Medical, Industry Outlook
PRNewswire | July 31, 2023
TriRx Pharmaceutical Services, LLC, a Contract Development and Manufacturing Organization (CDMO), welcomed the UK Government's recent announcement on England's second Investment Zone, focused on Life Sciences in the Liverpool City Region.
TriRx Speke Ltd. is the first investor and is well-positioned to further advance its capabilities by adding upstream technologies to manufacture monoclonal antibodies to an existing large-scale biotech purification facility. The current facility has significant capacity to support the high-growth large-molecule pharmaceutical market. Monoclonal antibodies (also referred to as mAbs) are a type of immunotherapy that work by blocking certain diseases from affecting healthy cells and are used to treat numerous types of diseases including cancers, arthritis and skin conditions. This additional investment to augment the TriRx facility at Speke will foster economic growth, create high-value jobs and complement the existing Speke Biopharmaceutical cluster in the region.
"We are delighted to be expanding our capability in this critical immunotherapy area, to become a worldwide center of technical excellence located in the UK in the monoclonal antibody development and manufacturing field to serve the human and animal pharmaceutical markets," said Tim Tyson, Chairman and CEO of TriRx.
About TriRx Pharmaceutical Services
TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving global pharmaceutical, biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs.
MedTech, Industry Outlook
Globenewswire | July 18, 2023
Vaxxinity, Inc. a U.S. company pioneering the development of a new class of medicines, announced new data from a Phase 1 clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson’s disease (PD), UB-312, slows seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays. These data signify that UB-312 has established clear target engagement in PD patient CSF, and provides further validation of Vaxxinity’s platform technology in neurodegenerative disease.
“This is a major milestone for Vaxxinity in our quest to help Parkinson’s patients. Our candidate has shown target engagement of the toxic species of alpha-synuclein in patients, demonstrating not only proof of our technology platform, but also proof of the mechanism of our vaccine-derived antibodies specifically engaging with the toxic target in vivo,” said Mei Mei Hu, CEO of Vaxxinity. “Showing target engagement has always been a key challenge to overcome in neurodegeneration, and is of critical importance when demonstrated – a milestone worth celebrating. It is beyond our expectation to see this in our Phase 1 trial. We are endlessly grateful to the patients who participated, and to The Michael J. Fox Foundation and our collaborators for their work on these cutting-edge assays that supported this breakthrough.”
UB-312 is designed to target aggregated forms of aSyn, the toxic species that underlies Parkinson’s disease and other synucleinopathies. Last month, Vaxxinity announced clinical data from Part B of its Phase 1 clinical trial of UB-312 demonstrating that UB-312 was well-tolerated and induced anti-aSyn antibody responses in participants with early PD, and that antibodies were detectable in the CSF. As part of this trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients, and to conduct exploratory research to characterize the anti-aSyn antibodies produced after UB-312 administration and assess target engagement.
Analyses from this and related research yielded insights about the pharmacodynamic effects of anti-aSyn antibodies generated by UB-312 in the Phase 1 trial.
UB-312-derived antibodies show preferential binding to aggregated aSyn isolated from patients with PD and Multiple System Atrophy (MSA), as measured by dot blot. Preclinical data published in Alzheimer’s Research & Therapy in 2020 showed similar characteristics of UB-312-derived antibodies.
UB-312-derived antibodies successfully demonstrate inhibition of aggregation of aSyn in both a seed amplification assay (SAA) and a protein misfolding cyclic amplification assay (PMCA). These techniques can potentially be used to identify people with PD, and also to measure the treatment response and pharmacodynamic properties of UB-312-derived antibodies from subjects in clinical trials.
Importantly, aSyn aggregation was slowed down in CSF samples from PD patients who received UB-312, as compared to those who received placebo, in the Phase 1 trial.
Vaxxinity plans to continue analyses of the clinical data as part of the collaborative project with MJFF, in addition to completing other target engagement assays and additional antibody characterization studies for binding kinetics and specificity. Mark Frasier, Ph.D., Chief Scientific Officer of MJFF, commented, “Integration of critical biomarker insight into therapeutic development programs is essential for building confidence in the treatment approach, and for designing informative trials. We’re pleased to support efforts of this kind that can have major impact for people with Parkinson’s disease.”
