PRNewswire. | July 03, 2023
Cresilon, Inc. a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for Cresilon Hemostatic Gel™ ("CHG™").
This marks Cresilon's first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company's global mission to transform wound care.
CHG™ utilizes Cresilon's proprietary hemostatic gel technology that rapidly controls bleeding when applied to a wound ‒ without the need for manual pressure. In addition to its versatility, the plant-based gel is easy-to-use and works instantaneously to both stop and control bleeding at the point of care
"The combination of these unique attributes will allow our technology to fill a critical unmet medical need while creating a significant and positive impact in helping to save lives and dramatically improving the standard of care in wound treatment." said Cresilon CEO and Co-Founder Joe Landolina. "The FDA clearance sets the predicate for our advanced technology and marks Cresilon's first step towards actualizing our long-term goal of expanding our technology within the broader human health market."
CHG leverages Cresilon's in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only. As the first product in the Cresilon portfolio approved for human use, CHG is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. For additional important safety information, please see the CHG Instructions For Use.
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives.
PRNewswire | August 04, 2023
BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures, today announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics.
"Tregs play a crucial role in maintaining balance in the body's immune system and controlling excessive immune reactions," said Stefan Irion, MD, Chief Scientific Officer of BlueRock Therapeutics. "iPSC-derived Treg based therapies have the potential to treat a broad range of autoimmune and inflammatory disorders, and we look forward to collaborating with the bit.bio team to explore how their opti-ox cell programming technology can accelerate our efforts to discover and manufacture Tregs from iPSCs."
"We are delighted to partner with the team at BlueRock, who are world-leaders in iPSC-derived cell therapies, and together address the significant unmet needs of these patients." said Mark Kotter, MD PhD, CEO of bit.bio. "Today's announcement marks an important milestone for bit.bio. As well as providing significant financial contributions, our collaboration is a testament to the unique capabilities of bit.bio's team."
Under the terms of the agreement, bit.bio will use its machine learning powered discovery platform to identify transcription factor (TF) combinations for reprogramming iPSCs into Tregs. The agreement also includes options for BlueRock to license bit.bio's opti-ox precision cell programming technology to control the expression of TF combinations within Treg cell therapies. opti-ox uses a dual genomic safe harbour approach to cell programming, and bit.bio uses opti-ox to drive the rapid TF-mediated conversion of iPSCs into highly defined cell types in a single step. This can be achieved within days and at industrial scale, while maintaining exceptional purity and unparalleled consistency.
BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from the collaboration. bit.bio receives an upfront payment and is eligible to receive milestone payments and royalties on worldwide sales of all therapies resulting from the collaboration.
About BlueRock Therapeutics
BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics’ cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology, and immunology indications.
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.