our clinical data demonstrates that our proprietary TriKE™ (CD16/IL15/CD33), safely activated and harnessed the patient's native NK cell's cancer killing ability in a target-directed fashion without side effects. Which is not the case with highly expensive and intrusive supplemental NK cell therapies. We look forward to progressing to the next level."
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.
CELL AND GENE THERAPY
Moderna, Aldevron | May 25, 2021
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Aldevron, LLC, the leading provider of high-quality plasmid DNA, mRNA, and recombinant proteins used for vaccines, gene and cell therapy, gene editing, and diagnostic applications, have announced an expanded collaboration in support of the Moderna COVID-19 Vaccine and additional programs in mRNA therapeutics and vaccines.
Aldevron will specifically provide plasmid DNA to act as the genetic template for the COVID-19 mRNA vaccine and other investigational programs in Moderna's pipeline.
“Aldevron has been a long-standing Moderna partner. We value their cooperation and expertise in the biologics space,” said Juan Andres, Moderna's Chief Technical Operations and Quality Officer. “We are looking to continue our work in this extended partnership.”
“Aldevron's support for the Moderna pipeline spans nearly a decade, and we're incredibly proud of the trust they've got in us,” said Kevin Ballinger, Aldevron's Chief Executive Officer. “Our extensive experience, combined with improved operational efficiencies and recent capacity expansion, puts us in an excellent position to support Moderna's efforts – especially at this critical stage. We look forward to extending our strategic partnership in the future to serve a pipeline of important new programs.”
Aldevron's DNA production continues in its 70,000 square foot GMP facility in Fargo, North Dakota. The design and validation of an additional 189,000 sq ft expansion to Aldevron's 14-acre Breakthrough Campus's GMP facility have been completed, allowing for increased production capability.
Aldevron is a world-class manufacturing partner in the area of genetic medicine. Michael Chambers and John Ballantyne founded the company in 1998, and it offers essential nucleic acids and proteins used in gene and cell therapies, DNA and RNA vaccines, and gene editing technologies. Aldevron's 600 employees assist thousands of scientists who are working to develop revolutionary treatments for millions of people.
Moderna has evolved from a science research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant. Moderna maintains partnerships with a wide range of domestic & global government and commercial collaborators, allowing for the pursuit of both groundbreaking science and accelerated manufacturing scaling. Recently, Moderna's capabilities came together to allow the authorized use of one of the earliest and most effective COVID-19 vaccines.