About Parkinson’s Disease
Parkinson’s disease (PD) affects approximately one million people in the United States and more than 10 million people worldwide. PD is a chronic and progressive neurodegenerative disorder that affects predominately dopamine-producing (“dopaminergic”) neurons in the substantia nigra area of the brain. While today’s approved products are aimed at providing symptomatic relief, they often produce significant side effects and lose their beneficial effects over time. There are no currently approved disease-modifying therapeutics for PD. Alpha-synuclein (aSyn) is a protein highly expressed in neurons, mostly at presynaptic terminals, suggesting a role in synaptic vesicle trafficking, synaptic functions and in regulation of neurotransmitter release at the synapse. Mutations in the gene encoding aSyn are known to cause or increase the risk of developing PD or dementia with Lewy bodies (DLB) and have been shown to alter the secondary structure of aSyn, resulting in misfolded and aggregated forms of the protein (i.e., pathological forms). While mutations in the aSyn gene are rare, aggregates of aSyn in the form of Lewy bodies (LB) and Lewy neurites are common neuropathological hallmarks of both familial and sporadic PD, suggesting a key role of aSyn in PD neuropathogenesis. Immunotherapy approaches targeting aSyn have been shown to ameliorate aSyn pathology as well as functional deficits in mouse models of PD and are now being investigated in the clinic.
UB-312 is a vaccine candidate targeting pathological forms of alpha-synuclein (aSyn) for the disease-modifying treatment and prevention of Parkinson’s disease (PD) and other synucleinopathies. Preclinical data indicated that UB-312 elicits antibodies that preferentially recognize pathological forms of aSyn, and improve motor performance in mouse models of synucleinopathies. Clinical data from the Phase 1 trial indicate that UB-312 elicits antibodies that target aggregated aSyn, and that these antibodies slow the aggregation of alpha-synuclein in the cerebrospinal fluid of patients with PD. The European Medical Agency has granted UB-312 orphan designation for multiple system atrophy.
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of medicines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel synthetic peptide immunotherapy candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s disease, Parkinson’s disease, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.
Medical, Industry Outlook
PRNewswire | July 19, 2023
BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced today that it has acquired PrecisionMed, LLC, a leading supplier of high-quality human biological material for genetics, drug discovery, and biomarker research and in vitro diagnostics.
Based in Carlsbad, CA, PrecisionMed has been collecting biospecimens for neurology and oncology research for more than 27 years, and it has the largest private, global repository of longitudinally collected human CSF for scientific research. Its collection contains both normal and diseased CSF samples together with other matched biofluids, such as plasma, sera, and whole blood.
"We are thrilled to announce BioIVT's acquisition of PrecisionMed. Our vision is to lead the biospecimen industry through expertise and innovation and our acquisition of PrecisionMed pushes us even closer to this goal. We are excited about the possibilities that lie ahead as we expand our supply network and inventory and strengthen our capacity to meet the increasing customer demand for CSF and liquid biopsy products. Together, we will drive even greater value for our customers and further our mission of enabling smarter science," said BioIVT Chief Executive Officer Richard Haigh, PhD.
"The vision at PrecisionMed has always been centered around positively impacting patients' lives through fueling innovation and scientific discovery. We have long viewed BioIVT as the gold standard in our industry with the track record and global reach to back that up. This partnership magnifies our collective ability to reach the research community and impact patient lives. We are proud to pair our talent and resources with the world-class team at BioIVT," said PrecisionMed CEO Eric Leach.
PrecisionMed's regulatory-compliant and privacy-protected biorepository contains more than 170,000 samples of CSF, whole blood, serum, plasma, PBMCs, and urine collected under Institutional Review Board-approved clinical protocols. This extensive collection of high-quality, well annotated biospecimens was amassed from PrecisionMed's sizable network of donors and collection sites. Each biospecimen includes detailed clinical data, such as the donor's diagnosis, demographics, family medical histories, treatment responses, and disease progression.
Underscoring the value of its contributions, PrecisionMed has received more than 120 citations in scientific journals and its collections have been part of U.S. NIH grants and have formed the basis of U.S. FDA submissions and subsequent U.S. FDA clearance for diagnostics.
Looking ahead, PrecisionMed will continue to operate out of its current headquarters and maintain its existing network of donor and collection sites. Financial details about this transaction were not disclosed.
About PrecisionMed, LLC.
PrecisionMed is a leading supplier of high-quality human biological material for research, and it is the largest private global source of longitudinally collected human cerebrospinal fluid (CSF) from living normal controls and diseased populations. Since 1996, its accurately annotated human biological samples have been utilized by more than 600 pharmaceutical and biotechnology companies, and academic research organizations worldwide.
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. Recognized as an industry leader, BioIVT specializes in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. By combining technical expertise and exceptional customer service with unmatched access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.